PRINCETON, N.J. - Bristol Myers Squibb (NYSE: NYSE:BMY) has announced that the European Medicines Agency (EMA) has begun reviewing the company's application for a subcutaneous (under the skin) injection form of Opdivo, a medication used in the treatment of multiple types of cancer in adults. This new formulation, if approved, could significantly reduce the time patients spend receiving their treatment.
The application is based on results from the Phase 3 CheckMate -67T trial, which demonstrated that the subcutaneous version of nivolumab is not inferior to the intravenous form in terms of pharmacokinetics - how the drug is absorbed, distributed, metabolized, and excreted in the body - and efficacy.
The study's primary endpoints, which are average serum concentration over 28 days and trough serum concentration at steady state, showed comparable results between the two forms. Additionally, the objective response rate, a key secondary endpoint, was also non-inferior in the subcutaneous version.
Patients in the trial were adults with advanced or metastatic clear cell renal cell carcinoma (ccRCC), a type of kidney cancer, who had received no more than two prior lines of systemic therapy. The subcutaneous injection, which can be administered in three to five minutes, offers the same quality of care as the intravenous form but with a much shorter administration time, potentially improving the patient experience by reducing the time spent at infusion centers.
The safety profile of the subcutaneous nivolumab was consistent with the known profile of its intravenous counterpart. Results from the CheckMate -67T trial were presented at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, with additional safety analyses and patient-reported outcomes shared at the 2024 ASCO Annual Meeting.
Opdivo works by inhibiting the programmed death-1 (PD-1) immune checkpoint, which is a mechanism that cancer cells exploit to evade attack by the body's immune system. By blocking PD-1, Opdivo aims to restore the immune system's ability to detect and fight tumor cells.
Bristol Myers Squibb is committed to improving the patient experience and is actively working on innovative formulations across its portfolio. The EMA's validation of the application signifies the start of the centralized review process. The review will determine whether the subcutaneous form of nivolumab will be approved for use in the European Union.
This news is based on a press release statement from Bristol Myers Squibb.
In other recent news, Bristol Myers Squibb has been actively making strides in its developments and operations. The company announced the appointment of Michael R. McMullen to its Board of Directors, a move that expanded the board to 11 members. McMullen, a seasoned executive, brings a wealth of experience from his previous role as president and CEO of Agilent Technologies (NYSE:A).
Bristol Myers Squibb also reported significant progress in its drug development efforts. The U.S. Food and Drug Administration (FDA) granted accelerated approval for Augtyro as a treatment for certain patients with solid tumors. In addition, Breyanzi has been approved by the FDA for broad lymphoma treatment, marking it as the only CAR T cell therapy to cover four distinct subtypes of non-Hodgkin lymphoma.
On the financial front, the company's Board of Directors approved quarterly dividend payments for both its common and preferred stock. However, Bristol Myers Squibb, along with Sanofi (NASDAQ:SNY), has been ordered to pay over $916 million to the state of Hawaii due to allegations of failure to adequately warn non-white patients about potential health risks associated with the blood thinner Plavix. Both companies plan to appeal the decision.
Citi maintained its Buy rating on Bristol Myers Squibb stocks, citing the company's financial health and the potential of its pipeline.
These are recent developments in the company's journey, reflecting its ongoing efforts in drug development and its financial decisions.
InvestingPro Insights
As Bristol Myers Squibb (NYSE: BMY) aims to enhance cancer treatment with a new subcutaneous injection form of Opdivo, the company's financial health and market performance remain key factors for investors. With a market capitalization of $83.19 billion, Bristol Myers Squibb showcases its substantial presence in the pharmaceutical industry. An InvestingPro Tip highlights the company's aggressive share buyback strategy, indicating management's confidence in the company's value and future prospects.
Despite a slight decline in revenue growth over the last twelve months as of Q1 2024, by -0.68%, the company's gross profit margin remains robust at 76.03%, underlining its ability to maintain profitability in its operations. Additionally, Bristol Myers Squibb boasts a noteworthy dividend yield of 5.85%, reflecting its commitment to return value to shareholders, a point further underscored by its impressive track record of maintaining dividend payments for 54 consecutive years—an InvestingPro Tip that income-focused investors may find particularly appealing.
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