Thursday, November 3, 2011

MDV1300 Making a Mark While Provenge Takes a Deep Plunge

Today San Francisco-based Medivation, Inc., ($MDVN) saw its stock value scale El Capitan within a day.  This coming on the heels of Dendreon Corp. ($DNDN) losing a huge chunk of its stock value yesterday is a good example of human psychology.  We reward "optimism" over "cautious behavior."  

Dendreon's Provenge is a great option for Prostate cancer patients because it takes the "vaccine" route and thus, should be a durable therapy.  But, less than expected sales forecast was like the forecast of continuing rain on their Seattle headquarters which left their stock damp and soggy.  On the other hand, Medivation, Inc., came out winner upon releasing the interim analysis of Phase III trial; the data which led people to believe that MDV1300 may have an edge over recently approved Zytiga (abiraterone acetate) and the optimism over MDV1300 was richly rewarded in the marketplace. [Medivation press release 11/3/2011]

MDV1300 is a three-in-one androgen receptor signaling inhibitor:  it inhibits binding of testosterone to receptor, inhibits translocation of these bound receptors to the nucleus, and finally also inhibits binding of these receptors to DNA.  Medivation is developing MDV1300 in collaboration with Astellas Oncology.

Trial and the press release

Phase III AFFIRM trial was conducted in men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy. 
It evaluated MDV3100 (160 mg/day) versus placebo in 1,199 patients.

Interim analysis demonstrated a clinically meaningful and statistically significant (p < 0.0001) improvement in overall survival compared to placebo. . . . The company has decided to stop the trial early and offer MDV1300 to all participants. 
Pre-NDA meeting with FDA is planned in early 2012.
"MDV3100 produced a 4.8-month advantage in median overall survival compared to placebo. The estimated median survival for men treated with MDV3100 was 18.4 months compared with 13.6 months for men treated with placebo. MDV3100 provided a 37 percent reduction in risk of death compared to placebo (Hazard Ratio=0.631)." [Press release]

The source of MDV1300 excitement

Part of the excitement comes from the fact that MDV1300 won the numbers game:  median overall survival of 4.8 months (vs 3.9 seen with Janssen Biotech's Zytiga) compared to placebo.  Bad comparison!  These trial were run by different companies at different times and at different locations.  

However, patients will come out winner because Zytiga targets different mechanism--it inhibits testosterone production by inhibiting cytochrome P450 17A1 (CYP17A1) enzyme.  There is a possibility of combining the two approaches in future.

In this crowded field, 2012 Olympics will see Provenge, Zytiga and Medivation trying to beat the 100m record by mere seconds.

Related Posts:  

  • Tran, C., Ouk, S., Clegg, N., Chen, Y., Watson, P., Arora, V., Wongvipat, J., Smith-Jones, P., Yoo, D., Kwon, A., Wasielewska, T., Welsbie, D., Chen, C., Higano, C., Beer, T., Hung, D., Scher, H., Jung, M., & Sawyers, C. (2009). Development of a Second-Generation Antiandrogen for Treatment of Advanced Prostate Cancer Science, 324 (5928), 787-790 DOI: 10.1126/science.1168175  PMID:19359544
  • Scher HI, Beer TM, Higano CS, Anand A, Taplin ME, Efstathiou E, Rathkopf D, Shelkey J, Yu EY, Alumkal J, Hung D, Hirmand M, Seely L, Morris MJ, Danila DC, Humm J, Larson S, Fleisher M, Sawyers CL, & Prostate Cancer Foundation/Department of Defense Prostate Cancer Clinical Trials Consortium (2010). Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. Lancet, 375 (9724), 1437-46 PMID: 20398925 

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