Surufatinib and Toripalimab in PD-L1+ NSCLC
In an open-label, single-arm, phase 2 study (ClinicalTrials.gov Identifier: NCT04169672), treatment with surufatinib and toripalimab produced durable responses in patients with advanced, PD-L1-positive NSCLC who had received no prior systemic chemotherapy.4
The 23 patients had a mean age of 63.8 years, and 69.6% were men. One patient had stage III disease, and the remaining patients had stage IV disease. More than half of patients (56.5%) had a PD-L1 tumor proportion score (TPS) below 50%, and 43.5% of patients had a PD-L1 TPS of 50% or more.
Patients received surufatinib at 250 mg daily and toripalimab at 240 mg every 3 weeks in 21-day cycles until disease progression, intolerable toxicity, or the maximum duration of treatment (24 months with toripalimab).
The median follow-up was 13.1 months, and 21 patients were evaluable. The ORR was 57.1% overall, 66.7% in patients with a PD-L1 TPS of 50% or more, and 50.0% in patients with a TPS of less than 50%.
The median duration of response was 8.31 months overall, not reached in patients with a PD-L1 TPS of less than 50%, and 8.31 months in patients with a TPS of 50% or more. The disease control rate was 100% overall.
The median PFS was 9.63 months overall, 9.7 months in patients with a PD-L1 TPS of 50% or more, and 6.9 months in patients with a TPS of less than 50%.
In the overall cohort, the median OS was not reached. The 12-month OS rate was 64% overall, 70% in patients with a PD-L1 TPS of 50% or more, and 62% in patients with a TPS of less than 50%.
All patients had at least 1 treatment-emergent AE, and 73.9% had grade 3 or higher treatment-emergent AEs. The most common grade 3 or higher treatment-emergent AEs were aspartate aminotransferase increase (17.4%), hypokalemia (13.0%), hepatic function abnormality (13.0%), lymphocyte count decrease (8.7%), hypertension (8.7%), and pneumonitis (8.7%).
“With such small numbers, it is difficult to draw meaningful conclusions, although most patients were alive at 12 months in both PD-L1 groups, with a slight enrichment in the PD-L1-high group,” said Dr Cummings, who was not involved in this study.
“It is concerning that 2 participants experienced at least grade 3 pneumonitis, and that safety signal must be watched closely, but this regimen could potentially offer another approach in those with intermediate PD-L1 that cannot receive chemotherapy, and a larger study could be considered,” Dr Cummings added.
Disclosures: The AEGEAN trial was sponsored by AstraZeneca. The MATCH study was sponsored by Hoffmann-La Roche. The study of rucaparib and nivolumab maintenance therapy was sponsored by Clovis Oncology, Inc. The surufatinib/toripalimab study was sponsored by the Hutchison Medipharma Limited. Dr Cummings receives research funding from AstraZeneca, Genentech, Novartis, and Tempus. Dr Reckamp and Dr Reis have no relevant disclosures. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original references for a full list of their disclosures.
1. Heymach JV, Harpole D, Mitsudomi T, et al. AEGEAN: A phase 3 trial of neoadjuvant durvalumab + chemotherapy followed by adjuvant durvalumab in patients with resectable NSCLC. AACR 2023. April 14-19, 2023. Abstract CT005.
2. Zhou L, Sun J, Xie C, et al. Efficacy and safety of low dose radiotherapy (LDRT) concurrent atezolizumab (atezo) plus chemotherapy as first line (1L) therapy for ES-SCLC: Primary analysis of phase II MATCH study. AACR 2023. April 14-19, 2023. Abstract CT219/9.
3. Chauhan A, Kolesar J, Yan D, et al. Phase II of frontline maintenance rucaparib in combination with nivolumab in ES SCLC. AACR 2023. April 14-19, 2023. Abstract CT221/11.
4. 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 CT225/15.