J-TAIL-2: A prospective, observational study of atezolizumab (atezo) combined with carboplatin and etoposide (CE) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) in Japan.
Authors: Ryota Saito, Makoto Nishio, Kadoaki Ohashi, Atsushi Osoegawa, Eiki Kikuchi, Hideharu Kimura, Yasushi Goto, Junichi Shimizu, Eisaku Miyauchi, Hiroshige Yoshioka, Ichiro Yoshino, Toshihiro Misumi, Takashi Kijima, Kenichi Chikamori, Hisashi Tanaka, Kazunori Tobino, Tatsuro Fukuhara, Hirotaka Kuroki, Misa Tanaka, Akihiko Gemma
Journal: Journal of Clinical Oncology (2024)

8092 Background: Atezo + CE is approved for the first-line treatment of ES-SCLC based on IMpower133 (IMp133; NCT02763579). Due to the limited data available in Japanese pts, J-TAIL-2 (NCT04501497) is evaluating the efficacy and safety of atezo + CE in Japanese pts in the clinical setting. Methods: Pts from Japan had ES-SCLC, were aged ≥20 y and were scheduled to start atezo + CE in clinical practice. The primary endpoint was 12-mo OS rate. Secondary endpoints included OS, PFS and safety. Efficacy and safety were evaluated in these subgroups: IMp133-unlike (e.g., ECOG PS 2-4, CNS metastases, history/complication of autoimmune or interstitial lung disease, previous treatment for ES-SCLC) vs IMp133-like (met IMp133 eligibility criteria), age &lt;70 vs ≥70 y and geriatric score (G8) &lt; median vs ≥ median. G8 was assessed in pts aged ≥70 y at baseline, with lower vs higher scores indicating poorer health status. Results: From Aug 21, 2020, to data cutoff (Feb 3, 2023), 403 pts were enrolled from 150 sites. Baseline characteristics are shown in the Table. In the efficacy analysis population (n=399), the 12-mo OS rate was 63.7% (95% CI: 58.6, 68.3), median OS (mOS) was 16.5 mo and mPFS was 5.1 mo. In the IMp133-unlike vs -like groups, mOS was 15.5 vs 19.1 mo (HR, 1.32; 95% CI: 0.98, 1.77) and mPFS was 4.8 vs 5.4 mo (HR, 1.14; 95% CI: 0.90, 1.45). In pts aged &lt;70 vs ≥70 y, mOS was 17.9 vs 16.4 mo (HR, 1.18; 95% CI: 0.90, 1.55) and PFS was 5.1 vs 5.1 mo (HR, 1.07; 95% CI: 0.86, 1.33). The median G8 score was 12; in pts with a G8 score &lt; median vs ≥ median, mOS was 11.1 vs 18.4 mo (HR, 1.95; 95% CI: 1.38, 2.77) and mPFS was 4.8 vs 5.2 mo (HR, 1.25; 95% CI: 0.94, 1.67). In the safety analysis population (n=400), treatment-related AEs occurred in 36.0% of pts, Grade (Gr) ≥3 AEs in 66.3% and Gr 5 AEs in 2.8%. Safety outcomes were similar for the IMp133-unlike vs -like and age &lt;70 vs ≥70 y groups. In pts with a G8 score &lt; median vs ≥ median, Gr ≥3 AEs occurred in 70.8% vs 63.5% of pts and Gr 5 AEs occurred in 5.2% vs 0.8% of pts. Conclusions: The efficacy and safety of atezo + CE in Japanese pts treated in clinical practice were consistent with those seen in IMp133. Subgroup analyses support the use of atezo + CE in pts who would have been ineligible for IMp133, although clinical outcomes favored the IMp133-like group. Efficacy and safety were similar for pts aged &lt;70 vs ≥70 y but were worse for those with lower vs higher G8 scores, suggesting that this assessment may be a useful tool for therapeutic strategies. These data support the use of atezo + CE in Japanese pts with ES-SCLC, including in subgroups excluded from IMp133. Clinical trial information: NCT04501497 . [Table: see text]