Sintilimab plus anlotinib as second or further-line therapy for small cell lung cancer: An objective performance trial.

8516 Background: Small cell lung cancer (SCLC) tends to progress rapidly on first-line therapies, with limited subsequent-line treatment options. Methods: In this single-arm objective performance trial, adult patients with extensive-disease SCLC (ED-SCLC) received intravenous sintilimab 200 mg on day 1 and oral anlotinib 12 mg on days 1-14. Treatment lasted for 3 weeks per cycle and was continued until disease progression, unacceptable toxicities, or death. The primary endpoint was the superiority of progression-free survival (PFS) versus a PFS of 2.8 months with historical topotecan control. Results: Forty-two patients were enrolled, and 39 patients were evaluable for efficacy. Twenty-six patients (66.7%) had ED-SCLC, and 13 (33.3%) relapsed after concurrent chemoradiotherapy. The median follow-up was 11.9 months. The median PFS was 6.0 months (95%CI: 4.8-7.2). The 6- and 12-month PFS rate was 50.5% and 27.8%, respectively. Fourteen patients died by the data cut-off date, and overall survival (OS) was immature (16.1 months, 95%CI: 9.4-22.7). The 12- and 18-month OS rate was 56.7% and 42.5%, respectively. Three patients attained complete response and 16 achieved partial response, and 12 patients had stable disease; the objective response rate was 48.7% and the disease control rate was 79.5%. Forty patients (95.2%) had at least one treatment-related adverse event (TRAE). The most frequent TRAEs were hypothyroidism (45.2%), hypoproteinemia (40.5%) and elevated gamma-glutamyl transpeptidase (38.1%). Conclusions: Immunotherapy with sintilimab plus antiangiogenic drug anlotinib demonstrated promising antitumor activities as second or further-line therapy for ED-SCLC and had manageable toxicities. The findings support further development of this combination regimen for ED-SCLC. Clinical trial information: NCT04055792.