Front-Line Toripalimab Plus Chemotherapy Improves Survival in Patients With Advanced NSCLC Without Actionable Mutations

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Adding the PD-1 inhibitor toripalimab to chemotherapy significantly improved survival compared with chemotherapy alone in patients with advanced non–small cell lung cancer (NSCLC) without EGFR/ALK mutations, according to research presented by Wang et al during the March 2022 session of the ASCO Plenary Series (Abstract 362936).

At the prespecified final progression-free survival analysis, 1-year progression-free survival rates more than doubled with the combination of toripalimab and histology-specific doublet chemotherapy vs doublet chemotherapy alone: 36.7% vs. 17.2%. Interim overall survival analysis of the CHOICE-01 study also showed significantly longer overall survival with the triplet regimen compared to the placebo arm.

“These results support the use of toripalimab with chemotherapy as first-line therapy for patients with advanced NSCLC without EGFR/ALK mutations,” said lead study author Jie Wang, MD, PhD, of the National Cancer Center and Chinese Academy of Medical Sciences and Peking Union Medical College.

CHOICE-01 Details and Findings

For the randomized, double-blind, placebo-controlled, multicenter phase III trial, 465 treatment-naïve patients with advanced NSCLC and no EGFR/ALK mutations were randomly assigned to receive toripalimab at 240 mg (n = 309) or placebo (n = 156) in combination with chemotherapy for four to six cycles, followed by maintenance of toripalimab or placebo plus standard care until disease progression, intolerable toxicity, or completion of 2 years of treatment.

Dr. Wang and colleagues stratified patients by PD-L1 expression status, histology, and smoking status. The primary endpoint was progression-free survival by investigator per Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints included progression-free survival (by a blinded independent review committee), overall survival, and safety.

At the cutoff date of October 31, 2021, data showed a significant improvement in progression-free survival for patients randomly assigned to receive toripalimab vs placebo. The median progression-free survival was 8.4 months with the triplet regimen vs 5.6 months with chemotherapy alone (hazard ratio = 0.49, P < .0001). Improvements in progression-free survival were observed across key subgroups, including histology and PD-L1 expression.

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“Genomic analysis using whole-exome sequencing revealed that patients with high tumor mutational burden were associated with significantly better progression-free survival in the toripalimab arm,” said Dr. Wang. “Patients with mutations in the FA-PI3K-Akt pathway also achieved significantly better progression-free survival and overall survival in the toripalimab arm.”

Additionally, interim overall survival analysis showed significantly longer overall survival in the toripalimab arm vs the placebo arm. Median overall survival has still not been reached with the triplet regimen compared to 17.1 months with chemotherapy alone.

Importantly, no new safety signals were observed, said Dr. Wang, and the incidence of grade 3 or greater adverse events was similar between the two arms (78.6% vs. 82.1%). Adverse events leading to discontinuation of treatment and fatal adverse events, however, were more frequent in the toripalimab arm.

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