- Bristol-Myers Squibb is testing its blockbuster immunotherapy Opdivo in two combinations with other oncology developers in an effort to further its combination strategy.
- The big pharma has inked an early-stage collaboration with Aveo Oncology to test the biotech's once-daily, vascular endothelial growth factor tyrosine kinase inhibitor tivozanib with Opdivo, a PD-1 inhibitor.
- Bristol-Myers will also supply Bavarian Nordic with a supply of Opdivo to test the drug in combination with the experimental CV301 in patients with non-small cell lung cancer (NSCLC).
Despite a clinical setback last week for Opdivo (nivolumab) in the first-line setting of NSCLC, Bristol-Myers is undeterred in its pursuit of a strong clinical profile for the checkpoint inhibitor.
The big pharma has previously said it will focus on combination therapies including Opdivo to further differentiate the drug. Since its FDA approval last summer, Opdivo has quickly outpaced Merck's rival PD-1 inhibitor Keytruda (pembrolizumab), racking up sales and new indications. The failure in first-line NSCLC opens the door for Merck to regain an edge, having already said Keytruda beat out chemotherapy in treatment-naive patients.
Bristol-Myers will supply its already-marketed drug to Bavarian Nordic for the biotech to test with its own CV301, which targets two tumor-associated antigens, CEA and MUC-1. CV301 has been shown to upregulate PD-1, potentially eliciting a greater response in patients who would normally not respond to Opdivo.
The agreement with Bavarian Nordic does not require anything more of Bristol-Myers than drug supply and allows the biotech to retain all rights to its drug.
On the other hand, Aveo will lead a Phase I trial of tivozanib in combination with Opdivo in patients with renal cell carcinoma. A Phase 2 cohort will then follow at an established combination dose.
Aveo is hoping that tying its fate to the hot blockbuster could help transform its development of Tivozanib, which has had more than its share of failures over the years. Tivozanib was rejected by the Food and Drug Administration for renal cell carcinoma in mid-2013 with scathing criticisms from the agency regarding its clinical program.
The compound has also failed to show statistically significant improvements in other indications. There has been uproar from investors—sending the stock into penny stock territory—after evidence arose that executives were hiding safety concerns about the drug.