Replies to post #125601 on Biotech Values

[NP1986]

EXEL:

Thanks for the link.

Exelexis has submitted the protocol for the first cabo phase III prostate cancer trial, called Study 306, to the U.S. Food and Drug Administration (FDA) with a primary endpoint of pain reduction and bone scan response. The company has requested a Special Protocol Assessment (SPA) for the trial which is a validation of the trial design and endpoints. Feedback from the FDA is expected as early as September 2011, and the trial is expected to begin by the end of 2011. A second phase III CRPC trial is scheduled to start in 2012 and will evaluate the impact of cabo on overall survival in CRPC patients. Whether cabo will be compared to placebo or an approved prostate cancer drug such as abiraterone acetate (Zytiga) or cabazitaxel (Jevtana) has not yet been announced. A third cabo phase III trial, also expected to begin in 2012, will evaluate cabo in the prevention of bone metastases in earlier-stage, non-metastatic CRPC patients. There are currently no drugs that are approved for this novel indication.

It appears EXEL is quite ambitious, and I wonder whether they are in a position to go the distance on their own. IMHO, the FDA will want to wait to see overall survival results unless there is a dramatic reduction in pain demonstrated by the first phase III study. On the surface, the ASCO results did look good, but there a number of reasons to be cautious (e.g the biomarker and bone scan data were not collected for all patients, the data were collected retrospectively, the lack of a control group, etc).