Nivolumab with carboplatin, paclitaxel, and bevacizumab for first-line treatment of advanced nonsquamous non-small-cell lung cancer

S Sugawara; J-S Lee; J-H Kang; H R Kim; N Inui; T Hida; K H Lee; T Yoshida; H Tanaka; C-T Yang; M Nishio; Y Ohe; T Tamura; N Yamamoto; C-J Yu; H Akamatsu; Y Namba; N Sumiyoshi; K Nakagawa

doi:10.1016/j.annonc.2021.06.004

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Nivolumab with carboplatin, paclitaxel, and bevacizumab for first-line treatment of advanced nonsquamous non-small-cell lung cancer

Authors: S Sugawara ; J-S Lee ; J-H Kang ; H R Kim ; N Inui ; T Hida ; K H Lee ; T Yoshida ; H Tanaka ; C-T Yang ; M Nishio ; Y Ohe ; T Tamura ; N Yamamoto ; C-J Yu ; H Akamatsu ; Y Namba ; N Sumiyoshi ; K Nakagawa

Citation: ANNALS OF ONCOLOGY, Vol.32(9) : 1137-1147, 2021-09

Journal Title: ANNALS OF ONCOLOGY

ISSN: 0923-7534

Issue Date: 2021-09

MeSH: Antineoplastic Combined Chemotherapy Protocols / adverse effects ; Bevacizumab / adverse effects ; Carboplatin / therapeutic use ; Carcinoma, Non-Small-Cell Lung* / drug therapy ; Double-Blind Method ; Humans ; Lung Neoplasms* / drug therapy ; Neoplasm Recurrence, Local / drug therapy ; Nivolumab / adverse effects ; Paclitaxel / adverse effects ; Protein-Tyrosine Kinases ; Proto-Oncogene Proteins

Keywords: NSCLC ; bevacizumab ; nivolumab

Abstract: Background: This international, randomized, double-blind phase III study (ONO-4538-52/TASUKI-52) evaluated nivolumab with bevacizumab and cytotoxic chemotherapy as first-line treatment for nonsquamous non-small-cell lung cancer (NSCLC).

Patients and methods: Between June 2017 and July 2019, this study enrolled treatment-naïve patients with stage IIIB/IV or recurrent nonsquamous NSCLC without sensitizing EGFR, ALK, or ROS1 alterations. They were randomly assigned in a 1 : 1 ratio to receive nivolumab or placebo in combination with carboplatin, paclitaxel, and bevacizumab every 3 weeks for up to six cycles, followed by nivolumab/placebo with bevacizumab until progressive disease or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) assessed by an independent radiology review committee (IRRC).

Results: Overall, 550 patients from Japan, Korea, and Taiwan were randomized; of these patients, 273 and 275 received the nivolumab and placebo combinations, respectively. In the present preplanned interim analysis with a median follow up of 13.7 months, the IRRC-assessed median PFS was significantly longer in the nivolumab arm than in the placebo arm (12.1 versus 8.1 months; hazard ratio 0.56; 96.4% confidence interval 0.43-0.71; P < 0.0001). The PFS benefit was observed across all patients with any programmed death-ligand 1 (PD-L1) expression levels including PD-L1-negative patients. The IRRC-assessed objective response rates were 61.5% and 50.5% in the nivolumab and placebo arms, respectively. The incidence of treatment-related adverse events of grade 3 or 4 was comparable between the two arms; treatment-related adverse events leading to death were observed in five and four patients in the nivolumab and placebo arms, respectively.

Conclusion: The TASUKI-52 regimen should be considered a viable new treatment strategy for treatment-naïve patients with advanced nonsquamous NSCLC.