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David S. Ettinger, MD, FACP, FCCP


CHOICE-01 Trial: Toripalimab Plus Chemotherapy in Advanced NSCLC

By: Kayci Reyer
Posted: Friday, March 18, 2022

Adding the anti–PD-1 antibody toripalimab to first-line chemotherapy may result in improved survival outcomes for patients with advanced non–small cell lung cancer (NSCLC) without EGFR/ALK mutations, according to research presented at the 2022 American Society of Clinical Oncology (ASCO) Plenary Series (Abstract 362936). The phase III CHOICE-01 trial compared progression-free and overall survival in previously untreated patients receiving toripalimab versus those receiving chemotherapy plus placebo.

“Toripalimab plus chemotherapy represents a first-line treatment option for patients with advanced NSCLC without driver mutations,” noted Jie Wang, MD, of the Chinese Academy of Medical Science and Peking Union Medical College, Beijing, in an ASCO press release.

The study included 465 patients with advanced disease who did not have EGFR/ALK mutations. Patients were randomly assigned to receive four to six cycles of chemotherapy plus either 240 mg of toripalimab (n = 309) or placebo (n = 156) before transitioning to maintenance medication plus the standard of care. Treatment ended when disease progression, unacceptable toxicity, or 2 completed years of therapy occurred.

At the time of data cutoff (October 31, 2021), median and 1-year progression-free survival were superior among patients receiving toripalimab (8.4 vs. 5.6 months and 36.7% vs. 17.2%, respectively). Progression-free survival remained superior in the toripalimab arm across patient subpopulations. Median overall survival was also longer for patients receiving toripalimab (not reached vs. 17.1 months).

A total of 394 patients underwent whole-exome sequencing, which revealed an association between high tumor mutational burden and significantly superior progression-free survival in the toripalimab arm. Survival outcomes were also better in that arm for patients with FAK-PI3K-Akt pathway or IL-7 signaling pathway mutations.

Grade 3 or higher adverse events occurred at comparable rates across both arms, the study authors reported. However, toripalimab was associated with more adverse events leading to treatment discontinuation (14.3% vs. 3.2%) and fatal adverse events (5.5% vs. 2.6%) than was placebo.

Disclosure: For full disclosures of the study authors, visit

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