Background

The phase III CheckMate 816 study demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and pathologic complete response (pCR) with neoadjuvant N + C vs C in patients (pts) with resectable NSCLC. Here, we report 3-y efficacy, safety, and exploratory biomarker analyses from CheckMate 816.

Methods

Adults with stage IB (tumors ≥4 cm)–IIIA (per AJCC 7th ed) resectable NSCLC, ECOG PS ≤ 1, and no known EGFR/ALK alterations were randomized to N 360 mg + C Q3W or C alone Q3W for 3 cycles followed by surgery. Primary endpoints were EFS and pCR, both per blinded independent review. Exploratory analyses included EFS by surgical approach and extent/completeness of resection, and EFS and pCR by a 4-gene (CD8A, CD274, STAT-1, LAG-3) inflammatory signature score derived from RNA sequencing of baseline (BL) tumor samples.

Results

At a median follow-up of 41.4 mo (database lock, Oct 14, 2022), continued EFS benefit was observed with N + C vs C (HR, 0.68; 95% CI, 0.49–0.93); 3-y EFS rates were 57% and 43%, respectively. N + C improved EFS vs C in pts who had surgery, regardless of surgical approach or extent of resection, and in pts with R0 resection (table). Recurrence occurred in 28% and 42% of pts who had surgery in the N + C (n = 149) and C arms (n = 135), respectively. In the N + C arm, BL 4-gene inflammatory signature scores were numerically higher in pts with pCR vs pts without, and EFS was improved in pts with high vs low scores (data to be presented). Grade 3–4 treatment-related and surgery-related adverse events occurred in 36% and 11% of pts in the N + C arm, respectively, vs 38% and 15% in the C arm.

Conclusions

Neoadjuvant N + C continues to provide long-term clinical benefit vs C in pts with resectable NSCLC, regardless of surgical approach or extent of resection. Exploratory analyses in pts treated with N + C suggested that high BL tumor inflammation may be associated with improved EFS and pCR.

Clinical trial identification

NCT02998528.

Editorial acknowledgement

Medical writing and editorial support for the development of this abstract, under the direction of the authors, was provided by Adel Chowdhury, PharmD, Samantha Dwyer, PhD, and Michele Salernitano of Ashfield MedComms, an Inizio company, and funded by Bristol Myers Squibb.

Legal entity responsible for the study

Bristol Myers Squibb.

Funding

Bristol Myers Squibb.

Disclosure

P.M. Forde: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, F-Star, G1 Therapeutics, Genentech, Iteos, Janssen, Merck, Novartis, Sanofi, Surface; Financial Interests, Institutional, Research Grant: AstraZeneca, BioNTech, Bristol Myers Squibb, Corvus, Kyowa, Novartis, Regeneron; Financial Interests, Personal, Other, Trial steering committee member: AstraZeneca, BioNTech, Bristol Myers Squibb, Corvus; Non-Financial Interests, Personal, Member of the Board of Directors: Mesothelioma Applied Research Foundation; Non-Financial Interests, Personal, Advisory Role, Scientific advisory board member: LUNGevity Foundation.

J. Spicer: Financial Interests, Institutional, Research Grant: AstraZeneca, Bristol Myers Squibb, CLS Therapeutics, Merck, Protalix Biotherapeutics, Roche; Financial Interests, Personal, Other, Consulting fees: Amgen, AstraZeneca, Bristol Myers Squibb, Merck, Novartis, Protalix Biotherapeutics, Regeneron, Roche, Xenetic Biosciences; Financial Interests, Personal, Speaker's Bureau: AstraZeneca, Bristol Myers Squibb, PeerView; Non-Financial Interests, Personal, Other, Data safety monitoring board member: Deutsche Forschungsgemeinschaft; Non-Financial Interests, Personal, Leadership Role, Industry chair: Canadian Association of Thoracic Surgeons.

N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi; Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer Ingelheim, Novartis, Sanofi, AbbVie, Amgen, Eli Lilly, Grunenthal, Takeda, Owkin; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS; Non-Financial Interests, Personal, Officer, International Thymic malignancy interest group, president: ITMIG; Other, Personal, Other, Family member is an employee: AstraZeneca.

M. Provencio: Financial Interests, Institutional, Research Grant: AstraZeneca, Bristol Myers Squibb, Janssen, Pfizer, Roche, Takeda; Financial Interests, Personal, Speaker's Bureau: AstraZeneca, Bristol Myers Squibb, MSD, Pfizer, Roche, Takeda.

S. Lu: Financial Interests, Personal, Advisory Role: AstraZeneca, Boehringer Ingelheim, GenomiCare, Hutchison MediPharma, Roche, Simcere, ZaiLab; Financial Interests, Personal, Speaker's Bureau: AstraZeneca, Hanosh, Roche.

M. Awad: Financial Interests, Personal, Other, Consulting fees: ArcherDX, Ariad, AstraZeneca, Blueprint Medicine, Bristol Myers Squibb, EMD Serono, Genentech, Maverick, Merck, Mirati, Nektar, NextCure, Novartis, Syndax; Financial Interests, Institutional, Research Grant: AstraZeneca, Bristol Myers Squibb, Genentech, Eli Lilly.

T. Mitsudomi: Financial Interests, Institutional, Research Grant: Boehringer Ingelheim, BridgeBio Pharma; Financial Interests, Personal, Other, Consulting fees: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, MSD, Novartis, Ono, Pfizer; Financial Interests, Personal, Speaker's Bureau: Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, Daiichi Sankyo, Eli Lilly, Guardant, Invitae, Merck, MSD, Novartis, Ono, Pfizer, Taiho; Financial Interests, Personal, Advisory Board: AstraZeneca; Non-Financial Interests, Personal, Leadership Role, Former president: IASLC.

E. Felip: Financial Interests, Institutional, Research Grant: Fundación Merck Salud, Merck KGAa; Financial Interests, Personal, Other, Consulting fees: Amgen, AstraZeneca, Bayer, BerGenBio, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, F. Hoffmann-La Roche, GlaxoSmithKline, Janssen, Merck, MSD, Novartis, Peptomyc, Pfizer, Sanofi, Takeda; Financial Interests, Personal, Speaker's Bureau: Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Janssen, Medical Trends, Medscape, Merck, MSD, PeerVoice, Pfizer, Sanofi, Takeda, touchONCOLOGY; Non-Financial Interests, Personal, Member of the Board of Directors: Grífols.

S.J. Swanson: Financial Interests, Personal, Speaker's Bureau: Ethicon.

F. Tanaka: Financial Interests, Institutional, Research Grant: Boehringer Ingelheim, Chugai, Eli Lilly, Ono, Taiho; Financial Interests, Personal, Other, Consulting fees: AstraZeneca, Chugai, Ono; Financial Interests, Personal, Speaker's Bureau: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, Covidien, Eli Lilly, Intuitive, Johnson & Johnson, Kyowa Kirin, MSD, Olympus, Ono, Pfizer, Stryker, Taiho, Takeda.

P. Tran: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb.

N. Hu: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb.

J. Cai: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb; Financial Interests, Personal, Other, Travel support for attending meetings and travel: Bristol Myers Squibb.

J. Bushong: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb.

J. Neely: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb.

D. Balli: Financial Interests, Personal, Other, patents planned, issued, or pending: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb.

S.R. Broderick: Financial Interests, Personal, Advisory Board: AstraZeneca.

All other authors have declared no conflicts of interest.

Background

EMPOWER-Lung 3, a randomized, double-blind, placebo-controlled phase III trial, examined cemiplimab (anti-PD-1) plus chemotherapy (chemo) in patients with advanced non-small cell lung cancer (NSCLC) without EGFR, ALK or ROS1 aberrations, with either squamous or non-squamous histology and any level of PD-L1 expression. Previously we reported that, after 16.4 months follow-up, cemiplimab + chemo improved median overall survival (OS) over chemo alone (21.9 vs 13.0 months, HR = 0.71, 0.53–0.93). Here, we report longer-term data after 28.4 months follow-up.

Methods

Patients were randomized 2:1 to receive 4 cycles of platinum-doublet chemo, with 350 mg cemiplimab (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and objective response rates (ORR).

Results

After a median of 28.4 months follow-up, cemiplimab + chemo continued to show significantly improved OS and PFS vs chemo alone. Median OS was 21.1 months for cemiplimab + chemo vs 12.9 months for chemo alone (HR = 0.65, 0.51–0.82, p = 0.0003). Median PFS was 8.2 months for cemiplimab + chemo vs 5.5 months for chemo alone (HR = 0.55, 0.44–0.68, p < 0.0001). ORRs were 43.6% vs 22.1%, with a duration of response of 16.4 and 7.3 months, respectively. Safety profiles for longer-term use of cemiplimab + chemo were generally consistent with previously reported data; Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 48.7% of patients in cemiplimab + chemo and 32.7% in chemotherapy alone.

Conclusions

At 28.4 months of follow-up, the EMPOWER-3 Lung trial continues to show an improvement in benefit of cemiplimab in combination with chemo, compared to chemo alone, for patients with advanced squamous and non-squamous NSCLC, regardless of PD-L1 expression level and without EGFR, ALK or ROS1 aberrations.

Clinical trial identification

NCT03409614.

Editorial acknowledgement

Medical writing support was provided by Rachel McGrandle, MSc, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc. and Sanofi. Responsibility for all opinions, conclusions, and data interpretation lies with the authors.

Legal entity responsible for the study

Regeneron Pharmaceuticals, Inc.

Funding

Regeneron Pharmaceuticals, Inc. and Sanofi.

Disclosure

K.D. Penkov: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Merck Sharp & Dohme, Nektar, Pfizer, Regeneron Pharmaceuticals, Inc., Roche; Financial Interests, Personal, Advisory Role: Nektar. E. Kalinka: Financial Interests, Personal, Other, Honoraria: Amgen, AstraZeneca, Bristol-Myers Squibb, Merck Sharp & Dohme, Nektar, Pfizer, Roche, Regeneron Pharmaceuticals, Inc. S. Li: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. Y. Li: Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc. M. Kaul: Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc. J. Pouliot: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. F. Seebach: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. I. Lowy: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. G. Gullo: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. P. Rietschel: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.

Background

Despite treatment (tx) with anti–PD-L1/PD-1 (αPD-(L)1) and platinum-based chemo, mNSCLC often progresses, suggesting a need for new second/third-line tx options. The TKI cabo may enhance αPD-(L)1 efficacy by promoting an immune-permissive environment. CONTACT-01 is a multicentre, randomised, open-label Ph3 study of atezo (anti–PD-L1) + cabo vs doc in pts with mNSCLC previously treated with αPD-(L)1 + chemo.

Methods

Eligible pts had ECOG PS 0-1, histologically or cytologically confirmed mNSCLC with progression after αPD-(L)1 + chemo (concurrent or sequential; regardless of response to prior αPD-(L)1) and any known PD-L1 status (or available tissue for central testing). Pts were randomised 1:1 to atezo 1200 mg IV q3w + cabo 40 mg PO qd or doc 75 mg/m² IV q3w. Stratification factors were sq vs nsq histology and sequence of prior NSCLC regimens. The primary EP was OS (ITT). Key secondary EPs were PFS, ORR, DOR and safety.

Results

Of 366 pts assigned to either atezo + cabo (n = 186) or doc (n = 180), 61% and 71% had ECOG PS 1, and 74% and 76% had nsq histology, respectively; median age was 64 and 66 y. At data cutoff 28 Sep 2022, minimum follow-up was 10.9 mo. No statistically significant OS benefit was seen with atezo + cabo vs doc (table). Median tx duration was 4.2 mo (range, 0–20; atezo), 3.9 mo (0–21; cabo) and 2.1 mo (0–19; doc). All-cause AEs occurred in 98% (G3-4, 48%) of safety-evaluable pts in the atezo + cabo arm and 94% (G3-4, 45%) in the doc arm and led to discontinuation in 17% and 14% of pts, respectively. G3-4 AEs of special interest for atezo were seen in 15% and 4% (G5 in 1% and 0%) and for cabo in 14% and 2% (G5 in 2% and 2%), respectively. G5 tx-related AEs occurred in 4 pts (2%) in the atezo + cabo arm and 1 pt (<1%) in the doc arm.

Conclusions

In this final OS analysis of CONTACT-01, atezo + cabo was not superior to doc in the ITT population. No new safety signals arose.

Clinical trial identification

NCT04471428.

Editorial acknowledgement

Editorial support for this abstract was provided by Michael Williams, PhD, of Health Interactions, Inc.

Legal entity responsible for the study

F. Hoffmann-La Roche, Ltd.

Funding

F. Hoffmann-La Roche, Ltd.

Disclosure

J. Neal: Financial Interests, Personal, Advisory Board: AstraZeneca, Genentech/Roche, Exelixis, Jounce Therapeutics, Takeda Pharmaceuticals, Eli Lilly and Company, Calithera Biosciences, Amgen, Iovance Biotherapeutics, Blueprint Pharmaceuticals, Regeneron Pharmaceuticals, Natera, Sanofi/Regeneron, D2G Oncology, Surface Oncology, Turning Point Therapeutics, Mirati Therapeutics; Financial Interests, Institutional, Funding: Genentech/Roche, Merck, Novartis, Boehringer Ingelheim, Exelixis, Nektar Therapeutics, Takeda Pharmaceuticals, Adaptimmune, GSK, Janssen, AbbVie; Other, Personal, Other, Honoraria: CME Matters, Clinical Care Options CME, Research to Practice CME, Medscape CME, Biomedical Learning Institute CME, MLI Peerview CME, Prime Oncology CME, Projects in Knowledge CME, Rockpointe CME, MJH Life Sciences CME, Medical Educator Consortium, HMP Education. N. Pavlakis: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, MSD, Merck KgA, BMS, AstraZeneca, Takeda, Pfizer, Roche, Amgen, BeiGene, Novartis, AllVascular; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Institutional, Invited Speaker: Bayer, Roche, Pfizer. Y. Goto: Financial Interests, Personal, Other, Honoraria (lecture fees): AstraZeneca, Pfizer, Novartis, Eli Lilly Japan. S.M. Lim: Financial Interests, Institutional, Invited Speaker: AstraZeneca, Boehringer Ingelheim, BridgeBio Therapeutics, Roche, GSK, Jiansu Hengrui; Financial Interests, Personal, Invited Speaker: Oscotec. G. Mountzios: Financial Interests, Personal, Advisory Board: Roche, BMS, Takeda, Janssen; Financial Interests, Personal, Invited Speaker: MSD, AstraZeneca, Pfizer, Novartis, Amgen. E. Fountzilas: Financial Interests, Personal, Other, Travel Grant: Merck, Pfizer, K.A.M. Oncology/Hematology; Financial Interests, Personal, Other, Speaker's fees: Roche, Leo, Pfizer; Financial Interests, Personal, Stocks/Shares: Deciphera Pharmaceuticals, Inc. D.C.C. Christoph: Financial Interests, Personal and Institutional, Other, Grants or contracts, consulting fees, payment or honoraria, payment for expert testimony, support for attending meetings and/or travel, participation on a data safety monitoring board/advisory board, and other payments made to institutions: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, Merck Sharpe & Dohme, Novartis, Pfizer, Roche, Sanofi, Takeda. A. Bearz: Financial Interests, Personal, Advisory Role, Speaking fees: Pfizer, Takeda, Boehringer Ingelheim, Merck Sharp & Dohme, AstraZeneca, Eli Lilly. X. Quantin: Financial Interests, Institutional, Invited Speaker: Sanofi; Financial Interests, Institutional, Advisory Board: BMS; Financial Interests, Personal, Other, Educational support: AstraZeneca. R. Palmero: Financial Interests, Personal, Invited Speaker: Guardant Health, Pfizer, Roche, Boehringer Ingelheim, Eli Lilly, Bristol-Myers Squibb, AstraZeneca, Merck-Sharp-Dome; Financial Interests, Personal, Other, ravel/meeting attendance expenses: Merck-Sharp-Dome, Roche; Financial Interests, Personal, Advisory Role, membership of data safety monitoring: Boehringer Ingelheim, Roche. V. Antic: Financial Interests, Personal, Full or part-time Employment: Roche; Financial Interests, Personal, Stocks/Shares: Roche. E. Chun: Financial Interests, Personal, Full or part-time Employment: Genentech; Financial Interests, Personal, Stocks/Shares: Roche. T. Rao Edubilli: Financial Interests, Personal, Full or part-time Employment: Roche; Financial Interests, Personal, Stocks/Shares: Roche. Y. Lin: Financial Interests, Personal, Full or part-time Employment: Genentech; Financial Interests, Personal, Stocks/Shares: Roche. M. Huseni: Financial Interests, Personal, Full or part-time Employment: Genentech; Financial Interests, Personal, Stocks/Shares: Roche. C. Scheffold: Financial Interests, Personal, Full or part-time Employment: Exelixis. P. Vervaet: Financial Interests, Personal, Full or part-time Employment: Exelixis. T. Newsom-Davis: Financial Interests, Personal, Other, Consulting fees: Takeda, Pfizer, Roche, Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Chugai, Janssen, Eli Lilly, Merck, MSD, Novartis, and Otsuka; Financial Interests, Personal, Other, Honoraris for lectures/presentations: Takeda, Pfizer, Roche, Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Chugai, Janssen, Eli Lilly, Merck, MSD, Novartis, and Otsuka; Financial Interests, Personal, Other, Support for attending meetings and/or travel: AstraZeneca, BMS, Boehringer Ingelheim, MSD, Roche, and Takeda; Financial Interests, Personal, Leadership Role, Chair of the Independent Monitoring Committee: Roche, BluePrint Medicines. All other authors have declared no conflicts of interest.

Background

Most patients with SCLC relapse within 1 year of receiving first-line (1L) platinum therapy; second-line treatment options are limited. We report the results of RESILIENT, a randomized, open-label phase III trial of liposomal irinotecan versus topotecan in patients with SCLC that had progressed on or after 1L platinum-based therapy.

Methods

Eligible patients with histologically or cytologically confirmed SCLC and radiologically confirmed disease progression despite 1L platinum-based chemotherapy were randomized (1:1) to receive intravenous liposomal irinotecan (70 mg/m², every 2 weeks in a 6-week cycle) or topotecan (1.5 mg/m²/day for 5 days, every 3 weeks in a 6-week cycle). The primary endpoint of overall survival (OS) was evaluated by log-rank test (stratified by region and platinum sensitivity) with 1-sided significance of 0.023. Secondary endpoints included progression-free survival (PFS) and objective response rate (ORR) per blinded independent central review (BICR).

Results

Overall, 461 patients (median [range] age, 62.0 [28.0–82.0] years; 67.9% men; 74.2% ECOG performance status 1) were randomized to receive liposomal irinotecan (n = 229) or topotecan (n = 232); median follow-up was 18.4 months. Median OS and PFS were 7.9 months and 4.0 months, respectively, with liposomal irinotecan versus 8.3 months and 3.3 months with topotecan. Hazard ratios (HRs) and 95% confidence intervals (CIs) for death, and for disease progression or death, are shown in the table together with ORR and grade >3 treatment-related treatment-emergent adverse events (TEAEs) occurring in >10% of either treatment group.

Conclusions

The primary endpoint of OS for was not met for liposomal irinotecan versus topotecan; however, a doubling of ORR was observed. The safety profile of liposomal irinotecan was consistent with its known safety profile and no new safety concerns emerged.

Clinical trial identification

NCT03088813.

Editorial acknowledgement

Medical writing support was provided by Emma Bolton, PhD, of Oxford PharmaGenesis, Oxford, UK which was funded by Ipsen in accordance with Good Publication Practice 2022 guidelines.

Legal entity responsible for the study

Ipsen.

Funding

Ipsen.

Disclosure

A. Dowlati: Financial Interests, Institutional, Other, Consultancy: AbbVie/Stemcentrx, ARIAD Pharmaceuticals; Financial Interests, Institutional, Research Grant: Amgen, Bristol Myers Squibb, Eli Lilly/ImClone Systems, EMD Serono, MedImmune; Financial Interests, Personal, Research Grant: OncoMed. Y. Chen: Financial Interests, Personal, Invited Speaker: Array BioPharma, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Genentech, Guardant Health, Heron Therapeutics, Merck, Novartis, Pfizer, Takeda; Financial Interests, Personal, Other, Consultant: Array BioPharma, AstraZeneca, Bristol Myers Squibb, Genentech, Heron Therapeutics, Novartis, Pfizer, Takeda; Financial Interests, Institutional, Funding: AstraZeneca; Financial Interests, Personal, Funding: Bristol Myers Squibb, Guardant Health, Helsinn, Ipsen, Roche; Non-Financial Interests, Personal, Expert Testimony: AstraZeneca, Takeda; Financial Interests, Institutional, Other, Clinical trials: AstraZeneca; Financial Interests, Personal, Other, Clinical trials: Bristol Myers Squibb, Ipsen, Roche. A.F. Navarro Mendivil: Other, Institutional, Advisory Board: Boehringer Ingelheim, Oryzon Genomics, Amgen, Hengenix Biotech, MedSIR; Other, Institutional, Speaker's Bureau: Roche, AstraZeneca, BMS, Pfizer, Takeda. J.C. Yang: Financial Interests, Institutional, Advisory Board: AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Amgen, Novartis, Bayer, GSK, Takeda Oncology, Puma Pharmaceuticals, Ono Pharmaceuticals, Merck Serono, MSD, Pfizer, Eli Lilly, Roche/Genentech, Janssen; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Boehringer Ingelheim, Novartis, AstraZeneca, MSD, Ipsen, Takeda Oncology; Financial Interests, Personal, Advisory Board: Yuhan Pharmaceuticals; Financial Interests, Personal, Invited Speaker: Dizal Pharmaceutical, Novartis, Numab, Merck, Daiichi Sankyo, Eli Lilly, Bayer, Janssen; Non-Financial Interests, Personal, Leadership Role, Board of Director: IASLC; Non-Financial Interests, Personal, Member: ASCO.

G. Stojanovic: Other, Institutional, Invited Speaker: MSD, Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca. Z.G. Andric: Financial Interests, Personal, Invited Speaker: MSD, Roche, AstraZeneca, Novartis, Merck-D. Y. Wu: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, Hengrui, Merk, MSD, Pfizer, Roche, Sanofi, AstraZeneca, Boehringer Ingelheim, BMS, Hengrui, Merk, MSD, Pfizer, Roche, Sanofi, Yunhan, Eli Lilly; Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Takeda; Non-Financial Interests, Personal, Leadership Role: Chinese Thoracic Oncology Group (CTONG); Non-Financial Interests, Personal, Other, WCLC 2020 Conference Chair: IASLC; Non-Financial Interests, Personal, Leadership Role, Past President: Chinese Society of Clinical Oncology (CSCO). H. Chen: Financial Interests, Personal and Institutional, Other, Employee: Ipsen. L. Zhang: Financial Interests, Institutional, Full or part-time Employment: Ipsen. S. Yeung: Financial Interests, Institutional, Full or part-time Employment: Ipsen. F.M. Benzaghou: Financial Interests, Institutional, Full or part-time Employment: Ipsen. L. Paz-Ares: Financial Interests, Personal, Advisory Board, Speaker fees: Roche, MSD, BMS, AstraZeneca, Eli Lilly, PharmaMar, BeiGene, Daiichi Sankyo, Medscape, PER; Financial Interests, Personal, Advisory Board: Merck Serono, Pfizer, Bayer, Amgen, Janssen, GSK, Novartis, Takeda, Sanofi, Mirati; Financial Interests, Personal, Other, Board member: Genomica, Altum sequencing; Financial Interests, Institutional, Invited Speaker: Daiichi Sankyo, AstraZeneca, Merck Sharp & Dohme, BMS, Janssen-Cilag international NV, Novartis, Roche, Sanofi, Tesaro, Alkermes, Eli Lilly, Takeda, Pfizer, PharmaMar; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Other, Member: AACR, ASCO, ESMO; Financial Interests, Personal, Other, Foundation Board Member: AECC; Financial Interests, Personal, Other, President ASEICA (Spanish Association of Cancer Research): ASEICA; Financial Interests, Personal, Other, Foundation president: ONCOSUR; Financial Interests, Personal, Other, member: Small Lung Cancer Group. P.A. Bunn: Financial Interests, Personal, Other, Consultancy: AstraZeneca, Ascentage, C-Stone, Genentech, Imidex, Ipsen, Celgene, Merck, Viecure. All other authors have declared no conflicts of interest.