Surufatinib Combo Displays Promising Efficacy in Frontline ES-SCLC

After a median follow-up of 13.40 months among 11 patients treated with the surufatinib-based combination, the median overall survival was 15.80 months.

The addition of surufatinib (Sulanda) to durvalumab (Imfinzi), etoposide, and platinum-based chemotherapy displayed promising efficacy and a manageable toxicity profile in a small cohort of patients with extensive-stage small cell lung cancer (ES-SCLC), according to findings from a single-arm, multicenter study (NCT05668767) presented at the IASLC 2025 World Conference on Lung Cancer (WCLC).

After a median follow-up of 13.40 months among 11 patients treated with the surufatinib-based combination, the median overall survival (OS) was 15.80 months (95% CI, 8.61-NA [not applicable]). The median progression-free survival (PFS) was 7.95 months (95% CI, 4.70-9.03). Additionally, the overall response rate (ORR) was 100% among these patients, all of which were partial responses.

Furthermore, the disease control rate (DCR) was 100%, and the median time to response was 1.58 months. The median duration of response (DOR) was 5.22 months.

“Surufatinib in combination with durvalumab, etoposide, and [etoposide plus cisplatin or carboplatin] chemotherapy exhibited promising efficacy and manageable toxicity as [frontline] treatment of [patients with] ES-SCLC,” corresponding author Ying Hu, professor of the Department of Medical Oncology, Beijing Chest Hospital, Capital Medicine University and Beijing Tuberculosis and Thoracic Tumor Research Institute, wrote in the presentation with study coinvestigators. “The combination of chemotherapy, immunotherapy and anti-angiogenesis merits further exploration in SCLC.”

Patients enrolled in the single-arm study were 18 years and older with pathologically or cytologically confirmed SCLC with measurable lesions. Those eligible for enrollment were also not previously treated with prior systemic therapy, had an ECOG performance score of 0 or 1, had an expected survival of at least 12 weeks, and had normal function of major organs. Patients with asymptomatic brain metastases were permitted for enrollment.

Treatment consisted of 250 mg of oral daily surufatinib and 1500 mg of intravenous durvalumab given on day 1 of each 3-week cycle. Chemotherapy consisted of intravenous etoposide at 100 mg/m² on days 1 to 3 of every 3-week cycle and either cisplatin at 75 mg/m² via continuous intravenous infusion for 3 hours on days 1 to 3 or carboplatin at area under the concentration curve 5 to 6 intravenously on day 1. Following 4 to 6 cycles of chemotherapy, patients who experienced at least stable disease continued maintenance therapy with surufatinib and durvalumab, with treatment continuing in the absence of disease progression, unacceptable toxicity, or withdrawal.

Those enrolled were mostly male (92%), with a median age of 64 years (range, 46-72). Additionally, 92% of patients had an ECOG performance status of 1, 62% had bone metastases, and 15% had brain metastases. Patients typically had 1 (46%) or 2 (38%) metastatic sites, and most had a smoking history (77%).

The primary end point of the trial was PFS. Secondary end points included DCR, ORR, OS, and safety. Additional exploratory end points included efficacy predictive factors such as combined positive score, tumor mutational burden, soluble vascular endothelial growth factor receptor-2 levels, and basic fibroblast growth factor.

The safety analysis revealed that the most common adverse effects (AEs) of all grades included white blood cell count decreases (61.54%), anemia (46.15%), and platelet decreases (38.46%). Additionally, the most common grade 3 AEs included white blood cell count decreases (46.15%), platelet count decreases (15.38%), fatigue (7.69%), and immune-related pneumonia (7.69%).

The study authors noted that, traditionally, platinum-based chemotherapy plus etoposide with immunotherapy is the current standard of care as frontline treatment of ES-SCLC. A synergistic effect between surufatinib and immunotherapy in SCLC formed the basis of the ongoing study exploring the addition of surufatinib to standard of care as first-line ES-SCLC treatment.

Reference

Zhang H, Sheng S, Wu C, et al. Efficacy and safety of surufatinib, durvalumab in combined with chemotherapy as first-line treatment of extensive-stage small-cell lung cancer. Presented at the IASLC 2025 World Conference on Lung Cancer; Barcelona, Spain; September 6-9, 2025. Abstract P3.13.22.