J-TAIL-2: A prospective observational study of atezolizumab (atezo) combination therapy in patients (pts) with non-small cell lung cancer (NSCLC) in Japan.

8573 Background: The IMpower130 (West et al. Lancet Oncol 2018), IMpower132 (Nishio et al. JTO 2021) and IMpower150 (1) trials led to the approval of first-line atezo combination therapies for NSCLC. As data remain limited in Japanese pts, J-TAIL-2 (NCT04501497) is evaluating the efficacy and safety of 3 atezo combination therapies for NSCLC in the clinical setting in Japan. Methods: Japanese pts had unresectable advanced or recurrent NSCLC, were ≥20 y old, and were scheduled to start atezo combination therapy in clinical practice. Pts received atezo + carboplatin and nab-paclitaxel (atezo + CnP), atezo + carboplatin or cisplatin + pemetrexed (atezo + PP) or atezo + bevacizumab + carboplatin + paclitaxel (atezo + bev + CP). The primary endpoint was 12-mo OS rate. Secondary endpoints included OS and safety. Efficacy and safety were analyzed in the IMpower-unlike (did not meet the main eligibility criteria of each IMpower study) and IMpower-like subgroups. Geriatric assessment (G8) was done in pts ≥70 y old at baseline; a score < median vs ≥ median indicated poorer health status. Results: From Aug 21, 2020, to data cut off (Feb 3, 2023), 814 pts were enrolled at 150 sites (atezo + CnP, n=217; atezo + PP, n=211; atezo + bev + CP, n=386). Baseline characteristics in the efficacy analysis population (n=791) are shown (Table). The IMpower-unlike group included pts with ECOG PS ≥2, brain metastases or interstitial lung disease. Twelve-mo OS rates (95% CI) were 62.9% (55.8, 69.2), 72.1% (65.2, 77.9) and 68.3% (63.2, 72.9), and median OS was 19.7, 23.5 and 17.3 mo with atezo + CnP, atezo + PP and atezo + bev + CP, respectively. OS HRs (95% CI) in the IMpower-unlike vs -like subgroups were 1.36 (0.91, 2.05), 1.08 (0.70, 1.68) and 1.49 (1.09, 2.06), respectively. The median G8 score for all evaluable pts was 13; in pts with a G8 score < median vs ≥ median, OS HRs (95% CI) were 2.10 (1.22, 3.61), 3.53 (1.95, 6.37) and 2.04 (1.22, 3.40) with atezo + CnP, atezo + PP and atezo + bev + CP, respectively. In the safety analysis population (n=800), Grade ≥3 AEs occurred in 60.4% of pts and Grade 5 AEs in 1.3%. Conclusions: In Japanese pts, the efficacy and safety of each atezo combination therapy were comparable to those seen in the relevant IMpower studies and largely consistent in pts who would have been ineligible for the trials. Pts aged ≥70 y with a G8 score < median vs ≥ median had poorer efficacy and safety outcomes. 1. Socinski et al. NEJM 2018. Clinical trial information: NCT04501497 . Table: see text