HOUSTON & NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and The University of Texas MD Anderson Cancer Center today announced a new clinical research collaboration to evaluate innovative strategies for the potential use of Bristol-Myers Squibb’s immuno-oncology (I-O) agents Opdivo (nivolumab) and Yervoy (ipilimumab) to treat early- and advanced-stage lung cancer patients.
The collaboration will help support multiple Phase 1 and 2 clinical trials testing Opdivo as monotherapy, in combination withYervoy, or in regimens with other agents, radiation or surgery in a range of clinical settings. These studies will also incorporate extensive translational work including exploration of novel biomarkers to better differentiate responders from non-responders in lung cancer as well as preclinical studies of next generation immunotherapeutic agents that may be used to expand the benefits to larger numbers of patients.
Opdivo is a PD-1 immune checkpoint inhibitor currently approved in 50 countries globally for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, and Yervoyis a CTLA-4 immune checkpoint inhibitor approved in 50 countries globally for patients with unresectable or metastatic melanoma.
The collaboration will leverage MD Anderson’s existing immunotherapy platform, which helps to link immunologic data with the genomic and proteomic platforms across a range of cancer types, and broaden the scientific understanding of I-O via preclinical and clinical studies in lung cancer. Data generated will assist Bristol-Myers Squibb in optimizing I-O combinations for future clinical trials while also enhancing mechanistic understanding of immune system function in mounting of anti-tumor responses.
“Immunotherapy agents, such as nivolumab, already have prolonged the lives of many patients with metastatic NSCLC. Through our multidisciplinary collaboration with Bristol-Myers Squibb, we look forward to exploring innovative ways to integrate immunotherapy with other treatments, including surgery and radiation, with the goal of improving standard of care and expanding treatment options for all patients, including those with early stage disease,” said John Heymach, M.D., Ph.D., chair of Thoracic/Head and Neck Medical Oncology at MD Anderson.
Heymach also is co-leader of MD Anderson’s Lung Cancer Moon Shot, part of the institution’s Moon Shots Program to reduce cancer deaths by accelerating the development of new therapies, prevention efforts and early detection from scientific discoveries.
“Strategic collaborations with academia have been central to helping Bristol-Myers Squibb develop and deliver new immuno-oncology treatment options to patients,” said Jean Viallet, M.D., Global Clinical Research Lead, Oncology, Bristol-Myers Squibb. “This collaboration will leverage the considerable experience of MD Anderson to accelerate and expand our scientific and clinical understanding of how the immune system and other treatments might work together to fight cancer.”
MD Anderson’s immunotherapy platform, also part of the Moon Shots Program, conducts immune monitoring of tumors and blood before, during and after treatment to better understand how and when immunotherapy works.
“Having approved PD-1 inhibitors for metastatic NSCLC gives us the chance to explore what it is about the tumor microenvironment that allows response to these agents,” said Padmanee Sharma, M.D., Ph.D., immunotherapy platform scientific director and professor of Genitourinary Medical Oncology and Immunology at MD Anderson. “Immune monitoring can generate data that will improve our understanding of the mechanisms that lead to response or resistance to treatment and facilitate the development of new biomarkers to personalize treatments and match patients to the right therapies or combinations.”
I-O is an innovative approach to cancer research and treatment that is designed to harness the body’s own immune system to fight cancer. Lung cancer is the leading cause of cancer deaths globally, resulting in more than 1.5 million deaths each year, according to the World Health Organization.
In September of 2014, Bristol-Myers Squibb and MD Anderson entered into an I-O clinical collaboration that is focused on the evaluation of Bristol-Myers Squibb I-O assets for the treatment of hematologic malignancies, such as acute and chronic leukemia. In December 2015, Bristol-Myers Squibb and MD Anderson signed a collaboration agreement to leverage MD Anderson’s immunotherapy platform to help to link immunologic data with the genomic and proteomic platforms across a range of cancer types.
Bristol-Myers Squibb & immuno-oncology: Advancing Oncology Research
At Bristol-Myers Squibb, we have a vision for the future of cancer care that is focused on immuno-oncology, now considered a major treatment choice alongside surgery, radiation, chemotherapy and targeted therapies for certain types of cancer.
We have a comprehensive clinical portfolio of investigational and approved immuno-oncology agents, many of which were discovered and developed by our scientists. Our ongoing immuno-oncology clinical program is looking at broad patient populations, across multiple solid tumors and hematologic malignancies, and lines of therapy and histologies, with the intent of powering our trials for overall survival and other important measures like durability of response. We pioneered the research leading to the first regulatory approval for the combination of two immuno-oncology agents, and continue to study the role of combinations in cancer.
We are also investigating other immune system pathways in the treatment of cancer including CTLA-4, PD-1, SLAMF7, CD-137, KIR, LAG-3, CSF1R, IDO, and a number of other targets. These pathways may lead to potential new treatment options – most likely in combination – to help patients fight different types of cancers.
Our collaboration with academia, as well as small and large biotech companies, to research the potential immuno-oncology and non-immuno-oncology combinations, helps achieve our goal of providing new treatment options in clinical practice. At Bristol-Myers Squibb, we are committed to changing survival expectations in hard-to-treat cancers and the way patients live with cancer.
About Opdivo
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 a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells, and blocks the binding of PD-L1 and PD-L2, preventing the PD-1 pathway’s suppressive signaling on the immune system, including the interference with an anti-tumor immune response.
Opdivo’s broad global development program is based on Bristol-Myers Squibb’s understanding of the biology behind immuno-oncology. Our company is at the forefront of researching the potential of immuno-oncology to extend survival in hard-to-treat cancers. This scientific expertise serves as the basis for the Opdivo development program, which includes a broad range of Phase 3 clinical trials evaluating overall survival as the primary endpoint across a variety of tumor types. The Opdivo trials have also contributed toward the clinical and scientific understanding of the role of biomarkers and how patients may benefit from Opdivo across the continuum of PD-L1 expression. To date, the Opdivo clinical development program has enrolled more than 18,000 patients. Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 50 countries including the United States, Japan, and in the European Union.
