Expanded indication for Opdivo plus Yervoy to treat HCC

Bristol-Myers Squibb’s immuno-oncology combination of Opdivo (nivolumab) and Yervoy (ipilimumab) is now approved to treat four types of cancer after it was approved by the FDA to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.

Approval for this latest indication has been granted under accelerated approval based on overall response rate and duration of response seen in the Opdivo + Yervoy cohort of the Phase 1/2 CheckMate -040 trial.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Opdivo + Yervoy is the only dual immunotherapy approved by the FDA in this setting. The therapy features a potentially synergistic mechanism of action that targets two different checkpoints (PD-1 and CTLA-4) and works in complementary ways.

The combination was granted Breakthrough Therapy Designation for this indication and a Priority Review from the FDA.

“The overall response rate observed in the Opdivo + Yervoy cohort of the CheckMate -040 trial underscores the potential of this dual immunotherapy as a possible treatment option for patients,” said lead investigator, Dr Anthony B. El- Khoueiry.

A message from the Editor:

Thank you for reading this story on our news site - please take a moment to read this important message:

As you know, our aim is to bring you, the reader, an editorially led news site but journalism costs money and we rely on advertising and digital revenues to help to support them.

With the Covid-19 lockdown having a major impact on our industry as a whole, the advertising revenues we normally receive, which helps us cover the cost of our journalists and this website, have been drastically affected.

As such we need your help. If you can support our news sites with a small donation of even £1, your generosity will help us weather the storm and continue in our quest to deliver quality journalism.

In the meantime may I wish you the very best.

- Advertisement -

Sanofi & Translate Bio expand collaboration to develop mRNA vaccines

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, are expanding their existing 2018...

Sarepta & Codiak to research, develop exosome-based therapeutics

Precision medicine specialist, Sarepta Therapeutics, and Codiak BioSciences, a company at the forefront of advancing engineered exosomes as a new class of biologic medicines,...

Gilead acquires equity interest in pioneering immunotherapy company

Gilead Sciences is acquiring a 49.9% equity interest in Pionyr Immunotherapeutics, a privately held San Fran company developing first-in-class cancer immunotherapies. The acquisition – for...

New class of precision medicine strips cancer of its DNA defences

A new precision medicine targeting cancer’s ability to repair its DNA has shown promising results in the first clinical trial of the drug class. The...

Tonix & Southern Research expand COVID-19 vaccine collaboration to include T cell study

New York biopharma, Tonix Pharmaceuticals, has expanded its strategic collaboration with Southern Research to include a study of T cell immune responses to SARS-CoV-2...

Related news

Avalon GloboCare & BOKU to advance intranasal & oral COVID-19 vaccine candidate

Avalon GloboCare, a New Jersey-based clinical-stage global developer of cell-based technologies and therapeutics, has partnered with the University of Natural Resources and Life Sciences...

Sanofi & Translate Bio expand collaboration to develop mRNA vaccines

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, are expanding their existing 2018...

Sarepta & Codiak to research, develop exosome-based therapeutics

Precision medicine specialist, Sarepta Therapeutics, and Codiak BioSciences, a company at the forefront of advancing engineered exosomes as a new class of biologic medicines,...

Gilead acquires equity interest in pioneering immunotherapy company

Gilead Sciences is acquiring a 49.9% equity interest in Pionyr Immunotherapeutics, a privately held San Fran company developing first-in-class cancer immunotherapies. The acquisition – for...