Bristol-Myers Squibb announces immunotherapy clinical collaboration with Janssen

Bristol-Myers Squibb Company (NYSE:BMY) today announced a new clinical research collaboration with Janssen Biotech, Inc. to evaluate the combination of Bristol-Myers Squibb's Immuno-Oncology (I-O) agent Opdivo and Janssen’s CD38-directed cytolytic antibody Darzalex in Phase 1b/2 clinical studies in multiple myeloma and solid tumors including non-small cell lung cancer, pancreatic cancer, colorectal cancer (CRC), triple negative breast cancer and head and neck cancer. In 2016 an existing Bristol-Myers Squibb Phase I study was expanded to include the combination of Opdivo and Darzalex in multiple myeloma; this study is ongoing. Additional studies will start in 2017.

Opdivo is a human antibody designed to alleviate immune suppression. Darzalex is a cytolytic antibody believed to induce tumor cell death through multiple immune-mediated mechanisms of action and also demonstrates immunomodulatory activities by targeting immuno-suppressive cells in the tumor microenvironment. The combination of these agents may enhance immune-mediated killing of tumors. Darzalex is indicated as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory to a PI and immunomodulatory agent. It is also in combination with other agents for the treatment of patients with multiple myeloma who have received at least one prior therapy.

"We continue to explore innovative I-O combination therapies to accelerate the discovery of new treatment options that harness the immune system to fight cancer and deliver benefits to patients," says Fouad Namouni, M.D., head of Development, Oncology, Bristol-Myers Squibb. "Our collaboration with Janssen will leverage the expertise of both organizations to rapidly evolve the science and treatments of both hematologic and solid tumors."

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 57 countries including the United States, Japan, and in the European Union.

This agreement builds off Bristol-Myers Squibb and Janssen’s previous clinical research collaboration announced in July, 2016 to evaluate Opdivo and Janssen's Live Attenuated Double-Deleted (LADD) Listerial monocytogenes cancer immunotherapy, expressing mesothelin and EGFRvIII (JNJ-64041757), in patients with non-small cell lung cancer.

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, CD-137, KIR, SLAMF7, PD-1, GITR, CSF1R, IDO and LAG-3. These pathways may lead to potential new treatment options - in combination or monotherapy - to help patients fight different types of cancers.

Our collaboration with academia, as well as small and large biotech and pharmaceutical companies, to research the potential of 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.

About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono), Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, China, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies - as single agents and combination regimens - for patients with cancer in Japan, South Korea and Taiwan, China.

About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.