Bristol-Myers Squibb’s Opdivo shows positive results in early stage trials for advanced skin cancer

pharmafile | April 19, 2016 | News story | Manufacturing and Production, Research and Development Bristol-Myers Squibb, drug trial, immuno-therapy, oncology, opdivo 

New data for Bristol-Myers Squibb’s (NYSE: BMY) Opdivo to treat advanced melanoma showed overall survival of five years in 34% patients, the company said.   

The early-stage trials for its blockbuster compound showed the longest survival follow-up of patients who received an anti-PD-1 therapy in a clinical trial, the company said. 

The data was from Phase I trials with Opdivo, which was approved by the US Food and Drug Administration (FDA) to treat melanoma in 2014. Bristol-Myers Squibb said the trials demonstrated an evident plateau in survival at about four years, with similar side effects to earlier studies.

The company also announced data for a mid-stage study combination with Opdivo and Yervoy. The Phase II trials showed a two-year overall survival rate of 69% in patients with another form of advanced melanoma. The safety profile of the Opdivo and Yervoycombination regimen in this study was consistent with previously reported studies, the company said.  

F. Stephen Hodi, director of the Melanoma Center at Dana-Farber Cancer Institute, said: “The data from CheckMate -069 and study -003 showed durable responses for some patients with advanced melanoma using new Immuno-Oncology approaches. These data contribute to our growing understanding of this aggressive cancer and are promising news for advanced melanoma patients. In particular, we are seeing further data that evaluate the potential survival benefit of the nivolumab and ipilimumab combination.”  

Jean Viallet, global clinical research lead, oncology, Bristol-Myers Squibb, said: “These data further validate our scientific rationale for studying the combination of these Immuno-Oncology agents. Additionally, study -003 shows five-year overall survival with Opdivo monotherapy in heavily pretreated advanced melanoma patients. These data provide important information about the possible role of Opdivo as a single agent in improving long-term survival for these patients.”

Melanoma continues to be the most aggressive and deadliest form of skin cancer, with an increase in global incidence rates over the last 30 years. Despite advances in treatment, patients with advanced stages of the disease have lower survival rates, with a five-year survival of 15% – 20% for Stage IV disease.

Anjali Shukla

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