Bristol Myers' (BMY) Opdivo SC Meets Kidney Cancer Study Goals
Bristol Myers BMY announced positive results from its late-stage study evaluating the efficacy of its subcutaneous (SC) formulation of Opdivo (nivolumab) compared with intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy.
BMY’s Opdivo SC is co-formulated with Halozyme’s HALO novel drug delivery technology, Enhanze. Notably, Enhanze is a recombinant human hyaluronidase enzyme, rHuPH20.
Halozyme’s Enhanze technology is used by several companies to develop an SC formulation of their currently marketed drugs. HALO currently has six marketed partnered drugs based on this technology.
Per the data readout, the phase III CheckMate-67T study of Opdivo SC met its co-primary pharmacokinetics noninferiority endpoints of Cavgd28 (time-averaged Opdivo serum concentration more than 28 days) and Cminss (trough serum concentration at steady state) compared with IV Opdivo.
Bristol Myers also reported that the CheckMate-67T study of Opdivo SC met its key secondary endpoint of non-inferior objective response rate compared with IV Opdivo. The safety profile of Opdivo SC observed in the study was also found to be consistent with that of the IV formulation.
Year to date, shares of BMY have lost 21.5% compared with the industry’s 19.8% decline.
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Opdivo, Bristol Myers’ PD-1 immune checkpoint inhibitor, was initially approved in 2014 to treat patients (IV-ly) with unresectable or metastatic melanoma and disease progression following treatment with Yervoy (ipilimumab). Currently, Opdivo is approved both as a monotherapy and in combination with Yervoy to treat a plethora of cancer indications in many countries, including the United States and EU.
With this SC formulation of Opdivo, the company hopes to meet the need for less invasive and additional administration options to address the treatment burden on patients and improve efficiencies in healthcare systems in treating ccRCC.
At present, BMY is gearing up to complete its full evaluation of data obtained from its phase III CheckMate-67T noninferiority study of Opdivo SC. Full detailed data is expected to be presented at an upcoming medical conference.
Bristol Myers also reported carrying out discussions with various regulatory bodies to figure out the next steps for Opdivo SC in multiple indications. The company is also currently conducting a follow-up analysis of the CheckMate-67T study to assess additional secondary efficacy and safety endpoints.
Bristol Myers Squibb Company Price and Consensus
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Zacks Rank and Stocks to Consider
Bristol Myers currently has a Zacks Rank #3 (Hold).
A few better-ranked stocks in the same industry are Anixa Biosciences ANIX and Adicet Bio, Inc. ACET, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has remained constant at 32 cents. The estimate for Anixa Biosciences’ 2024 loss per share has remained constant at 37 cents. Year to date, shares of ANIX have lost 24.9%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 26.29%.
In the past 30 days, the estimate for Adicet Bio’s 2023 loss per share has remained constant at $2.93. The estimate for Adicet’s 2024 loss per share has remained constant at $2.40. Year to date, shares of ACET have fallen 83.7%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 7.70%.
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