[Updated: 7:10 am PT] San Francisco-based Medivation has some big news to report today with a prostate cancer drug candidate that has been shown to prolong lives.
Medivation (NASDAQ: MDVN) and its partner, Japan-based Astellas Pharma, said today that their experimental drug MDV3100 was able to prolong lives of men with advanced prostate cancer by a median time of 4.8 months compared with a placebo. The results were from a study called Affirm that looked at 1,199 men, and the results were taken from an interim analysis after 520 of the patients had died. Men on the new Medivation/Astellas drug lived a median time of 18.4 months compared with 13.6 for those on placebo, which prompted an independent data monitoring committee to recommend the trial be halted early for ethical reasons, so all patients could start getting the new drug.
Full analysis of the data, including the product’s safety profile, will be released at a future medical meeting. Shares of Medivation skyrocketed after the opening bell, rising $20.52 to reach $37.05 a share.
The Medivation drug, an oral pill, is designed to target prostate cancer cells that become resistant to standard hormone-deprivation therapies, which are supposed to cut off the fuel that testosterone provides tumors to grow. The drug is supposed to hit three different molecular targets which the company hopes will give it an advantage over recently FDA-approved prostate cancer drugs like Johnson & Johnson’s abiraterone (Zytiga), Sanofi’s cabazitaxel (Jevtana), and Dendreon’s sipuleucel-T (Provenge). About 30,000 men in the U.S. die each year from prostate cancer, and the numbers are expected to increase as baby boomers get this common disease of aging.
“MDV3100 was rationally designed to target androgen receptor signaling, a key driver of prostate cancer growth, and the overall survival benefit the compound demonstrated in the AFFIRM interim analysis is significant,” said Howard Scher, a prostate cancer specialist at Memorial-Sloan Kettering Cancer Center, and the co-principal investigator of the Affirm study, in a statement. “If approved, MDV3100 will be a welcome option for men with prostate cancers that have progressed on hormones and initial chemotherapy.”
[Updated comment from analyst] JP Morgan Geoff Meacham that Wall Street was expecting the Medivation drug to extend survival by a median of about three months, according to Reuters. The data that arrived today stacks up favorably with Johnson & Johnson’s abiraterone (Zytiga), Meacham said.
“MDV3100 does look better than Zytiga from an efficacy perspective,” Meacham said in a note to clients.
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