As the field of immuno-oncology continues to grow, many organizations are launching interesting collaborations to speed discovery and trial periods. Recently, the University of Texas MD Anderson Cancer Center announced a strategic partnership with Pfizer to examine new combinations of immunotherapies with other therapies for blood cancers and solid tumors. This collaboration will involve a number of different studies, the first of which will involve up to 188 patients with solid tumors. These participants will be assigned to seven different treatment groups that will receive immuno-oncology agents or immunotherapies and radiotherapy.
A second study, which is almost at the recruiting stage, seeks to enroll about 160 patients at MD Anderson for treatment of acute myeloid leukemia (AML) to look at Pfizer immunotherapy agents in the context of blood cancer. MD Anderson and Pfizer have planned three other studies to look at other drugs with therapeutic potential for blood cancers. According to the two partners, most of these trials will open before the end of the year. Each of the trials will look at specific mechanisms of response or resistance to given immunotherapies in different types of cancers.
Approved Therapies to Be Tested at MD Anderson Cancer Center
A joint steering committee with representatives from both Pfizer and MD Anderson will oversee the collaboration, which has already identified five cancer therapy candidates in the Pfizer pipeline to examine. However, the partnership has left the door open to examine additional therapies in the future.
One of these candidates is avelumab, which is perhaps better known by the brand name Bavencio. Pfizer developed Bavencio through a $2.85 billion partnership launched in 2014 with Merck KGaA. This year, the Food and Drug Administration (FDA) approved the therapy, which is a checkpoint inhibitor for programmed death-ligand 1 (PD-L1), for use in the treatment of metastatic Merkel cell carcinoma and metastatic or locally advanced urothelial carcinoma. Patients with the latter condition must have exhibited disease progression during or following platinum-based chemotherapy to be eligible to receive Bavencio. Evidently, Pfizer hopes to secure additional indications for the drug.
MD Anderson will also conduct trials for gemtuzumab ozogamicin (Mylotarg). This CD33-directed conjugate of drug and antibody recently received approval from the FDA for use in adults with recently diagnosed CD33-positive AML and children and adults experiencing relapse of the disease. Mylotarg previously hit the market in 2000, when the FDA approved it for use in patients 60 years and older with relapsed CD33-positive AML and who could not receive other forms of chemotherapy. However, a later trial did not show any clinical benefit of Mylotarg while also associating it with toxicity, so Pfizer withdrew the agent. The company contends that the therapy is the only option for AML treatment that targets CD33, an antigen that appears on AML cells in a vast majority of patients with the disease.
Experimental Therapies Examined through the Partnership
In addition to the two therapies above, at least three experimental drugs will be given to patients at MD Anderson as a result of the partnership. Glasdegib is an oral smoothened inhibitor that the partnership will include in six of its studies. One Phase II study involves people with AML who are at high risk of relapse following an allogeneic stem cell transplantation. Another Phase II study looks at people with myelofibrosis. In addition, the partnership will sponsor a Phase I study of glasdegib for Japanese patients treated with the agent alone or in combination with other therapies.
The partnership will also examine two pipeline drugs. The first is OX40 (CD-134), an agonist being considered as a monotherapy and in combination with other Pfizer therapies, including Bavencio, utomilumab, and Inlyta. The second drug is utomilumab, a 4-1BB (CD-137) agonist that the partnership will study in combination trials with Genentech, Merck, and Pfizer drugs, as well as the anti-CCR4 antibody Poteligeo made by Kyowa Hakko Kirin.
A Continuation of a Former Immuno-Oncology Alliance
The new partnership between MD Anderson and Pfizer is not the first time these two organizations have worked together. Early in 2014, the two joined forces to accelerate and improve immunotherapies through the Moon Shots Program—a push by MD Anderson to investigate six potential therapies for eight cancers. Much like the current agreement, this partnership aimed to identify effective combination therapies for some of the most deadly and difficult-to-treat cancers. This program also had the added goal of tracking biomarkers that could aid in identifying patients with the greatest potential for therapeutic benefit.
The immune checkpoint ipilimumab earned FDA approval in 2011, and the Moon Shots Program largely investigated this drug in combination with other therapies for the treatment of prostate, gastric, breast, and lung cancer, as well as lymphoma and melanoma. To fuel the initiative, the hospital invested $40 million; this included philanthropic funding and an Established Investigator grant to recruit a leading figure from Memorial Sloan-Kettering Cancer Center. As a result of these efforts, MD Anderson became one of the primary nucleuses of cancer immunotherapy research.