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Dr. Eric K. Singhi discusses the significance of the FDA approval of subcutaneous Opdivo for patients with solid tumors.
Dr. Eric K. Singhi, an assistant professor in both the Department of General Oncology and the Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center, in Houston, Texas, recently sat down for an interview with CURE®.
In the interview, he discussed the Dec. 27, 2024, Food and Drug Administration (FDA) approval of subcutaneous Opdivo and Qvantig (nivolumab and hyaluronidase-nvhy) for patients with solid tumors. He goes on to discuss the significance of the regulatory approval, as well as the trial data that led the approval.
Intravenous (IV): when a needle is inserted into a vein to administer fluids or medications directly into the bloodstream.
Overall response rate: how many patients experienced a significant shrinkage or disappearance of their tumors after treatment.
Subcutaneous: beneath the skin.
To read our full interview with Singhi, check it out here!
Transcript:
As of Dec. 27, 2024, the FDA approved subcutaneous — or under the skin — Opdivo for patients with a wide range of solid tumors. This includes renal cell carcinoma [RCC], melanoma, non-small cell lung cancer and others. The new approval applies to almost all existing solid tumor indications for the IV [intravenous] formulation, except it is not allowed for use in combination with what we call dual immunotherapy or CTLA4 inhibition with Yervoy [ipilimumab].
This approval brings a subcutaneously administered PD1 inhibitor to the market, and it could be significant for patients because it provides a new, more convenient option for treatment. This allows patients to potentially receive treatment closer to home with less time spent at treatment facilities, and it can improve both convenience and accessibility.
This approval was based on data from the phase 3 CHECKMATE-67T trial, and that included 495 patients with advanced or metastatic clear cell RCC, which is a type of kidney cancer. Importantly, these patients had to have received no more than two prior lines of treatment against their cancer. The trial compared subcutaneous — under the skin — Opdivo with the IV formulation of Opdivo, which is that traditional form of immunotherapy. What they looked at was a primary focus on assessing drug pharmacokinetics. Specifically, they looked at exposure through the time average concentration and minimum concentration at steady state.
What they saw from the results perspective was that the subcutaneous, under-the-skin Opdivo was non-inferior to the IV version, so it indicated comparable levels of drug exposure. What they also saw was that the overall response rate, meaning the percentage of patients that respond to treatment, was actually higher for subcutaneous nivolumab, at 24% compared with 18% for the IV formulation. This really supports the efficacy of the subcutaneous version.
Safety profiles were also the same, or very similar between the two arms. In the subcutaneous, under-the-skin arm, the most common adverse effects were reported in at least 10% of patients, and they included fatigue, musculoskeletal pain, pruritus or intense itching, rash and cough.
Transcript was edited for clarity and conciseness.
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