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Subcutaneous Opdivo improves cancer care by offering faster, accessible therapy, reducing time toxicity and expanding patient access, according to experts.
Subcutaneous Opdivo improves cancer care by offering faster, accessible therapy, reducing time toxicity and expands patient access.
The utility of immunotherapy in the treatment of cancer has aided in the rapid expansion of the solid tumor therapeutic landscape. Immunotherapy combats various forms of cancer by using the body’s own immune system to attack malignant cells, and unlike conventional cancer treatments, immunotherapy offers a more targeted and nuanced approach. One such example of immunotherapy is Opdivo (nivolumab).
Opdivo binds the protein PD-L1 on the surface of some cancer cells, which keeps cancer cells from suppressing the immune system, allowing the immune system to attack the cancer cells. The agent is typically administered by a nurse or other trained health professional in a medical facility intravenously, or through an IV which is placed into the patient’s vein. According to an article published by the Mayo Clinic, the medication must be given slowly, so the IV will have to remain in place for at least 30 minutes, and is usually given every two, three or four weeks.
The subcutaneous agent was initially approved for melanoma in December 2014, though it now currently has several indications for which it is approved.
Intravenous (IV): when a needle is inserted into a vein to administer fluids or medications directly into the bloodstream.
Subcutaneous: beneath the skin.
The Food and Drug Administration (FDA): a federal agency that protects the public's health.
Most recently, 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 on Dec. 27, 2024. This new indication for Opdivo represents a new wave of immunotherapy options for patients with solid tumors.
“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,” 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, explained in an interview with CURE®.
“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.”
Although it is important to recognize this new addition to the treatment landscape, it is just as important to ask: What does this approval mean for patients? Compared with the IV formulation of Opdivo, the subcutaneous treatment option offers various benefits which enhance the patient treatment experience without compromising the efficacy of the treatment.
“Currently, the conventional version is given through an IV, so an IV has to be placed. Generally speaking, this is typically given in an infusion center. Many times, the patient needs to be seen in the office by a doctor and then go to an infusion center; maybe it's in the same building but maybe it is not, and [they then] have to wait for an infusion chair, get an IV placed, and get the medicine that way. This new version allows the injection under the skin to be given in a larger variety of settings. Maybe it can be in the doctor's office. Maybe in the future, it can be in patients’ homes as well. It allows flexibility and also saves some time,” Dr. Balazs Halmos shared in another interview with CURE.
Halmos is a professor in the Department of Oncology (Medical Oncology) and in the Department of Medicine (Oncology & Hematology) at the Albert Einstein College of Medicine, as well as an Associate Director of Clinical Science at the Montefiore Einstein Comprehensive Cancer Center, located in New York City.
According to Halmos, the subcutaneous treatment option of Opdivo stands out because, “There's no need to wait for the infusion chair, no need to wait for an IV to be placed [with this new indication].” Time toxicity is a very real concern for patients with any kind of cancer undergoing their respective treatment. This time toxicity can come in the form of traveling to and from doctor’s offices, waiting in doctor’s offices for appointments, or the actual receiving of treatment, as well as coordinating care and picking up medications.
“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,” Singhi emphasized. “This doesn't seem like a lot, but when you think about the impact of time toxicity that's associated with cancer treatments, 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.”
In addition to minimizing time toxicity, subcutaneous treatment options, such as Opdivo, allow more patients to get the standard of care that has the best potential to treat their cancers. This includes, for example, patients in more rural areas, or those with limited access to transportation to and from treatment centers.
“I do think that the subcutaneous administration option could help address health care disparities, especially for those patients that are coming from rural or underserved areas,” Singhi explained. “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.”
The subcutaneous administration of Opdivo was approved by the FDA based on data from the CHECKMATE-67T trial which evaluated the treatment in patients with advanced or metastatic clear-cell renal cell carcinoma who had been treated with no more than two prior systemic lines of therapy, according to a notice from the FDA. The notice also stated that CHECKMATE-67T revealed similar safety findings between subcutaneous Opdivo Qvantig and intravenous Opdivo.
“This is one of those medicines that we've been very successfully using for a decade in many different cancer types. This medicine, Opdivo, is based on a discovery that led to a Nobel Prize and is one of those immune checkpoint inhibitors that can re-energize the immune system's ability to fight different cancers as foreign elements in our bodies. This is a very successful drug. We use it frequently in the management of different types of lung, skin and gynecological cancers,” Halmos shared about the agent.
Overall, this regulatory approval opens up an avenue for more research to be done like what has been done with subcutaneous Opdivo. Singhi cited ongoing research with subcutaneous treatment formulations of IV drugs, saying that, “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.”
The advent of immunotherapy treatment options, such as Opdivo, has significantly transformed the therapeutic landscape for solid tumors. The subcutaneous Opdivo treatment option offers the same efficacy of its IV counterpart, while offering substantial benefits in terms of convenience and accessibility, allowing the life-saving therapy to reach more patients, in turn reducing barriers to treatment and enhancing patient quality of life.
“I think we're all thrilled that there's a broader and broader range of patients that can benefit from novel medicines, whether those are targeted medicines or immunotherapies, the range is getting wider and wider. Now, we can allow some patients to receive it more flexibly, more conveniently, by saving time, maintaining quality of life and allowing patients to spend as much time away from the infusion center and the physician's office as possible. That's definitely a nice goal and advance to be seen,” Halmos emphasized.
“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,” Singhi concluded.
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“The Evolution of Cancer Immunotherapy: a Comprehensive Review of its History and Current Perspectives” by Dr. Sana Ahuja, et al., Korean Journal of Clinical Oncology.
