A Randomized Comparison of Nivolumab versus Nivolumab+Docetaxel for Previously Treated Advanced or Recurrent ICI-Naïve Non-Small Cell Lung Cancer: TORG1630

Yuri Taniguchi, Tsuneo Shimokawa, Yuichi Takiguchi, Toshihiro Misumi, Yukiko Nakamura, Yosuke Kawashima, Naoki Furuya, Yoshimasa Shiraishi, Toshiyuki Harada, Hisashi Tanaka, Satoru Miura, Ayumi Uchiyama, Yoshiro Nakahara, Takaaki Tokito, Katsuhiko Naoki, Akihiro Bessho, Yasuhiro Goto, Masahiro Seike, Hiroaki Okamoto

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: The addition of cytotoxic chemotherapy to immunecheckpoint inhibitor (ICI) may enhance antitumor effects. We conducted an open-label randomized phase II/III study to evaluate nivolumab + docetaxel combination therapy in comparison with nivolumab monotherapy for previously treated ICI-naïve non- small cell lung cancer (NSCLC). Patients and Methods: The primary endpoint of the phase III study was overall survival (OS), and the secondary endpoints included progression-free survival (PFS), overall response rate (ORR), and toxicity. As ICI and platinum-doublet combination chemotherapy was approved in the first-line setting during this study, patient accrual was discontinued. Results: One hundred twenty-eight patients (each arm, n = 64) were included in the full analysis set. The median OS in nivolumab (arm A) and nivolumab+docetaxel (arm B) was 14.7 months (95% CI, 11.4-18.7) and 23.1 months (95% CI, 16.7-NR), respectively. The HR for OS was 0.63 (90% CI, 0.42-0.95; P = 0.0310). The median PFS in arms A and arm B was 3.1 months (95% CI, 2.0-3.9) and 6.7 months (95% CI, 3.8-9.4), respectively. The HR for progression was 0.58 (95% CI, 0.39-0.88; P = 0.0095). The ORR was 14.0% (95% CI, 6.3-25.8) in armAand 41.8% (95% CI, 28.7-55.9) in arm B. Hematotoxicity and gastrointestinal adverse events were more common in arm B than in arm A. Two treatment-related deaths were observed, including one patient in arm A who died of pneumonitis and one in arm B who died of myocarditis. Conclusions: Despite a slightly elevated toxicity, the addition of docetaxel to nivolumab has significantly prolonged the OS and PFS of patients with previously treated ICI-naïve NSCLC.

Original languageEnglish
Pages (from-to)4402-4409
Number of pages8
JournalClinical Cancer Research
Volume28
Issue number20
DOIs
Publication statusPublished - Oct 15 2022
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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