AbbVie, Bristol-Myers Squibb Announce Clinical Research Collaboration

AbbVie and Bristol-Myers Squibb announced a clinical trial collaboration to evaluate the combination of AbbVie's investigational antibody drug conjugate ABBV-399 and Bristol-Myers Squibb's immunotherapy Opdivo (nivolumab) in c-Met overexpressing non-small cell lung cancer (NSCLC).

A Phase 1b clinical study is underway that includes evaluating the potential of combining Opdivo, which is designed to alleviate immune suppression, with ABBV-399 to explore the tolerability and potential efficacy of the combination in subjects with advanced c-Met overexpressing NSCLC who failed one prior line of chemotherapy.

"Cancer remains one of the most challenging medical conditions for patients and physicians," said Tom Hudson, M.D., vice president, oncology early discovery and development, AbbVie. "Therapeutic advances continue to be achieved every day and we are committed to exploring the potential of our investigational compounds with other approved treatments with the goal to deliver a significant impact to patients."

AbbVie is the sponsor conducting the trial. Specific terms of the agreement were not disclosed.

"We continue to explore the potential of novel combinations of medicines with Opdivo, and AbbVie's investigational treatments will help evaluate the role of new targets in combination with immunotherapy," said Fouad Namouni, M.D., Head of Development, Oncology, Bristol-Myers Squibb. "We look forward to continuing to partner our PD1 with AbbVie's early- and late-stage assets as a possible treatment option for patients with lung cancer."

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response. By harnessing the body's own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo's leading global development program is based on Bristol-Myers Squibb's scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union, and Japan. In October 2015, the company's Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

ABBV-399 (telisotuzumab vedotin) is a first-in-class anti-c-Met antibody drug conjugate that targets both MET-amplified and c-Met-overexpressing tumors. It is currently being investigated to treat advanced solid tumors. c-Met expression is significantly higher in many solid tumors compared to normal tissue and is a marker of poor prognosis. ABBV-399 is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.