The addition of toripalimab to chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) in patients with advanced non-small cell lung cancer (NSCLC), according to results of the phase 3 CHOICE-01 study.1

The median PFS was 8.4 months in the toripalimab plus chemotherapy arm and 5.6 months in the placebo plus chemotherapy arm, as assessed by the investigators (hazard ratio [HR], 0.49; 95% CI, 0.39-0.61; P <.0001).

The interim OS analysis showed a 31% reduction in the risk of death with the addition of toripalimab to chemotherapy. The median OS was not reached in the toripalimab arm and was 17.1 months in the placebo arm (HR, 0.69; 95% CI, 0.52-0.92; P =.0099).


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These findings were presented in an American Society of Clinical Oncology (ASCO) Monthly Plenary Series presentation by Jie Wang, MD, PhD, of National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College in Beijing, China.

“Toripalimab plus chemotherapy represents a first-line treatment option for patients with advanced NSCLC without driver mutations,” Dr Wang said in a press release.2

In the double-blind, phase 3 CHOICE-01 trial (ClinicalTrials.gov Identifier: NCT03856411), researchers compared the efficacy and safety of toripalimab with placebo in combination with first-line chemotherapy for treatment-naïve, advanced NSCLC.

The research team enrolled 465 patients who had advanced NSCLC without EGFR mutations and ALK mutations; patients were randomly assigned to the toripalimab arm (309 patients) or the placebo (156 patients). 

Patients received 240 mg of toripalimab or placebo in combination with chemotherapy for 4 to 6 cycles, followed by maintenance toripalimab or placebo plus standard care until disease progression or intolerable toxicity.

The 1-year PFS rate was significantly longer in the toripalimab arm (36.7%) than in the placebo arm (17.2%), as assessed by the blinded independent review committee. The PFS benefit with toripalimab was observed across key subgroups independent of histology and PD-L1 expression.

Patients in the toripalimab arm also had better response rates than those in the placebo arm. The objective response rate was 65.7% in the toripalimab arm and 46.2% in the placebo arm (P <.0001).

Whole-exome sequencing revealed significant improvement in PFS with toripalimab in a subset of patients with high tumor mutational burden (≥10 mutations per million base pairs). In this group, the median PFS was 13.1 months with toripalimab and 5.5 months with placebo (P =.026).

Dr Wang and colleagues also noted superior PFS and OS with toripalimab in patients with mutations in the FAK-PI3K-AKT signaling pathway or IL-7 signaling pathways (P ≤.01).

The incidence of grade 3 or higher adverse events (AEs) was comparable with toripalimab (78.6%) and placebo (82.1%). Fatal AEs were more frequent in the toripalimab arm (5.5%) compared with the placebo arm (2.6%).

AEs leading to discontinuation were reported in 14.3% of patients in the toripalimab arm and 3.2% of patients in the placebo arm. No new safety signals were identified.

Disclosures: This research was supported by Shanghai Junshi Biosciences. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

  1. Wang J, Wang Z, Wu L, et al. Final progression-free survival, interim overall survival, and biomarker analyses of CHOICE-01: A phase III study of toripalimab versus placebo in combination with first-line chemotherapy for advanced NSCLC without EGFR/ALK mutations. 2022 ASCO Monthly Plenary Series; March 15, 2022. Abstract 362936.
  2. Addition of toripalimab to first-line chemotherapy leads to better progression free survival in non-small cell lung cancer. ASCO News Releases. Published March 14, 2022. Accessed March 15, 2022. https://www.asco.org/about-asco/press-center/news-releases/addition-toripalimab-first-line-chemotherapy-leads-better