Bintrafusp alfa demonstrates therapeutic potential in cervical cancer

Bintrafusp alfa, an investigational first-in-class bifunctional fusion protein, appears to induce response in patients with recurrent or metastatic cervical cancer, according to a phase II study.

In the study, patients with recurrent or metastatic cervical cancer with disease progression during or after platinum-based chemotherapy were given bintrafusp alfa 1,200 mg intravenously once every 2 weeks. Of the 203 patients who were screened, 146 (median age 53 years) received at least one dose of bintrafusp alfa.

The confirmed objective response rate (assessed Response Evaluation Criteria in Solid Tumors version 1.1) was 21.9 percent (95 percent confidence interval [CI], 15.5–29.5), with the study meeting the primary endpoint of a 95 percent CI above the objective response rate benchmark of 15 percent.

Response was sustained for at least 6 months in 19 of 32 patients (59.4 percent), with 13 patients (40.6 percent) exhibiting ongoing treatment response at data cutoff.

In terms of safety, anaemia (17.1 percent) was the most common treatment-related adverse event (TEAE), followed by rash (14.4 percent), hypothyroidism (10.3 percent) and pruritus (10.3 percent). Any-cause adverse events of special interest included anaemia (56.2 percent), bleeding events (55.5 percent), and immune-related adverse events (33.6 percent).

Bintrafusp alfa is composed of the extracellular domain of the human transforming growth factor β receptor II (or transforming growth factor β trap) fused via a flexible linker to the C-terminus of each heavy chain of an immunoglobulin G1 antibody blocking programmed cell death 1 ligand 1.