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Long-Term Efficacy and Safety of Brigatinib in Crizotinib-Refractory + NSCLC: Final Results of the Phase 1/2 and Randomized Phase 2 (ALTA) Trials. | LitMetric

AI Article Synopsis

  • Brigatinib shows long-term effectiveness and safety for NSCLC patients with ALK rearrangements, based on phase 1/2 and ALTA trials.
  • In these studies, patients previously treated with crizotinib demonstrated median progression-free survival (PFS) of 9.2 months (arm A) and 15.6 months (arm B) along with overall survival up to 40.6 months in arm B.
  • Long-term results indicate manageable safety profiles with no new safety concerns emerging, confirming brigatinib as a viable treatment option for patients resistant to crizotinib.

Article Abstract

Introduction: We report brigatinib long-term efficacy and safety from phase 1/2 and phase 2 (ALTA) trials in -rearrangement positive (+) NSCLC.

Methods: The phase 1/2 study evaluated brigatinib 30 to 300 mg/d in patients with advanced malignancies. ALTA randomized patients with crizotinib-refractory NSCLC to brigatinib 90 mg once daily (arm A) or 180 mg once daily (7-d lead-in at 90 mg; arm B).

Results: In the phase 1/2 study, 79 of 137 brigatinib-treated patients had NSCLC; 71 were crizotinib pretreated. ALTA randomized 222 patients (n = 112 in arm A; n = 110 in arm B). Median follow-up at phase 1/2 study end (≈5.6 y after last patient enrolled) was 27.7 months; at ALTA study end (≈4.4 y after last patient enrolled), 19.6 months (A) and 28.3 months (B). Among patients with + NSCLC in the phase 1/2 study, median investigator-assessed progression-free survival (PFS) was 14.5 months (95% confidence interval [CI]: 10.8-21.2); median overall survival was 47.6 months (28.6-not reached). In ALTA, median investigator-assessed PFS was 9.2 months (7.4-11.1) in arm A and 15.6 months (11.1-18.5) in arm B; median independent review committee (IRC)-assessed PFS was 9.9 (7.4-12.8) and 16.7 (11.6-21.4) months, respectively; median overall survival was 25.9 (18.2-45.8) and 40.6 (32.5-not reached) months, respectively. Median intracranial PFS for patients with any brain metastases was 12.8 (9.2-18.4) months in arm A and 18.4 (12.6-23.9) months in arm B. No new safety signals were identified versus previous analyses.

Conclusions: Brigatinib exhibited sustained long-term activity and PFS with manageable safety in patients with crizotinib-refractory NSCLC.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9440305PMC
http://dx.doi.org/10.1016/j.jtocrr.2022.100385DOI Listing

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