Generic name: nivolumab
Companies: Bristol-Myers Squibb; Ono Pharmaceutical
2015 sales: $1.12 billion
2022 sales: $12.62 billion
Current indications: non-small cell lung cancer; metastatic melanoma; renal cell carcinoma; classical Hodgkin lymphoma
Opdivo was the first drug in the PD-1/PD-L1 inhibitor class to reach the market after its approval in Japan in 2014, but then followed Merck & Co.’s Keytruda by several months in winning an FDA approval. The two drugs have seesawed for dominance ever since.
Though Keytruda's new approval in first-line lung cancer could prove a spoiler for Opdivo's 2022 sales, the med has been the favorite to rule the roost among this new generation of immuno-oncology drugs.
Prospects for Opdivo took a knock after it failed to meet its objectives in the CheckMate-026 trial in first-line non-small cell lung cancer (NSCLC), largely because it did not confine its study population to patients whose tumors tested positive for high-level PD-L1 expression.
For now, that means Opdivo has probably ceded control of that territory to other drugs in the class, most notably Keytruda, which won its first-line approval in the U.S. in October. Roche's newer Tecentriq will be going for a first-line approval, too. But for that setback, Opdivo would have been at the head of the cancer drug pack in 2022 with sales of a $14.6 billion, according to EvaluatePharma's analysis.
A $2 billion deficit is clearly huge, but Opdivo's second-place position in this list goes some way to put the first-line failure into perspective. A massive clinical trial program for the drug, both as a monotherapy and in combination with other cancer drugs, could unlock new uses in other solid tumors such as breast, colorectal, small cell lung and gastric cancers, as well as hematological malignancies including follicular lymphoma and diffuse large B-cell lymphoma.
All is not necessarily lost in first-line NSCLC either, and it is worth noting that three-quarters of first-line NSCLC patients are PD-L1-negative and so still have to be treated with chemotherapy. A lot is therefore riding on the outcome of the CheckMate-227 trial that will look at the combination of Opdivo with another BMS immuno-oncology asset—Yervoy—and is due to report results in 2018. If positive, that data could return Opdivo to a position of strength in lung cancer.