- Andres Cervantes (Valencia, Valencia, Spain)
- Solange Peters (Lausanne, Switzerland)
LBA1 - Niraparib therapy in patients with newly diagnosed advanced ovarian cancer (PRIMA/ENGOT-OV26/GOG-3012 study) (ID 4627)
- Antonio González Martín (Madrid, Spain)
Abstract
Background
Niraparib has shown progression-free survival (PFS) benefit in recurrent OC after platinum-based chemotherapy (CT) in all patients (pts) regardless of BRCA status. This study evaluated the efficacy of niraparib in pts with newly diagnosed advanced OC after completion of first-line (1L) CT regardless of BRCA status.
Methods
This double-blind, placebo (PBO)-controlled phase III trial evaluated niraparib in pts with newly diagnosed advanced high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer with a complete or partial response (CR or PR) to 1L platinum-based CT. Stratification factors were best response to the 1L CT regimen (CR/PR), receipt of neoadjuvant CT (NACT; yes/no), and homologous recombination deficiency (HRD) status (positive/negative/unknown) per the Myriad myChoice HRD test. Pts received niraparib or PBO once daily. PFS assessed by blinded independent central review was the primary end point, analyzed using a stratified Cox proportional hazards model and hierarchically tested in HRD-positive (HRDpos) pts and then the overall population.
Results
Of 733 randomized pts (niraparib, 487; PBO, 246), 373 (51%) were HRDpos (niraparib, 247; PBO, 126). Overall, 35% had stage IV disease, 67% received NACT, and 31% had a PR to 1L CT. Niraparib-treated pts in the HRDpos subgroup and overall population had a significant reduction in the risk of disease recurrence or death with a substantial improvement in PFS (Table). All subgroups showed a sustained and durable treatment effect. The most common grade ≥3 adverse events were anemia (31%), thrombocytopenia (29%), and neutropenia (13%). No treatment-related deaths occurred. LBA1 CI, confidence interval; mPFS, median progression-free survival; NE, not estimable.Niraparib mPFS (95% CI) PBO mPFS (95% CI) Hazard Ratio (95% CI) P Value HRDpos subgroup 21.9 (19.3–NE) 10.4 (8.1–12.1) 0.43 (0.31–0.59) P < 0.0001 Overall population 13.8 (11.5–14.9) 8.2 (7.3–8.5) 0.62 (0.5–0.75) P < 0.0001
Conclusions
Niraparib significantly improved PFS in pts with newly diagnosed advanced OC, including pts at high risk of progressive disease in the HRDpos subgroup and overall population. No new safety signals were identified. Niraparib should be considered as a treatment option for pts with advanced OC after completion of 1L CT.
Clinical trial identification
NCT02655016.
Editorial acknowledgement
Writing and editorial support, funded by Tesaro, a GSK Company (Waltham, MA, USA) and coordinated by Ashujit Tadge, PhD of TESARO, was provided by Nicole Renner, PhD of Ashfield Healthcare Communications (Middletown, CT, USA) and Adrienne M. Schreiber, of Tesaro (Waltham, MA, USA).
Legal entity responsible for the study
Tesaro: A GSK Company.
Funding
Tesaro: A GSK Company.
Disclosure
A. González Martín: Research grant / Funding (institution): Roche; Advisory / Consultancy: AstraZeneca Tesaro; Advisory / Consultancy: Pharmamar; Advisory / Consultancy: Tesaro, Inc.. B. Pothuri: Advisory / Consultancy: Tesaro, Inc.; Advisory / Consultancy: Clovis; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Intuitive. I.B. Vergote: Advisory / Consultancy: GCI Health, Oncoinvent AS, Roche NV; Research grant / Funding (institution): Roche; Advisory / Consultancy: Genmab A/S, Advaxid Inc, Morphotek Inc; Advisory / Consultancy: F. Hoffmann-La Roche Ltd, Cerulean Pharma Inc, Novocure GMBH; Advisory / Consultancy: AstraZeneca, Mateon Therapeutics Inc; Advisory / Consultancy: Immunogen, Eli Lilly; Advisory / Consultancy, Research grant / Funding (self): Amgen; Advisory / Consultancy: Theradex Europe Limited, Pfizer, Debiopharma International SA; Advisory / Consultancy: Vifor Pharma Belgie NV, Novartis, MSD Belgium BVBA; Advisory / Consultancy: Oxigene, Janssen-Dilag, Nektar Therapeutics, Bayer; Travel / Accommodation / Expenses: Tesaro, Theradex, Elsevier. R.D. Christensen: Advisory / Consultancy: Tesaro: A GSK Company. W. Graybill: Advisory / Consultancy, Speaker Bureau / Expert testimony: Tesaro, Inc.. M.R. Mirza: Advisory / Consultancy: Clovis; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Tesaro, Inc.. D. Lorusso: Honoraria (self), Personal fees: AstraZeneca; Honoraria (self), Personal fees: Clovis Oncology; Honoraria (self), Personal fees: Genmab; Honoraria (self), Personal fees: Immunogen; Honoraria (self), Personal fees: Pharma Mar S.A; Honoraria (self), Personal fees: Amgen; Honoraria (self), Personal fees: Merck; Research grant / Funding (institution): Pharma Mar S.A; Research grant / Funding (institution): Merck. G. Freyer: Honoraria (self), Personal fees: Tesaro: A GSK Company; Honoraria (self), Personal fees: Clovis Oncology; Honoraria (self), Personal fees: Bristol-Myers Squibb ; Honoraria (self), Personal fees: MSD; Honoraria (self), Personal fees: Pfizer Inc. ; Honoraria (self), Personal fees: Novartis; Honoraria (self), Personal fees: Eli Lilly ; Honoraria (self), Personal fees: Biogara S.A.S; Honoraria (self), Research grant / Funding (institution), Personal fees: AstraZeneca; Honoraria (self), Research grant / Funding (institution), Personal fees: Roche Holding AG ; Honoraria (self), Research grant / Funding (institution), Personal fees: Mylan. F. Backes: Honoraria (self), Advisory / Consultancy, Personal fees: Clovis Oncology ; Honoraria (self), Advisory / Consultancy, Personal fees: Merck ; Honoraria (self), Advisory / Consultancy, Personal fees: Eisai ; Honoraria (self), Personal fees: Tesaro; Honoraria (self), Personal fees: Agenus; Honoraria (self), Personal fees: CEC Oncology; Research grant / Funding (institution): Immunogen. A. Redondo: Advisory / Consultancy, Research grant / Funding (institution): Pharmamar; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Tesaro; Research grant / Funding (institution): Eisai. R.G. Moore: Research grant / Funding (institution): Angle PLC; Advisory / Consultancy: Fugirebio Diagnostics Inc. R.E. O’Cearbhaill: Advisory / Consultancy: Clovis; Advisory / Consultancy: Tesaro; Advisory / Consultancy: GlaxoSmithKline. Y. Li: Shareholder / Stockholder / Stock options, Full / Part-time employment: Tesaro, Inc.. D. Gupta: Shareholder / Stockholder / Stock options, Full / Part-time employment: Tesaro, Inc.. B.J. Monk: Honoraria (self), Advisory / Consultancy: AbbVie, Advaxis; Honoraria (self), Advisory / Consultancy: Agenus, Amgen; Honoraria (self), Advisory / Consultancy: AstraZeneca, Biodesix; Honoraria (self), Advisory / Consultancy: Clovis, Conjupro; Honoraria (self), Advisory / Consultancy: Genmab, Gradalis; Honoraria (self), Advisory / Consultancy: ImmunoGen, Immunomedics; Honoraria (self), Advisory / Consultancy: Incyte, Janssen; Honoraria (self), Advisory / Consultancy: Mateon, Merck; Honoraria (self), Advisory / Consultancy: Myriad, Perthera; Honoraria (self), Advisory / Consultancy: Pfizer, Precision; Honoraria (self), Advisory / Consultancy: Puma, Roche; Honoraria (self), Advisory / Consultancy: Samumed, Takeda; Honoraria (self), Advisory / Consultancy: Tesaro, VB. All other authors have declared no conflicts of interest.
LBA2_PR - Phase III PAOLA-1/ENGOT-ov25 trial: Olaparib plus bevacizumab (bev) as maintenance therapy in patients (pts) with newly diagnosed, advanced ovarian cancer (OC) treated with platinum-based chemotherapy (PCh) plus bev (ID 3955)
- Isabelle L. Ray-Coquard (Lyon, CEDEX, France)
Abstract
Background
PAOLA-1/ENGOT-ov25 (NCT02477644) is the first phase III trial to evaluate the efficacy and safety of a PARP inhibitor with bev as first-line (1L) maintenance therapy for advanced OC, regardless of BRCA1/2 mutation (BRCAm) status.
Methods
PAOLA-1 is a randomized, double-blind, international phase III trial. Eligible pts had newly diagnosed, FIGO stage III–IV, high-grade serous or endometrioid OC, fallopian tube or primary peritoneal cancer. Pts had received standard PCh plus bev and were in clinical complete or partial response. Pts were randomized (2:1) to olaparib tablets (300 mg bid for up to 24 months [m]) plus bev (15 mg/kg, d1, q3w, for 15 m including when combined with PCh) or placebo (pbo) plus bev, stratified by 1L treatment outcome and tumour BRCAm status. The primary endpoint was investigator-assessed progression-free survival in the intent-to-treat population (PFS; modified RECIST v1.1).
Results
537 pts were randomized to olaparib plus bev and 269 to pbo plus bev. Pt characteristics were well balanced. Median follow-up was 24.0 m in the olaparib arm and 22.7 m in the pbo arm. PFS was significantly increased in the olaparib arm. PFS2 is immature. LBA2_PR These were prespecified subgroup analyses. PFS by tBRCAm was analysed using the electronic case report form dataset and PFS by HRD status by the myChoice® HRD Plus assay dataset (Myriad Genetic Laboratories, Inc); HRD score ≥42 including pts with a tBRCAm; HRD score ≥42 excluding pts with a tBRCAm; HRD score <42 or inconclusive, missing or failed test CI, confidence interval; HR, hazard ratio; HRD, homologous recombination deficiency; PFS2, time to second progression; tBRCAm, tumour BRCA1/2 mutation.Median, months HR (95% CI) Olaparib arm Placebo arm P value PFS, investigator-assessed (59% maturity) (n = 806) 22.1 16.6 0.59 (0.49–0.72) P < 0.0001 PFS by tBRCAm status* tBRCAm (n = 237) 37.2 18.9 21.7 16.0 0.31 (0.20–0.47) Non-tBRCAm (n = 569) 0.71 (0.58–0.88) PFS by HRD status HRD-positive*†(n = 387) HRD-positive, non-tBRCA*‡(n = 152) HRD-negative/unknown§ (n = 419) 37.2 28.1 16.9 17.7 16.6 16.0 0.33 (0.25–0.45) 0.43 (0.28–0.66) 0.92 (0.72–1.17)
Conclusions
Addition of olaparib to bev maintenance therapy following 1L PCh plus bev led to a statistically significant and clinically meaningful PFS benefit in pts with advanced OC. The PFS benefit in pts with a tBRCAm and in HRD-positive pts was substantial.
Clinical trial identification
NCT02477644.
Editorial acknowledgement
Medical writing assistance was provided by Laura Smart, MChem, from Mudskipper Business, Ltd, funded by ARCAGY Research, AstraZeneca, and MSD.
Legal entity responsible for the study
ARCAGY Research.
Funding
ARCAGY Research, AstraZeneca, Merck & Co., Inc. and Hoffmann-La Roche Ltd.
Disclosure
I.L. Ray-Coquard: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy: Clovis Oncology; Honoraria (self), Advisory / Consultancy: Tesaro; Honoraria (self), Advisory / Consultancy: Pharma Mar; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Genmab; Advisory / Consultancy, Research grant / Funding (self): MSD; Advisory / Consultancy: Pfizer. P. Pautier: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: Tesaro; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Genentech; Research grant / Funding (institution): PharmaMar. S. Pignata: Honoraria (self), Research grant / Funding (institution): Roche; Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self), Research grant / Funding (institution): MSD; Honoraria (self): Pfizer; Honoraria (self): Incyte; Honoraria (self): Novartis; Honoraria (self): PharmaMar; Honoraria (self): Clovis Oncology; Honoraria (self): Tesaro. D. Pérol: Honoraria (self), Travel / Accommodation / Expenses: Roche; Honoraria (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self): Eli-Lilly; Honoraria (self): Ipsen; Honoraria (self): Novartis; Honoraria (self): BMS. A. González-Martín: Advisory / Consultancy: Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Pfizer; Advisory / Consultancy: ImmunoGen; Advisory / Consultancy: PharmaMar; Advisory / Consultancy: MSD; Advisory / Consultancy: Genmad. P. Sevelda: Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Novartis; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Amgen. K. Fujiwara: Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self), Research grant / Funding (institution): Chugai Roche; Honoraria (self): Zeria; Honoraria (self): Taiho; Honoraria (self): Nihon Kayaku; Honoraria (self): Kyowahakko Kirin; Honoraria (self): Janssen; Honoraria (self): Daiichi Sankyo; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Kaken. I.B. Vergote: Advisory / Consultancy: Advaxis, Inc.; Advisory / Consultancy: Eisai, Inc.; Advisory / Consultancy: MSD, Belgium; Advisory / Consultancy: Roche NV; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Genmab; Advisory / Consultancy: F. Hoffman-La Roche Ltd; Advisory / Consultancy, Travel / Accommodation / Expenses: PharmaMar; Advisory / Consultancy: Millennium Pharma; Advisory / Consultancy, Travel / Accommodation / Expenses: Clovis Oncology; Advisory / Consultancy: AstraZeneca NV; Advisory / Consultancy, Travel / Accommodation / Expenses: Tesaro; Advisory / Consultancy: Oncoinvent AS; Advisory / Consultancy, Travel / Accommodation / Expenses: Immunogen Inc.; Advisory / Consultancy: Sotio; Research grant / Funding (institution): Oncoinvent AS; Research grant / Funding (self): Amgen; Research grant / Funding (self), Travel / Accommodation / Expenses: Roche; Research grant / Funding (self): Stichting Tegen Kanker; Travel / Accommodation / Expenses: Takeda Oncology; Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy: BIOCAD. N. Colombo: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: PharmaMar; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Tesaro; Honoraria (self), Advisory / Consultancy: Clovis Oncology; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: BIOCAD; Honoraria (self), Advisory / Consultancy: Takeda. J. Mäenpää: Honoraria (self), Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Tesaro; Advisory / Consultancy: Glovis. F. Selle: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Travel / Accommodation / Expenses: MSD France; Honoraria (self): PharmaMar; Honoraria (self), Travel / Accommodation / Expenses: Tesaro; Honoraria (self): Clovis Oncology; Honoraria (self), Travel / Accommodation / Expenses: AstraZeneca; Non-remunerated activity/ies: Post-university teaching. J. Sehouli: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: PharmaMar; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Clovis Oncology; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Tesaro; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy: Roche Diagnostics; Advisory / Consultancy: Merck; Advisory / Consultancy: Bayer; Advisory / Consultancy: Eisei; Advisory / Consultancy: Johnson & Johnson; Advisory / Consultancy: MSD; Advisory / Consultancy: Novocure; Advisory / Consultancy: Amgen; Advisory / Consultancy, Research grant / Funding (institution): Lilly; Research grant / Funding (institution): MedImmune; Research grant / Funding (institution): Bristol-Myers Squibb. D. Lorusso: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: Tesaro; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Clovis Oncology; Advisory / Consultancy: Immunogen; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: PharmaMar; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Officer / Board of Directors: GCIG. E.M. Guerra Alia: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: AstraZeneca; Speaker Bureau / Expert testimony: V Simposio Grupo Español de Investigación en Cáncer de Ovario (GEICO); Travel / Accommodation / Expenses: Baxter; Speaker Bureau / Expert testimony: Sociedad Española de Nutrición (SENPE)Parenteral y Enteral. C. Lefeuvre-Plesse: Advisory / Consultancy: AstraZeneca; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Pfizer. U. Canzler: Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony: Lilly. A. Lortholary: Honoraria (self): AstraZeneca; Honoraria (self): Tesaro. F. Marmé: Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self): Tesaro; Honoraria (self): Clovis Oncology; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self): Celgene; Honoraria (self): Genomic Health; Honoraria (self), Advisory / Consultancy: PharmaMar; Honoraria (self): Amgen; Advisory / Consultancy: Curvac Celgene; Advisory / Consultancy: Curevac; Advisory / Consultancy: Vaccibody. E. Pujade-Lauraine: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Tesaro; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Clovis Oncology; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Tesaro; Advisory / Consultancy: Genmab; Advisory / Consultancy: Incyte; Advisory / Consultancy: MSD; Advisory / Consultancy: Pfizer. P. Harter: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Sotio; Honoraria (self), Advisory / Consultancy: Tesaro; Honoraria (self): Stryker; Honoraria (self): ASCO; Honoraria (self): Zai Lab; Honoraria (self): MSD; Advisory / Consultancy: Lilly; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Immunogen; Advisory / Consultancy: MSD/Merck.
Invited Discussant LBA1 and LBA2_PR (ID 7279)
- Ana Oaknin (Barcelona, Spain)
LBA3 - VELIA/GOG-3005: Integration of veliparib (V) with front-line chemotherapy and maintenance in women with high-grade serous carcinoma of ovarian, fallopian tube, or primary peritoneal origin (HGSC) (ID 2772)
- Robert L. Coleman (Houston, TX, United States of America)
Abstract
Background
This phase III randomized placebo (PL) controlled multinational trial evaluated whether progression-free survival (PFS) is increased when V is added to front-line carboplatin and paclitaxel (CP) and continued as maintenance in newly diagnosed HGSC pts considering BRCA mutations (m), homologous recombination deficiency (HRD), and neoadjuvant chemotherapy (NACT) utilization.
Methods
Previously untreated Stage III-IV HGSC pts were to receive 6 cycles (21-d interval) of CP using 3-wkly or wkly paclitaxel, following primary cytoreduction or NACT with interval cytoreduction. V or PL was administered during CP (150 mg BID PO) and as maintenance (400 mg BID for 30 cycles). Randomization was 1:1:1, stratified by Stage III vs IV, residual disease and regimen, region, and gBRCA status: Arm 1: CP + PL then PL maintenance Arm 2: CP + V then PL maintenance Arm 3: CP + V then V maintenance Primary endpoints were PFS (Kaplan-Meier) in Arm 3 vs 1 using hierarchical testing in BRCAm, HRD (incl. BRCAm), and whole populations by log-rank tests. Secondary endpoints were PFS (Arm 2 vs 1), overall survival, and disease related symptom scores. Germline and tissue BRCAm and HRD were determined by central testing.
Results
1140 pts were enrolled with 26% in BRCAm and 55% in HRD populations. Efficacy results summarized in Table. Relative CP dose intensities were similar between arms. Grade 3-4 adverse events (AE; Arm 3 vs 1) were similar during CP with the exception of thrombocytopenia (27% vs 8%); during maintenance, any grade 3-4 AE was higher for V treatment (45% vs 32%) but serious AEs were similar (17% vs 19%). LBA3 BRCAm, BRCA mutated; HRD, homologous recombination deficient; HR, hazard ratio; P value by stratified log-rank test; PFS, progression-free survival.Population BRCAm HRD Whole Arm 3 n = 108 Arm 1 n = 92 Arm 3 n = 214 Arm 1 n = 207 Arm 3 n = 382 Arm 1 n = 375 Median PFS (months) 34.7 22.0 31.9 20.5 23.5 17.3 PFS HR (95% CI) P value 0.44 [0.28, 0.68] < 0.001 0.57 [0.43, 0.76] < 0.001 0.68 [0.56, 0.83] < 0.001
Conclusions
V added to front-line CP and continued as monotherapy maintenance significantly extended PFS in all women with newly diagnosed HGSC without selection according to BRCAm or HRD status, or response to CP. Observed toxicities were consistent with known V safety profile.
Clinical trial identification
NCT02470585.
Editorial acknowledgement
Medical writing support was provided by Ana Mrejeru, Ph.D., of AbbVie.
Legal entity responsible for the study
AbbVie.
Funding
AbbVie.
Disclosure
R.L. Coleman: Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Clovis Oncology; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Genentech/Roche; Advisory / Consultancy, Research grant / Funding (self): Esperance; Advisory / Consultancy: NCCN; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: AstraZeneca/MedImmune; Advisory / Consultancy: Genmab; Advisory / Consultancy: GamaMabs Pharma; Advisory / Consultancy: Tesaro; Advisory / Consultancy, Research grant / Funding (self): OncoMed; Advisory / Consultancy: Sotio; Advisory / Consultancy: Oncolytics; Advisory / Consultancy: AbbVie/Stemcentrx; Research grant / Funding (self), Travel / Accommodation / Expenses: Merck; Research grant / Funding (self), Travel / Accommodation / Expenses: Array Biopharma; Travel / Accommodation / Expenses: Research to Practice; Travel / Accommodation / Expenses: GOG; Travel / Accommodation / Expenses: Sotio; Travel / Accommodation / Expenses: Vaniam Group; Research grant / Funding (self): Johnson & Johnson; Research grant / Funding (self): Abbott/AbbVie. G.F. Fleming: Research grant / Funding (self): Corcept Therapeutics; Research grant / Funding (self): AbbVie; Research grant / Funding (self): Genentech; Research grant / Funding (self): Tesaro; Research grant / Funding (self): Syndax; Research grant / Funding (self): Forty Seven; Research grant / Funding (self): Iovance; Research grant / Funding (self): Syros; Research grant / Funding (self): Astex; Research grant / Funding (self): Merck. K.D. Steffensen: Honoraria (self), Research grant / Funding (institution): AstraZeneca; Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AbbVie. M. Friedlander: Advisory / Consultancy: AbbVie; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Takeda; Research grant / Funding (self): BeiGene. A. Okamoto: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Chugai; Honoraria (self): MSD; Research grant / Funding (self): Kaken; Research grant / Funding (self): Mochida; Research grant / Funding (self): Kissei; Research grant / Funding (self): Pfizer. K. Moore: Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Genentech/Roche; Advisory / Consultancy, Research grant / Funding (institution): Immunogen; Advisory / Consultancy, Research grant / Funding (institution): Advaxis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Non-remunerated activity/ies: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Clovis Oncology; Advisory / Consultancy, Research grant / Funding (institution): Tesaro; Advisory / Consultancy: VBL Therapeutics; Advisory / Consultancy: Janssen Oncology; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: Aravive; Advisory / Consultancy: Samumed; Advisory / Consultancy: OncoMed; Advisory / Consultancy: Pfizer/EMD Serono ; Advisory / Consultancy: Eisai; Research grant / Funding (institution): PTC Therapeutics; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Lilly Foundation; Research grant / Funding (institution): Regeneron; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Verastern; Research grant / Funding (institution): Agenus; Research grant / Funding (institution): Takeda; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Forty Seven; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Novogen. N. Ben-Baruch: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Eli Lilly; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Novartis; Research grant / Funding (self): AbbVie. T.L. Werner: Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Roche/Genentech; Research grant / Funding (institution): Mirati Therapeutics; Research grant / Funding (institution): Tesaro; Research grant / Funding (institution): Clovis; Research grant / Funding (institution): AstraZeneca. A. Oaknin: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: Pharmamar; Advisory / Consultancy, Travel / Accommodation / Expenses: Clovis Oncology; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Immunogen ; Advisory / Consultancy: Genmab. J. Nam: Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): Zeria Pharmaceutical Co.. C.A. Leath III: Honoraria (self), Research grant / Funding (institution): Mateon Therapeutics; Advisory / Consultancy, Research grant / Funding (institution): Celsion; Advisory / Consultancy: Unleash Immuno Oncolytics; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Plexxikon; Research grant / Funding (institution): Tesaro; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Roche/Genentech; Advisory / Consultancy, Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Syros; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Eisai. S. Nicum: Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy, Travel / Accommodation / Expenses: Tesaro. D. Cella: Advisory / Consultancy: AbbVie; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Advisory / Consultancy: GlaxoSmithKline; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy, Travel / Accommodation / Expenses: Astellas; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: PledPharma; Advisory / Consultancy: Puma Biotechnology; Research grant / Funding (institution), Travel / Accommodation / Expenses: Ipsen; Shareholder / Stockholder / Stock options: FACIT.org; Research grant / Funding (institution): Genentech. D.M. Sullivan: Shareholder / Stockholder / Stock options, Full / Part-time employment: AbbVie. P.J. Ansell: Shareholder / Stockholder / Stock options, Full / Part-time employment: AbbVie. M. Dinh: Shareholder / Stockholder / Stock options, Full / Part-time employment: AbbVie. C. Aghajanian: Advisory / Consultancy, Research grant / Funding (institution): Clovis Oncology; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Mateon Therapeutics; Advisory / Consultancy: Immunogen; Research grant / Funding (institution): Genentech/Roche; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy: Cerulean Pharma; Advisory / Consultancy: Eisai/Merck. M.A. Bookman: Non-remunerated activity/ies, Member, international protocol steering committee (AbbVie GOG3005): AbbVie; Non-remunerated activity/ies, protocol steering committee: Genentech-Roche; Non-remunerated activity/ies, protocol steering committee: ARAVIVE; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Merck; Advisory / Consultancy: AstraZeneca. All other authors have declared no conflicts of interest.
Invited Discussant LBA3 (ID 7280)
- Mansoor Raza Mirza (Copenhagen, Denmark)
LBA4_PR - Nivolumab (NIVO) + low-dose ipilimumab (IPI) vs platinum-doublet chemotherapy (chemo) as first-line (1L) treatment (tx) for advanced non-small cell lung cancer (NSCLC): CheckMate 227 part 1 final analysis (ID 7128)
- Solange Peters (Lausanne, Switzerland)
Abstract
Background
Part 1 of CheckMate 227 (NCT02477826), a phase III study in 1L NSCLC, has dual primary endpoints. The primary endpoint of progression-free survival (PFS) with NIVO + IPI vs chemo in patients (pts) with tumor mutational burden ≥ 10 mut/Mb was met, as reported previously. Here we present the primary endpoint of overall survival (OS) for NIVO + IPI vs chemo in pts with tumor PD-L1 expression ≥ 1%.
Methods
Pts were chemo-naive, with stage IV or recurrent NSCLC without EGFR or known ALK alterations, ECOG PS 0–1. Pts with PD-L1 ≥1% (n = 1189) were randomized 1:1:1 to NIVO 3 mg/kg Q2W + IPI 1 mg/kg Q6W, NIVO 240 mg Q2W, or histology-based chemo; pts with PD-L1 < 1% (n = 550) were randomized 1:1:1 to NIVO 3 mg/kg Q2W + IPI 1 mg/kg Q6W, NIVO 360 mg Q3W + chemo, or chemo. Pts were stratified by histology in both populations. Pts were treated until disease progression, unacceptable toxicity, or for 2 y of immunotherapy.
Results
Baseline characteristics were balanced across tx arms. Minimum follow-up for the primary endpoint was 29.3 mo. For pts with PD-L1 ≥ 1%, OS was significantly longer with NIVO + IPI vs chemo (HR 0.79, 97.72% CI: 0.65–0.96; P = 0.007); PFS, objective response rates, and duration of response favored NIVO + IPI vs chemo. OS benefit was also observed in pts with PD-L1 < 1% and all randomized pts (Table). Prespecified analyses showed enhanced efficacy with NIVO + IPI relative to NIVO in PD-L1 ≥ 1% and relative to NIVO + chemo in PD-L1 < 1%. Grade 3–4 tx-related adverse event rates in all randomized pts were 33% with NIVO + low-dose IPI, 19% with NIVO, and 36% with chemo. Efficacy outcomes with NIVO + IPI, NIVO, NIVO + chemo, and chemo in 1L advanced NSCLC with PD-L1 ≥ 1%, PD-L1 < 1%, and in all randomized pts in CheckMate 227 part 1 Study treatment only in PD-L1 ≥ 1% population; 95% CI for NIVO vs chemo; study treatment only in PD-L1 < 1% population. Minimum follow-up for OS and PFS was 29.3 mo and for objective response rate, 28.3 mo.PD-L1 ≥ 1% NIVO + IPI n = 396 Chemo n = 397 NIVOa n = 396 Median OS, mo (95% CI) HR vs chemo (97.72% CI) P value 1-year OS rate, % 2-year OS rate, % 17.1 (15.0–20.1) 0.79 (0.65–0.96) P = 0.007 63 40 14.9 (12.7–16.7) - - 56 33 15.7 (13.3–18.1) 0.88 (0.75–1.04)b - 57 36 Median PFS, mo (95% CI) HR vs chemo (95% CI) 5.1 (4.1–6.3) 0.82 (0.69–0.97) 5.6 (4.6–5.8) - 4.2 (3.0–5.3) 0.99 (0.84–1.17) Objective response rate, n (%) Median duration of response, mo (95% CI) 142 (35.9) 23.2 (15.2–32.2) 119 (30.0) 6.2 (5.6–7.4) 109 (27.5) 15.5 (12.7–23.5) PD-L1 < 1% NIVO + IPI n = 187 Chemo n = 186 NIVO + chemoc n = 177 Median OS, mo (95% CI) HR vs chemo (95% CI) 1-year OS rate, % 2-year OS rate, % 17.2 (12.8–22.0) 0.62 (0.48–0.78) 60 40 12.2 (9.2–14.3) - 51 23 15.2 (12.3–19.8) 0.78 (0.62–0.98) 59 35 All randomized pts NIVO + IPI n = 583 Chemo n = 583 Median OS, mo (95% CI) HR vs chemo (95% CI) 1-year OS rate, % 2-year OS rate, % 17.1 (15.2–19.9) 0.73 (0.64–0.84) 62 40 13.9 (12.2–15.1) - 54 30
Conclusions
CheckMate 227 met its primary endpoint of significantly improved OS with NIVO + IPI vs chemo in 1L advanced NSCLC with PD-L1 ≥ 1%. OS was also improved with NIVO + IPI in PD-L1 < 1% and in all randomized pts. Safety profile was consistent with previous reports in NSCLC. NIVO + IPI represents a new chemo-free tx option for pts in 1L advanced NSCLC.
Clinical trial identification
NCT02477826; Release date: June 23, 2015.
Editorial acknowledgement
Writing and editorial assistance was provided by Namiko Abe, PhD, of Caudex, funded by Bristol-Myers Squibb.
Legal entity responsible for the study
Bristol-Myers Squibb.
Funding
Bristol-Myers Squibb.
Disclosure
S. Peters: Advisory / Consultancy, Research grant / Funding (institution): AbbVie, Amgen, AstraZeneca, Bayer, Biocartis, Bioinvent, Blueprint Medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann-La Roche, Foundation Medicine, Illumina, Janssen, Merck Sharp and Dohme, M. S.S. Ramalingam: Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Personal fees, advisory board: Amgen; Honoraria (self), Advisory / Consultancy, Personal fees, advisory board: AbbVie; Honoraria (self), Advisory / Consultancy, Personal fees, advisory board: Lilly; Honoraria (self), Advisory / Consultancy, Personal fees, advisory board: Genentech; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Personal fees, advisory board: Takeda; Honoraria (self), Personal fees: Loxo; Research grant / Funding (institution): Advaxis; Honoraria (self), Research grant / Funding (institution), Personal fees: Tesaro; Honoraria (self), Research grant / Funding (institution), Personal fees: Merck; Honoraria (self), Research grant / Funding (self), Personal fees: AstraZeneca. L. Paz-Ares: Advisory / Consultancy, Advisory board: Genómica; Honoraria (self), Personal fees: Lilly, MSD, Roche, Pharmamar, Merck, AstraZeneca, Novartis, Boehringer Ingelheim, Celgene, Servier, Sysmex, Amgen, Incyte, Pfizer, Ipsen, Adacap, Sanofi, Bayer, Blueprint, Bristol-Myers Squibb; Advisory / Consultancy, Scientific advice/speaker: Lilly, MSD, Roche, Pharmamar, Merck, AstraZeneca, Novartis, Boehringer Ingelheim, Celgene, Servier, Sysmex, Amgen, Incyte, Pfizer, Ipsen, Adacap, Sanofi, Bayer, Blueprint, Bristol-Myers Squibb; Officer / Board of Directors, Co-founder and board member: Altum Sequencing; Research grant / Funding (institution), Grant: MSD, AstraZeneca, Pfizer, Bristol-Myers Squibb. H. Sakai: Research grant / Funding (institution), Grant: Ono Pharmaceutical Company, Bristol-Myers Squibb Company, AstraZeneca, Chugai Pharmaceutical Company, Merck & Co, Merck KGaA; Honoraria (self), Personal fees: Ono Pharmaceutical Company, Bristol-Myers Squibb Company, AstraZeneca, Chugai Pharmaceutical Company, Merck & Co, Merck KGaA. A. Vergnenegre: Honoraria (self), Advisory / Consultancy, Personal fees, travels for medical conferences and fees for consulting: Bristol-Myers Squibb, MSD, AstraZeneca. M. Reck: Honoraria (self), Advisory / Consultancy, Honoraria for lectures and consultancy: AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Lilly, Merck, MSD, Novartis, Pfizer, Roche. H. Borghaei: Research grant / Funding (institution): Millennium, Merck/Celgene, Bristol-Myers Squibb/Lilly; Advisory / Consultancy: BMS, Lilly, Genentech, Celgene, Pfizer, Merck, EMD-Serono, Boehringer Ingelheim, AstraZeneca, Novartis, Genmab, Regeneron, BioNTech, Cantargia AB, Amgen, AbbVie, Axiom, PharmaMar, Takeda, Huya Bio, Diiachi; Advisory / Consultancy, Data Safety and Monitoring Board: University of Pennsylvania, CAR T Program; Takeda; Full / Part-time employment: Fox Chase Cancer Center. J.R. Brahmer: Advisory / Consultancy, Research grant / Funding (institution), Grant, advisory board: Bristol-Myers Squibb; Advisory / Consultancy, Advisory board: AstraZeneca, Genentech, Merck. K.J. O’Byrne: Advisory / Consultancy, Speaker Bureau / Expert testimony, Advisory board and speaker bureau fees and travel grants to national and international meetings: Bristol-Myers Squibb, Pfizer, AstraZeneca, MSD, Roche-Genentech, Boehringer Ingelheim; Advisory / Consultancy, Advisory board: Novartis, Teva, Natera; Advisory / Consultancy, Speaker Bureau / Expert testimony, Advisory board and speaker bureau fees: Janssen-Cilag; Speaker Bureau / Expert testimony, Speaker bureau: Mundipharma; Shareholder / Stockholder / Stock options, Shareholder: Carp Pharmaceuticals, Carpe Vitae Pharmaceuticals; Licensing / Royalties, Various patents issues with licensee as listed: Queensland University of Technology and Trinity College Dublin. W.J. Geese: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bristol-Myers Squibb. P. Bhagavatheeswaran: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bristol-Myers Squibb. F.E. Nathan: Full / Part-time employment: Bristol-Myers Squibb. M.D. Hellmann: Advisory / Consultancy, Fees for consulting: Genentech, Merck, Novartis, Janssen, Mirati, Syndax, Nektar, Blueprint Medicines; Advisory / Consultancy, Research grant / Funding (institution), Research grant to institution, fees for consulting and travel (grant, personal fees, non-financial support): Bristol-Myers Squibb; Advisory / Consultancy, Fees for consulting and travel: AstraZeneca; Advisory / Consultancy, Fees for consulting and equity: Shattuck Labs, Immunai; Licensing / Royalties, Patent filed by Memorial Sloan Kettering related to the use of tumor mutation burden to predict response to immunotherapy: PGDx. All other authors have declared no conflicts of interest.
Invited Discussant LBA4_PR (ID 7281)
- Sanjay Popat (London, United Kingdom)
LBA5_PR - Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): Final overall survival analysis (ID 567)
- Suresh S. Ramalingam (Atlanta, United States of America)
Abstract
Background
Osimertinib is a 3rd-generation, irreversible, oral EGFR-TKI that potently and selectively inhibits both EGFR-mutated (EGFRm) and EGFR T790M resistance mutations, and has demonstrated efficacy in NSCLC CNS metastases. In the phase III FLAURA study (NCT02296125), osimertinib resulted in significant progression-free survival (PFS) benefit (primary endpoint; datacut off [DCO] 12 June 2017) over comparator EGFR-TKI (HR 0.46, p < 0.001). Overall survival (OS) data were immature (25% maturity) at that time. Here, we report the final OS analysis (58% maturity).
Methods
Eligible patients (pts): ≥18 years (Japan: ≥20), treatment-naïve with Ex19del/L858R EGFRm advanced NSCLC; WHO performance status 0–1. Pts with stable CNS metastases not requiring steroids for ≥2 weeks were allowed. Pts were randomised 1:1 to osimertinib 80 mg once daily (qd) orally (po) or comparator EGFR-TKI (gefitinib 250 mg qd/erlotinib 150 mg qd po), stratified by mutation status (Ex19del/L858R) and race (Asian/non-Asian). Crossover was allowed for pts in the comparator EGFR-TKI arm upon central confirmation of progression and T790M positivity. Primary endpoint: PFS by RECIST v1.1, per investigator. OS was a secondary endpoint. DCO 25 June 2019.
Results
Globally, 556 pts were randomised to osimertinib (n = 279) or comparator EGFR-TKI (n = 277). Per study protocol, 70 (25%) pts crossed over from comparator EGFR-TKI to osimertinib. Osimertinib significantly improved OS vs comparator EGFR-TKI. All causality AEs, per investigator: osimertinib, 98% (grade ≥3, 42%); comparator EGFR-TKI, 98% (grade ≥3, 47%). AEs leading to discontinuation: osimertinib, 15%; comparator EGFR-TKI, 18%. The safety profile appears consistent with previously reported data. LBA5_PR OS for patients in the full analysis set was analysed using a log rank test (stratified by race and mutation type) for generation of the p-value and using the Breslow approach for handling ties. The median OS with 95% confidence intervals were calculated by Kaplan Meier technique. For statistical significance, a 2-sided p-value of less than 0.0495, as determined by the O’Brien-Fleming approach was required due the previous interim analysis.*Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive.Efficacy output Osimertinib n = 279 Comparator EGFR-TKI n = 277 OS hazard ratio 0.799 (0.641, 0.997); p = 0.0462 (95.05% confidence interval) Median OS, months 38.6 31.8 (95% confidence interval) (34.5, 41.8) (26.6, 36.0) Deaths, total pts (%) 155 (56) 166 (60) Median follow-up for OS in all pts, months 35.8 27.0 Median follow-up for OS in censored* pts, months 43.1 43.1 12-month survival rate, % 89 83 (95% confidence interval) (85, 92) (77, 87) 24-month survival rate, % 74 59 (95% confidence interval) (69, 79) (53, 65) 36-month survival rate, % 54 44 (95% confidence interval) (48, 60) (38, 50)
Conclusions
Osimertinib provided a statistically significant and clinically meaningful improvement in OS vs comparator EGFR-TKI in first-line pts with EGFRm advanced NSCLC.
Clinical trial identification
NCT02296125.
Editorial acknowledgement
Natalie Griffiths, PhD, from iMed Comms, an Ashfield Company; funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
S.S. Ramalingam: Honoraria (self), Advisory / Consultancy: AstraZeneca, Amgen, Bristol-Myers Squibb, Merck, Roche/Genentech, Loxo, Nektar, Tesaro; Research grant / Funding (institution): AstraZeneca, Amgen, Bristol-Myers Squibb, Merck, Tesaro, Advaxis, Takeda. J.E. Gray: Honoraria (self): AstraZeneca, Bristol-Myers Squibb, Takeda; Advisory / Consultancy: AstraZeneca, Bristol-Myers Squibb, Celgene, Takeda; Research grant / Funding (institution): Array, Merck, AstraZeneca, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb. Y. Ohe: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca, Chugai, Dainippon Lilly, Ono, BMS Japan, Daiichi Sankyo, BI, Bayer, Ignyta, Pfizer, MSD, Taiho, Novartis, Kyorin, Kyowa Hakko Kirin, Takeda, Celltrion, Kissei, Amgen, Janssen, ROXO. B.C. Cho: Honoraria (institution), Advisory / Consultancy: Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD, Boehringer Ingelheim, Roche, Bristol-Myers Squibb, Pfizer, Eli Lilly, Takeda; Speaker Bureau / Expert testimony: Novartis; Research grant / Funding (institution): Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD; Licensing / Royalties: Champions Oncology; Shareholder / Stockholder / Stock options: TheraCanVac Inc.. J. Vansteenkiste: Research grant / Funding (institution): MSD; Advisory / Consultancy: Apotex, AstraZeneca, Boehringer Ingelheim, MSD, Novartis, Roche; Speaker Bureau / Expert testimony: AstraZeneca, BMS, MSD, Roche. C. Zhou: Honoraria (self): Roche, Eli Lilly, Boehringer Ingelheim, Merck, Hengrui and Qiru. B. Chewaskulyong: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca. R. Shah: Honoraria (self), Travel / Accommodation / Expenses: Boehringer Ingelheim, Roche, AstraZeneca. P. Cheema: Honoraria (self), Advisory / Consultancy: AstraZeneca, Boehringer Ingelheim, Roche, Bristol-Myers Squibb, Merck, Takeda, Novartis, Genomic Health, Pfizer. M. Tiseo: Advisory / Consultancy: AstraZeneca, Bristol-Myers Squibb, MSD, Boehringer Ingelheim, Takeda; Research grant / Funding (institution): AstraZeneca. T. John: Advisory / Consultancy: Roche, Bristol-Myers Squibb, Merck, Ignyta, AstraZeneca, Takeda, Boehringer Ingelheim, Pfizer. F. Imamura: Honoraria (self), Research grant / Funding (institution): AstraZeneca. R. Hodge: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. Y. Rukazenkov: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. J. Soria: Advisory / Consultancy: AstraZeneca, Astex, Clovis, GSK, GamaMabs, Lilly, MSD, Mission Therapeutics, Merus, Pfizer, PharmaMar, Pierre Fabre, Roche/Genentech, Sanofi, Servier, Symphogen, and Takeda; Shareholder / Stockholder / Stock options: AstraZeneca, Gritstone; Full / Part-time employment: AstraZeneca. D. Planchard: Advisory / Consultancy: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Merck, MedImmune, Novartis, Pfizer, prIME Oncology, Peer CME, Roche; Honoraria (self): AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Merck, Novartis, Pfizer, prIME Oncology, Peer CME, Roche; Research grant / Funding (institution): AstraZeneca, Bristol-Myers Squibb, AbbVie, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, Pfizer, Roche, Medimmun, Sanofi-Aventis, Taiho Pharma, Novocure, Daiichi Sankyo; Travel / Accommodation / Expenses: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim , Roche, Merck,Novartis, prIME Oncology, Pfizer. All other authors have declared no conflicts of interest.
Invited Discussant LBA5_PR (ID 7282)
- Pasi A. Jänne (Boston, MA, United States of America)