Medivation, Inc. and Astellas Pharma Inc. Announce Positive New, Long-Term Follow-Up Data From Phase 1-2 Trial of MDV3100 in Advanced Prostate Cancer Patients

Marketwire

Medivation, Inc. and Astellas Pharma Inc. today announced positive, new, long-term follow-up data from the Phase 1-2 trial of MDV3100 in patients with advanced prostate cancer. MDV3100 is a novel, triple-acting, oral androgen receptor antagonist. These new results showed that MDV3100 continues to show durable antitumor activity as evaluated by median times to prostate-specific antigen (PSA) progression and radiographic progression. These findings confirm the initial Phase 1-2 results published in The Lancet, in which MDV3100 consistently demonstrated anti-tumor activity in both chemotherapy-na�ve and post-chemotherapy patients across endpoints, as evaluated by PSA levels, radiographic findings and circulating tumor cell (CTC) counts.

"We are very encouraged by these promising new, long-term efficacy findings, which continue to demonstrate the antitumor activity of MDV3100 and give us confidence that MDV3100 has the potential to benefit patients with advanced prostate cancer," said Lynn Seely, M.D., chief medical officer of Medivation.

Long-Term Follow-Up Results A total of 140 men with progressive disease were enrolled in the Phase 1-2 trial between July 2007 and December 2008. Of those, 18 remained on active treatment (16 chemotherapy-naive and 2 post-chemotherapy) at the time of this analysis.

PSA progression data were calculated using three distinct reporting criteria: the criteria specified in the Phase 1-2 trial protocol; the most recent published PSA reporting consensus criteria (the Prostate Cancer Clinical Trials Working Group 2, or PCWG2, criteria)(1); and an older commonly used reporting method (the Prostate-Specific Antigen Working Group 1, or PSAWG1, criteria)(2).

Exelixis opens books on promising set of "cabo" cancer data

By John Carroll   

Exelixis has pulled back the covers from a new set of promising mid-stage data for its lead cancer treatment, once referred to as XL184 but now dubbed "cabo." Investigators determined that 85 percent of the prostate cancer patients taking cabozantinib experienced complete or partial elimination of bone lesions at an interim point. And tumors shrank in two thirds of the patients whose cancer had metastasized to soft tissue.

The interim numbers--a full set of results should arrive this summer--were promising enough to boost the price of Exelixis' shares, which are now largely staked to the fate of this therapy. The South San Francisco-based developer restructured twice last year as it circled its wagons around its XL184 program. Once run by George Scangos (photo), now CEO of Biogen Idec, Exelixis is now helmed by Michael Morrissey, who makes no secret of his high hopes for this therapy.

"These interim data give us further confidence in our comprehensive development plan for cabozantinib in CRPC that includes three potential pivotal trials, the first focused on a composite endpoint that incorporates bone scan resolution and improvement in bone pain, and future trials evaluating overall survival and bone metastasis prevention in CRPC patients," said the CEO in a statement.

In the mid-stage study, researchers found that the bone lesions of 53 out of 62 evaluated patients had shrunk or been cleared. These lesions can cause fractures and intense pain for patients. The therapy was also linked to higher hemoglobin in anemic patients and a reduced need for powerful painkillers.

Bristol-Myers Squibb handed back the rights to cabozantinib last year after the two companies failed to agree on a development plan for the drug. The therapy is now involved in six separate studies for a variety of cancers, including one Phase III trial.