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

SAN FRANCISCO, CA — (Marketwired) — 12/21/15 — 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.

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