Categorized | MRV Research, Regulatory

Genentech Submits NDA For Cobimetinib With Zelboraf To Treat Advanced Melanoma

Source: RTT News, December 2014

Genentech, a part of Swiss pharmaceutical giant Roche Holding AG (RHHBY.PK, ROG.SW, RO.SW), Monday announced that it has submitted a New Drug Application or NDA to the U.S. Food and Drug Administration or FDA for Investigational Cobimetinib used in combination with Zelboraf (vemurafenib).

The application is for treating people with BRAF V600 mutation-positive advanced melanoma. The company said the submission is based on results of the coBRIM Phase III study . Roche has already submitted the coBRIM data to the European Medicines Agency.

Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer. The coBRIM study is an international, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of 60 mg once daily of cobimetinib in combination with 960 mg twice daily of Zelboraf, compared to 960 mg twice daily of Zelboraf alone.

The study showed that people who received the MEK inhibitor cobimetinib plus Zelboraf lived significantly longer without their disease worsening or death, ie., progression-free survival or PFS, compared to Zelboraf alone.

In the coBRIM study, cobimetinib and Zelboraf reduced the risk of disease worsening or death by half, with a median PFS of 9.9 months for cobimetinib plus Zelboraf compared to 6.2 months with Zelboraf alone.

According to the firm, the safety profile was consistent with a previous study of the combination. The most common Grade 3 or higher adverse events in the combination arm included liver lab abnormalities, elevated creatine phosphokinase and diarrhea. The most common adverse events seen in the combination arm included diarrhea, nausea, rash, photosensitivity and lab abnormalities.

The results were presented at the European Society of Medical Oncology 2014 Congress and published in the New England Journal of Medicine.

Sandra Horning, chief medical officer and head of Global Product Development , said, “In the past several years we have made significant progress in treating advanced melanoma, but it remains a serious and difficult to treat cancer that affects more people each year. We look forward to working with the FDA as they review the NDA and hope the combination of cobimetinib and Zelboraf will soon become a new option for people with BRAF mutation-positive advanced melanoma.”

Cobimetinib (GDC-0973, XL518) was discovered by Exelixis Inc. (EXEL: Quote) and is being developed in collaboration with Exelixis. Zelboraf is a prescription medicine used to treat a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene. Zelboraf was co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon, now a member of the Daiichi Sankyo Group (DSKYF.PK).

In Zurich, Roche shares lost 2.01 percent on Friday and settled at 287 Swiss francs.

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