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news.MDV3100 shows encouraging anti-tumor activity across dose levels and endpoints
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Medivation, a biopharmaceutical company, has reported new positive efficacy and safety data from an ongoing Phase I-II clinical trial of the company’s novel androgen receptor antagonist MDV3100 in castration-resistant prostate cancer patients.
The new efficacy data cover all 114 patients who have been followed for 12 weeks or longer, and show that MDV3100 consistently demonstrated encouraging anti-tumor activity across dose levels and endpoints.
All patients had progressive disease upon enrollment and were heavily pretreated, with 77% having failed at least two lines of prior hormonal therapy and 43% having also failed one or more chemotherapy regimens. Efficacy endpoints in the study included circulating tumor cell (CTC) counts, serum prostate specific antigen (PSA) levels, soft tissue and bony metastases, and time on treatment.
Almost all patients with favorable CTC counts (four or less) at the start of treatment maintained favorable counts at week 12 (89% of chemotherapy naive patients and 100% of post-chemotherapy patients). Importantly, a significant number of patients with unfavorable CTC counts of five or higher at baseline converted to favorable counts of less than five at week 12 (73% of chemotherapy naive patients and 40% of post-chemotherapy patients). This CTC conversion rate is encouraging, in which post-treatment conversion to a CTC count below five was associated with a 15-month survival benefit in castration-resistant prostate cancer patients, the company said.
According to the company, MDV3100 also produced significant PSA declines (50% or more from baseline) and radiographic control in both chemotherapy naive and post-chemotherapy patients at week 12. Thus far, the median time on treatment for chemotherapy-naive patients and post-chemotherapy patients is 276 and 145 days, respectively.
The new safety data include all 140 patients enrolled in the trial. MDV3100 has been generally well tolerated at doses of up to and including 240 mg/day.
David Hung, president and CEO of Medivation, said: We are pleased to continue to see concordance of data across endpoints – CTC changes, PSA declines, radiographic findings and time on treatment. We continue to move forward with clinical development of MDV3100 and expect to seek the FDA approval to advance to a pivotal Phase III registration study in 2009.