MDV3100 achieved durable antitumor activity as reflected by median times to PSA progression and radiographic progression in men with advanced prostate cancer (Abstract 134, Higano et al). These updated results at 42 months of follow-up of a phase I-II study confirmed interim results of the trial showing antitumor activity with this agent in patients who developed resistance to bicalutamide or other standard anti-androgen treatments.
The phase I-II trial enrolled 140 men with progressive disease between July 2007 and December 2008. Of those, 18 remained on active treatment at the time of ASCO GU. Median time to PSA progression according to protocol-specified criteria had not yet been reached in 65 chemotherapy-naïve patients and was 316 days in 75 patients post-chemotherapy. Median time to radiographic progression was 392 days and 175 days, respectively. Circulating tumor cell counts were available for 128 patients; of these, 70 of 77 (91%) with favorable pre-treatment counts remained favorable post-treatment, and 15 of 51 patients (49%) converted from unfavorable to favorable post-treatment counts.
The drug is currently under evaluation in two randomized, placebo-controlled phase III trials: AFFIRM and PREVAIL. MDV3100 is the first triple-acting, oral androgen receptor antagonist being developed for the treatment of advanced prostate cancer and provides more complete suppression of the androgen receptor pathway than bicalutamide, the most commonly-used anti-androgen, according to the company’s news releases. Unlike abiraterone, no steroids are necessary with MDV3100.
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