BMS, AbbVie Form Clinical Trial Pact for ADC, Immuno-Oncology DrugBy
AbbVie and Bristol-Myers Squibb (BMS) have begun a clinical trial collaboration to evaluate the safety, tolerability, and efficacy of AbbVie’s Rova-T (rovalpituzumab tesirine), an investigational antibody drug conjugate, in combination with BMS' immuno-oncology drugs, Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab), a combination regimen, for relapsed extensive-stage small-cell lung cancer. This collaboration will determine if the targeted cell killing and antigen release caused by Rova-T may further enhance the effect of immunotherapy.
The Phase I/II clinical program will explore the potential of combining BMS' immuno-oncology agents, which are designed to alleviate immune suppression, in conjunction with AbbVie’s Rova-T, to drive efficacy and tolerability of the cancer regimen. Rova-T targets and eliminates tumor-initiating cells and other bulk tumor cells.
Opdivo is a programmed-cell-death-1 immune checkpoint inhibitor that first received regulatory approval in Japan in July 2014 for treating unresectable melanoma. Yervoy is BMS' cytotoxic T lymphocyteâ€“associated antigen-4 immune checkpoint inhibitor approved in 50 countries for melanoma.
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. It is also approved for treating metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy and for treating advanced renal cell carcinoma who have 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 slated by some analysts for blockbuster status. It had 2015 global sales of $942 million, and a recent Thomson Reuters analysis projects 2019 sales to reach nearly $8.9 billion.