Found 1 Presentation For Request "ALTA"
1195P - Brigatinib (BRG) vs crizotinib (CRZ) in ALK TKI–naive ALK+ NSCLC: Final results from ALTA-1L
- Sanjay Popat (London, United Kingdom)
Abstract
Background
In 2 planned interim analyses of ALTA-1L (NCT02737501), BRG BIRC-assessed PFS was superior to CRZ. We report final ALTA-1L results.
Methods
Patients (pts) with ALK TKI–naive advanced ALK+ NSCLC were enrolled and stratified by baseline (BL) brain metastases (BM) and prior chemotherapy (CT). One prior CT for advanced NSCLC and asymptomatic BM was allowed. Pts were randomized 1:1 to BRG 180 mg qd (7-day lead-in at 90 mg) or CRZ 250 mg BID. Pts in the CRZ arm were offered BRG at progression. Primary endpoint: BIRC-assessed PFS (RECIST v1.1). Secondary endpoints included confirmed iORR, iPFS by BIRC, OS, safety, and QoL.
Results
275 pts randomized (BRG/CRZ, n=137/138); median age 58/60 y; prior CT 26%/27%; BL BM 29%/30%. As of 29 Jan 2021 (last patient contact), median follow-up was (BRG/CRZ): 40.4/15.2 mo, with 166 (73/93) PFS events. BIRC-assessed PFS HR was 0.48 (95% CI: 0.35–0.66, log-rank aPer investigator; b95% CI; cLog-rank; dPer BIRC; eResponse,≥1 assessment; fCochran-Mantel-Haenszel test; gConfirmed responders
Efficacy per BIRC BRG CRZ 40 41a PFS events, n (%) 24 (60) 31 (76) HR 0.25 (0.14–0.46b) <0.0001c OS events, n (%) 11 (28) 22 (54) 3-yr OS, % 74 (57–85b) 55 (38–69b) HR 0.43 (0.21–0.89b) 0.0199c 47d 49d 97a 97a PFS events, n (%) 49 (51) 62 (64) HR 0.62 (0.43–0.91b) 0.0131c 90d 89d iPFS events, n (%) 25 (28) 23 (26) HR 0.70 (0.39–1.26b) 0.2410c 18 23 iORRe, % 78 (52–94b) 30 (13–53b) 0.0036f Confirmed iORR, % 78 (52–94b) 26 (10–48b) 0.0014f Median iDoRg, mo 28 (6–NEb) 9 (4–NEb)
Conclusions
BRG demonstrated durable overall and intracranial efficacy, and the tolerability profile remained consistent and manageable despite extended treatment duration, confirming BRG as an effective standard-of-care treatment in pts with treatment-naive ALK+ NSCLC.
Clinical trial identification
NCT02737501; Release date: 30 March 2016.
Editorial acknowledgement
Professional medical writing assistance was provided by Lauren Gallagher, RPh, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, USA, and funded by Millennium Pharmaceuticals, Inc.
Legal entity responsible for the study
ARIAD Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Funding
ARIAD Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Disclosure
S. Popat: Financial Interests, Institutional, Advisory Board: Amgen, AstraZeneca, Bayer, Beigene, Blueprint, BMS, Boehringer Ingelheim, Daiichi Sankyo, Guardant Health, Janssen, Lilly, Merck KGaA, Novartis, Roche, Takeda; Financial Interests, Institutional, Other, Sub-investigator: Amgen, MSD; Financial Interests, Institutional, Other, Coordinating PI: ARIAD, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Takeda, Turning Point Therapeutics; Financial Interests, Institutional, Other, Local PI: AstraZeneca, GlaxoSmithKline, Roche, Trizel; Non-Financial Interests, Personal, Officer: European Society of Medical Oncology; Non-Financial Interests, Personal, Leadership Role: British Thoracic Oncology Group, European Thoracic Oncology Platform; Non-Financial Interests, Personal, Advisory Role: ALK Positive UK, International Association for the Study of Lung Cancer, Lung Cancer Europe, Ruth Strauss Foundation; Non-Financial Interests, Personal, Member of the Board of Directors: Mesothelioma Applied Research Foundation. H.R. Kim: Financial Interests, Personal, Other, Honoraria, consulting or advisory role: AstraZeneca, Roche, Boehringer Ingelheim. M. Ahn: Financial Interests, Personal, Other, Honoraria: AstraZeneca, BMS, Boehringer Ingelheim, MSD, Novartis; Financial Interests, Personal, Other, consulting or advisory role: AstraZeneca, BMS, Boehringer Ingelheim, MSD, Novartis. J.C. Yang: Financial Interests, Personal, Other, Honoraria or advisory role: Boehringer Ingelheim, Eli Lilly, Bayer, Roche/Genentech/Chugai, Astellas, MSD, Merck Serono, Pfizer, Novartis, Celgene, Merrimack, Yuhan Pharmaceuticals, BMS, Ono Pharmaceutical, Daiichi Sankyo, Takeda, AstraZeneca, Hansoh Pharmaceuticals. J. Han: Financial Interests, Personal, Other, Research funding: Roche. M.J. Hochmair: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Merck Sharp & Dohme, Pfizer, Roche, Takeda; Financial Interests, Personal, Other, consulting or advisory role: Boehringer Ingelheim, Merck Sharp & Dohme, Novartis, Roche, Takeda. K.H. Lee: Financial Interests, Personal, Other, Honoraria, advisory role: AstraZeneca, Eli Lilly, Boehringer Ingelheim. A. Delmonte: Financial Interests, Personal, Other, Consulting/advisory role: AstraZeneca, Boehringer Ingelheim. M.R. Garcia Campelo: Financial Interests, Personal, Invited Speaker, Consulting/advisory role: Takeda, AstraZeneca, Roche, Pfizer, BMS, Boehringer Ingelheim, Pfizer, Janssen, Eli Lilly, MSD, Sanofi. D. Kim: Financial Interests, Institutional, Other, Research funding: Alpha Biopharma, Amgen, AstraZeneca/MedImmune, Boehringer Ingelheim, Daiichi Sankyo, Hanmi, Janssen, Merus, Mirati Therapeutics, MSD, Novartis, Ono Pharmaceutical, Pfizer, Roche/Genentech, Takeda, TP Therapeutics, Xcovery, Yuhan, Chong Keun Dang, Bridge B; Financial Interests, Personal, Other, travel/accommodations: Amgen, Daiichi Sankyo. F. Griesinger: Financial Interests, Personal, Other, Consulting or advisory role: ARIAD, Takeda, Roche, Novartis, Pfizer. E. Felip: Financial Interests, Personal, Other, Consulting/advisory role: AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Guardant Health, MSD, Novartis, Pfizer, Roche, Takeda, Merck. R. Califano: Financial Interests, Personal, Other, Honoraria and consulting or advisory role: AstraZeneca, BMS, Roche, MSD, Boehringer Ingelheim, Takeda, Novartis. A. Spira: Financial Interests, Personal, Other, Consulting/advisory role: ARIAD, AstraZeneca, Clovis Oncology, Roche, Amgen, Mirati, BMS, Merck. S.N. Gettinger: Financial Interests, Personal, Invited Speaker, Consulting or advisory role: ARIAD, BMS, Janssen; Financial Interests, Personal, Other, Research funding: ARIAD, AstraZeneca/MedImmune, BMS, Boehringer Ingelheim, Incyte, Pfizer, Roche/Genentech. M. Tiseo: Financial Interests, Personal, Other, Speakers bureau or advisory role: AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Otsuka, Pfizer, Pierre Fabre, Roche. H.M. Lin: Financial Interests, Personal, Full or part-time Employment: Takeda. Y. Liu: Financial Interests, Personal, Full or part-time Employment: Takeda. F. Vranceanu: Financial Interests, Personal, Full or part-time Employment: Takeda. D