Adding toripalimab to chemotherapy can improve outcomes in patients with treatment-naïve, advanced non-small cell lung cancer (NSCLC), according to results from the CHOICE-01 study published in the Journal of Clinical Oncology.

Toripalimab improved both progression-free survival (PFS) and overall survival (OS), researchers found.

For the phase 3 CHOICE-01 study ( Identifier: NCT03856411), researchers enrolled 465 patients who had advanced NSCLC without EGFR/ALK mutations. The patients were randomly assigned 2:1 to receive toripalimab plus chemotherapy (n=309) or placebo plus chemotherapy (n=156).

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Patients with squamous NSCLC received nab-paclitaxel (100 mg/m2 on days 1, 8, and 15 once every 3 weeks) plus carboplatin (AUC 5 IV once every 3 weeks) and toripalimab or placebo (240 mg once every 3 weeks for 4-6 cycles), followed by maintenance with toripalimab or placebo.

Patients with nonsquamous NSCLC received pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC 5 once every 3 weeks) and toripalimab or placebo (240 mg once every 3 weeks for 4-6 cycles), followed by maintenance with pemetrexed plus toripalimab or placebo.

At the final PFS analysis (data cutoff of October 31, 2021), the median PFS was significantly longer with toripalimab plus chemotherapy than with placebo plus chemotherapy — 8.4 months and 5.6 months, respectively (hazard ratio [HR], 0.49; 95% CI, 0.39-0.61; P <.0001).

The overall response rate and duration of response were superior with toripalimab as well. The overall response rate was 65.7% with toripalimab and 46.2% with placebo (P <.0001). The median duration of response was 8.4 months and 4.2 months, respectively.

The researchers also observed a significant improvement in OS with toripalimab. The median OS was not reached in the toripalimab arm and was 17.1 months in the placebo arm (HR, 0.69; 95% CI, 0.53-0.92; P =.0099).

The improvements in PFS and OS observed with toripalimab occurred regardless of PD-L1 expression, the researchers noted. However, the OS benefit was driven mainly by patients with nonsquamous NSCLC. In patients with squamous NSCLC, there was no significant difference in OS between the treatment arms.

The incidence of grade 3 or higher treatment-emergent adverse events (TEAEs) was 78.6% in the toripalimab arm and 82.1% in the placebo arm. Serious TEAEs occurred in 44.8% and 35.3%, respectively. Fatal TEAEs occurred in 5.5% and 2.6%, respectively.

The researchers noted that although this study included only patients from China, the results likely can be extrapolated to Western patients.

“These results support the use of toripalimab with chemotherapy as a first-line therapy for patients with advanced NSCLC without EGFR/ALK mutations,” the researchers concluded.

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.


Wang Z, Wu L, Li B, et al. Toripalimab plus chemotherapy for patients with treatment-naive advanced non–small-cell lung cancer: A multicenter randomized phase III trial (CHOICE-01). J Clin Oncol. Published online October 7, 2022. doi:10.1200/JCO.22.00727