Bristol Myers' Opdivo+Yervoy Gets FDA Nod in First-Line NSCLC

Bristol-Myers Squibb BMY announced that the combination of its blockbuster immuno-oncology drug Opdivo (nivolumab) 3 mg/kg and Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the FDA for the lucrative indication of first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).

The combination has been approved for NSCLC patients whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. This is the fifth indication approved for the combination.

This approval was based on positive results from part 1a of the phase III CheckMate -227 study, wherein the combination demonstrated superior overall survival (OS) versus chemotherapy, regardless of tumor histology, with a minimum follow up of 29.3 months. The median OS was 17.1 months versus 14.9 months. In the trial, 63% of patients treated with Opdivo + Yervoy and 56% treated with chemotherapy were alive at one year, and 40% and 33% at two years, respectively. At three years (median 43.1 months follow up), 33% of patients treated with Opdivo + Yervoy and 22% of those treated with chemotherapy were still alive.

This is a very important indication for the combination, given the widespread prevalence. NSCLC is one of the most common types of lung cancer and accounts for approximately 84% of diagnoses.

The approval not only opens an important treatment option for the affected patients but also presents an opportunity for Opdivo to gain market share.

Opdivo sales were not impressive in the first quarter. Notably, the drug faces stiff competition from Merck’s MRK Keytruda and Roche’s RHHBY Tecentriq. AstraZeneca’s AZN Imfinzi is also approved for lung cancer.

We note that Opdivo is currently approved in many regions, including the United States, the EU and Japan, for several cancer indications. The company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents. The Opdivo + Yervoy combination is already approved for the treatment of patients with unresectable or metastatic melanoma and intermediate or poor risk, previously untreated advanced renal cell carcinoma. The combination is also indicated for the treatment of adults and pediatric patients 12 years or older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) and for HCC.

Bristol-Myers’ shares have lost 0.1% so far this year compared with the industry’s decline of 1%.

 

The label expansion of the combination for additional indications should boost sales but gaining market share from Keytruda will be a daunting task.

Bristol-Myers currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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