MD Anderson, BMS enter research collaboration in immuno-oncology focused on leukemia and hematologic malignancies

The agreement represents an innovative approach to research by focusing numerous clinical trials using multiple agents, in mono and combination regimens, on a specific disease target, in this case select hematologic malignancies.

Through this approach, Bristol-Myers Squibb and MD Anderson aim to benefit patients by expediting the delivery of new therapies. The collaboration will launch up to 10 phase 1 and 2 clinical trials, conducted by MD Anderson, focused on evaluating investigational immune-based approaches for acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), chronic myeloid leukemia (CML), myelodysplastic syndrome (MDS) and myelofibrosis (MF). Additional studies will be determined by the collaboration at a later date.

Opdivo (nivolumab) is an investigational PD-1 immune checkpoint inhibitor currently approved in Japan for the treatment of patients with unresectable melanoma, and Yervoy (ipilimumab) is a CTLA-4 immune checkpoint inhibitor approved in the U.S. and more than 40 countries for patients with unresectable or metastatic melanoma.

Bristol-Myers Squibb has proposed the name Opdivo (pronounced op-dee-voh), which, if approved by health authorities, will serve as the trademark for nivolumab.

"Collaborations between industry and academia can offer a faster and broader spectrum of clinical trials to benefit patients," said Hagop Kantarjian, M.D., chair of leukemia at MD Anderson.

"We hope innovative collaborations such as this can help lead to a higher likelihood for success across the board and will speed up the clinical development of new compounds for delivery to the patients who need them."

"Immunotherapy is an extremely promising area of research and a key area of focus for MD Anderson’s Moonshots Program," said MD Anderson President Ron DePinho, M.D. "Partnerships between academia and industry have the potential to significantly advance the application of new discoveries to cancer treatment."

"Bristol-Myers Squibb is committed to advancing the field of immuno-oncology and complementing our broad research and discovery programs through innovative collaborations with partners who share our commitment to patients," said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb. "Cooperation between industry and academia offers a tremendous opportunity to strengthen our scientific and clinical understanding of the role of the immune system in treating cancer."

Immuno-oncology is an innovative approach to cancer research and treatment that is designed to harness the body’s own immune system to fight cancer. Hematologic malignancies represent significant areas of high unmet need marked by poor outcomes among the elderly, high-risk patients and for those with multiple relapses. Existing clinical research, including studies by MD Anderson, support further research into the potential of immunotherapies as treatment options for leukemia and other hematologic malignancies.

Cancer cells may exploit "regulatory" pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells.

Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 35 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin lymphoma.