Bristol-Myers Squibb Company (BMY - Free Report) announced that the phase III CheckMate-451 study on immuno-oncology drug Opdivo in combination with Yervoy was unsuccessful.
The global, double-blind, randomized phase III study evaluated the Opdivo-Yervoy combination and Opdivo monotherapy versus placebo as a maintenance therapy in patients with extensive-stage small cell lung cancer (SCLC) without disease progression after completion of first-line platinum-based chemotherapy.
The study did not meet primary endpoint of overall survival (OS). However, no new safety signals were observed.
We remind investors that Opdivo is already approved for the treatment of patients with metastatic SCLC with progression after platinum-based chemotherapy and at least one other line of therapy.
A potential label expansion of the drug would have boosted sales. Bristol-Myers’ stock has decreased 11.7%, against the industry’s growth of 10.4%.
Nevertheless, Opdivo is already approved in the United States for RCC. The drug is approved for several indications in the United States and Europe. It became the first PD-1 inhibitor to be approved for a hematological malignancy — classical Hodgkin lymphoma. Opdivo obtained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (“SCCHN”) with disease progression on or after platinum-based therapy.
The European Commission (“EC”) also approved Opdivo as a monotherapy for the treatment of SCCHN in adults progressing on or after platinum-based therapy in April 2017. The drug has been performing impressively, owing to demand resulting from the rapid commercial acceptance for several indications, including melanoma, renal cell carcinoma and second-line non-small-cell lung cancer (“NSCLC”). The FDA also approved the drug for intravenous use in patients with hepatocellular carcinoma (“HCC”) who have been previously treated with Nexavar.
However, Opdivo faces stiff competition from Merck’s (MRK - Free Report) anti-PD-1 therapy, Keytruda, which is approved in the first-line lung cancer setting. Also, Roche’s (RHHBY - Free Report) anti-PDL1 immunotherapy, Tecentriq is approved for the treatment of metastatic NSCLC.
In October, the FDA extended the action date by three months for a supplemental Biologics License Application (sBLA) seeking approval of Opdivo+Yervoy as a treatment for first-line NSCLC with tumor mutational burden ≥10 mutations/megabase. The Committee for Medicinal Products for Human Use also requested additional data to review a regulatory application for a similar indication.
Zacks Rank & Other Key Pick
Bristol-Myers currently carries a Zacks Rank #1 (Strong Buy). Another top-ranked stock from the same space is Gilead Sciences, Inc. (GILD - Free Report) , which carries the same rank as Bristol-Myers. You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates increased from $6.60 to $6.93 for 2018 over the past 60 days. Estimates for 2019 are also up by 30 cents.
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