Date: 2015-12-00
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Medivation (USA - CA) now Pfizer (USA - NY)
Product: pidilizumab (MDV9300)
Action
mechanism: monoclonal antibody. Pidilizumab is a humanized monoclonal antibody which belongs to a class of anticancer therapies that target the immune system. Although the molecule was originally understood to work primarily via PD-1 (Programmed Death-1) binding, Medivation's work as well as that of others has shown other potential activity as well. Testing and characterization work has been performed to better identify the binding target and, in late December 2015, Medivation concluded that pidilizumab does not bind PD-1. Clinical and preclinical data continue to indicate that pidilizumab administration is associated with enhanced maturation and survival of T lymphocytes, which may improve adaptive immunity, as well as activation of natural killercells, which may improve innate immunity that facilitates anti-tumor activity. Such broad effects on both sides of the immune response are not widely reported with checkpoint inhibitors and may serve to differentiate pidilizumab from other agents in the competitive PD-1 landscape. Based on clinical and preclinical data, including data from Dr. Benson presented at the American Society of Hematology, Medivation plans to develop pidilizumab in other hematologic malignancies such as multiple myeloma.
Disease: relapsed or refractory diffuse large B-cell lymphoma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: Medivation has initiated a Phase 2 clinical trial evaluating pidilizumab (MDV9300) in patients with relapsed or refractory diffuse large B-cell lymphoma in the fourth quarter of 2015. The trial is on partial clinical hold pending a revision of certain investigator brochure, protocols and informed consent documents. We submitted the revised documents to the FDA in early February 2016 and the FDA has 30 days thereafter to notify us if the partial hold is lifted. The open-label trial 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. 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. The primary endpoint of the trial is best overall response rate.
In early January 2016, Medivation advised FDA of its conclusion that pidilizumab does not bind PD-1, and the agency placed the IND on partial clinical hold and requested that the company revises its characterization of the product in the related investigator brochure, protocols and informed consent documents.
