Bristol-Myers Squibb Company (BMY - Free Report) announced that its PD-1 immune checkpoint inhibitor, Opdivo, in combination with Yervoy, demonstrated superiority in improving progression free survival (“PFS”) in a phase III lung cancer study. The positive data again showed the blockbuster potential of Opdivo, which is already approved in multiple indications and is also being evaluated in several others.
Shares of the company have returned 18% in the past year, outperforming the industry’s gain of 13.8% in that period.
The phase III study – CheckMate-227 – is evaluating Opdivo monotherapy and combination regimens in non-squamous and squamous advanced non-small cell lung cancer (“NSCLC”) in first-line setting. The study is being conducted in three parts.
The data was announced from the part of the study, which evaluated the combination regimen for overall survival (“OS”) in patients whose tumors express PD-L1 and for PFS in patients with high tumor mutation burden (“TMB”), regardless of PD-L1 expression.
Data showed that the regimen significantly improved PFS in patients compared to chemotherapy. However, the Data Monitoring Committee has recommended to continue the study for overall survival endpoint based on an interim analysis.
This is the first study to evaluate combination regimens of two immune-oncology drugs in first line NSCLC patients with high TMB.
Another part of the study is evaluating Opdivo in combination with chemotherapy in broad patient population.
We remind investors that the combination regimen has achieved durable clinical benefit in a phase II study in patients with DNA mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer.
Please note that Merck’s (MRK - Free Report) anti-PD-1 immunotherapy, Keytruda, is approved in first-line NSCLC. Data announced from a late stage study in January 2018 showed that Keytruda, in combination with Eli Lilly and Company’s (LLY - Free Report) Alimta, resulted in significantly improved OS and PFS in metastatic non-squamous NSCLC patients.
Zacks Rank & Stock to Consider
Bristol-Myers carries a Zacks Rank #3 (Hold).
Exelixis, Inc. (EXEL - Free Report) is a better-ranked stock in the pharma sector, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Exelixis’ earnings estimates increased from 73 cents to 77 cents for 2018 over the last 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 572.92%. The stock is up 42.1% in the past year.
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