clinical trialAbbVie and Bristol-Myers Squibb Company have announced a clinical trial collaboration to evaluate the safety, tolerability and efficacy of AbbVie’s investigational biomarker-specific antibody drug conjugate Rova-T (rovalpituuzumab tesirine) in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a treatment for relapsed extensive-stage small cell lung cancer (SCLC).

The Phase I/II clinical programme will explore the potential of combining Bristol-Myers Squibb’s immuno-oncology agents, which are designed to alleviate immune suppression, in conjunction with AbbVie’s investigational antibody drug conjugate, Rova-T, to drive improved and sustained efficacy and tolerability above the current standard of care.

Rova-T is a novel antibody drug conjugate that targets and eliminates tumour initiating cells and other bulk tumour cells. This collaboration will determine if the targeted cell killing and antigen release caused by Rova-T may further enhance the effect of immunotherapy.

“We are excited to explore the potential benefits of combining Bristol-Myers Squibb’s immunotherapies with a targeted approach such as Rova-T in small cell lung cancer where the need for new therapies is particularly acute for this aggressive form of lung cancer,” said Jean Viallet, MD, Global Clinical Research Lead, Oncology, Bristol-Myers Squibb. “As the science around cancer research continues to rapidly evolve, we are building on our leadership in Immuno-Oncology with numerous collaborations that may help advance new therapies for cancers in need of better options.”

“We believe the combination of these cancer-fighting agents may offer patients a new treatment option in a disease with limited therapies,” said Scott J. Dylla, PhD, Vice President, Research and Development, AbbVie. “By combining immune-checkpoint inhibitors that prime the body’s immune system to fight cancer cells with Rova-T’s approach to target cancer stem cells, we hope to build on our goal to develop differentiated treatments with therapeutic benefit that elevate the standard of care for small cell lung cancer patients.”

Small cell lung cancer is a difficult-to-treat form of cancer that accounts for approximately 15% of all lung cancers. The 5-year survival rate for extensive-stage SCLC is less than 5% and treatment options are limited for the more than 234,000 people diagnosed annually.

Rova-T is a novel biomarker-specific therapy that targets cancer stem cells and combines a targeted antibody that delivers a cytotoxic agent directly to cancer cells expressing a delta-like protein 3 (DLL3). DLL3 is expressed in more than 80% of SCLC patient tumours and is not present in healthy tissue. Rova-T is currently in investigational studies as a third-line treatment for SCLC. AbbVie will initiate a first-line clinical study for Rova-T in SCLC and several other types of tumours in the near-term.

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 54 countries including the United States, Japan, and in the European Union. Yervoy is a CTLA-4 immune checkpoint inhibitor approved in 50 countries globally for patients with unresectable or metastatic melanoma.