Register Now: From Clinical to Commercial: Accelerating ADC Late-Stage Development with Technology Innovation and Integrated Platform
Logo Image
|Articles|April 20, 2015

Combination of Yervoy and Opdivo Shrinks Melanoma Tumors Drastically in NEJM Case Report

The combination of two mAb drugs eradicated a large tumor, but also sparked new toxicity concerns associated with immunotherapies.

 

A case report published on Apr. 20, 2015 in the New England Journal of Medicine (NEJM) investigating the use of monoclonal antibodies Yervoy (ipilumumab) and Opdivo (nivolumab) found that the combination of drugs reduced the tumors by 80% in more than half of melanoma patients. Even though there were only 13 patients in the Phase I trial, the researchers observed a “remarkable” tumor response in one patient whose large chest-wall melanoma almost completely disappeared in three weeks after only one dose of the drug combination.

While the results of the immunotherapy treatment are impressive, the study investigators warn that they have concerns about the “overly vigorous antimelanoma” response they observed and say that “such an antitumor effect occurring in a transmural metastasis in the small bowel or myocardium, common sites for metastatic melanoma, could have grave consequences.” Despite these warnings and a treatment delay due to a rash, the patient in question who had remarkable results has resumed treatment.

The results of the case study were published alongside a larger double-blind study involving 142 patients with metastatic melanoma with BRAF V600 wild-type tumors. In that study, 61% (44 of 72) patients receiving the drug combination of Yervoy and Opdivo responded to the drug, and 22% (16 patients) reported a complete response. Eleven percent (4 of 37 patients) in the group that received Yervoy and placebo showed a response of some kind, indicating that the combination of drugs is more efficacious than Yervoy alone. Progression-free survival was also significantly higher in the Yervoy/Opdivo group than in the Yervoy group alone.

The success of the drug combination of Yervoy and Opdivo comes at a price, however, as serious drug-related adverse events were reported in more than half of patients in this arm (54%), which is significantly more than the 24% of those on Yervoy plus placebo who experienced side effects.

Source: NEJM

Related to this article

View more
The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
Read more
The BioPharm Brief: FDA Designations for a Bispecific CAR-T, a BLA for Friedreich’s Ataxia, and Phase 2b MASH Data for Efinopegdutide
The BioPharm Brief: FDA Designations for a Bispecific CAR-T, a BLA for Friedreich’s Ataxia, and Phase 2b MASH Data for Efinopegdutide
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
Read more