Tatsuya Yoshida, Toru Kumagai, Ryo Toyozawa, Ryohei Katayama, Makoto Nishio, Takashi Seto, Koichi Goto, Nobuyuki Yamamoto, Yuichiro Ohe, Kentarou Kudou, Takayuki Asato, Pingkuan Zhang, Kazuhiko Nakagawa

Brigatinib in Japanese patients with ALK‐positive non‐small‐cell lung cancer: Final results of the phase 2 J‐ALTA trial

  • Cancer Research
  • Oncology
  • General Medicine
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AbstractThe phase 2, single‐arm, multicenter, open‐label J‐ALTA study evaluated the efficacy and safety of brigatinib in Japanese patients with advanced ALK+ non‐small‐cell lung cancer (NSCLC). One expansion cohort of J‐ALTA enrolled patients previously treated with ALK tyrosine kinase inhibitors (TKIs); the main cohort included patients with prior alectinib ± crizotinib. The second expansion cohort enrolled patients with TKI‐naive ALK+ NSCLC. All patients received brigatinib 180 mg once daily (7‐day lead‐in at 90 mg daily). Among 47 patients in the main cohort, 5 (11%) remained on brigatinib at the study end (median follow‐up: 23 months). In this cohort, the independent review committee (IRC)‐assessed objective response rate (ORR) was 34% (95% CI, 21%–49%); median duration of response was 14.8 months (95% CI, 5.5–19.4); median IRC‐assessed progression‐free survival (PFS) was 7.3 months (95% CI, 3.7–12.9). Among 32 patients in the TKI‐naive cohort, 25 (78%) remained on brigatinib (median follow‐up: 22 months); 2‐year IRC‐assessed PFS was 73% (90% CI, 55%–85%); IRC‐assessed ORR was 97% (95% CI, 84%–100%); the median duration of response was not reached (95% CI, 19.4–not reached); 2‐year duration of response was 70%. Grade ≥3 adverse events occurred in 68% and 91% of TKI‐pretreated and TKI‐naive patients, respectively. Exploratory analyses of baseline circulating tumor DNA in ALK TKI‐pretreated NSCLC showed associations between poor PFS and EML4‐ALK fusion variant 3 and TP53. Brigatinib is an important treatment option for Japanese patients with ALK+ NSCLC, including patients previously treated with alectinib.

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