Bigger Moves Coming For Exelixis Print E-mail
By Brian Wilson   
Tuesday, 15 July 2014 08:05

It took a while for investor sentiment in Exelixis (EXEL) to recover after the company released less-than-stellar interim results for its Phase III Metastatic Castration-Resistant Prostate Cancer (mCRPC) trial for cabozantinib (COMET-1) back in March, but it appears that positive news from the cobimetinib program is helping to lighten the mood a bit.

Exelixis was up 23% by the end of yesterday’s trading, and still remains at an elevated price despite some selling pressure in premarket trading today.

 

Cobimetinib is a drug that was developed by Exelixis in partnership with Roche (RHBBY) as a combination drug to be used with vemurafenib. Vemurafenib is a first-line therapy that is used against late-stage melanoma patients who also have a specific mutation known as BRAF V600.

The top-line results from the coBRIM Phase III trial, which enrolled 500 BRAF V600 positive melanoma patients, show (with statistical significance) that the drug extends progression-free survival when used with vemuravenib. This means that the drug extended the length of time in which melanoma patients saw no progression (or growth) of their tumors.

Because adverse events were not too serious for this drug, I think the drug could do well in the high-risk BRAF V600 melanoma patient population.

Investors should also note that there is more data coming before the end of the year that will probably move Exelixis more than this cobimetinib data has. Fully-owned drug cabozantinib is expected to produce Top-line results from the COMET-1 and COMET-2 trials, which have overall survival and pain relief endpoints that could support an NDA next year. We will also see overall survival analysis from the EXAM trial for medullary thyroid cancer, and completion of enrollment into a Phase III cabozantinib trial in renal cell cancer.

The COMET data could prove most interesting, as it could reverse the damage that was done to EXEL back in March after the drug’s nasty GI side effects became more pronounced. Overall survival data could also be a big help to Cometriq (cabozantinib), which will become a more attractive option for oncologists with a proven survival benefit.

 

 

 




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