Results of the multicohort phase 1b ACTION trial indicated that anlotinib plus TQB2450 shows encouraging antitumor activity and tolerable toxicity in patients with recurrent advanced ovarian cancer.
An open-label, multicohort, multicenter phase 1b trial (ACTION; NCT04236362) evaluated the efficacy and safety of the multitarget tyrosine kinase inhibitor, anlotinib, combined with the PD-L1 monoclonal antibody TQB2450 in patients with advanced gynecologic cancer. The results of the ovarian cancer cohort of the ACTION trial were presented at the 2021 American Society of Clinical Oncology Annual Meeting.
Between February 21, 2020, and January 15, 2021, the study enrolled patients aged 18 to 70 years with platinum-resistant or platinum-refractory epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as well as an Eastern Cooperative Oncology Group performance status of 0 or 1, and measurable disease according to the Response Evaluation Criteria in Solid Tumors. Eligible patients received anlotinib (12 mg per day orally, days 1-14 of each cycle) and TQB2450 (1200 mg intravenously on day 1 of each cycle) every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. The primary end point was investigator-assessed objective response rate (ORR); secondary end points included progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety. The data cutoff date was January 15, 2021.
A total of 33 patients received the combination treatment in the ovarian cancer cohort. The median age of the study population was 55 years; the majority had received ≥1 platinum-based chemotherapies, with a median of 3 previous lines of chemotherapy. At median follow-up of 5.1 months, an ORR of 52% was achieved (n = 25 evaluable patients), including 13 partial responses. The median PFS was 6.7 months. The median DOR and the median OS were not reached.
Overall, 54.5% of patients had grade 3 or 4 treatment-related adverse events (TRAEs). The most frequent TRAEs were palmar-plantar erythrodysesthesia syndrome (also known as hand-foot syndrome) (21.2%) and hypertension (18.2%). Immune-related adverse events of grade 1 or 2 severity included hypothyroidism (24.2%) and fatigue (9.1%). No treatment-related deaths were reported.
Based on these results, the investigators concluded that anlotinib plus TQB2450 shows encouraging antitumor efficacy and tolerable toxicity in patients with recurrent advanced ovarian cancer.
Source: Lan C, Zhao J, Yang F, et al. Anlotinib in combination with TQB2450 in patients with recurrent ovarian cancer (ACTION): a multicenter, single-arm, open-label, phase Ib trial. J Clin Oncol. 2021;39(suppl_15). Abstract 5557.