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Bristol-Myers, Janssen enter into new immunotherapy clinical research collaboration

PBR Staff Writer Published 06 January 2017

Bristol-Myers Squibb (BMS) and Janssen Biotech are expanding their clinical research collaboration, which was announced in July 2016, with new combo trials.

BMS’ immuno-oncology agent Opdivo will now be assessed with Janssen’s Darzalex in multiple myeloma, as well as several solid tumor types including including non-small cell lung cancer, pancreatic cancer, colorectal cancer, triple negative breast cancer and head and neck cancer.

In 2016 an existing BMS phase I trial was extended to include the combination of Opdivo and Darzalex in multiple myeloma. Further studies are due to commence in 2017.

The latest development is the second step in a joint research program that started with trials of 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 head of development for oncology Fouad Namouni said: “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.

“Our collaboration with Janssen will leverage the expertise of both organizations to rapidly evolve the science and treatments of both hematologic and solid tumors.”

Darzalex, approved by the U.S. Food and Drug Administration in late 2015, was the first immunotherapy to work by inhibiting CD38.

The FDA also approved Darzalex for use in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, or bortezomib (a PI) and dexamethasone, in patients with multiple myeloma who have received at least one prior therapy.

Opdivo is a human antibody designed to alleviate immune suppression. It presently has regulatory approval in 57 countries including the US, Japan, and in the European Union.


Image: Bristol-Myers Squibb facility in New Brunswick, New Jersey, US. Photo: courtesy of Bristol-Myers Squibb Company.