First-line nivolumab, paclitaxel, carboplatin, and bevacizumab for advanced non-squamous non-small cell lung cancer: Updated survival analysis of the ONO-4538-52/TASUKI-52 randomized controlled trial.

Abstract

BACKGROUND:

ONO-4538-52/TASUKI-52 was performed in Japan, Korea, and Taiwan to determine the oncological effectiveness and safety of combining nivolumab or placebo with bevacizumab plus platinum chemotherapy for the initial (first-line) treatment of patients with advanced non-squamous non-small cell lung cancer (nsNSCLC). At the interim analysis (minimum follow-up, 7.4 months), the independent radiology review committee-assessed progression-free survival was significantly longer in the nivolumab arm, but overall survival (OS) data were immature.

METHODS:

Here, we present the updated OS data. Patients with treatment-naïve stage IIIB/IV or recurrent nsNSCLC without driver mutations in ALK, EGFR, or ROS1, were randomized 1:1 to receive either nivolumab or placebo. Patients in both arms received paclitaxel, carboplatin, and bevacizumab, administered 3-weekly for a maximum of 6 cycles. Nivolumab/placebo and bevacizumab were subsequently continued until disease progression or unacceptable toxicity.

RESULTS:

Overall, 550 patients were randomized. At the time of the analysis (minimum follow-up: 19.4 months), the median OS was longer in the nivolumab arm than in the placebo arm (30.8 vs. 24.7 months; hazard ratio 0.74, 95% confidence interval 0.58-0.94). The 12-month OS rates were 81.3% vs. 76.3% in the nivolumab vs. placebo arms, respectively. The respective 18-month OS rates were 69.0% vs. 61.9%.

CONCLUSION:

Nivolumab plus platinum chemotherapy and bevacizumab demonstrated longer OS vs. the placebo combination. We believe this regimen is viable as a standard, first-line treatment for patients with advanced nsNSCLC without driver mutations in ALK, EGFR, or ROS1.

• Authors: Hye Ryun Kim, Shunichi Sugawara, Jong-Seok Lee, Jin-Hyoung Kang, Naoki Inui, Toyoaki Hida, Ki Hyeong Lee, Tatsuya Yoshida, Hiroshi Tanaka, Cheng-Ta Yang, Makoto Nishio, Yuichiro Ohe, Tomohide Tamura, Nobuyuki Yamamoto, Chong-Jen Yu, Hiroaki Akamatsu, Shigeru Takahashi, Kazuhiko Nakagawa
• Journal: Cancer medicine (Cancer Med) Vol. 12 Issue 16 Pg. 17061-17067 (08 2023) ISSN: 2045-7634 [Electronic] United States
• PMID: 37641544 (Publication Type: Randomized Controlled Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Chemical References

• Nivolumab
• Bevacizumab
• Paclitaxel
• Carboplatin
• Platinum
• Protein-Tyrosine Kinases
• Proto-Oncogene Proteins
• ErbB Receptors
• Receptor Protein-Tyrosine Kinases

Topics

• Humans
• Carcinoma, Non-Small-Cell Lung (drug therapy)
• Nivolumab (adverse effects)
• Bevacizumab (adverse effects)
• Paclitaxel (adverse effects)
• Carboplatin (adverse effects)
• Platinum
• Protein-Tyrosine Kinases
• Lung Neoplasms (drug therapy)
• Proto-Oncogene Proteins
• Neoplasm Recurrence, Local
• Survival Analysis
• ErbB Receptors
• Receptor Protein-Tyrosine Kinases