Results from the phase 2 DURABLE trial demonstrated that adding anlotinib, a novel anti-vascular agent, to durvalumab in the maintenance setting improved progression-free survival (PFS) and overall survival (OS), compared to durvalumab alone, among patients with extensive-stage small cell lung cancer (SCLC). 

These results were first presented by Baohui Han, MD, PhD, Shanghai Jiao Tong University School of Medicine, Shanghai, China, at the 2024 World Conference on Lung Cancer. 

In this open-label study, researchers enrolled 66 patients with extensive-stage SCLC who did not experience disease progression after 4 cycles of durvalumab plus platinum etoposide. Patients were randomized to receive 1500 mg of durvalumab once every 4 weeks either alone (n = 32), or plus 12 mg of anlotinib once every 3 weeks on days 1 through 14 (n = 34), until disease progression or unacceptable toxicity. The primary end point was PFS from maintenance. Secondary end points included PFS from the first dose of treatment, OS, and safety. 

At a median follow-up of 15.1 months, the median PFS from maintenance was 5.3 months in the durvalumab-anlotinib arm and 1.9 months in the durvalumab arm. The median PFS from the first dose of treatment was 8.4 months and 5.6 months, respectively. The median OS was not reached in the durvalumab-anlotinib arm and 12.9 months in the durvalumab arm. The 12-month OS rates were 63.3% and 57.5%, respectively. 

Grade ≥ 3 treatment-emergent adverse events were experienced by 17.6% of patients in the durvalumab-anlotinib arm and 12.5% of patients in the durvalumab arm and most frequently included hematological toxicity. Treatment-emergent adverse events leading to treatment discontinuation occurred in 2.9% of patients in the durvalumab-anlotinib arm and 3.1% of patients in the durvalumab arm. At the time of data cut-off, 17 patients remained on study treatment. Further assessment is ongoing.

“Durvalumab in combination with anlotinib as maintenance therapy demonstrated significant PFS benefit (about 3 months) and trend of improved OS compared with durvalumab alone in in ES-SCLC patients not progressed from durvalumab plus platinum-etoposide,” as Dr Han et al concluded.

Source: 

Han B, Zhang B, Zhong R, et al. Durvalumab plus anlotinib versus durvalumab as maintenance treatment in ES-SCLC (DURABLE): A randomized, phase 2 trial. Presented at the World Conference on Lung Cancer; September 7-10, 2024. San Diego, CA. Abstract # MA17.07