Overall survival (OS) update in ALTER 1202: Anlotinib as third-line or further-line treatment in relapsed small-cell lung cancer (SCLC)

Abstract Background As a multicentre, randomized, double-blind phase II trial, ALTER 1202 (NCT03059797) suggests that anlotinib is a promising treatment option for patients with relapsed SCLC who failed ≥ 2 lines of chemotherapy. The median progress-free survival (PFS) was significantly longer in the anlotinib group compared with the placebo group (4.1 months vs 0.7 months; HR 0.19, 95% CI 0.12 to 0.32], P  Methods Eligible either limited- or extensive-stage SCLC patients with disease progression after ≥ 2 lines of chemotherapy were randomized 2:1 to anlotinib or placebo (12 mg PO QD from day 1 to 14, every 3 weeks). The primary endpoint was PFS. OS was a pre-specified secondary endpoint. Results Between March 2017 and May 2018, 120 patients from 11 centers were randomized to either anlotinib arm (n = 82) or placebo arm (n = 38). In the final analysis (04 APR 2019), median OS was significantly prolonged about 2.4 months in anlotinib arm (7.3 months vs 4.9 months). OS at this date showed 60 events in anlotinib arm and 33 events in placebo arm (HR 0.53, 95%CI 0.3-0.8; p = 0.0029). Six-month, 1-y survival rates were 63.9%, 30.6% in the anlotinib group and 32.7%, 13.1% in the placebo group. The hazard ratio for OS favored anlotinib in most subgroups, especially for patients with brain metastases (OS 6.3m vs 2.6m; HR 0.23, 95%CI 0.09-0.59; p = 0.0009) and patients that received study drug as third-line therapy (OS 7.3m vs 4.9m; HR 0.50, 95%CI 0.31-0.82; p = 0.0051). No newly adverse events were observed. Conclusions The updated results showed that anlotinib prolonged not only PFS but also OS significantly than placebo with favorable safety profile. These data suggested that anlotinib is a promising treatment option for patients with relapsed SCLC who have experienced treatment failure with two lines of chemotherapy. Clinical trial identification NCT03059797. Legal entity responsible for the study Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Funding Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Disclosure All authors have declared no conflicts of interest.