Pfizer said today it will collaborate with the National Cancer Institute’s Center for Cancer Research (CCR) to assess three immunotherapy candidates by arranging and conducting clinical and preclinical trials.
The three include the Phase III candidate avelumab (also called PF-06834635 and MSB0010718C), the fully human anti-programmed cell death ligand 1 (PD-L1) immunoglobulin G1 (IgG1) monoclonal antibody that is being co-developed by Pfizer and Merck KgaA, and two Pfizer proprietary candidates—PF-04518600, an agonistic monoclonal antibody targeting OX40, and utomilumab (PF-05082566), an agonistic monoclonal antibody targeting 4-1BB (CD137).
Pfizer and CCR have entered into a Cooperative Research and Development Agreement (CRADA) through which the three investigational immunotherapies will be studied alone, in various combinations with each other, and in combination with standard therapies, such as chemotherapy, radiation, and targeted therapies across a range of cancers.
The collaborative preclinical and clinical studies will be co-led by Jeffrey Schlom, Ph.D., chief of the Laboratory of Tumor Immunology and Biology at CCR; James Gulley, M.D., Ph.D., chief of the Genitourinary Malignancies Branch at CCR; and Chris Boshoff, M.D., Ph.D., FMedSci, svp and head of immuno-oncology, translational and early development, Pfizer Global Product Development.
“We are looking forward to combining our expertise with those at the NCI to explore agents targeting the immune system in doublet and triplet combinations,” Dr. Boshoff said in a statement.
Pfizer added that it is advancing the three candidates and other immuno-oncology assets through single-agent and novel combination studies, both internally and through collaborations with other partners.
As of November 1, according to Pfizer’s website, avelumab was the subject of Phase III trials in several forms of cancer, including first- and second-line non-small-cell lung cancer (NSCLC), first- and third-line gastric cancer, platinum-resistant/refractory ovarian cancer, first-line ovarian cancer, first-line urothelial cancer, and first-line renal cell carcinoma (RCC) in combination with Pfizer’s marketed advanced RCC treatment Inlyta® (axitinib).
Avelumab is also in Phase II studies for second-line metastatic Merkel cell carcinoma in the U.S., as well as for a combination with utomilumab for NSCLC, squamous cell head and neck cancer, and melanoma. Avelumab is also in a Phase I combination study with PF-04518600, while utomilumab is in Phase I studies in combination with Merck & Co.’s marketed cancer immunotherapy Keytruda® (pembrolizumab), Pfizer added.