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Bristol Myers' (BMY) Opdivo+Yervoy Fails First-Line SCCHN Study

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Bristol-Myers Squibb Company (BMY - Free Report) announced updated data from the phase III CheckMate -651 study which is evaluating the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) compared to the EXTREME regimen (cetuximab, cisplatin/carboplatin and fluorouracil) as a first-line treatment in platinum-eligible patients with recurrent or metastatic squamous cell carcinoma of the head and neck (“SCCHN”), a difficult-to-treat cancer.

Data from the same showed that treatment with the combo of Opdivo+Yervoy led to a clear, positive trend toward overall survival (“OS”) in patients whose tumors express PD-L1. However, the study did not meet its primary endpoints.

Shares of Bristol Myers have rallied 8.5% so far this year against the industry’s decrease of 2.8%.

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We remind investors that Opdivo as a monotherapy is currently approved for treating adult patients with recurrent/metastatic SCCHN after platinum-based therapy.

Per the company, the combination of Opdivo plus Yervoy has demonstrated significant improvements in OS in six late-stage studies evaluating the same across five different tumors.

Opdivo is approved in several countries for various indications — unresectable or metastatic melanoma, metastatic non-small-cell lung carcinoma (“NSCLC”) with progression on or after platinum-based chemotherapy, metastatic small cell lung cancer with progression after platinum-based chemotherapy, advanced renal cell carcinoma (“RCC”), adult patients with classical Hodgkin lymphoma (cHL), and recurrent or metastatic squamous cell carcinoma of the head and the neck, among others.

It is also approved for various indications in combination with Yervoy, like metastatic melanoma, NSCLC, malignant pleural mesothelioma and RCC, among others. The company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents.

Approval of additional indications should boost Opdivo sales, which were not impressive in the first quarter of 2021. Notably, the drug faces stiff competition from Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq.

Zacks Rank & Stock to Consider

Bristol Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Repligen Corporation (RGEN - Free Report) , which sports a Zacks Rank #2 (Buy) at present. You can see  the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Repligen’s earnings estimates have been revised 2.3% upward for 2021 and 1.2% upward for 2022 over the past 60 days. The stock has increased 4.5% year to date.