Second-Line Bintrafusp Alfa Shows Promise Among Patients With Recurrent or Metastatic Cervical Cancer

According to results from a phase 2 study, bintrafusp alfa, a first-in class bifunctional fusion protein, demonstrated promising clinical activity among patients with recurrent or metastatic cervical cancer.

In this patient population “second-line treatment options include cytostatic agents, such as vinorelbine, topotecan, gemcitabine, pemetrexed, or nanoparticle albumin-bound paclitaxel; however, response rates are low,” stated Michael Birrer, MD, PhD, University of Arkansas Medical Sciences, Little Rock, Arkansas, and coauthors. “As a result, there is no established consensus for second-line treatment, and better treatment options are needed.”

In this multicenter, open-label, single-arm trial, 146 patients with recurrent or metastatic cervical cancer who experienced disease progression during or after treatment with a platinum-containing regimen received 1200 mg of intravenous bintrafusp alfa once every 2 weeks until disease progression or unacceptable toxicity. The primary end point was confirmed objective response rate (ORR) via an independent review committee. Secondary end points included investigator-assessed ORR, durable response rate (DRR), progression-free survival (PFS), overall survival (OS), and safety. 

At the data cutoff point, confirmed ORR via independent review was 21.9% and confirmed ORR via investigator assessment was 17.1%. A DRR of ≥ 6 months was reported in 59.4% of patients who achieved an objective response. The median PFS was 1.9 months with a 6-month PFS rate of 30.6% and a 12-month PFS rate of 20.1%. The median OS was 13.7 months with a 12-month OS rate of 53%. 

Grade ≥3 treatment-related adverse events occurred in 31.5% of patients and most frequently included anemia (17.1%), rash (14.4%), hypothyroidism (10.3%), and pruritus (10.3%). Serious treatment-related adverse events occurred in 26% of patients. Results demonstrated that 26 patients permanently discontinued treatment due to a treatment-related adverse event which most frequently included colitis (2.1%), erythema multiforme (2.1%), anemia (0.7%), abnormal hepatic function (0.7%), diabetic ketoacidosis (1.4%), immune-mediated dermatitis (1.4%), and rash (1.4%). No treatment-related deaths were reported. 

As Dr Birrer et al concluded, “these findings support the potential of a bispecific therapy targeting transforming growth factor β and programmed cell death 1 ligand 1 in patients with recurrent or metastatic cervical cancer.”

Source: 

Birrer M, Li G, Yunokawa M, et al. Bintrafusp alfa for recurrent or metastatic cervical cancer after platinum failure. JAMA Oncol. Published online: July 25, 2024. doi: 10.1001/jamaoncol.2024.2145