Final results from TAIL: updated long-term efficacy of atezolizumab in a diverse population of patients with previously treated advanced non-small cell lung cancer.

In patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), atezolizumab therapy improves survival with manageable safety. The open-label, single-arm phase III/IV TAIL study (NCT03285763) evaluated atezolizumab monotherapy in patients with previously treated NSCLC, including those with Eastern Cooperative Oncology Group performance status of 2, severe renal impairment, prior anti-programmed death 1 therapy, autoimmune disease, and age ≥75 years. Patients received atezolizumab intravenously (1200 mg) every 3 weeks. At data cut-off for final analysis, the median follow-up was 36.1 (range 0.0-42.3) months. Treatment-related (TR) serious adverse events (SAEs) and TR immune-related adverse events (irAEs) were the coprimary endpoints. Secondary endpoints included overall survival (OS), progression-free survival (PFS), overall response rate, and duration of response. Safety and efficacy in key patient subgroups were also assessed. TR SAEs and TR irAEs occurred in 8.0% and 9.4% of patients, respectively. No new safety signals were documented. In the overall population, median OS and PFS (95% CI) were 11.2 months (8.9 to 12.7) and 2.7 months (2.3 to 2.8), respectively. TAIL showed that atezolizumab has a similar risk-benefit profile in clinically diverse patients with previously treated NSCLC, which may guide treatment decisions for patients generally excluded from pivotal clinical trials.

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Competing interests: AA reports personal honoraria for lectures from BMS, Astra Zeneca, and MSD; advisory board participation for Roche, Astra Zeneca, BMS, Sanofi, and Eli Lilly. BR-V reports honoraria for educational events for Janssen, MSD, and Bristol-Myers Squibb; advisory board participation for MSD and Takeda. DR-A reports personal and/or other fees from BMS, MSD, Roche/Genentech, Novartis, Astra Zeneca, and Boehringer-Ingelheim. JA-A reports advisory board participation for Astra Zeneca, Roche, MSD, BMS, Takeda, and Pfizer; speaker bureau for Roche, MSD, BMS, Takeda, and Pfizer. HJMS reports payment for expert testimony from BMS for immune-oncology educational website advice; advisory board participation for MSD. EH reports employment by Roche and stockholding in Roche. MK reports employment by Genentech and stockholding in Roche. JT reports former employment by Roche and stockholding in Roche. YH reports employment by Roche and stockholding in Roche. HKV reports employment by Roche and stockholding in Roche. TN-D reports personal consulting fees from Takeda, Pfizer, Roche, Amgen, Astra Zeneca, Bayer, BMS, Boehringer-Ingelheim, Chugai, Janssen, Lilly, Merck, MSD, Novartis, and Otsuka; personal honoraria for lectures/presentations from Takeda, Pfizer, Roche, Amgen, Astra Zeneca, Bayer, BMS, Boehringer-Ingelheim, Chugai, Janssen, Lilly, Merck, MSD, Novartis, and Otsuka; support for attending meetings and/or travel from Astra Zeneca, BMS, Boehringer-Ingelheim, MSD, Roche, and Takeda; chair of the independent monitoring committee for Roche and BluePrint Medicines. SA, JY, and KS report no competing interests.