The University of Texas MD Anderson Cancer Center and Pfizer Inc. announced that they have entered into a clinical collaboration to study novel combinations of three Pfizer investigational immuno-oncology therapies and other Pfizer agents in the treatment of various solid tumors and hematologic malignancies.
“This alliance aims to define patients with solid tumors who may benefit from immunotherapy and to develop therapy resistance strategies,” said Aung Naing, M.D., associate professor of Investigational Cancer Therapeutics, MD Anderson. “The studies are designed to hone in on specific combinations and tumor types and explore unique mechanisms of response and resistance to immunotherapies. Our comprehensive approach will allow us to study new combinations of immunotherapy and standard therapies for patients with solid tumors in need of new treatment options.”
The alliance includes multiple studies. The first study aims to enroll up to 188 patients with solid tumors, who will be placed in seven different treatment groups of immuno-oncology agents alone or immuno-oncology agents combined with radiotherapy. The second study includes eight different treatment groups and is expected to enroll up to 159 patients with acute myeloid leukemia (AML) undergoing treatment at MD Anderson. Three additional studies are planned to evaluate investigational Pfizer agents in patients with blood cancers. The majority of the trials are expected to open in late 2017, with Naing heading the solid tumor program and Naval Daver, M.D., assistant professor of Leukemia, MD Anderson, leading the blood cancer clinical trial.
“This series of Phase Ib trials will involve an accelerated series of combination immunotherapy trials for acute myeloid leukemia (AML) and solid tumors,” said Daver. “Our aim is to deliver new therapeutic solutions to our patients through this uniquely designed clinical trial program.”
“Pfizer believes that meaningful treatment advancements for patients with blood cancers will come from novel combinations of immuno-oncology agents and targeted therapies,” said Chris Boshoff, M.D., Ph.D., senior vice president and head of immuno-oncology, early development, and translational oncology, Pfizer Global Product Development. “We are delighted to work with MD Anderson – one of the world’s best cancer research institutions – to explore unique combinations that may have a significant impact for patients.”
An MD Anderson-Pfizer joint steering committee will oversee the initiative to conduct clinical trials using various combinations of investigational Pfizer therapies including but not limited to:
- Bavencio® (avelumab), a PD-L1 inhibitor being developed in collaboration by Pfizer and Merck KGaA, Darmstadt, Germany.
- Utomilumab (the proposed non-proprietary name for PF-05082566), an investigational 4-1BB (also called CD137) agonist.
- PF-04518600, an investigational OX40 agonist.
- Gemtuzumab ozogamicin, an antibody-drug conjugate.
- Glasdegib (PF-04449913), an investigational oral, smoothened (SMO) inhibitor.