AbbVie and Bristol-Myers Squibb (BMS) said today they will launch an oncology clinical collaboration to assess two combination treatments for relapsed, extensive-stage, small-cell lung cancer (SCLC).

The value of the Phase I/II clinical collaboration was not disclosed.

The companies will study AbbVie's investigational biomarker-specific antibody drug conjugate Rova-T (rovalpituzumab tesirine) in combination with BMS’ marketed immuno-oncology treatment Opdivo® (nivolumab), as well as the combination of Rova-T and an Opdivo + Yervoy® (ipilimumab) immuno-oncology regimen.

AbbVie and BMS said they aim to determine if the targeted cell killing and antigen release caused by Rova-T further enhances the effect of immunotherapy.

“We believe the combination of these cancer-fighting agents may offer patients a new treatment option in a disease with limited therapies,” Scott J. Dylla, Ph.D., AbbVie vp, R&D, said in a statement. “We hope to build on our goal to develop differentiated treatments with therapeutic benefit that elevate the standard of care for SCLC patients.”

Rova-T is a novel biomarker-specific therapy that targets cancer stem cells. It combines a targeted antibody that delivers a cytotoxic agent directly to cancer cells expressing a delta-like protein 3 (DLL3) that is expressed in more than 80% of SCLC patient tumors and is not present in healthy tissue.

Rova-T is now in investigational studies as a third-line treatment for SCLC. AbbVie said in the statement that it plans to launch a first-line clinical study for Rova-T in SCLC and several other types of tumors “in the near term.”

AbbVie added Rova-T to its cancer pipeline in April when it agreed to acquire Stemcentrx for up to $9.8 billion cash and stock. The collaboration with BMS continues AbbVie’s expansion of its cancer R&D efforts—an expansion that saw three research collaborations launched in April.

AbbVie agreed to co-develop at least one CytomX Probody™ Drug Conjugate against CD71, also known as transferrin receptor 1 (TfR1). The collaboration could generate up to $500 million for CytomX. AbbVie also agreed to develop and commercialize argenx’s preclinical cancer immunotherapy ARGX-15 in an up-to-$685 million partnership, and AbbVie joined the University of Chicago in launching a collaboration intended to advance research in several areas of oncology.

Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014 and now has regulatory approval in 54 countries including the U.S., the EU, and Japan. Yervoy is a CTLA-4 immune checkpoint inhibitor approved in 50 countries globally for patients with unresectable or metastatic melanoma.








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