SOURCE: Medivation

Medivation

December 21, 2015 07:00 ET

Medivation Initiates Pivotal Clinical Trial of MDV9300 in Diffuse Large B-Cell Lymphoma

SAN FRANCISCO, CA--(Marketwired - Dec 21, 2015) - Medivation, Inc. (NASDAQ: MDVN) today announced the initiation of an international Phase 2 clinical trial that will evaluate the safety and efficacy of MDV9300 (pidilizumab) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). In light of the unmet medical need in this area, a positive outcome in this trial has the potential to support registration for this indication in the U.S. and European Union utilizing available expedited pathways.

"Despite overall improvement in outcomes following the incorporation of rituximab into standard initial chemoimmunotherapy, curative treatment options do not exist for an appreciable number of patients with relapsed disease," said Jason Westin, M.D., leader, DLBCL clinical research, The University of Texas MD Anderson Cancer Center. "Patients with DLBCL who have residual disease following autologous stem cell transplant or salvage chemotherapy have few effective therapies available, none of which are approved or proven to be capable of deepening and prolonging their response. It is my hope that this trial will demonstrate that MDV9300 is an efficacious and well tolerated treatment option for these patients."

"Our data indicate that administration of MDV9300 is associated with enhanced maturation and survival of T lymphocytes, which may improve adaptive immunity, as well as activation of natural killer cells, which may improve innate immunity," said David Hung, M.D., president and chief executive officer of Medivation. "Such broad effects on both sides of the immune response are not widely reported with checkpoint inhibitors and may differentiate pidilizumab from other agents in the complex immuno-oncology landscape."

About the Phase 2 Trial
The international, open-label, Phase 2 trial of MDV9300 is expected to enroll approximately 180 patients with an incomplete response following salvage therapy or autologous stem cell transplantation for relapsed or refractory CD20+ diffuse large B-cell lymphoma, transformed indolent lymphoma or primary mediastinal B-cell lymphoma. The patients will be assessed in two parallel cohorts of approximately 90 patients each. One cohort will enroll patients who have received an autologous stem cell transplant, and the second cohort will enroll patients who have received salvage chemotherapy, but are transplant-ineligible. MDV9300 will be administered at a dose of 200 mg by IV infusion. The primary endpoint of the trial is best overall response rate.

About Medivation Inc.
Medivation, Inc. is a biopharmaceutical company focused on the development and commercialization of medically innovative therapies to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their families. For more information, please visit us at http://www.medivation.com

Forward-Looking Statements
This press release contains forward-looking statements regarding the clinical development of MDV9300 and therapeutic potential in diffuse large B-cell lymphoma (DLBCL), which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties. Actual results may differ substantially for a number of reasons, including, but not limited to: risks related to the timing and results of Medivation's clinical trials, including difficulties or delays in enrolling and retaining patients; the clinical trial results may not be positive and even if positive, may not be sufficient to support registration utilizing expedited pathways or approval for the indication from the regulatory authorities; adverse safety findings could result in the discontinuation of MDV9300; and manufacturing costs and difficulties; and other risks detailed in Medivation's filings with the Securities and Exchange Commission, or SEC, including its quarterly report on Form 10-Q for the quarter ended September 30, 2015, which was filed on November 6, 2015. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Medivation disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

Contact Information

  • Contacts:
    Rick Bierly
    Chief Financial Officer
    (415) 543-3470

    Anne Bowdidge
    Senior Director, Investor Relations
    (650) 218-6900