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- James Larkin (London, United Kingdom)
- Rodabe Amaria (Houston, United States of America)
LBA43 - Spartalizumab plus dabrafenib and trametinib (Sparta-DabTram) in patients (pts) with previously untreated BRAF V600–mutant unresectable or metastatic melanoma: Results from the randomized part 3 of the phase III COMBI-i trial
- Paul Nathan (Northwood, Middlesex, United Kingdom)
Abstract
Background
Treatment (tx) with immune checkpoint inhibitors + targeted therapy may induce durable and deeper responses in a higher proportion of pts. Results from the safety run-in (part 1) and biomarker cohort (part 2) of COMBI-i (NCT02967692) have been previously reported. Part 3 is a global, placebo (PBO)-controlled, double-blind, Phase III study evaluating the anti -PD-1 antibody Sparta + Dab and Tram in pts with previously untreated BRAF V600 -mutant unresectable or metastatic melanoma. Here we report the primary analysis for part 3 of COMBI-i.
Methods
Pts were randomized 1:1 to receive Sparta 400 mg IV Q4W + Dab 150 mg orally BID + Tram 2 mg orally QD vs PBO-DabTram. The statistical plan ensured 80% power assuming a 5-month tx delay. The primary endpoint is investigator-assessed progression-free survival (PFS) using RECIST 1.1; significance threshold was P < .025 [equivalent HR < 0.801]. Overall survival (OS) is a key secondary endpoint.
Results
532 pts were randomized to receive Sparta-DabTram (n = 267) or PBO-DabTram (n = 265). At the data cutoff (July 1, 2020), median follow-up was 27.2 mo. Baseline characteristics were balanced across tx arms. Sparta-DabTram did not significantly improve PFS vs PBO (median PFS, 16.2 mo vs 12.0 mo; HR, 0.82 [95% CI, 0.655-1.027]; P = .042). Estimated 12- and 24-mo PFS rates with Sparta-DabTram vs PBO were 58% vs 50% and 44% vs 36%, respectively. While OS was not formally tested, median OS was not reached (NR) across tx arms (HR, 0.785). The objective response rate was 69% in the Sparta-DabTram arm (complete response rate [CRR], 20%) vs 64% in the PBO arm (CRR, 18%); median duration of response was NR vs 20.7 mo, respectively. Tx-related adverse events (TRAEs) grade ≥ 3 occurred in 55% vs 33% of pts treated with Sparta-DabTram vs PBO. TRAEs leading to discontinuation of all 3 study drugs occurred in 12% vs 8% of pts, respectively.
Conclusions
The primary endpoint was not met. Sparta-DabTram did not significantly improve PFS vs PBO-DabTram; analyses interrogating OS benefit are ongoing. AE management was challenging and resulted in frequent dose adaptations.
Clinical trial identification
NCT02967692; conducted in accordance with Study Protocol CPDR001F2301.
Editorial acknowledgement
Medical editorial assistance was provided by Michael Demars, PhD, and Allison Lytle, PhD, from ArticulateScience LLC and funded by Novartis Pharmaceuticals Corporation (East Hanover, NJ).
Legal entity responsible for the study
Novartis Pharmaceuticals Corporation.
Funding
Novartis Pharmaceuticals Corporation.
Disclosure
P. Nathan: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Immunocore; Honoraria (self), Advisory/Consultancy: 4SC. R. Dummer: Advisory/Consultancy: Novartis; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Roche; Advisory/Consultancy: Amgen; Advisory/Consultancy: Takeda; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Sun Pharma; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Catalym; Advisory/Consultancy: Second Genome; Advisory/Consultancy: Regeneron; Advisory/Consultancy: Alligator. G.V. Long: Advisory/Consultancy: Aduro; Advisory/Consultancy: Amgen; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Mass-Array; Advisory/Consultancy: Merck; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: OncoSec Medical; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Roche; Advisory/Consultancy: Sandoz. P.A. Ascierto: Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Roche-Genentech; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy, Research grant/Funding (institution): Array; Advisory/Consultancy: Merck Serono; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Incyte; Advisory/Consultancy: NewLink Genetics; Advisory/Consultancy: Genmad; Advisory/Consultancy: Medimmune; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Syndax; Advisory/Consultancy: Sun Pharma; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Idera; Advisory/Consultancy: Ultimovacs; Advisory/Consultancy: Sandoz; Advisory/Consultancy: Immunocore; Advisory/Consultancy: 4SC; Shareholder/Stockholder/Stock options: PrimeVax; Advisory/Consultancy: Alkermes; Advisory/Consultancy: Italfarmaco; Advisory/Consultancy: Nektar; Advisory/Consultancy: Boehringer-Ingelheim; Leadership role: Fondazione Melanoma; Leadership role: Campania Society of ImmunoTherapy of Cancer; Leadership role: Society of Melanoma Research; Leadership role: Cancer Development Drug Forum; Leadership role: Society of Immuno Therapy of Cancer. H.A. Tawbi: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck; Honoraria (self), Advisory/Consultancy: Array; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): GlaxoSmithKline. C. Robert: Honoraria (self), Advisory/Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Pierre Fabre; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self), Advisory/Consultancy: Biothera. P. Rutkowski: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self): Roche; Honoraria (self), Speaker Bureau/Expert testimony: Pierre Fabre; Honoraria (self): Amgen; Honoraria (self): Blueprint Medicines; Honoraria (self): Eli Lilly; Speaker Bureau/Expert testimony: Pfizer. C. Dutriaux: Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Pierre Fabre; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck. M. Mandala': Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Sanofi. P. Lorigan: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pierre Fabre; Advisory/Consultancy: Amgen; Non-remunerated activity/ies: Roche; Advisory/Consultancy: NeraCare GmbH. P.F. Ferrucci: Advisory/Consultancy: Roche; Advisory/Consultancy: Novartis; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Pierre Fabre. K.T. Flaherty: Officer/Board of Directors: Clovis Oncology; Officer/Board of Directors: Strata Oncology; Officer/Board of Directors: Vivid Biosciences; Officer/Board of Directors: Checkmate Pharmaceuticals; Advisory/Consultancy: X4 Pharmaceuticials; Advisory/Consultancy: PIC Therapeautics; Advisory/Consultancy, Research grant/Funding (institution): Sanofi; Advisory/Consultancy: Amgen; Advisory/Consultancy: Asana BioSciences; Advisory/Consultancy: Adaptimmune; Advisory/Consultancy: Fount Therapeutics; Advisory/Consultancy: Aeglea BioTherapeutics; Advisory/Consultancy: Shattuck Labs; Advisory/Consultancy: Tolero Pharmaceuticals; Advisory/Consultancy: Apricity Therapeutics; Advisory/Consultancy: Oncoceutics; Advisory/Consultancy: FogPharma; Advisory/Consultancy: Neon Therapeutics; Advisory/Consultancy: Tvardi Therapeutics; Advisory/Consultancy: xCures; Advisory/Consultancy: Monopteros Therapeutics; Advisory/Consultancy: Vibliome Therapeutics; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy: Genentech; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Merck; Advisory/Consultancy: Takeda; Advisory/Consultancy: Verastem Oncology; Advisory/Consultancy: Boston Biomedical; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Debiopharm. J.C. Brase: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis. S. Green: Full/Part-time employment: Novartis. T. Haas: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis. A. Masood: Full/Part-time employment: Novartis. E. Gasal: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis. A. Ribas: Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Chugai; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self), Advisory/Consultancy: Compugen; Honoraria (self), Advisory/Consultancy: CytomX Therapeutics; Honoraria (self), Advisory/Consultancy: Highlight Therapeutics; Honoraria (self), Advisory/Consultancy: ImaginAb; Honoraria (self), Advisory/Consultancy: Isoplexis; Honoraria (self), Advisory/Consultancy: Merus; Honoraria (self), Advisory/Consultancy: RAPT Therapeutics; Honoraria (self), Advisory/Consultancy: Rgenix; Honoraria (self), Advisory/Consultancy: Tango Therapeutics; Honoraria (self), Advisory/Consultancy, Officer/Board of Directors: Arcus Biosciences; Honoraria (self), Advisory/Consultancy, Officer/Board of Directors: Lutris Pharma; Honoraria (self), Advisory/Consultancy, Officer/Board of Directors: PACT Pharma. D. Schadendorf: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Sharp & Dohme ; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Sanofi; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Regeneron; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Pierre Fabre; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Array; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Genentech; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Merck EMR; Advisory/Consultancy: Immunocore; Honoraria (institution), Advisory/Consultancy: Nektar; Honoraria (self), Advisory/Consultancy: 4SC. All other authors have declared no conflicts of interest.
LBA44 - Lenvatinib (len) plus pembrolizumab (pembro) for advanced melanoma (MEL) that progressed on a PD-1 or PD-L1 inhibitor: Initial results of LEAP-004
- Ana Maria Arance Fernandez (Barcelona, Spain)
Abstract
Background
Identification of safe and effective treatment options for MEL that progressed on anti–PD-1-based therapy is a large unmet need. The open-label, single-arm, phase 2 LEAP-004 study (NCT03776136) evaluates the combination of len (multikinase inhibitor) and pembro (anti–PD-1) in this population.
Methods
Eligible pts had unresectable stage III-IV MEL, PD confirmed per iRECIST within 12 wk of the last dose of a PD-1/L1 inhibitor given alone or with anti–CTLA-4 or other therapies for ≥2 doses, measurable disease, and ECOG PS 0/1. Pts received len 20 mg/d PO QD + ≤35 doses of pembro 200 mg IV Q3W until PD or unacceptable toxicity; eligible pts could be treated beyond PD. Imaging is done Q9W through wk 54, Q12W through wk 102, and Q24W thereafter. Primary end point is ORR per RECIST v1.1 by blinded independent central review (BICR). Secondary end points are PFS and DOR per RECIST v1.1 by BICR, OS, and safety.
Results
From Feb to Sep 2019, 103 pts were enrolled and treated; median age was 63 y, 67.0% had stage M1c/M1d disease, 55.3% had LDH >ULN (20.4% ≥2 × ULN), and 36.9% had BRAFV600 mutation. 61.2% received ≥2 prior therapies for MEL, 32.0% received prior BRAF ± MEK inhibition, and 28.2% had PD on prior anti–PD-1/L1 + anti–CTLA-4. Median study follow-up was 12.0 mo (range 8.7-15.6). Confirmed ORR by BICR was 21.4% (95% CI 13.9-30.5; 2 CRs, 20 PRs) overall and 31.0% (15.3-50.8; 1 CR, 8 PRs) for pts with PD on prior anti–PD-1/L1 + anti–CTLA-4. DCR was 65.0%. Median DOR was 6.3 mo (range 2.1+-11.1+); KM estimate of DOR ≥6 mo was 72.6%. Median (95% CI) PFS and OS were 4.2 mo (3.5-6.3) and 13.9 mo (95% CI 10.8-NR). 9-mo PFS and OS estimates were 26.2% and 65.4%. Most common treatment-related AEs (TRAEs) were hypertension (56.3%), diarrhea (35.9%), and nausea (34.0%). TRAEs were gr 3-5 in 44.7%, gr 5 in 1.0%, and led to discontinuation of len and/or pembro in 7.8%.
Conclusions
The combination of len and pembro has activity in pts with advanced MEL with confirmed progression on a PD-1/L1 inhibitor, including those with PD on combined anti–PD-1/L1 + anti–CTLA-4. The safety profile was consistent with prior studies. These data support len + pembro as a potential regimen for this population of high unmet need.
Clinical trial identification
NCT03776136, originally posted on December 14, 2018.
Editorial acknowledgement
Melanie Leiby of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Legal entity responsible for the study
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Funding
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Disclosure
A.M. Arance Fernandez: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pierre-Fabre; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Research grant/Funding (institution): Eisai Ltd. S.J. O'Day: Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.; Research grant/Funding (institution): Eisai Ltd.; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Agenus; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Biothera; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: ImaginAb; Honoraria (self), Advisory/Consultancy: RadImmune; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Exicure; Research grant/Funding (institution): Genocea; Research grant/Funding (institution): Incyte; Research grant/Funding (institution): Oncotherapeutics; Research grant/Funding (institution): Ultimovacs; Research grant/Funding (institution): Viralytics; Travel/Accommodation/Expenses: Caris MPI. L. de la Cruz Merino: Advisory/Consultancy: Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy: Amgen; Research grant/Funding (institution): Eisai Ltd.; Research grant/Funding (institution): Celgene. T. Petrella: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Novartis; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self), Advisory/Consultancy: Pfizer; Research grant/Funding (self): Roche; Research grant/Funding (institution): Eisai Ltd. R. Jamal: Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution): Bristol Myers Squibb; Advisory/Consultancy, unpaid: Merck; Research grant/Funding (institution): Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.; Research grant/Funding (institution): Eisai Ltd.; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Evelo Biosciences; Research grant/Funding (institution): Astellas; Research grant/Funding (institution): MedImmune; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Roche/Genentech; Non-remunerated activity/ies: Conferences and advisory/consultancy. L. Ny: Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Pierre-Fabré; Advisory/Consultancy: Sanofi; Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Leo Pharma; Research grant/Funding (institution): Syndax Pharmaceuticals; Research grant/Funding (institution): Eisai Ltd. A. Carneiro: Research grant/Funding (institution): MSD; Research grant/Funding (institution): Eisai Ltd. A. Berrocal: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pierre Fabre; Advisory/Consultancy, Speaker Bureau/Expert testimony: Sanofi; Research grant/Funding (institution): Eisai Ltd. I. Márquez-Rodas: Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Pierre Fabre; Advisory/Consultancy: GSK; Advisory/Consultancy: Amgen; Advisory/Consultancy: Incyte; Advisory/Consultancy: Regeneron; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: Bioncotech; Research grant/Funding (institution): Eisai Ltd. A. Spreafico: Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy: Oncorus; Advisory/Consultancy: Janssen; Research grant/Funding (institution): Symphogen; Research grant/Funding (institution): AstraZeneca/MedImmune; Research grant/Funding (institution): Surface Oncology; Research grant/Funding (institution): Eisai Ltd.; Research grant/Funding (institution): Northern Biologics; Research grant/Funding (institution): Janssen Oncology/Johnson & Johnson; Research grant/Funding (institution): Roche; Research grant/Funding (institution): Regeneron; Research grant/Funding (institution): Alkermes; Research grant/Funding (institution): Array Biopharma; Research grant/Funding (institution): GSK; Research grant/Funding (institution): Bayer. V. Victoria Atkinson: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck; Honoraria (self), Advisory/Consultancy: Pierre Fabre; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Nektar; Research grant/Funding (institution): Eisai Ltd. F. Costa Svedman: Research grant/Funding (institution): MSD; Research grant/Funding (institution): Eisai Ltd. A.D. Smith: Full/Part-time employment: Eisai Ltd. K. Chen: Full/Part-time employment: Merck & Co., Inc. S.J. Diede, C. Krepler: Shareholder/Stockholder/Stock options, Full/Part-time employment: Merck & Co., Inc. G.V. Long: Advisory/Consultancy: Aduro; Advisory/Consultancy: Amgen; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Highlight Therapeutics S.L.; Advisory/Consultancy: Mass-Array; Advisory/Consultancy: Merck; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: OncoSec Medical; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Roche; Advisory/Consultancy: QBiotics; Advisory/Consultancy: Skyline DX; Advisory/Consultancy: Sandoz; Research grant/Funding (institution): Eisai Ltd.
LBA45 - First report of efficacy and safety from the phase II study SECOMBIT (SEquential COMBo Immuno and Targeted therapy study)
- Paolo A. Ascierto (Napoli, Italy)
Abstract
Background
Treatment of
Methods
From Nov 2016 to May 2019, n.251 patients with untreated, metastatic
Results
69 patients were treated in arm A, 71 in arm B and 69 in arm C. At a median follow-up of 17.5 months (IQR 10.2-23.4– d.b.lock July 2020), we report preliminary data of PFS, ORR and safety. mPFS was 15.8 months in Arm A, 7.2 months in Arm B, and 11.4 months in Arm C. In the 3 Arms 1-year PFS was 60%, 43% and 46% and 2-year PFS was 35%, 38% and 39% respectively. ORR was 82.6% (CR 21.7%) in Arm A, 45.1% (CR 15.5%) in Arm B and 78.3% (CR 29.0%) in Arm C. G3/4 toxicity was 49% in Arm A, 73% in Arm B and 51% in Arm C, while G.3/4 treatment-related adverse events were 28%, 54% and 32%. 18 pts were discontinued due to adverse events, 7 in Arm A, 8 in Arm B and 3 in Arm C.
Conclusions
At a minimum follow up of 1 year, our data confirm what reported in the pivotal studies. Despite the difference in term of mPFS, the 2-yrs PFS rate is similar among the different arms. The study is still ongoing for the completion of the main endpoint (OS).
Clinical trial identification
NCT02631447.
Legal entity responsible for the study
Fondazione Melanoma Onlus.
Funding
Bristol Myers Squibb and Array Biopharma.
Disclosure
P.A. Ascierto: Advisory/Consultancy, Research grant/Funding (institution): Bristol Myers-Squibb; Advisory/Consultancy, Research grant/Funding (institution): Roche-Genentech; Advisory/Consultancy, Research grant/Funding (institution): Array; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Merck Serono; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Incyte; Advisory/Consultancy: Newlink Genetics; Advisory/Consultancy: Genmab; Advisory/Consultancy: MedImmune; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Syndax; Advisory/Consultancy: SunPharma; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Idera; Advisory/Consultancy: Ultimovacs; Advisory/Consultancy: Sandoz; Advisory/Consultancy: Immunocore; Advisory/Consultancy: 4SC; Advisory/Consultancy: Alkermes; Advisory/Consultancy: Italfarmaco; Advisory/Consultancy: Nektar; Advisory/Consultancy: Boehringer-Ingelheim. M. Mandala: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Roche; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Merck Serono. P.F. Ferrucci: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Roche-Genentech; Advisory/Consultancy: Pierre Fabre. P. Rutkowski: Honoraria (self), Advisory/Consultancy: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Pierre Fabre; Honoraria (self), Advisory/Consultancy: Blueprint Medicines; Honoraria (self), Advisory/Consultancy: Eli Lilly; Honoraria (self), Advisory/Consultancy: Amgen. M. Guidoboni: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Novartis; Research grant/Funding (institution): Merck Sharp & Dohme. A.M. Arance Fernandez: Advisory/Consultancy, Speaker Bureau/Expert testimony: Pierre Fabre; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck Sharp & Dohme; Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck Serono; Advisory/Consultancy, Speaker Bureau/Expert testimony: Sanofi; Advisory/Consultancy, Speaker Bureau/Expert testimony: Amgen. V. Ferraresi: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre. E. Maiello: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Servier; Advisory/Consultancy: Sanofi Genzyme; Advisory/Consultancy: Roche; Advisory/Consultancy: Merck; Advisory/Consultancy: Eisai; Advisory/Consultancy: Pfizer. M. Guida: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre. M. Del Vecchio: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Sanofi. M.T. Fierro: Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pierre Fabre. P. Queirolo: Advisory/Consultancy: Roche; Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Merck; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Sun Pharma; Advisory/Consultancy: Sanofi. C. Lebbé: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self): Pierre Fabre; Honoraria (self), Advisory/Consultancy: Merck Serono; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self): Pfizer; Honoraria (self): Incyte. I. Melero: Honoraria (self), Advisory/Consultancy, Part of AstraZeneca partners of choice: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Part of BMS I-ON consortium: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Bioncotech; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Alligator; Honoraria (self): Numab; Honoraria (self), Advisory/Consultancy: F-Star; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Part of Roche imCORE: Roche; Honoraria (self): Bayer; Honoraria (self), Research grant/Funding (self): Merck Serono; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self): Boston Pharmaceuticals; Honoraria (self): Servier; Research grant/Funding (self): Palo Biopharma. G. Palmieri: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Incyte; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Roche Genentech. A.M. Grimaldi: Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self): Roche; Travel/Accommodation/Expenses: Sun Pharma; Travel/Accommodation/Expenses: Pierre Fabre; Honoraria (self), Travel/Accommodation/Expenses: Merck Serono. R. Dummer: Advisory/Consultancy, Project focused consulting: Novartis; Advisory/Consultancy, Project focused consulting: Merck Sharp & Dohme; Honoraria (institution), Project focused consulting: Bristol Myers Squibb; Advisory/Consultancy, Project focused consulting: Roche; Advisory/Consultancy, Project focused consulting: Amgen; Advisory/Consultancy, Project focused consulting: Takeda; Advisory/Consultancy, Project focused consulting: Pierre Fabre; Advisory/Consultancy, Project focused consulting: Sun Pharma; Advisory/Consultancy, Project focused consulting: Sanofi; Advisory/Consultancy, Project focused consulting: Catalym; Advisory/Consultancy, Project focused consulting: Second Genome; Advisory/Consultancy, Project focused consulting: Regeneron; Advisory/Consultancy, Project focused consulting: Alligator. V. Chiarion Sileni: Speaker Bureau/Expert testimony: Novartis; Travel/Accommodation/Expenses: Bristol Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses: Pierre Fabre; Speaker Bureau/Expert testimony: Merck Sharp & Dohme. All other authors have declared no conflicts of interest.
Invited Discussant LBA43, LBA44 and LBA45
- Bartosz Chmielowski (Los Angeles, United States of America)
Q&A and live discussion
- James Larkin (London, United Kingdom)
LBA46 - Pembrolizumab versus placebo after complete resection of high-risk stage III melanoma: Final results regarding distant metastasis-free survival from the EORTC 1325-MG/Keynote 054 double-blinded phase III trial
- Alexander M. Eggermont (Utrecht, Netherlands)
Abstract
Background
We conducted the randomized phase III double-blind EORTC 1325/KEYNOTE-054 trial to evaluate pembrolizumab vs placebo in patients (pts) with resected high-risk stage III melanoma. At a 1.25-year (yr) median follow-up, pembrolizumab improved recurrence-free survival (RFS) (hazard ratio [HR] 0.57, P<0.0001) as compared to placebo (Eggermont, NEJM 2018). This led to the approval of pembrolizumab adjuvant treatment by EMA and FDA.
Methods
Eligible pts included those ≥18 yrs of age with complete resection of cutaneous melanoma metastatic to lymph node(s), classified as AJCC-7 stage IIIA (at least one lymph node metastasis >1 mm), IIIB or IIIC (without in-transit metastasis). Between Aug-2015 until Nov-2016, 1019 pts were randomized to pembrolizumab at a flat dose of 200 mg (N=514) or placebo (N=505) every 3 weeks for a total of 18 doses (∼1 year) or until disease recurrence or unacceptable toxicity. The 2 main co-primary endpoints were RFS in the intention-to-treat (ITT) overall population and in pts with PD-L1-positive tumors. Secondary endpoints included distant metastasis-free survival (DMFS) in these 2 respective populations. The final DMFS analysis was foreseen when approximately 423 DMFS events (distant metastases or deaths) are reported (∼87% power to detect a HR of 0.725 in the overall population).
Results
By April 2020, 418 DMFS events were reported. At 3.5 yr median follow-up, pembrolizumab compared with placebo significantly prolonged DMFS in the overall population (3.5-yr DMFS rate: 65.3% vs 49.4%; HR 0.60, 95% CI 0.49-0.73; P<0.0001) and in the PD-L1-positive tumor (N=853; HR 0.61; 95% CI 0.49-0.76; P<0.0001). The impact of pembrolizumab on DMFS was similar in pts with a PD-L1-negative tumor (N=116; HR 0.49, 99% CI 0.24-0.99) and in other subgroups, in particular according to AJCC-7 and -8 staging, and BRAF mutation status. The RFS improvement was confirmed (HR in the ITT population 0.59; 95% CI 0.49-0.70).
Conclusions
At 3.5-yr median follow-up, pembrolizumab adjuvant therapy provided a clinically meaningful improvement in DMFS in resected high-risk stage III melanoma pts.
Clinical trial identification
EudraCT: 2014-004944-37.
Legal entity responsible for the study
Merck & Co., Inc.
Funding
Merck & Co., Inc.
Disclosure
A.M.M. Eggermont: Honoraria (self): Biocad; Honoraria (self): BioInvent; Honoraria (self): BMS; Honoraria (self): Ellipses Pharma; Honoraria (self): GSK; Honoraria (self): HalioDx; Honoraria (self): IO Biotech; Honoraria (self): MedImmune; Honoraria (self): MSD; Honoraria (self): Nektar Therapeutics; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Regeneron Pharmaceuticals; Honoraria (self): Sanofi; Honoraria (self): Sallas Life Sciences. C.U. Blank: Honoraria (institution): MSD; Honoraria (institution): BMS; Honoraria (institution): Roche; Honoraria (institution): Novartis; Honoraria (institution): Pfizer; Honoraria (institution): Lilly; Honoraria (institution): GSK. M. Mandala': Advisory/Consultancy: BMS; Advisory/Consultancy: MSD; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy: Pierre Fabre; Research grant/Funding (institution): Genentech/Roche. G.V. Long: Honoraria (self): Aduro; Honoraria (self): Amgen; Honoraria (self): Array BioPharma; Honoraria (self): BMS; Honoraria (self): Merck; Honoraria (self): Novartis; Honoraria (self): OncoSec. V. Victoria Atkinson: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck Serano; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: OncoSec; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pierre Fabre; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche. S. Dalle: Shareholder/Stockholder/Stock options, Spouse/Financial dependant: Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Travel/Accommodation/Expenses: Pierre Fabre. A.M. Haydon: Honoraria (self): Merck. A. Meshcheryakov: Advisory/Consultancy: Lilly Pharma; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck; Advisory/Consultancy: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Travel/Accommodation/Expenses: Biocad; Travel/Accommodation/Expenses: Servier; Travel/Accommodation/Expenses: Merck Serono; Travel/Accommodation/Expenses: Lilly Pharma. A. Khattak: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MSD. M. Carlino: Honoraria (self): Amgen; Honoraria (self): BMS; Honoraria (self): Ideaya Biosciences; Honoraria (self): MSD; Honoraria (self): Novartis; Honoraria (self): Roche. S. Sandhu: Research grant/Funding (institution): Amgen; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): BMS; Research grant/Funding (institution): Endocyte; Research grant/Funding (institution): MSD. S. Puig Sarda: Advisory/Consultancy: Isdin; Advisory/Consultancy, Research grant/Funding (institution): Leo Pharma; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Almirall; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Sanofi; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bioderma; Speaker Bureau/Expert testimony: La Roche Posay; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: BMS; Speaker Bureau/Expert testimony: Pierre Fabre; Research grant/Funding (institution): Castle Bioscience; Research grant/Funding (institution): AMLO Bioscience; Research grant/Funding (institution): Melagenics. P.A. Ascierto: Advisory/Consultancy, Research grant/Funding (institution): BMS; Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy: MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: Amgen; Advisory/Consultancy, Research grant/Funding (institution): Array BioPharma; Advisory/Consultancy: Merck Serano; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Newlink Genetics; Advisory/Consultancy: Genmab; Advisory/Consultancy: Incyte; Advisory/Consultancy: MedImmune; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Syndax; Advisory/Consultancy: Sun Pharma; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Idera; Advisory/Consultancy: Ultimovacs; Advisory/Consultancy: Sandoz; Advisory/Consultancy: Immunocore; Advisory/Consultancy: 4SC; Advisory/Consultancy: Alkermes; Advisory/Consultancy: Italfarmaco. A.C.J. van Akkooi: Honoraria (institution), Research grant/Funding (institution): Amgen; Honoraria (institution), Research grant/Funding (institution): BMS; Honoraria (institution), Research grant/Funding (institution): Novartis; Honoraria (institution), Research grant/Funding (institution): MSD; Honoraria (institution), Research grant/Funding (institution): Pfizer; Honoraria (institution), Research grant/Funding (institution): Sanofi; Honoraria (institution), Research grant/Funding (institution): 4SC. C. Krepler: Shareholder/Stockholder/Stock options, Full/Part-time employment: Merck. N. Ibrahim: Shareholder/Stockholder/Stock options, Full/Part-time employment: Merck; Shareholder/Stockholder/Stock options: GSK. M. Kicinski: Research grant/Funding (institution): MSD. S. Suciu: Research grant/Funding (institution): MSD. C. Robert: Advisory/Consultancy: BMS; Advisory/Consultancy: MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: Roche; Advisory/Consultancy: Amgen; Advisory/Consultancy: Biothera; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: CureVac. All other authors have declared no conflicts of interest.
1076O - Adjuvant nivolumab (NIVO) vs ipilimumab (IPI) in resected stage III/IV melanoma: 4-y recurrence-free and overall survival (OS) results from CheckMate 238
- Jeffrey Weber (New York, NY, United States of America)
Abstract
Background
NIVO has shown improved recurrence-free survival (RFS) vs IPI in patients (pts) with resected stage III/IV melanoma in the phase III CheckMate 238 study. Updated 48-mo RFS and distant metastases-free survival (DMFS) and primary OS are presented.
Methods
Pts aged ≥ 15 y with completely resected stage IIIB/C or IV melanoma were stratified by stage and tumor programmed death ligand 1 (PD-L1) status and randomized 1:1 to NIVO (3 mg/kg Q2W; n = 453) or IPI (10 mg/kg Q3W for 4 doses, Q12W thereafter; n = 453) for ≤ 1 y or until disease recurrence/unacceptable toxicity. The primary endpoint was RFS. Secondary endpoints included OS and safety; DMFS in stage III disease was exploratory.
Results
At 48 mo of follow-up, NIVO continued to demonstrate superior RFS vs IPI (HR 0.71; 95% CI 0.60–0.86;
Conclusions
NIVO continued to demonstrate improved RFS and DMFS vs IPI at 48 mo in pts with stage III/IV melanoma at high risk of recurrence. OS events (n = 211) were lower than anticipated (n = 302). OS rates were similar to NIVO and IPI, although use of subsequent IO therapy was higher in the IPI arm. Late-emergent TRAEs were consistent with the established safety profile of NIVO and IPI, with more events reported with IPI. Data are HR (95% CI) for NIVO vs IPI; aStratified; b95.03% CI; cAJCC 7th ed.; Ind, indeterminate.
RFS DMFS OS ITT populationa 0.71 (0.60–0.86) 0.79 (0.63–0.99) 0.87 (0.66–1.14)b Stagec IIIB 0.70 (0.50–0.98) 0.78 (0.54–1.14) 0.88 (0.53–1.47) IIIC 0.74 (0.57–0.96) 0.82 (0.62–1.09) 0.96 (0.67–1.39) IV 0.74 (0.49–1.11) - 0.72 (0.38–1.38) PD-L1 ≥ 1% 0.68 (0.54–0.86) 0.77 (0.58–1.04) 0.73 (0.51–1.04) < 1%/ind 0.76 (0.57–1.02) 0.80 (0.56–1.14) 1.09 (0.72–1.67) ≥ 5% 0.67 (0.47–0.96) 0.79 (0.51–1.22) 0.74 (0.43–1.27) < 5%/ind 0.74 (0.59–0.91) 0.80 (0.61–1.04) 0.92 (0.68–1.26) Mutant 0.79 (0.60–1.05) 0.82 (0.57–1.16) 1.13 (0.73–1.74) Wild-type 0.69 (0.53–0.91) 0.79 (0.57–1.09) 0.76 (0.51–1.12)
Clinical trial identification
NCT02388906.
Editorial acknowledgement
Writing and editorial assistance were provided by Jessica Augello, PhD, and Michele Salernitano of Ashfield Healthcare Communications, funded by Bristol-Myers Squibb Company.
Legal entity responsible for the study
Bristol-Myers Squibb Company.
Funding
Bristol-Myers Squibb Company.
Disclosure
J. Weber: Honoraria (self), Advisory/Consultancy: Celldex; Honoraria (self), Advisory/Consultancy: Ichor Medical Systems; Honoraria (self), Advisory/Consultancy: cCam Biotherapeutics; Honoraria (self), Advisory/Consultancy: Lion Biotechnologies; Honoraria (self), Advisory/Consultancy: Pieris Pharmaceuticals; Honoraria (self), Advisory/Consultancy, Shareholder/Stockholder/Stock options: Altor BioScience; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): BMS; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Genentech; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): GSK; Honoraria (self), Advisory/Consultancy: Daiichi Sankyo; Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy: Eisai; Honoraria (self), Advisory/Consultancy, Shareholder/Stockholder/Stock options: CytomX Therapeutics; Honoraria (self), Advisory/Consultancy: Nektar; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Shareholder/Stockholder/Stock options: Biond; Honoraria (self): Medivation; Honoraria (self): Sellas Life Sciences; Honoraria (self): WindMIL; Research grant/Funding (institution): Astellas Pharma; Research grant/Funding (institution): Incyte; Licensing/Royalties, Named on patent submitted by Moffitt Cancer Center for an IPILIMUMAB biomarker issued: Moffitt Cancer Center; Licensing/Royalties, Named on a patent from Biodesix for a PD-1 antibody biomarker issued: Biodesix. M. Del Vecchio: Advisory/Consultancy: Novartis; Advisory/Consultancy: BMS; Advisory/Consultancy: Merck; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Pierre Fabre. M. Mandala: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Pierre Fabre; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche/Genentech; Honoraria (self), Advisory/Consultancy: MSD Oncology. H. Gogas: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (self): Novartis; Honoraria (self), Travel/Accommodation/Expenses: Pierre Fabre; Advisory/Consultancy: Amgen; Travel/Accommodation/Expenses: Roche. A.M. Arance Fernandez: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pierre Fabre; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Amgen. S. Dalle: Advisory/Consultancy, Research grant/Funding (institution): MDS; Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS; Research grant/Funding (institution): Roche; Research grant/Funding (institution): AstraZeneca; Spouse/Financial dependant, An immediate family member is employed by Sanofi Pasteur: Sanofi Pasteur. C.L. Cowey: Research grant/Funding (institution): BMS; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Regeneron; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Caudex; Research grant/Funding (institution): Array; Research grant/Funding (institution): Amgen. M. Schenker: Research grant/Funding (self), Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (self), Research grant/Funding (institution): MSD; Research grant/Funding (self), Research grant/Funding (institution): Roche; Research grant/Funding (self), Research grant/Funding (institution): AstraZeneca; Research grant/Funding (self), Research grant/Funding (institution): Novartis; Research grant/Funding (self), Research grant/Funding (institution): Eli Lilly; Research grant/Funding (self), Research grant/Funding (institution): AbbVie; Research grant/Funding (self), Research grant/Funding (institution): Regeneron; Research grant/Funding (self), Research grant/Funding (institution): Pfizer; Research grant/Funding (self), Research grant/Funding (institution): Merck Serono; Research grant/Funding (self), Research grant/Funding (institution): Mylan; Research grant/Funding (self), Research grant/Funding (institution): Samsung; Research grant/Funding (self), Research grant/Funding (institution): Gilead; Research grant/Funding (self), Research grant/Funding (institution): Amgen. J-J. Grob: Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy: Roche; Advisory/Consultancy: Amgen; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Merck; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Sanofi. V. Chiarion Sileni: Travel/Accommodation/Expenses: Bristol-Myers Squibb; Travel/Accommodation/Expenses: Pierre Fabre. I. Márquez-Rodas: Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Sharpe & Dohme; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Pierre Fabre; Advisory/Consultancy: Sanofi; Advisory/Consultancy: INCYTE; Advisory/Consultancy: Merck SERONO; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Bioncotech. M.O. Butler: Advisory/Consultancy: Merck & Co., Inc.; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Novartis; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Pfizer; Advisory/Consultancy, Leadership role, Safety Review Board Member: Adaptimmune; Advisory/Consultancy, Leadership role, Safety Review Board Member: GlaxoSmithKline. M. Maio: Honoraria (self), Advisory/Consultancy, Patient Fees to my institution: Bristol-Myers Squibb; Honoraria (institution), Advisory/Consultancy: AstraZeneca; Honoraria (institution), Advisory/Consultancy: Roche; Honoraria (institution), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (institution), Advisory/Consultancy: Merck Serono; Honoraria (institution), Advisory/Consultancy: GlaxoSmithKline; Honoraria (institution), Advisory/Consultancy: Incyte. M. Middleton: Advisory/Consultancy: Amgen; Honoraria (self), Research grant/Funding (institution): Roche; Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): GlaxoSmithKline; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Millennium; Research grant/Funding (institution), Travel/Accommodation/Expenses: Immunocore; Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, IDSMC: Merck/Merck Sharp & Dohme; Advisory/Consultancy, Research grant/Funding (institution): Rigontec (acquired by MSD); Research grant/Funding (institution): Regeneron; Advisory/Consultancy, Research grant/Funding (institution): BioLineRx; Advisory/Consultancy, Research grant/Funding (institution): Array Biopharma (now Pfizer)); Advisory/Consultancy: Kineta; Advisory/Consultancy: Silicon Therapeutics; Research grant/Funding (self), Travel/Accommodation/Expenses: Replimune. M. Lobo: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb; Shareholder/Stockholder/Stock options: Advaxis Immunotherapies. V. de Pril: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb. J. Larkin: Advisory/Consultancy, Research grant/Funding (institution): Achilles Therapeutics; Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Boston Biomedical; Advisory/Consultancy: Eisai; Advisory/Consultancy: EUSA Pharma; Advisory/Consultancy: GlaxoSmithKline; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Imugene; Advisory/Consultancy: Incyte; Advisory/Consultancy: iOnctura; Advisory/Consultancy: Kymab; Advisory/Consultancy: Merck Serono; Advisory/Consultancy, Research grant/Funding (self): Merck Sharp & Dohme; Advisory/Consultancy, Research grant/Funding (self): Nektar; Advisory/Consultancy, Research grant/Funding (self): Novartis; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy, Research grant/Funding (self): Pfizer; Advisory/Consultancy, Research grant/Funding (self): Roche; Advisory/Consultancy: Secarma; Advisory/Consultancy: Vitaccess; Advisory/Consultancy: Covance; Advisory/Consultancy, Research grant/Funding (self): Immunocore; Advisory/Consultancy: Aveo; Advisory/Consultancy: Pharmacyclics. P.A. Ascierto: Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy, Research grant/Funding (self): Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (self): Roche/Genentech; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy, Research grant/Funding (self): Array BioPharma; Advisory/Consultancy, Leadership role: Merck Serono; Advisory/Consultancy: Newlink Genetics; Advisory/Consultancy: Genmab; Advisory/Consultancy: Incyte; Advisory/Consultancy: MedImmune; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Syndax; Advisory/Consultancy: Sun Pharma; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Idera; Advisory/Consultancy: Ultimovacs; Advisory/Consultancy: Sandoz; Advisory/Consultancy: Immunocore; Advisory/Consultancy: 4SC; Advisory/Consultancy: Alkermes; Advisory/Consultancy: Italfarmaco; Advisory/Consultancy: Nektar; Advisory/Consultancy: Boehringer-Ingelheim; Travel/Accommodation/Expenses: Merck Sharp & Dohme. All other authors have declared no conflicts of interest.
Invited Discussant LBA46 and 1076O
- Rodabe Amaria (Houston, United States of America)
Q&A and live discussion
- James Larkin (London, United Kingdom)