Bristol-Myers Squibb Company and The University of Texas MD Anderson Cancer Center have begun a research partnership to investigate novel approaches for the potential use of Bristol-Myers Squibb’s immuno-oncology agents Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of early and advanced-stage lung cancer.
The research alliance will support several Phase 1 and 2 studies evaluating Opdivo as a single-agent combined with Yervoy, or in treatment regimens with other drug agents, radiation or surgery in a range of medical situations. The clinical trials will integrate large translational research projects on the evaluation of new biomarkers to better distinguish lung cancer responders from non-responders.
Opdivo (nivolumab) is a humanized IgG4 anti-PD-1 monoclonal antibody used to treat cancer. It works as a checkpoint inhibitor, blocking a signal that would have prevented activated immune T cells from attacking the cancer, thus allowing the immune system to clear the malignant cells. It is approved in 50 countries worldwide to treat patients with metastatic non-small cell lung cancer (NSCLC), whose disease progressed during or following platinum-based chemotherapy.
Yervoy (ipilimumab) is a monoclonal antibody that activates the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system. The drug is approved in 50 countries globally for inoperable or metastatic melanoma.
The collaboration will leverage MD Anderson’s existing immunotherapy platform, which helps link immunologic data with the genomic and proteomic platforms across a range of cancer types, and broaden the scientific understanding of immunotherapy via preclinical and clinical studies in lung cancer.
Data generated will help Bristol-Myers Squibb optimize immunotherapy combinations for future clinical trials, while also enhancing the mechanistic understanding of immune system function in anti-tumor responses.
Dr. John Heymach, chair of Thoracic/Head and Neck Medical Oncology at MD Anderson and co-leader of MD Anderson’s Lung Cancer Moon Shot, said immotherapy agents are extending the lives of patients living 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,” Heymach said.
The Lung Cancer Moon Shot program aims to find drugs that target every cancer-driving molecular aberration, and use agents already approved for other cancers to significantly speed up the process.
“Strategic collaborations with academia have been central to helping Bristol-Myers Squibb develop and deliver new immuno-oncology treatment options to patients,” said Dr. Jean Viallet, 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, provides investigators with support to develop immunotherapies for treatment of a wide variety of tumor types, and help link immunologic data with genomic and proteomic platforms.
“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 Dr. Padmanee Sharma, 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,” Sharma said.