LBA1 - Efficacy and safety of adjuvant alectinib vs platinum-based chemotherapy (CT) in patients (pts) from Asia with resected, early-stage ALK+ non-small cell lung cancer (NSCLC): A sub analysis of ALINA

Background

Adjuvant CT yields modest survival benefits in pts with resected early-stage ALK+ NSCLC. Alectinib has shown efficacy in pts with advanced ALK+ NSCLC. ALINA (NCT03456076) is a global, open-label, phase 3, randomized trial of adjuvant alectinib vs CT in pts with resected stage IB–IIIA, ALK+ NSCLC. In the global ALINA population, a significant disease-free survival (DFS) benefit was seen with alectinib vs CT (hazard ratio [HR] in the stage IB–IIIA population [n=257]: 0.24, 95% CI 0.13–0.43, p<0.0001). This subgroup analysis focuses on the pts enrolled in South Korea, mainland China, Japan, Taiwan and Thailand.

Methods

Eligible pts were ≥18 years old with an ECOG PS of 0/1 and completely resected, stage IB (≥4 cm)–IIIA ALK+ NSCLC (UICC/AJCC 7^th edition). Pts were randomized 1:1 to receive oral alectinib 600 mg twice daily for up to 24 months or platinum-based CT for four 21-day cycles. Stratification factors were stage (IB vs II vs IIIA) and race (Asian vs non-Asian). Primary endpoint: investigator-assessed DFS, evaluated in the stage II–IIIA and the stage IB–IIIA populations. Other endpoints included CNS-DFS, overall survival (OS), and safety.

Results

At data cutoff (26 June 2023), 140 pts (alectinib: n=69; CT: n=71) from Asia were enrolled. Median follow up was 28 months. Baseline characteristics were well balanced between arms. A clinically meaningful benefit in DFS (stage IB–IIIA: HR 0.39, 95% CI 0.18–0.85; Table) and CNS-DFS (stage IB–IIIA: HR 0.24, 95% CI 0.05–1.12) was observed with alectinib vs CT in Asian pts. OS data were immature. The overall safety of alectinib was generally consistent with its known risk profile.

Conclusions

ALINA is the first phase 3 trial in resected ALK+ NSCLC. Consistent with the global ALINA data, adjuvant alectinib was associated with clinically meaningful DFS and CNS-DFS benefits vs CT, and had a manageable safety profile, in pts from Asia with resected ALK+ NSCLC. Table: LBA1

AE, adverse event; NE, not estimable *No Grade 5 AE reported

Clinical trial identification

NCT03456076.

Editorial acknowledgement

Medical writing support for the development of this abstract, under the direction of the authors, was provided by Tahmina Alam, MA, of Ashfield MedComms, an Inizio Company, and funded by F. Hoffmann-La Roche Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

J.S. Ahn: Financial Interests, Personal, Advisory Role: Immuneoncia, Daiichi Sankyo Korea, Pharmbio Korea, Therapex, Guardant, Yuhan, Bayer Korea, Yooyoung; Financial Interests, Personal, Invited Speaker: Novartis Korea, Yuhan, Samyang, Amgen Korea, Boryung, BC World, Takeda Korea, Menarini Korea, Pfizer, Lilly Korea, Boehringer Ingelheim, Kyowa Kirin, AstraZeneca Korea, Bayer Korea; Financial Interests, Institutional, Local PI: Roche, GSK, WEX Pharmaceuticals, Yuhan, Daiichi Sankyo, Bridgebio Therapeutics, Paxman, Jiansu Hengrul Medicine, AstraZeneca; Financial Interests, Personal and Institutional, Steering Committee Member: Roche. Y. Wu: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, Hengrui, Merck, MSD, Pfizer, Roche, Sanofi; Financial Interests, Institutional, Research Grant: AstraZeneca, BMS, Boehringer Ingelheim ; Non-Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Takeda; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, Hengrui, Merck, MSD, Pfizer, Roche. R. Dziadziuszko: Financial Interests, Personal, Invited Speaker: Roche, Pfizer, Amgen; Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Takeda, Novartis, MSD, Bristol Myers Squibb, Pfizer. F. Barlesi: Financial Interests, Institutional, Advisory Board: AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd., Novartis, Merck, Mirati, MSD, Pierre Fabre, Pfizer, Sanofi Aventis, Seattle Genetics, Takeda, AbbVie, ACEA, Amgen, Eisai, Ignyta; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca, BMS, Merck, Pierre Fabre, F. Hoffmann-La Roche Ltd., Innate Pharma, Mirati. M. Nishio: Financial Interests, Personal, Invited Speaker, lectures fee: Ono Pharmaceuticals; Financial Interests, Personal, Invited Speaker, lectures: Chugai Pharmaceutical, Taiho Pharmaceutical, Bristol Myers Squibb, Daiichi Sankyo, AstraZeneca, MSD, AbbVie, Takeda, Pfizer, Boehringer Ingelheim, Novartis, Nippon Kayaku, Merck, Janssen; Financial Interests, Personal, Invited Speaker, lectures,: Lilly. D.H. Lee: Financial Interests, Personal, Advisory Role: AbbVie, AstraZeneca, Boheringer Ingelheim, Bristol Myers Squibb, Eli Lilly ChongKeunDang, Janssen, MSD, Novartis, Ono, Pfizer, Roche, ST Cube, Takeda, BC World Pharm, Yuhan. H. Horinouchi: Financial Interests, Personal, Invited Speaker: AstraZeneca, Roche/Chugai, Amgen, AbbVie, Daiichi Sankyo, BMS, Ono, MSD; Financial Interests, Institutional, Research Grant: AstraZeneca, AbbVie, Roche/Chugai, Daiichi Sankyo, MSD, BMS, Ono, Jansen, Bayer, Amgen; Financial Interests, Personal, Advisory Board: AstraZeneca, AbbVie, Daiichi Sankyo, BMS, Ono, Amgen; Financial Interests, Institutional, Principal Investigator: AstraZeneca, AbbVie, Roche/Chugai, MSD, BMS, Ono. S. Lu: Financial Interests, Personal, Advisory Role: AstraZeneca, Pfizer, Hutchison MediPharma, ZaiLab, GenomiCare, Novartis, Yuhan Corporation, Menarini, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., D3 Bio Limited, Simcere, Takeda, Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca, Roche, Hansoh; Non-Financial Interests, Personal, Member of Board of Directors: Innovent Biologics, Inc.; Financial Interests, Personal, Research Grant: AstraZeneca, Hutchison, BMS, Heng Rui BeiGene, Roche, Hansoh; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Roche, Hansoh. C. Yang: Non-Financial Interests, Personal and Institutional, Local PI: AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Daiichi Sankyo, Eli Lilly, Gilead Sciences, Novartis, Ono, Pfizer, Takeda; Non-Financial Interests, Personal and Institutional, Principal Investigator: AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Daiichi Sankyo, Eli Lilly, Gilead Sciences, Novartis, Ono, Pfizer, Takeda; Non-Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, BMS, Boehringer Ingelheim, Sankyo, Eli Lilly, Gilead Sciences, Novartis, Ono, Pfizer, Takeda. K. Korphaisarn: Financial Interests, Institutional, Principal Investigator: Amgen, AstraZeneca, BeiGene, Incyte, Merck Sharp&Dohme, Novartis, Roche; Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, AZ, Bayer, Boehringer Ingelheim (BI), BMS, Camber, Eisai, MSD, Novartis, Pfizer, Roche, Sanofi, Taiho, Servier, Takeda. T. Xu: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd. L. Bu: Financial Interests, Personal, Full or part-time Employment: Roche Ltd. A. Scalori: Financial Interests, Personal, Full or part-time Employment: Roche Ltd.; Financial Interests, Personal, Stocks or ownership: Roche Ltd. P. Petric, K. Redhead: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd.; Financial Interests, Personal, Stocks or ownership: F. Hoffmann-La Roche Ltd. B. Solomon: Financial Interests, Personal, Invited Speaker: Roche/Genentech, Pfizer, AstraZeneca, Amgen, GSK; Financial Interests, Personal, Advisory Board: Roche/Genentech, Pfizer, Merck, Bristol Myers Squibb, AstraZeneca, Amgen, Lilly, BeiGene, D3 Bio, Takeda, Janssen, GSK; Non-Financial Interests, Personal, Member of Board of Directors: Cancer Council of Victoria, Thoracic Oncology Group of Australasia, International Association for the Study of Lung Cancer; Financial Interests, Institutional, Research Grant: Sanofi ; Financial Interests, Institutional, Sponsor/Funding, Clinical trial funding to institution: Pfizer, Novartis, Roche/Genentech, BeiGene, Lilly, Bristol Myers Squibb, Nuvalent, AstraZeneca. All other authors have declared no conflicts of interest.