BMS and Roche to team up in melanoma

pharmafile | June 3, 2011 | News story | Sales and Marketing BMS, Roche, melanoma, oncology 

Bristol-Myers Squibb and Roche are to use two of their drugs in an exploratory phase I/II study a bid to treat a specific type of skin cancer.

The manufacturers’ agreement will see BMS’s Yervoy (ipilimumab) and Roche’s investigational oral BRAF inhibitor vemurafenib – co-developed with Plexxikon – combined to treat metastatic melanoma.

Yervoy, a CTLA-4 inhibitor, was approved by the FDA in March for patients with inoperable or metastatic melanoma – the first such treatment to demonstrate a significant improvement in overall survival.

Vemurafenib (formerly RG7204) has also impressed in late-stage trials, the first drug of its kind to increase overall survival in metastatic melanoma patients who over-express the V600 mutation.

Last month Roche submitted it to European and American regulators for approval, aware that BMS has stolen a march by getting the FDA green light for Yervoy.

“Metastatic melanoma is one of the most aggressive forms of cancer,” said Brian Daniels, BMS senior vice president, development and medical affairs.

“We have made significant progress in treating metastatic melanoma and hope to further improve outcomes by combining two agents that target this deadly disease in different ways,” said Hal Barron, Roche’s head of global product development.

The companies may conduct further work into the safety and efficacy of the combination.

Although analysts suggest it could be worth up to $1.7 billion by 2015, Yervoy has received a black box warning from the FDA due to the number of serious adverse events in clinical trials.

Yet skin cancer is an increasingly competitive area, with GlaxoSmithKline also beginning late-stage trials with two drugs, GSK2118436 and GSK1120212, to see if they help patients with the BRAF V600 mutation.

Other treatments

Meanwhile Pfizer is to co-develop its own monoclonal antibody treatment for advanced melanoma with Swiss company Debiopharm, while Novartis is studying Tasigna as a possible treatment for hard to treat sub-types of melanoma.

And after acquiring BioVex for $1 billlion, Amgen now has rights to first-in-class oncolytic vaccine candidate OncoVEXGM-CSF, which is designed to treat melanoma.

But it is far from plain sailing in this field: Lilly had to halt phase III trials of its own melanoma candidate tasisulam in December after 12 people died during the study.

Adam Hill

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