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Dr. Eric K. Singhi discusses the benefit of subcutaneous immunotherapy following the FDA approval of subcutaneous Opdivo for patients with solid tumors.
Dr. Eric K. Singhi discusses the benefit of subcutaneous versus intravenous Opdivo for patients with solid tumors.
On Dec. 27, 2024, the Food and Drug Administration (FDA) approved treatment with the subcutaneous injection formulation of Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for patients with solid tumors. This regulatory approval presents eligible patients with an effective, more convenient treatment option with faster administration times and reduced logistical burden, according to Dr. Eric K. Singhi.
In an interview with CURE®, Singhi delved into the advantages of subcutaneous drugs compared with their intravenous (IV) counterparts, highlighting that the subcutaneous administration of the immunotherapy treatment is a welcome alternative for patients.
“This approval not only maintains the efficacy and safety of the traditional IV formulation, but also offers a significant improvement in convenience. For patients, this is a welcome step towards making cancer treatment more manageable and potentially less disruptive to their daily lives,” he emphasized.
In the interview, he also discussed the data that led to this FDA approval, how this formulation may impact treatment adherence and quality of life for patients and expanded on other potential subcutaneous treatment options in the pipeline.
Singhi currently serves as 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.
Singhi: 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 formulation, except it is not allowed for use in combination with what we call dual immunotherapy, or CTLA4 inhibition with Yervoy [ipilimumab].
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.
The Food and Drug Administration (FDA): a federal agency that protects the public's health.
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.
From the patient perspective, the primary advantages of having this under-the-skin, subcutaneous formulation of Opdivo can include a shorter administration time. The subcutaneous injection can be completed in just three to five minutes compared with the 30-minute infusion time that's required for the IV version of Opdivo. This doesn't seem like a lot, but when you think about the impact of time toxicity that's associated with cancer treatments, — which includes visits to the doctor, lab checks, scans, infusion times and even going to the pharmacy to pick up your medications — just saving 25 minutes or more could mean a lot for a patient and their family, allowing them to maintain a more normal routine. This is definitely something to think about.
It's also more convenient. Some patients have difficulty with venous access, getting an IV put in, being able to get the IV formulation of a medication. This is an opportunity to have an under-the-skin immunotherapy version that could be much more convenient for those patients. It also offers a more patient-centric experience. The option for under-the-skin, subcutaneous injections could reduce the frequency of hospital visits. It could potentially allow for treatments to be closer to a patient's home.
The subcutaneous formulation could improve treatment adherence by making the therapy more convenient and less disruptive to patients’ lives. With a quicker administration time and the possibility of receiving the treatment closer to home, patients may find it easier to want to continue their treatment as prescribed, reducing the likelihood of missed doses. This convenience can also improve the overall quality of life by minimizing the time that patients and their loved ones have to spend in medical facilities.
I do think that the subcutaneous administration option could help address healthcare disparities, especially for those patients that are coming from rural or underserved areas. For patients, for example, who had to previously travel long distances for IV treatments, they now may be able to receive these subcutaneous under the skin injections locally. Because Opdivo is now easier to administer, this could potentially help immunotherapy reach certain community practices that have so far not used immunotherapy very much because of the logistical barriers.
One of the other subcutaneous medications that we are very excited about, from a thoracic oncologist perspective, is Rybrevant [amivantamab]. We were hoping that the subcutaneous, under-the-skin version of Rybrevant would be ready for us by 2024 but, unfortunately, there were some logistical issues. They are still actively evaluating how to get that out there, but that has the potential to transform the time toxicity for a patient that's receiving that IV infusion.
Usually that can take several hours, especially for cycle one day one, and those first infusions and treatments. The potential to reduce a treatment from hours to minutes could be a game-changing impact. I think that's one example of another medication that I'm really excited about hopefully getting [the chance to roll out] for an under the skin version [of therapy] in the near future.
I'm excited about this FDA approval. The key takeaway for patients is the opportunity for a more patient-centric treatment experience with faster administration times, the possibility of receiving treatment closer to home and the reduced logistical burden. Patients now have a new and potentially more convenient and flexible option for managing their cancer treatment.
Transcript was edited for clarity and conciseness.
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