- Takashi Seto (Fukuoka, Fukuoka, Japan)
378MO - EMPOWER-Lung 1: Phase III first-line (1L) cemiplimab monotherapy vs platinum-doublet chemotherapy (chemo) in advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50% (ID 504)
- Ahmet Sezer (Adana, Turkey)
Abstract
Background
EMPOWER-Lung 1 is a multicentre, open-label, global, phase III study of cemiplimab, an anti–PD-1, in patients (pts) with treatment-naïve stage IIIB, IIIC or IV squamous or non-squamous NSCLC with PD-L1 expressed in ≥50% of tumour cells.
Methods
Pts were randomised 1:1 to receive cemiplimab 350 mg Q3W IV or investigator’s choice of chemo. Crossover (CO) from chemo to cemiplimab was allowed following progression. The primary endpoints were overall survival (OS) and progression-free survival (PFS) per blinded Independent Review Committee. A prespecified interim analysis was performed after 50% of OS events. Data are presented per intention-to-treat (ITT) and in a PD-L1 ≥50% ITT population which comprised only pts with PD-L1 ≥50% by 22C3 per instruction for use (after recommended retesting in some pts). Data cut-off was 1 March 2020.
Results
In the ITT population (median follow-up: 13.1 months), median OS was 22.1 months (95% CI: 17.7–not evaluable [NE]) with cemiplimab (n=356) vs 14.3 months (95% CI: 11.7–19.2) with chemo (n=354; HR, 0.68; 95% CI: 0.53–0.87; P=0.002). Median PFS was 6.2 months (95% CI: 4.5–8.3) with cemiplimab vs 5.6 months (95% CI: 4.5–6.1) with chemo (HR, 0.59; 95% CI: 0.49–0.72; P<0.0001). In the PD-L1 ≥50% ITT population (median follow-up: 10.8 months), median OS was not reached (95% CI: 17.9–NE) with cemiplimab (n=283) vs 14.2 months (95% CI: 11.2–17.5) with chemo (n=280; HR, 0.57; 95% CI: 0.42–0.77; P=0.0002). Median PFS was 8.2 months (95% CI: 6.1–8.8) with cemiplimab vs 5.7 months (95% CI: 4.5–6.2) with chemo (HR, 0.54; 95% CI: 0.43–0.68; P<0.0001). CO rate to cemiplimab was 73.9%. In the ITT population, cemiplimab was associated with higher response rate (36.5% vs 20.6%), longer median duration of response (21.0 months vs 6.0 months) and lower rates of Grade ≥3 adverse events regardless of attribution (37.2% vs 48.5%) compared to chemo.
Conclusions
In this study, 1L cemiplimab monotherapy significantly improved OS and PFS vs chemo in pts with advanced NSCLC with PD-L1 ≥50%, despite high CO rate, providing rationale for cemiplimab as a new treatment option for this patient population.
Clinical trial identification
NCT03088540.
Editorial acknowledgement
Medical writing support was provided by Emmanuel Ogunnowo, PhD of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi.
Legal entity responsible for the study
Regeneron Pharmaceuticals, Inc. and Sanofi.
Funding
Regeneron Pharmaceuticals, Inc. and Sanofi.
Disclosure
A. Sezer: Research grant/Funding (institution), outside the submitted work: Roche; Research grant/Funding (institution), outside the submitted work: Merck Sharp & Dohme; Research grant/Funding (institution), outside the submitted work: Merck Serono; Research grant/Funding (institution), outside the submitted work: AstraZeneca; Research grant/Funding (institution), outside the submitted work: Lily; Research grant/Funding (institution), outside the submitted work: Novartis; Research grant/Funding (institution), outside the submitted work: JohnsonJohnson; Research grant/Funding (institution), outside the submitted work: Regeneron Pharmaceuticals, Inc.; Research grant/Funding (institution), outside the submitted work: Sanofi. M. Gümüş: Honoraria (institution), outside the submitted work: Roche; Honoraria (institution), outside the submitted work: Merck Sharp & Dohme; Honoraria (institution), outside the submitted work: Gen İlaç; Honoraria (institution), outside the submitted work: Novartis. N. Rizvi: Advisory/Consultancy, outside the submitted work: AbbVie; Advisory/Consultancy, outside the submitted work: Apricity; Advisory/Consultancy, outside the submitted work: AstraZeneca; Advisory/Consultancy, outside the submitted work: Boehringer; Advisory/Consultancy, outside the submitted work: Calithera; Advisory/Consultancy, outside the submitted work: Dracen; Advisory/Consultancy, outside the submitted work: Editas; Advisory/Consultancy, outside the submitted work: EMD Sorono; Advisory/Consultancy, outside the submitted work: G1 Therapeutics; Advisory/Consultancy, outside the submitted work: Genentech, Gilead and GSK; Advisory/Consultancy, outside the submitted work: Illumina; Advisory/Consultancy, outside the submitted work: Lilly; Advisory/Consultancy, outside the submitted work: Merck; Advisory/Consultancy, outside the submitted work: Neogenomics; Advisory/Consultancy, outside the submitted work: Novartis; Advisory/Consultancy, Shareholder/Stockholder/Stock options, outside the submitted work: Brooklyn ImmunoTherapeutics; Advisory/Consultancy, outside the submitted work: Takeda; Advisory/Consultancy, Shareholder/Stockholder/Stock options, outside the submitted work: Bellicum; Shareholder/Stockholder/Stock options, outside the submitted work: Gritstone; Licensing/Royalties, Patent (pending) filed by MSKCC, in the form of royalties, on “determinants of cancer response to immunotherapy, (PCT/US2015/062208)” licensed to Personal Genome Diagnostics: MSKCC. S. Li; S. Lee; G. Gullo: Shareholder/Stockholder/Stock options, Full/Part-time employment: Regeneron Pharmaceuticals, Inc. I. Lowy; P. Rietschel: Shareholder/Stockholder/Stock options, Licensing/Royalties, Full/Part-time employment: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.
379MO - Durvalumab (D) ± tremelimumab (T) + platinum-etoposide (EP) in 1L ES-SCLC: Characterization of long-term clinical benefit and tumour mutational burden (TMB) in CASPIAN (ID 621)
- Jun Ho Ji (Changwon, Korea, Republic of)
Abstract
Background
In the phase III CASPIAN trial, 1L D+EP significantly improved OS vs EP (HR 0.73 [95% CI 0.59‒0.91; p=0.0047]) in pts with ES-SCLC, with sustained benefit after >2 yr median follow-up (HR 0.75 [95% CI 0.62‒0.91; nominal p=0.0032]). Landmark analyses indicated 22% of pts were alive at 24m with the addition of D±T to EP. Here we assess the clinical characteristics and outcomes of pts deriving long-term benefit, as well as the relationship between TMB and efficacy outcomes in the ITT population.
Methods
805 pts with ES-SCLC were randomised 1:1:1 to D+EP, D+T+EP, or EP. Exploratory subgroup analyses defined long-term clinical benefit as PFS ≥12m. Tumour tissue was mandated at screening, if available. TMB was assessed in tissue (tTMB) using the FoundationOne CDx platform.
Results
45 (17%), 42 (16%), and 12 (5%) pts treated with D+EP, D+T+EP, and EP had PFS ≥12m, respectively (data cutoff 27 Jan 2020). In all arms, the PFS ≥12m subgroup had a higher incidence of favorable prognostic factors (more women and pts with PS 0, fewer pts with brain/liver metastases). In the D+EP arm, pts with PFS ≥12m received more D (median 25 vs 7 cycles) and had improved ORR (96% vs 63%), median DoR (NR vs 4m) and OS at 24m (77% vs 11%) compared with the PFS <12m subgroup (Table). Similar results were observed with EP and when both IO arms were combined. Safety and additional efficacy outcomes in the subgroups will be presented. Across all 3 arms, 283 pts (35% of ITT) were evaluable for tTMB. tTMB was not predictive of a differential treatment effect for D±T+EP vs EP (OS, PFS, or ORR).
D+EP IO arms combined PFS ≥12m n=45 PFS <12m n=220 PFS ≥12m n=87 PFS <12m n=444 Ongoing durvalumab at DCO, n (%) 27 (60) 5 (2) 50 (57) 12 (3) Durvalumab cycles, median (range) 25 (6–37) 7 (1–28) 25 (2–37) 6 (1–33) Male, % 60 73 63 75 Never / ever smoker, % 9 / 91 8 / 92 9 / 91 7 / 93 PS 0 / 1, % 47 / 53 35 / 65 48 / 52 36 / 64 Brain mets, % 7 11 3 14 Liver mets, % 20 44 23 46 ORR, n/N (%) 43/45 (96) 139/220 (63) 82/87 (94) 256/443 (58) Median DoR, m (95% CI) NR (18–NE) 4 (3.5–5) NR (24–NE) 4 (4–5) OS at 24m, % (95% CI) 77 (61–87) 11 (7–16) 82 (72–89) 11 (8–14)
Conclusions
Across all arms, pts with PFS ≥12m had exceptional 2 yr OS rates >75%, despite some having poor prognostic factors such as baseline brain or liver metastases. There were >3 times more pts deriving long-term benefit when treated with durvalumab + EP vs EP alone. Further investigation into predictive factors for long-term benefit with durvalumab is ongoing.
Clinical trial identification
NCT03043872 release date 6 February, 2017.
Editorial acknowledgement
Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Beena John, PhD, of Cirrus Communications (Macclesfield, UK), an Ashfield company, and was funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca Plc.
Funding
AstraZeneca.
Disclosure
J.W. Goldman: Research grant/Funding (institution): Genentech; AstraZeneca; Advisory/Consultancy, Advisory board: Genentech; AstraZeneca. M.C. Garassino: Research grant/Funding (institution), Grants and personal fees: Eli Lilly, Otsuka Pharmaceutical, AstraZeneca, Novartis, BMS, Roche, Pfizer, Celgene, Incyte, Bayer, MSD, GlaxoSmithKline, Spectrum Pharmaceuticals, Blueprint Medicines; Research grant/Funding (self), Personal fees: Boehringer Ingelheim, Inivata, Takeda, Sanofi, Seattle Genetics, Daiichi-Sankyo, Janssen; Research grant/Funding (institution), Grants: Tiziana Life Sciences, Clovis, Merck Serono, United Therapeutics Corporation, Merck KGaA, Turning Point Therapeutics, Ipsen, Exelisis; Non-remunerated activity/ies, Non-financial support: MSD, Pfizer, Eli Lilly. Y. Chen: Research grant/Funding (institution): AstraZeneca / spen / Roche, BMS; Advisory/Consultancy, Personal fees (consultancy): Pfizer, Array Biopharma, AstraZeneca, Genentech, BMS, Novartis, Takeda; Speaker Bureau/Expert testimony, Personal fees (speaker bureau): AstraZeneca, Genentech, BMS, Merck, Novartis, Takeda, Eli Lilly, Guardant Health. N. Reinmuth: Research grant/Funding (self), Personal fees: AstraZeneca, Boehringer Ingelheim Hoffmann La-Roche, MSD Sharp & Dohme, Takeda, BMS, Pfizer; Non-remunerated activity/ies, Non-financial support: AstraZeneca, Boehringer Ingelheim, Hoffmann La-Roche, AbbVie, BMS, Pfizer. K. Hotta: Research grant/Funding (self), Research grant/Funding (institution), Research grant and personal fees: AstraZeneca, Lilly, BMS, MSD, Chugai; Research grant/Funding (self), Personal fees: Pfizer, Ono, Nippon Kayaku, Taiho, Boehringer Ingelheim, Novartis, Daiichi-Sankyo, Kyorin; Research grant/Funding (institution), Research grant: Astellas. M. Özgüroğlu: Advisory/Consultancy: Janssen, Sanofi, Astellas; Honoraria (self): Novartis, Roche, Janssen, Sanofi, Astellas; Honoraria (institution): Novartis, Roche, Janssen, Sanofi, Astellas; Travel/Accommodation/Expenses: BMS, Janssen. S. Spencer, M. Xie, S. Jones, A. Franks, Y. Shrestha: Full/Part-time employment: AstraZeneca. L. Paz-Ares: Honoraria (self), Travel/Accommodation/Expenses, Spouse/Financial dependant: Merck Sharp and Dohme; Honoraria (self), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Spouse/Financial dependant: Roche/Genentech; Honoraria (self), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Travel/Accommodation/Expenses: Lilly; Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Spouse/Financial dependant: Novartis; Honoraria (self), Spouse/Financial dependant: Amgen; Honoraria (self): Incyte; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Blueprint Medicines; Honoraria (self): Bayer; Leadership role: Altum Sequencing; Leadership role: Genomica; Honoraria (self): PharmaMar; Honoraria (self), Spouse/Financial dependant: Ipsen; Travel/Accommodation/Expenses: AstraZeneca Spain; Honoraria (self): Celgene; Honoraria (self): Sysmex; Spouse/Financial dependant: Servier; Spouse/Financial dependant: Sanofi. All other authors have declared no conflicts of interest.
380MO - A phase II trial of atezolizumab, bevacizumab, pemetrexed and carboplatin combination for metastatic EGFR-mutated NSCLC after TKI failure (ID 688)
- Tai Chung Lam (Hong Kong, Hong Kong PRC)
Abstract
Background
Acquired resistance to TKI is an important unmet need in the management of metastatic EGFR-mutated lung cancer. The current trial examined the efficacy of combinational approach with VEGF inhibitor, check point inhibitor immunotherapy and platinum-based chemotherapy in an Asian cohort.
Methods
Metastatic EGFR mutated NSCLC patients who failed at least one TKI were recruited. For those with T790M mutation, radiological progression on osimertinib was required for enrollment. Patients were treated with combination regimen of atezolizumab (1200mg), bevacizumab (7.5mg/kg), pemetrexed (500mg/m2) and carboplatin (AUC 5) once every 3 weeks until progression. Endpoints were objective response rate (ORR), progression free survival (PFS) and overall survival (OS).
Results
Forty patients were enrolled with median age of 62. More than half (57.5%) had progressed on osimertinib. Stable brain metastases were present in 22.5% at baseline. PD-L1 expression was <1% in 52.5%. Median follow-up time was 11.0 months. ORR was 62.5%. Median PFS was 9.43 month (95% CI: 7.62 – 12.1 months). Among the 31 patients who progressed on the clinical trial treatment, 11 of these had CNS being the only site of progression. Median OS was not mature yet and the 1-year OS rate was 72.5%. Treatment related grade 3 or above adverse events (AE) occurred in 37.5% (15/40) and led to 1 discontinuation (2.5%), 7 dose interruption (17.5%) and 1 death (2.5%, myocardial infarct). Grade 2 hypertension developed in 27.5% of patients. Two patients developed asymptomatic pulmonary embolism and one patient deep vein thrombosis. All these three patients were able to resume clinical trial treatment after treatment. Immune-related AE occurred in 32.5% (13/40). All were grade 1-2 moderate hypo/hyperthyroidism and adrenal insufficiency except 2 patients who developed transient grade 3 liver transaminase increase and grade 4 poly-neuropathy.
Conclusions
Combination approach of atezolizumab, bevacizumab, pemetrexed and carboplatin achieved promising efficacy in metastatic EGFR-mutated NSCLC after TKI failure. The results were comparable with taxane based combinational approach. Most of the adverse events were moderate and manageable.
Clinical trial identification
NCT03647956.
Legal entity responsible for the study
The authors.
Funding
F. Hoffmann-La Roche AG.
Disclosure
T.C. Lam: Advisory/Consultancy: Roche Diagnostics; Research grant/Funding (institution): Mundipharma; Research grant/Funding (institution): Pfizer. V.H.F. Lee, K.O. Lam: Research grant/Funding (institution): MSD. C.L. Chiang: Research grant/Funding (self): Merck; Research grant/Funding (self): BMS. All other authors have declared no conflicts of interest.
Invited Discussant abstracts 378MO, 379MO and 380MO (ID 1107)
- Yi-Long Wu (Guangzhou, Guangdong, China)
LIVE Q&A (ID 1108)
- Takashi Seto (Fukuoka, Fukuoka, Japan)
356MO - Osimertinib adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) NSCLC (ADAURA): Central nervous system (CNS) disease recurrence (ID 502)
- Masahiro Tsuboi (Kashiwa, Chiba, Japan)
Abstract
Background
CNS relapse is common in NSCLC, and is a poor prognostic factor. In the resected EGFRm NSCLC setting, the impact of treatment on sites of recurrence, including the CNS, is a key consideration. Osimertinib is a 3rd-generation EGFR-TKI with demonstrated efficacy in NSCLC CNS metastases. In ADAURA, osimertinib demonstrated a highly statistically significant and clinically meaningful improvement in disease-free survival vs placebo (PBO; DFS, hazard ratio [HR]: 0.20 [99.12% CI 0.14, 0.30; p<0.001) in resected stage IB–IIIA EGFRm (ex19del/L858R) NSCLC (Ph III ADAURA; NCT02511106). We report an exploratory analysis of recurrence patterns.
Methods
Pts with resected stage IB–IIIA EGFRm NSCLC, with/without adjuvant chemotherapy, were randomised 1:1 to receive osimertinib 80 mg once-daily or PBO until recurrence/discontinuation/3 years. Patterns of recurrence and CNS DFS (time to CNS recurrence/death) were exploratory endpoints. An MRI/CT brain scan was mandated at baseline either before surgery or upon enrolment, but was not required in absence of symptoms. Recurrence was categorised as local/regional and/or distant, with sites of relapse recorded. Data cutoff: 17/01/20.
Results
Overall, 682 pts were randomised (osimertinib: 339; PBO: 343). Pts treated with osimertinib had fewer recurrence events vs PBO (Table); 45 pts had CNS DFS events (osimertinib: 6; PBO: 39; median follow-up 22 months [mo]). Conditional probability of CNS recurrence at 12 mo (95% CI): <1% (0%, 2%) with osimertinib vs 7% (4%, 10%) with PBO. Median CNS DFS: not reached (95% CI 39.0 mo, not calculable [NC]) with osimertinib vs 48.2 (NC, NC) mo with PBO. CNS DFS HR: 0.18 (95% CI 0.10, 0.33); p<0.0001. *Death in absence of CNS disease recurrence, or death within two visits of baseline where the patient has no evaluable assessments or no baseline data. †Death in the absence of disease recurrence (any site), or death within two visits of baseline where the patient has no evaluable assessments or no baseline data.
Osimertinib n=339 PBO n=343 CNS DFS events, pts (%): 6 (2) 39 (11) CNS recurrence 4 (1) 33 (10) Death* 2 (1) 6 (2) DFS events, pts (%): 37 (11) 159 (46) Disease recurrence 37 (11) 157 (46) —— Non-CNS recurrence 33 (10) 123 (36) —— CNS recurrence 4 (1) 33 (10) —— Disease recurrence with missing location 0 1 (0) Death† 0 2 (1)
Conclusions
There was a clinically meaningful improvement in CNS DFS with osimertinib: 82% reduction in risk of CNS disease recurrence or death. Results support that osimertinib reduces risk of CNS recurrence in the resected EGFRm NSCLC setting.
Clinical trial identification
NCT02511106.
Editorial acknowledgement
Natasha Learmond, BSC, of Ashfield Healthcare Communications, Macclesfield, UK, part of UDG Healthcare plc for medical writing support that was funded by AstraZeneca in accordance with Good Publications Practice (GPP3) guidelines.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
M. Tsuboi: Honoraria (self): Johnson & Johnson Japan; Eli Lilly Japan; Chugai Pharmaceutical Co., Ltd.; Bristol-Myers Squibb KK; Teijin Pharma; Taiho Pharma; Medtronic Japan; Ono Pharmaceutical Co., Ltd.;Honoraria (self), Research grant/Funding (self): AstraZeneca KK; MSD; Research grant/Funding (self): Boehringer-Ingelheim Japan. Y-L. Wu: Speaker Bureau/Expert testimony: Boehringer Ingelheim; Eli Lilly; MSD; Sanofi; Speaker Bureau/Expert testimony, Research grant/Funding (institution): AstraZeneca; BMS; Pfizer; Roche. T. John: Advisory/Consultancy: Roche; BMS; Merck; Ignyta; AstraZeneca; Takeda; MSD; Specialised Therapeutics; Pfizer. C. Grohe: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD. Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Boehringer Ingelheim; M. Majem: Honoraria (self), Research grant/Funding (self): BMS; Honoraria (self): MSD; Boehringer Ingelheim; AstraZeneca; Roche; Kyowa Kyrin; Pierre Fabre; Takeda; Bayer. J.W. Goldman: Honoraria (self), Research grant/Funding (self): AstraZeneca; Speaker Bureau/Expert testimony, Research grant/Funding (self): Merck; Research grant/Funding (self): AbbVie; Research grant/Funding (self): BMS. S-W. Kim: Advisory/Consultancy, Speaker Bureau/Expert testimony: Boeringer-Ingelheim; Advisory/Consultancy, Financial support or relationship with tobacco and/or e-cigarette company: AstraZeneca; Advisory/Consultancy: BMS; Lilly; Novartis. T. Kato: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): AbbVie; Advisory/Consultancy, Speaker Bureau/Expert testimony: Amgen; Speaker Bureau/Expert testimony, Research grant/Funding (self): BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Chugai; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Full/Part-time employment, Employment (spouse): Eli Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Merck Biopharma; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): MSD; Speaker Bureau/Expert testimony, Research grant/Funding (self): Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Ono; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Pfizer; Speaker Bureau/Expert testimony, Research grant/Funding (institution): Taiho; Speaker Bureau/Expert testimony: Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony: Daiichi-Sankyo; Speaker Bureau/Expert testimony: F.Hoffman-La Rohe; Speaker Bureau/Expert testimony: Shionogi; Advisory/Consultancy: Nippon Kayaku; Advisory/Consultancy: Nitto Denko; Advisory/Consultancy: Sumitomo Dainippon, Takeda; Research grant/Funding (self): Astellas, Kyorin, Kyowa-Kirin, Regeneron. F. de Marinis: Advisory/Consultancy: Roche; BMS; AstraZeneca; MSD. M. Domine: Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; BMS; Boehringer Ingelheim; MSD; Pfizer; Roche. F.A. Shepherd: Shareholder/Stockholder/Stock options: AstraZeneca. C. Yan; A. Atasoy: Full/Part-time employment: AstraZeneca. R. Herbst: Honoraria (self), Personal Fees: AbbVie Pharmaceuticals; ARMO Biosciences; Honoraria (self), Research grant/Funding (self), Personal Fees: AstraZeneca; Honoraria (self), Personal Fees: Biodesix; Bolt Biotherapeutics; Bristol-Myers Squibb; Honoraria (self), Research grant/Funding (self), Personal Fees: Eli Lilly and Company; Honoraria (self), Personal Fees: EMD Serrano; Honoraria (self), Research grant/Funding (self), Personal Fees: Genentech/Roche; Honoraria (self), Personal Fees: Genmab; Honoraria (self), Personal Fees: Halozyme; Honoraria (self), Personal Fees: Heat Biologics; Honoraria (self), Personal Fees: IMAB Biopharma; Honoraria (self), Personal Fees: Immunocore; Honoraria (self), Personal Fees: Infinity Pharmaceuticals; Officer/Board of Directors, Board Member: Junshi Pharmaceuticals; Honoraria (self), Personal Fees: Loxo Oncology; Honoraria (self), Research grant/Funding (self), Personal Fees: Merck and Company; Honoraria (self), Personal Fees: Mirati Therapeutics; Honoraria (self), Personal Fees: Nektar, Neon Therapeutics, Novartis, Pfizer, Sanofi, Seattle Genetics, Shire PLC, Spectrum Pharmaceuticals, Symphogen, Takeda, Tesaro, Tocagen, Cybrexa, Oncternal Therapeutics. All other authors have declared no conflicts of interest.
366MO - Osimertinib plus platinum/pemetrexed in newly diagnosed EGFR mutation (EGFRm)-positive advanced NSCLC: Safety run-in results from the FLAURA2 study (ID 734)
- Sang-We Kim (Seoul, Korea, Republic of)
Abstract
Background
Osimertinib, a 3rd-generation, CNS-active, oral EGFR-TKI, showed superior efficacy vs comparator EGFR-TKIs (erlotinib/gefitinib) in treatment-naïve EGFRm advanced NSCLC (median OS 38.6 vs 31.8 months; median PFS 18.9 vs 10.2 months). Gefitinib plus carboplatin/pemetrexed chemotherapy has shown improved ORR and PFS vs gefitinib alone. Combining osimertinib with platinum/pemetrexed may further improve patient outcomes.
Methods
The safety run-in to allow the opening of the phase III global FLAURA2 (NCT04035486) study was designed to assess safety and tolerability of osimertinib with platinum/pemetrexed chemotherapy. Thirty adults with confirmed EGFRm (ex19del/L858R) locally advanced/metastatic NSCLC, WHO PS 0/1, with no prior therapy for advanced disease, received osimertinib 80 mg QD, and either cisplatin 75 mg/m2 (n=15) or carboplatin AUC5 (n=15), plus pemetrexed 500 mg/m2 every 3 weeks (Q3W) for 4 cycles, then osimertinib 80 mg QD with pemetrexed 500 mg/m2 maintenance Q3W until discontinuation criteria were met (data cut-off [DCO] Feb 2020).
Results
Median age was 61 years (range 45–84), 63% female, 73% Asian, 37% smoker, 67% ex19del/33% L858R. At DCO, 23 (77%) pts had completed 4 cycles of carboplatin/cisplatin chemotherapy. 27 (90%) pts had adverse events (AEs; Table). Two (7%) pts discontinued all study treatments due to AEs, including 1 ILD (CTCAE grade 2) and 1 fatal AE (haemoptysis) attributed to NSCLC, unrelated to treatment. Grade 3 / 4 CTCAE haematological toxicities were reported by 7 / 2 (23 / 7%) pts; the majority recovered by DCO. ∗1 pt also discontinued all study treatment due to fatal AE.†1 pt switched from cisplatin to carboplatin after 1 cycle; pt completed 4 cycles of platinum chemotherapy.
n (%) Osimertinib + carboplatin + pemetrexed (n=15) Osimertinib + cisplatin + pemetrexed (n=15) Total (N=30) Any AE 15 (100) 12 (80) 27 (90) Treatment-related AE 15 (100) 12 (80) 27 (90) CTCAE grade ≥3 3 (20) 8 (53) 11 (37) Serious AE 3 (20) 3 (20) 6 (20) Death 1 (7) 0 1 (3) Discontinuation of any study drug 4 (27) 3 (20) 7 (23) Discontinuation of osimertinib 1∗ (7) 0 1 (3) Discontinuation of carboplatin/cisplatin 2 (13) 2† (13) 4 (13) Discontinuation of pemetrexed 3 (20) 3 (20) 6 (20)
Conclusions
Osimertinib plus platinum/pemetrexed chemotherapy was generally well tolerated; no new safety signals were identified. No clear differences were observed between chemotherapy regimens. These results support further assessment of this combination in the FLAURA2 randomised study period (planned enrolment: 556; primary endpoint: PFS).
Clinical trial identification
NCT04035486.
Editorial acknowledgement
Alexandra Webster, MSc, from iMed Comms, an Ashfield Company, part of UDG Healthcare plc, who provided medical writing support funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
D. Planchard: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy: Bristol-Myers Squibb; Boehringer Ingelheim; Celgene; Eli Lilly; Merck; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Pfizer; prIME Oncology; Honoraria (self), Advisory/Consultancy: Peer CME; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Daiichi Sankyo; Samsung. T.M. Kim: Honoraria (institution), Advisory/Consultancy: AstraZeneca; Boryung; Novartis; Regeneron; Roche/Genentech; Sanofi; Takeda; Voronoi; Research grant/Funding (self), outside this work: AstraZeneca-KHIDI. C.K. Lee: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: Takeda. N. Yanagitani: Advisory/Consultancy: Chugai Pharmaceutical Co., Ltd. S. Powar: Full/Part-time employment: AstraZeneca. X. Huang: Shareholder/Stockholder/Stock options, Full/Part-time employment: AstraZeneca. P. Howarth: Full/Part-time employment: AstraZeneca. P. Jänne: Advisory/Consultancy, Research grant/Funding (self): AstraZeneca, Boehringer Ingelheim; Licensing/Royalties: LabCorp; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Roche/Genentech; Advisory/Consultancy: Acea Biosciences; Advisory/Consultancy: Ignyta; Shareholder/Stockholder/Stock options: Loxo Oncology, Gatekeeper Pharmaceuticals; Advisory/Consultancy, Research grant/Funding (self): Eli Lilly pharmaceuticals; Advisory/Consultancy: Araxes pharmaceuticals; Advisory/Consultancy: SFJ Pharmarceuticals; Advisory/Consultancy: Voronoi; Advisory/Consultancy, Research grant/Funding (self): Daiichi Sankyo; Advisory/Consultancy: Biocartis; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Takeda Oncology; Advisory/Consultancy: Mirati Therapeutics; Research grant/Funding (self): Astellas Pharmaceuticals; Research grant/Funding (self): Puma; Research grant/Funding (self): Revolution Medicines; Research grant/Funding (self): Takeda Oncology. K. Kobayashi: Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Bristol-Myers Squibb Japan; Speaker Bureau/Expert testimony: Ono Pharmaceutical; Speaker Bureau/Expert testimony: Boehringer Ingelheim; Speaker Bureau/Expert testimony: Taiho Pharmaceutical Company. All other authors have declared no conflicts of interest.
381MO - Durability of clinical benefit and biomarkers in patients (pts) with advanced non-small cell lung cancer (NSCLC) treated with AMG 510 (sotorasib) (ID 538)
- Keunchil Park (Seoul, Korea, Republic of)
Abstract
Background
The phase I trial of sotorasib, a KRASG12C inhibitor, demonstrated a favorable safety profile and preliminary antitumor activity in pts with advanced solid tumors harboring KRAS p.G12C. Here, we present durability of clinical benefit and biomarker data in pts with NSCLC.
Methods
Key eligibility criteria include KRAS p.G12C mutation and prior systemic anticancer treatment (tx). Primary endpoint is safety; key secondary endpoints include objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and progression-free survival (PFS). KRAS p.G12C mutant allele frequency (MAF) and PD-L1 level were examined.
Results
As of July 17, 2019, 40 pts with NSCLC (22 female [55.0%], median age: 68.0 years [range: 49-77]) were enrolled. Data cutoff date was March 25, 2020. 31 (77.5%) and 19 pts (47.5%) received ≥ 2 and 3 prior lines of therapy, respectively. Median follow-up was 10.2 (range: 8.3–19.0) months (mos). 3 pts (7.5%) had adverse events leading to discontinuation. There were no dose-limiting toxicities or fatal tx-related adverse events. Median PFS for all pts was 6.9 (range: 1.2–13.9) mos. ORR was 30% (95% Cl, 16.56–46.53). DOR ranged from 1.6 (+) to 12.7 mos, with 7 of 12 responders still in response at data cutoff. DCR was 92.5% (95% Cl, 79.61–98.43). 18 pts (45.0%) had progressive disease. At data cutoff, 10 pts (25.0%) were on study without disease progression, and 9 pts (22.5%) died. 18 pts (45.0%) (5 partial response (PR), 12 stable disease (SD), 1 progressive disease (PD)) had KRAS p.G12C MAF data available. There was no significant association between KRAS p.G12C MAF and response (Wilcoxon P = 0.80 for PR vs SD). 11 pts (27.5%) had PD-L1 data available. The median PD-L1 tumor proportion score [TPS] was 3% (range: 1–5) in 2 pts with PR, 0% (range: 0–0) in 8 pts with SD, and 75% (range: 75–75) in the pt with PD (Wilcoxon P = 0.044 for PR vs. SD).
Conclusions
In pts with heavily pretreated NSCLC, durable responses to sotorasib were seen, with the majority of pts achieving disease control leading to a median PFS of 6.9 months. The current limited dataset suggests that neither KRAS p.G12C MAF nor PD-L1 expression level predicts response to sotorasib.
Clinical trial identification
NCT03600883.
Editorial acknowledgement
Medical writing support was provided by Liz Leight (Amgen Inc.).
Legal entity responsible for the study
Amgen Inc.
Funding
Amgen Inc.
Disclosure
D.S. Hong: Research grant/Funding (institution), Non-remunerated activity/ies: Bayer; Honoraria (self), Research grant/Funding (institution): Loxo; Mirati; Research grant/Funding (institution): Lilly; Genentech; Pfizer; Amgen; Ignyta; Merck; Daichii-Sanko; Eisai; Adaptimmune; AbbVie; AstraZeneca; BMS; Genmab; Infinity; Kite; MedImmune; Molecular Template, Novartis, Takeda; Non-remunerated activity/ies: Baxter, Guidepoint global, Oncoresponse, Janssen, Molecular Match, outside the submitted work. Y-J. Bang: Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Novartis; Genentech/Roche; MSD; Merck Serano; Bayer; BMS; Eli Lilly; Taiho; Daiich-Sankyo; Astellas; BeiGene; GreenCross; Advisory/Consultancy: Samyang Biopharm; Hanmi; Advisory/Consultancy, Research grant/Funding (institution): Genexine; Research grant/Funding (institution): GSK; Pfizer; Boeringer Ingelheim; MacroGenics, Boston Biomedical, FivePrime, Curis, Takeda, Ono, CKD Pharma. F. Barlesi: Honoraria (self), Leadership role, Research grant/Funding (institution), Principal Investigator for sponsored clinical trial: AstraZeneca; Bristol-Myers Squibb; F. Hoffmann-La Roche Ltd; Honoraria (self), Research grant/Funding (institution), Principal Investigator for sponsored clinical trial: Merck; Honoraria (self), Research grant/Funding (institution): Bayer; Boehringer Ingelheim; Eli Lilly Oncology; Novartis; MSD; Pierre Fabre; Pfizer; Takeda; Research grant/Funding (institution): AbbVie; ACEA; Amgen; Eisai; Genentech; Ipsen; Ignyta; Innate Pharma, Loxo, MedImmune, Sanofi-Aventis. G. Durm: Research grant/Funding (institution): Merck; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Bristol-Myers Squibb; Non-remunerated activity/ies: Amgen. G.S. Falchook: Honoraria (self): Wolters Kluwer; Advisory/Consultancy, Travel/Accommodation/Expenses: Fujifilm; EMD Serono; Travel/Accommodation/Expenses: Bristol-Myers Squibb; Millennium; Sarah Cannon Research Institute; Honoraria (self): Total Health Conferencing; Rocky Mountain Oncology Society; Research grant/Funding (institution): 3-V Biosciences; Abbisko; Abbvie; ADC Therapeutics; Aileron; American Society of Clinical Oncology; Amgen; ARMO; AstraZeneca; BeiGene; Bioatla; Celldex, Celgene, Ciclomed, Curegenix, Curis, Cyteir, Daiichi, DelMar, eFFECTOR, Eli Lilly, EMD Serono, Epizyme, Exelixis, Fujifilm, Genmab, GlaxoSmithKline, Hutchison MediPharma, Ignyta, Incyte, Jacobio, Jounce, Kolltan, Loxo, MedImmune, Millennium, Merc. K. Park: Advisory/Consultancy: Amgen. J.H. Strickler: Advisory/Consultancy, Research grant/Funding (institution): Amgen. T.F. Burns: Advisory/Consultancy: Novartis; Advisory/Consultancy: Blueprint Medicine; Advisory/Consultancy: Thermo Fisher Scientific. J. Kim; A. Ang; J.R. Lipford; G. Ngarmchamnanrith; A. Anderson: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. B.T. Li: Advisory/Consultancy: Thermo Fisher Scientific; Guardant Health; Mersana Therapeutics; Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Hengrui Therapeutics; Eli Lilly; Travel/Accommodation/Expenses: Resolution Bioscience; Research grant/Funding (institution), Travel/Accommodation/Expenses: MORE Health; Research grant/Funding (institution): Amgen; Daiichi Sankyo; AstraZeneca; BioMedValley Discoveries; Illumina; Research grant/Funding (institution): GRAIL ; Research grant/Funding (institution): Guardant Health. All other authors have declared no conflicts of interest.
382MO - The preliminary safety result of a phase II study of osimertinib in combination with platinum + pemetrexed in patients with previously untreated EGFR-mutated advanced NSCLC (NEJ032C/LOGIK1801: OPAL) (ID 282)
- Ryo Morita (Akita, Japan)
Abstract
Background
Based on the result of the FLAURA trial, osimertinib (OSI) is a standard of care in patients (pts) with previously untreated EGFR-mutated advanced non-small cell lung cancer (NSCLC). One of the promising strategies to further improve pts' outcome is a combination therapy with OSI and platinum-doublet chemotherapy.
Methods
An ongoing multicenter phase II study is assessing the safety and efficacy of OSI + cisplatin (CDDP)/carboplatin (CBDCA) + pemetrexed (PEM) in previously untreated pts with EGFR-mutated NSCLC. A total of 67 pts were enrolled in arm A (CDDP) or arm B (CBDCA) at the discretion of each investigator. In addition to OSI 80 mg administered orally daily, CDDP (75 mg/m2)/CBDCA (AUC=5) and PEM (500 mg/m2) were administered intravenously every 3 weeks for up to 4 cycles. Pts without disease progression (PD) after 4 cycles of induction therapy continued OSI + PEM until PD or unacceptable toxicity. The co-primary endpoints are safety and objective response rate, and the secondary endpoints include complete response rate, disease control rate, and progression-free survival.
Results
As of 25 Feb 2020, 67 pts (34 in arm A; 33 in arm B) were enrolled: (median age 67 [range, 26-75] years; 43 female [64.2%]; 46 ECOG PS 0 [68.7%]; 66 adenocarcinoma [98.5%]; 31 EGFR ex19del [46.3%], 35 ex21 L858R [52.2%], 1 both [1.5%]). At the data cut-off (31 Mar 2020), 11 pts (16.4%) discontinued treatment: 2 (3.0%) due to PD; 6 (9.0%) adverse event (AE); 3 (4.5%) pts’ withdraw. At least one dose reduction was required in 41.2% (arm A) and in 57.6% (arm B). Most common (>5%) Grade 3≥ AEs were neutropenia (37.3%), lymphocyte count decreased (29.9%), white blood cell decreased (25.4%), platelet count decreased (19.4%), anemia (17.9%), anorexia (7.5%) and alanine aminotransferase increased (6.0%). One patient in arm B experienced grade 4 QT prolongation and terminated protocol treatment.
Conclusions
This is the first study to explore the efficacy and safety of OSI in combination with platinum-based chemotherapy as the first line treatment. This combination treatment has been well tolerated and follow-up is ongoing.
Clinical trial identification
jRCTs031180226.
Legal entity responsible for the study
The authors.
Funding
AstraZeneca.
Disclosure
H. Asahina: Honoraria (self): AstraZeneca; Chugai; Kyowa Hakko Kirin. K. Tanaka: Honoraria (self): AstraZeneca; Eli Lilly; Advisory/Consultancy: AstraZeneca; Eli Lilly; Research grant/Funding (institution): AstraZeneca; Eli Lilly. S. Sugawara: Honoraria (self): AstraZeneca; Eli Lilly. R. Ko: Honoraria (self): Boehringer Ingelheim; Taiho Pharmaceutical; Chugai Pharmaceutical; Ono Pharmaceutical; Pfizer; AstraZeneca; Research grant/Funding (institution): Boehringer Ingelheim. S. Morita: Honoraria (self): AstraZeneca K.K.; Bristol-Myers Squibb Company; Chugai Pharmaceutical Co. Ltd.; Eli Lilly Japan K.K.; MSD K.K.; Nippon Boehringer Ingelheim Co. Ltd.; Ono Pharmaceutical Co. Ltd.; Pfizer Japan Inc.; Taiho Pharmaceutical Co. Ltd. M. Maemondo: Honoraria (self): AstraZeneca; Eli Lilly. M. Seike: Honoraria (self): AstraZeneca; Research grant/Funding (institution): Eli Lilly Japan. O. Isamu: Honoraria (self): AstraZeneca; Eli Lilly; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Eli Lilly. K. Sugio: Research grant/Funding (institution): MSD. K. Kobayashi: Speaker Bureau/Expert testimony: AstraZeneca; Bristol-Myers Squibb Japan; Ono Pharmaceutical; Taiho Pharmaceutical Company. All other authors have declared no conflicts of interest.
383MO - Tepotinib in Asian patients (pts) with advanced NSCLC with MET exon 14 (METex14) skipping (ID 293)
- James Chih-Hsin Yang (Taipei, Taiwan)
Abstract
Background
Tepotinib, an oral, once daily (QD), highly selective, potent MET inhibitor that has shown durable activity in pts with METex14 skipping advanced NSCLC, is approved in Japan. The phase II VISION study showed an overall objective response rate (ORR) of 44.5–47.4% by independent review (IRC), and 54.7–58.3% by investigator assessment (INV); onset of response was mostly observed within 6 weeks. Here, we report outcomes in Asian pts.
Methods
Pts with advanced EGFR/ALK wild-type and METex14 skipping NSCLC, detected by liquid or tissue biopsy, received oral tepotinib 500 mg QD until disease progression, intolerable toxicity, or withdrawal of consent. The primary endpoint was objective response (OR) (confirmed by two scans ≥4 weeks apart) by IRC; secondary endpoints were OR by INV, duration of response (DOR), progression-free survival (PFS), and safety. Pts evaluable for ORR had ≥2 post-baseline assessments or discontinuation for any reason.
Results
At data cut-off (Jan 1, 2020), 38 pts evaluable for efficacy were Asian with a median age of 70 years (52–85), 32% female, 39% non-smokers, and 32% treatment naïve. Asian pts were enrolled from Japan (50%), Korea (26%), Taiwan (13%), Spain (3%), and the US (8%). Efficacy of tepotinib in Asian pts was similar to the overall population; ORR (95% CI) was 47.4% (31.0, 64.2) by IRC (median DOR [mDOR] was not reached) and 60.5% (43.4, 76.0) by INV (mDOR was 10.9 months [9.7, ne]). Disease control rate (confirmed complete or partial response, or stable disease lasting ≥12 weeks) was 68.4% (51.3, 82.5) by IRC and 81.6% (65.7, 92.3) by INV. Although still immature, median PFS (95% CI) was 11.0 months (4.9, ne). Overall, 50 Asian pts received at least one dose of tepotinib. The most common adverse events (any cause) were peripheral edema, increased blood creatinine, and diarrhea. Grade ≥3 treatment-related adverse events (TRAEs) were observed in 26% of pts. TRAEs led to dose reductions in 28%, temporary discontinuation in 36%, and permanent discontinuation in 10% of pts.
Conclusions
Tepotinib showed robust, durable clinical activity in Asian pts with METex14 skipping NSCLC. Adverse events were mostly mild and manageable, with few discontinuations. The VISION study will enroll pts at 55 sites in Asia.
Clinical trial identification
NCT02864992; 13 September, 2016.
Editorial acknowledgement
Medical writing assistance (funded by Merck KGaA, Darmstadt, Germany) was provided by Syneos Health, London, UK.
Legal entity responsible for the study
Merck KGaA, Darmstadt, Germany.
Funding
Merck KGaA, Darmstadt, Germany.
Disclosure
J.C-H. Yang: Advisory/Consultancy, personal fees: Boehringer Ingelheim; Advisory/Consultancy, personal fees: Eli Lilly; Advisory/Consultancy, personal fees: Bayer; Advisory/Consultancy, personal fees: Roche/Genentech; Advisory/Consultancy, personal fees: Chugai Pharmaceutical; Advisory/Consultancy, personal fees: MSD; Advisory/Consultancy, personal fees: Pfizer; Advisory/Consultancy, personal fees: Novartis; Advisory/Consultancy, personal fees: BMS; Advisory/Consultancy, personal fees: Ono Pharmaceuticals; Advisory/Consultancy, personal fees: AstraZeneca; Advisory/Consultancy, personal fees: ACT Genomics; Advisory/Consultancy, personal fees: Merck Serono; Advisory/Consultancy, personal fees: Celgene; Advisory/Consultancy, personal fees: Yuhan Pharmaceuticals; Advisory/Consultancy, personal fees: Daiichi Sankyo; Advisory/Consultancy, personal fees: Hansoh Pharmaceuticals; Advisory/Consultancy, personal fees: Takeda Pharmaceuticals; Advisory/Consultancy, personal fees: Blueprint Medicines; Advisory/Consultancy, personal fees: Amgen. X. Le: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Research grant/Funding (self): Eli Lilly; Advisory/Consultancy: EMD Serono; Research grant/Funding (self): Boehringer Ingelheim. B.C. Cho: Advisory/Consultancy, Research grant/Funding (self): Novartis; Research grant/Funding (self): Bayer; Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Research grant/Funding (self): MOGAM Institute; Research grant/Funding (self): Dong-A ST; Research grant/Funding (self), Licensing/Royalties: Champions Oncology; Advisory/Consultancy, Research grant/Funding (self): Janssen; Advisory/Consultancy, Research grant/Funding (self): Yuhan; Advisory/Consultancy, Research grant/Funding (self): Ono; Research grant/Funding (self): Dizal Pharma; Advisory/Consultancy, Research grant/Funding (self): MSD; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Roche; Advisory/Consultancy: BMS; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Takeda; Advisory/Consultancy: Pfizer; Shareholder/Stockholder/Stock options: TheraCanVac Inc; Shareholder/Stockholder/Stock options: Gencurix Inc; Shareholder/Stockholder/Stock options: Bridgebio Therapeutics. M. Morise: Speaker Bureau/Expert testimony: Chugai; Speaker Bureau/Expert testimony: MSD; Speaker Bureau/Expert testimony: ONO; Speaker Bureau/Expert testimony: AstraZeneca. J-H. Kang: Research grant/Funding (self): CKD; Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy, Research grant/Funding (self): Yuhan; Research grant/Funding (self): Ono; Advisory/Consultancy, Research grant/Funding (self): Boehringer Ingelheim; Research grant/Funding (self): Daichii Sankyo; Advisory/Consultancy: MSD; Advisory/Consultancy: Roche; Advisory/Consultancy: BMS; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Genexin. T. Kato: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Spouse/Financial dependant, Immediate family member employment: Lilly; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Chugai Pharma; Honoraria (self), Advisory/Consultancy: Nitto Denko; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AbbVie; Advisory/Consultancy, Research grant/Funding (institution): Merck Serono; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Honoraria (self): Roche; Honoraria (self): Boehringer Ingelheim; Honoraria (self), Research grant/Funding (institution): Ono Pharmaceutical; Honoraria (self), Research grant/Funding (institution): Taiho Pharmaceutical; Honoraria (self), Research grant/Funding (self): BMS; Honoraria (self), Research grant/Funding (institution): Merck Sharp & Dohme; Honoraria (self), Research grant/Funding (self): Novartis; Honoraria (self): Sumitomo Dainippon Pharma; Honoraria (self): Takeda; Honoraria (self): Merck KGaA; Honoraria (self): Daiichi Sankyo; Honoraria (self): Shionogi; Honoraria (self): Nippon Kayaku; Research grant/Funding (self): Kyorin; Research grant/Funding (self): Regenoron; Research grant/Funding (self), Research grant/Funding (institution): Kyowa Hakko Kirin. H. Sakai: Speaker Bureau/Expert testimony: BMS; Speaker Bureau/Expert testimony: Ono Pharmaceutical; Speaker Bureau/Expert testimony: MSD K.K.; Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Chugui Pharma; Speaker Bureau/Expert testimony: Taiho Pharmaceutical; Speaker Bureau/Expert testimony: Boehringer Ingelheim; Speaker Bureau/Expert testimony: Merck KGaA. K. Park: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Clovis; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Hanmi; Advisory/Consultancy: Novartis; Advisory/Consultancy: Ono; Advisory/Consultancy: Roche. Y-L. Wu: Advisory/Consultancy, Research grant/Funding (institution), personal fees: AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution), personal fees: Roche; Advisory/Consultancy, Research grant/Funding (institution), personal fees: Boehringer Ingelheim; Speaker Bureau/Expert testimony, personal fees (speaker): BMS; Speaker Bureau/Expert testimony, personal fees (speaker): MSD; Speaker Bureau/Expert testimony, personal fees (speaker): Eli Lilly; Speaker Bureau/Expert testimony, personal fees (speaker): Pfizer. K. Schumacher, R. Bruns, J. Straub: Full/Part-time employment: Merck KGaA, Darmstadt, Germany. P. Paik: Advisory/Consultancy: AbbVie; Advisory/Consultancy: BMS; Advisory/Consultancy: Calithera; Advisory/Consultancy, Research grant/Funding (institution): Celgene; Advisory/Consultancy: Lilly; Advisory/Consultancy: Takeda; Research grant/Funding (self), Research grant/Funding (institution): EMD Serono. All other authors have declared no conflicts of interest.
Invited Discussant abstracts 356MO, 366MO, 381MO, 382MO and 383MO (ID 1109)
- Ross A. Soo (Singapore, Singapore)
LIVE Q&A (ID 1110)
- Takashi Seto (Fukuoka, Fukuoka, Japan)