AbbVie and Bristol-Myers Squibb will jointly conduct a Phase I/II clinical trial of Rova-T (rovalpituuzumab tesirine) in combination with Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen to treat relapsed extensive-stage, small-cell lung cancer (SCLC).

Rova-T is AbbVie’s investigational antibody drug conjugate targeting the cancer-stem, cell-associated target, delta-like protein 3 that characterise SCLC tumours but do not occur in healthy tissues.

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Bristol-Myers Squibb’s Opdivo is a PD-1 immune checkpoint inhibitor that fuses with the checkpoint receptor PD-1 expressed on activated T-cells and inhibits the binding of PD-L1 and PD-L2, thereby blocking the PD-1 pathway’s interfering signals to the immunity system.

Yervoy is a CTLA-4 immune checkpoint inhibitor approved to treat patients with unresectable or metastatic melanoma.

The Phase I/II clinical programme has been designed to determine the efficacy of a combination of the immuno-oncology agent Opdivo with Rova-T.

"We believe the combination of these cancer-fighting agents may offer patients a new treatment option in a disease with limited therapies."

The combination is expected to explore Rova-T’s targeted cell killing and antigen release to enhance the effect of immunotherapy.

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AbbVie research and development vice-president Scott Dylla said: “We believe the combination of these cancer-fighting agents may offer patients a new treatment option in a disease with limited therapies.

“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.”

Rova-T is currently being investigated as a third-line treatment for SCLC and AbbVie is also planning to begin a first-line clinical study for Rova-T in SCLC, along with several other types of tumours in the near future.

Image: Micrograph displaying small cell lung cancer. Photo: courtesy of Nephron.