Atezolizumab + Chemotherapy for Advanced Non‐Small Cell Lung Cancer in Japanese Clinical Practice (J‐TAIL‐2)

ABSTRACT First‐line atezolizumab combination therapies were approved for the treatment of metastatic non‐small cell lung cancer (NSCLC) based on results from the global phase 3 trials IMpower130, IMpower132, and IMpower150. These trials reported 12‐month overall survival (OS) rates of 60%–67% with atezolizumab combination therapy. J‐TAIL‐2 (NCT04501497), a prospective, multicenter, observational study, evaluated atezolizumab combination therapy in routine clinical practice in Japan. Patients ≥ 20 years old with NSCLC received atezolizumab plus carboplatin and nab‐paclitaxel (atezo + CnP), atezolizumab plus carboplatin or cisplatin plus pemetrexed (atezo + PP), or atezolizumab plus bevacizumab plus carboplatin and paclitaxel (atezo + bev + CP) in clinical practice. The primary endpoint was the 12‐month OS rate. Secondary endpoints included OS, progression‐free survival, and subgroup analyses, including IMpower‐unlike (did not meet the main eligibility criteria of each IMpower trial) and IMpower‐like patients. In total, 814 patients were enrolled (atezo + CnP, n = 217; atezo + PP, n = 211; atezo + bev + CP, n = 386). The IMpower‐unlike group included patients with Eastern Cooperative Oncology Group performance status ≥ 2, autoimmune disease, or interstitial lung disease. Twelve‐month OS rates (95% confidence interval CI) were 62.9% (55.8–69.2), 72.1% (65.2–77.9), and 68.3% (63.2–72.9) with atezo + CnP, atezo + PP, and atezo + bev + CP, respectively. OS hazard ratios (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. No new safety signals were observed. Real‐world efficacy and safety for each atezolizumab combination were comparable to those in the relevant IMpower trials.