M7824

Shows activity

Also known as:

Bintrafusp alfa

Cancer types include:

bladder cancer kidney cancer prostate cancer sarcoma

TrialFetch AI Analysis

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Overview

Bintrafusp alfa (M7824) is an investigational cancer immunotherapy studied in several solid tumors. Early trials found responses in some patients, but a randomized phase 3 trial in advanced non–small cell lung cancer (NSCLC) did not show an efficacy advantage over pembrolizumab. (aacrjournals.org)

Mechanism of action

The drug combines a PD-L1–blocking antibody with the extracellular portion of TGF-β receptor II, which acts as a “trap” for TGF-β. It is designed to inhibit two pathways that can suppress antitumor immune responses. (aacrjournals.org)

Efficacy

Advanced NSCLC, phase 3: Among 304 previously untreated patients with high PD-L1 expression, median progression-free survival was 7.0 months with bintrafusp alfa versus 11.1 months with pembrolizumab; median overall survival was 21.1 versus 22.1 months. Neither primary outcome showed a significant improvement with bintrafusp alfa. (pubmed.ncbi.nlm.nih.gov)
Recurrent or metastatic cervical cancer, phase 2: In a single-arm study of 146 patients whose disease had progressed during or after platinum chemotherapy, the confirmed objective response rate was 21.9%: 10 complete and 22 partial responses. Without a concurrent comparison group, this result cannot establish an advantage over other treatments. (jamanetwork.com)

Safety

In the phase 3 NSCLC trial, grade 3–4 treatment-related adverse events occurred in 42.4% of bintrafusp alfa recipients versus 13.2% of pembrolizumab recipients. In the cervical-cancer study, 31.5% had grade 3 or higher treatment-related adverse events, and 17.8% discontinued treatment because of treatment-related events. Bleeding and immune-related adverse events were among the safety concerns monitored. (pubmed.ncbi.nlm.nih.gov)

Active trials using M7824

Found 3 active trials using this drug:

A Phase I/II Study of M9241 With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and M9241 With Docetaxel in Castration Resistant Prostate Cancer

Sponsor: National Cancer Institute (NCI) (federal) Phase: 1/2 Start date: Feb. 23, 2021

TrialFetch AI summary: Men with metastatic castration-sensitive prostate cancer starting ADT receive M9241 plus docetaxel, abiraterone, and prednisone; men with metastatic castration-resistant disease previously treated with ADT and a modern antiandrogen, but not docetaxel for mCRPC, receive M9241 plus docetaxel and prednisone. M9241 is an investigational IL-12 immunocytokine designed to bind tumor-associated histone–DNA complexes and stimulate antitumor immune activity.

ClinicalTrials.gov ID: NCT04633252

A Phase I Study of Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies

Sponsor: National Cancer Institute (NCI) (federal) Phase: 1 Start date: July 13, 2020

TrialFetch AI summary: Adults with progressing metastatic non-prostate genitourinary cancer, including urothelial or renal cell cancer, receive bintrafusp alfa (PD-L1 blockade and TGF-β trapping) plus PDS01ADC (tumor DNA-targeted IL-12), either alone or with sequential or concurrent SBRT. Prior checkpoint inhibition is permitted; radiation arms require an irradiable lesion.

ClinicalTrials.gov ID: NCT04235777

Phase I/II Study of PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma

Sponsor: National Cancer Institute (NCI) (federal) Phase: 1/2 Start date: July 13, 2020

TrialFetch AI summary: Adults with advanced, biopsy-confirmed Kaposi sarcoma requiring systemic therapy, including eligible patients with controlled HIV, receive NHS-IL12 (PDS01ADC) alone or with bintrafusp alfa. NHS-IL12 targets exposed tumor DNA to deliver IL-12–mediated immune stimulation; bintrafusp alfa blocks PD-L1 and traps TGF-β.

ClinicalTrials.gov ID: NCT04303117