Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer

Summary

The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy.

Timeline

Start

2020-03-30

Primary completion

2022-04-05

Completion

2022-12-14

Outcome

Met primary endpoint

paper The study met its primary end point of a 95% CI above the objective response rate benchmark of 15% PMID 39052242 ↗

Publications

• Background Strauss J, Heery CR, Schlom J, Madan RA, Cao L, Kang Z, Lamping E, Marte JL, Donahue RN, Grenga I, Cordes L, Christensen O, Mahnke L, Helwig C, Gulley JL. Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFbeta, in Advanced Solid Tumors. Clin Cancer Res. 2018 Mar 15;24(6):1287-1295. doi: 10.1158/1078-0432.CCR-17-2653. Epub 2018 Jan 3.
• Background Lan Y, Zhang D, Xu C, Hance KW, Marelli B, Qi J, Yu H, Qin G, Sircar A, Hernandez VM, Jenkins MH, Fontana RE, Deshpande A, Locke G, Sabzevari H, Radvanyi L, Lo KM. Enhanced preclinical antitumor activity of M7824, a bifunctional fusion protein simultaneously targeting PD-L1 and TGF-beta. Sci Transl Med. 2018 Jan 17;10(424):eaan5488. doi: 10.1126/scitranslmed.aan5488.
• Background Vugmeyster Y, Grisic AM, Wilkins JJ, Loos AH, Hallwachs R, Osada M, Venkatakrishnan K, Khandelwal A. Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1. Cancer Chemother Pharmacol. 2022 Oct;90(4):369-379. doi: 10.1007/s00280-022-04468-6. Epub 2022 Sep 6.
• Birrer M, Li G, Yunokawa M, Lee JY, Kim BG, Oppermann CP, Zhou Q, Nishio S, Okamoto A, Wu X, Mileshkin L, Oaknin A, Ray-Coquard I, Hasegawa K, Jehl G, Vugmeyster Y, Zhang S, Bajars M, Yonemori K. Bintrafusp Alfa for Recurrent or Metastatic Cervical Cancer After Platinum Failure: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Sep 1;10(9):1204-1211. doi: 10.1001/jamaoncol.2024.2145.

Drugs

Indications