Surufatinib plus toripalimab could be a first-line treatment option for patients with advanced, PD-L1-positive non-small cell lung cancer (NSCLC), according to researchers.

In a phase 2 trial, first-line treatment with surufatinib and toripalimab produced responses in more than half of evaluable patients with NSCLC and provided disease control in all of the patients. These results were presented in a poster at the AACR Annual Meeting 2023.

The trial ( Identifier: NCT04169672) was designed to evaluate surufatinib and toripalimab in patients with advanced solid tumors. Surufatinib is a small-molecule inhibitor of VEGFR 1-3, FGFR1, and CSF-1R. Toripalimab is a PD-1 inhibitor.

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At AACR 2023, researchers presented results with the combination in 23 trial participants with advanced NSCLC. The patients had received no prior systemic therapy and had PD-L1-positive disease (tumor proportion score [TPS] ≥1%). Their mean age at baseline was 63.8 years, 69.6% were men, and 52.2% had squamous cell carcinoma. 

The patients received surufatinib at 250 mg orally every day and toripalimab at 240 mg intravenously every 3 weeks. Patients were treated until disease progression, intolerable toxicity, or the 2-year mark. 

The primary endpoint was objective response rate (ORR), and 21 patients were evaluable for efficacy. The ORR was 57.1% overall, 66.7% for patients with higher PD-L1 expression (TPS ≥50%), and 50% for patients with lower PD-L1 expression (TPS <50%).

Among all evaluable patients, there were no complete responses. Twelve patients had a partial response, and 9 had stable disease. The disease control rate was 100%. 

The median duration of response was 8.31 months, and the median progression-free survival (PFS) was 9.6 months. The median PFS was 9.7 months in patients with higher PD-L1 expression and 6.9 months in patients with lower PD-L1 expression. 

All 23 patients were evaluable for safety, and all of them had at least 1 treatment-emergent adverse event (TEAE). The most common TEAEs were aspartate aminotransferase increase (65.2%), proteinuria (65.2%), and hypertriglyceridemia (56.5%). The most common grade 3 or higher TEAE was aspartate aminotransferase increase (17.4%).

The researchers concluded that surufatinib and toripalimab conferred “manageable toxicity” and “promising antitumor activity.” Therefore, the combination “might represent a potential treatment option” for patients with previously untreated, advanced, PD-L1-positive NSCLC. 

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


Cheng Y, Shen L, Chen Z, et al. Surufatinib plus toripalimab for first-line treatment of advanced non-small cell lung cancer (NSCLC) with PD-L1 positive expression: A multicenter, single-arm phase 2 study. AACR 2023. April 14-19, 2023. Abstract CT225.