Bristol-Myers Squibb (BMS) and Janssen Biotech have formed a new clinical research collaboration to evaluate Bristol-Myers Squibb's immuno-oncology agent, Opdivo (nivolumab), and Janssen's live attenuated double–deleted (LADD) Listerial monocytogenes cancer immunotherapy for treating non-small cell lung cancer (NSCLC).

Janssen's immunotherapy compound is an antigen-presentation therapeutic based on LADD Listeria monocytogenes strains engineered to induce an immune response against NSCLC tumors. It is currently in Phase I clinical development for lung cancer. BMS' Opdivo is a human antibody designed to alleviate immune suppression. It is indicated for the treatment of patients with NSCLC with progression on or after platinum-based chemotherapy. The companies will conduct a Phase II clinical trial to evaluate the tolerability and clinical activity of the combination of these agents in NSCLC patients.

In addition to being approved for treating NSCLC, in the US, Opdivo is approved as a single agent for treating BRAF V600 wild-type unresectable or metastatic melanoma and as a single agent for treating BRAF V600 mutation-positive unresectable or metastatic melanoma. It is also approved in combination with Yervoy (ipilimumab) for treating unresectable or metastatic melanoma and for treating advanced renal cell carcinoma that has received prior anti-angiogenic therapy. It is also approved for treating patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin.

Opdivo is projected to be a blockbuster drug by some analysts. In 2015 it had global sales of $942 million, and a recent Thomson Reuters analysis projects that 2019 sales will reach nearly $8.9 billion.

Source: Bristol-Myers Squibb