629MO - ALESIA 7-year update: Alectinib vs crizotinib in Asian patients (pts) with treatment-naïve advanced ALK+ non-small cell lung cancer (NSCLC)

Background

The ALK inhibitor alectinib is approved as first-line therapy for treating ALK+ NSCLC. In the phase III ALESIA trial (NCT02838420), evaluating the efficacy and safety of alectinib vs crizotinib in Asian pts with advanced ALK+ NSCLC, a clinically meaningful overall survival (OS) improvement (HR 0.60) was previously seen with alectinib vs crizotinib after ≥5 years of follow-up. We present updated OS data for these pts, after ≥7 years of follow-up.

Methods

Asian pts aged ≥18 years, with stage IIIB/IV ALK+ NSCLC and an ECOG PS 0–2 were randomized 2:1 to receive alectinib 600mg (n=125) or crizotinib 250mg (n=62) twice daily, until disease progression (PD), unacceptable toxicity, consent withdrawal, or death. Asymptomatic CNS metastases (mets) were allowed. Key secondary endpoints included OS and safety.

Results

At the updated data cutoff (May 16, 2024), the median survival follow-up was 75 months with alectinib (n=125) vs 52 months with crizotinib (n=62). In line with the 5-year OS data, a clinically meaningful improvement in OS (HR 0.72, 95% CI 0.46–1.14) was seen with alectinib vs crizotinib (Table). This OS benefit of alectinib was shown in pts with or without baseline CNS mets (Table). Among pts with PD, 69.3% of pts from the alectinib arm vs 78.0% of pts from the crizotinib arm received ≥1 post-progression anti-cancer therapy: alectinib was received by 28.0% of pts from the crizotinib arm, and crizotinib was received by 14.7% of pts from the alectinib arm, after PD. Despite a longer treatment duration with alectinib vs crizotinib (42.3 vs 12.6 months), both drugs had a similar safety profile (Grade 3–5 adverse events [AE]: 50.4% vs 54.8%, respectively; serious AE: 33.6% vs 29.0%; fatal AE: 4.8% vs 4.8%; AE leading to discontinuation: 12.0% vs 16.1%) Table: 629MO

*CNS metastases by independent review committee. CI, confidence interval; HR, hazard ratio; NE, not estimable

Conclusions

After ≥7 years of follow-up, alectinib continued to yield a clinically meaningful OS benefit vs crizotinib in Asian pts with advanced ALK+ NSCLC and was well tolerated.

Clinical trial identification

NCT02838420.

Editorial acknowledgement

Medical writing support for the development of this abstract, under the direction of the authors, was provided by Laura Vergoz, PhD, of Ashfield MedComms, an Inizio company.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

C. Zhou: Financial Interests, Personal, Advisory Role: Innovent Biologics, Qilu, Hengrui, TopAlliance Biosciences Inc; Financial Interests, Personal, Other, Payment or honoraria: Eli Lilly China, Sanofi, Boehringer Ingelheim, Roche, Merck Sharp & Dohme, Qilu, Hengrui, Innovent Biologics, Alice, C-Stone, LUYE Pharma, TopAlliance Biosciences Inc, Amoy Diagnostics, AnHeart. Y. Lu: Financial Interests, Personal, Advisory Role: Roche/Genentech, AstraZeneca, Pfizer, Bristol Myers Squibb, Merck Sharp & Dohme, BeiGene; Financial Interests, Personal, Invited Speaker: BeiGene, Roche/Genentech, AstraZeneca, Pfizer; Financial Interests, Personal, Leadership Role: Roche/Genentech, AstraZeneca, BeiGene, Shanghai Henlius Biotech, Inc. S. Kim: Financial Interests, Personal, Advisory Role: Amgen, AstraZeneca, Boehringer Ingelheim, Janssen, Novartis, Takeda, Yuhan ; Financial Interests, Personal, Invited Speaker: Amgen, Boehringer Ingelheim, Janssen, Novartis, Takeda; Financial Interests, Personal, Research Funding: Yuhan. T.R. Baisamut: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, MSD, BMS, Amgen, Janssen, Yuhan, Pfizer, Takeda; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, MSD, BMS, Amgen, Janssen, Pfizer, Takeda; Financial Interests, Personal, Other, Participation in clinical research: AstraZeneca, F. Hoffmann-La Roche Ltd, Merck Sharp & Dohme, Novartis, Yuhan; Financial Interests, Personal, Principal Investigator: Roche, AstraZeneca, MSD, Yuhan, Novartis; Financial Interests, Personal, Speaker, Consultant, Advisor, Speaker roles: Amgen, AstraZeneca, Bristol Myers Squibb, F. Hoffmann-La Roche Ltd, Merck Sharp & Dohme, Novartis, Yuhan, Zuellig Pharma, Takeda, Janssen, Amgen. S. Lee: Financial Interests, Personal, Advisory Role: AstraZeneca, Roche, Merck, Pfizer, Lilly, BMS/Ono, Takeda, Jannssen, IMBdx, Novartis; Financial Interests, Personal, Other, Consultant: AstraZeneca, Roche, Merck, Pfizer, Lilly, BMS/Ono, Takeda, Janssen, IMBdx, Novartis; Financial Interests, Personal, Research Funding: Merck, AstraZeneca, Lunit. L. Bu: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd. L. Qian: Financial Interests, Personal, Full or part-time Employment: Roche Pharma Product Development China. V.R. Archer: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Stocks/Shares: F. Hoffmann-La Roche Ltd. M. Zhou: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd. L. Zhang: Financial Interests, Personal, Advisory Role: AstraZeneca, Innovent Biologics ; Financial Interests, Personal, Invited Speaker: AstraZeneca, Roche, MSD, Akesobio, Sichuan Biokin Pharmaceutical; Financial Interests, Personal, Member: ASCO, ESMO, CSCO, AACR, IASLC, MASCC; Financial Interests, Personal, Principal Investigator: AstraZeneca, Novartis, Pierre Fabre, Pfizer, Akesobio, Henrui Pharm, CHINA SHIYAO PHARMA, QiLu pharm, KELUN PHARM, Sichuan Biokin Pharmaceutical; Financial Interests, Personal, Research Funding: AstraZeneca, Novartis, Roche, Pierre Fabre, Pfizer, Akesobio, CHINA SHIYAO PHARMA, Henrui Pharm, QiLu pharm, KELUN PHARM, Sichuan Biokin Pharmaceutical. All other authors have declared no conflicts of interest.