A New, More Convenient Way to Receive Opdivo: Subcutaneous Administration

Immunotherapy is a type of treatment that stimulates the immune system to find and kill melanoma cells. Immune checkpoint inhibitors (ICIs) are one type of immunotherapy. ICIs work by blocking certain checkpoint molecules that put the brakes on the immune cells’ ability to find and kill cancer cells. The FDA has approved several ICIs for melanoma.

One ICI approved to treat melanoma is called nivolumab (Opdivo). This ICI blocks a checkpoint molecule called PD-1. Blocking PD-1 takes the brakes off immune cells so they can find and kill melanoma cells. In some patients with advanced melanoma, Opdivo can shrink tumors, help patients live longer, and reduce the risk of the melanoma coming back after surgery. Opdivo is also approved for use in the adjuvant setting (treatment given after surgery to remove the melanoma).

Opdivo is typically given by IV, which requires a port or new access to a vein. However, the FDA recently approved a new, potentially more convenient way to administer this treatment: by subcutaneous injection (full name: Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy)). To learn more about subcutaneous and IV options for Opdivo, we talked to Roxana Dronca, MD, Director of the Mayo Clinic Comprehensive Cancer Center in Florida.

What is Subcutaneous Injection of Opdivo?

Subcutaneous injection means that the drug is injected just under the skin in the abdomen area or thigh using a standard needle or butterfly needle and can be more comfortable and convenient for patients. Opdivo Qvantig, the subcutaneous injection, is co-formulated with an enzyme called hyaluronidase, which helps disperse the Opdivo and increase its absorption from under the skin into the rest of the body.¹

Who Can Receive Subcutaneous Opdivo (Opdivo Qvantig)?

Opdivo Qvantig was recently FDA approved for most previously approved Opdivo intravenous indications. In melanoma, that includes patients whose melanoma has spread or cannot be removed with surgery (advanced melanoma) and patients with Stage IIB, Stage IIC, Stage III, or Stage IV melanoma after it has been completely removed with surgery.

It is important to note that if a patient receives ipilimumab (Yervoy®) in combination with Opdivo, the combination must be given by IV. After completing combination treatment by IV, some patients may continue treatment with Opdivo alone, which may be given either by IV or subcutaneous injection. Most patients will receive Opdivo every 4 weeks, whether it is given by IV infusion or subcutaneous injection. For some patients who require more frequent clinic visits, Opdivo may be given every 2 weeks.

How Well Does Opdivo Qvantig Work Compared to IV Administration and is it Safe?

FDA approval of Opdivo Qvantig was based on results from the phase III CheckMate-67T clinical trial.² This trial enrolled patients with a type of kidney cancer.

In the study, Opdivo Qvantig worked similarly to IV Opdivo. A similar percentage of patients had their cancer shrink or disappear and the side effects were comparable. Some common side effects that were similar in both IV and subcutaneous administration were joint pain, diarrhea, high blood sugar, and rash.²

Dr. Dronca wants patients to know, “the reasons for considering subcutaneous versus IV administration are not related to effectiveness or safety.” Although the dose delivered with subcutaneous injection is initially higher, both types of administration result in similar levels of the drug in the patient’s body.

“The two types of injections have comparable safety profiles,”said Dr. Dronca. “Patients are still followed closely, and lab tests and safety remain the same.”

What are the Advantages and Disadvantages of Opdivo Qvantig?

Opdivo Qvantig could be a beneficial alternative for patients for several reasons.

• Time: Subcutaneous injection takes only 3-5 minutes rather than 30 minutes for IV administration. This can reduce total time at a clinic visit and may allow more flexible scheduling of clinic visits.
• Clinic location: Patients can receive Opdivo Qvantig at a doctor’s office without needing to go to an infusion center. This can be beneficial if they live far from an infusion center and could allow them to receive Opdivo closer to home.
• No vein access is needed: Unlike with IV administration, no port or other vein access is needed. Opdivo Qvantig may be the preferred choice if a patient has fragile veins and nurses have difficulty finding a vein.
• Preference and comfort: Subcutaneous injection can reduce anxiety and discomfort. Patients report high levels of satisfaction and low levels of pain with subcutaneous Opdivo.³ More than two-thirds of patients prefer subcutaneous administration.^4,5 If a patient has trouble sitting in a chair for a long time, Opdivo Qvantig may be a good choice.
• Cost: The cost of subcutaneous administration is lower, in part because patients and caregivers can spend more time at work and less time at the clinic.⁵

There are reasons that subcutaneous administration may not be the right choice for a patient.

• Comfort: Some people do experience pain, injection site reactions, or unintended injection into the muscle.⁵ “Opdivo Qvantig may be less comfortable and more challenging in some very thin patients, although it is still possible,” explained Dr. Dronca.” Although less common, people with skin conditions or wound healing problems may have difficulty receiving Opdivo Qvantig.”
• Getting other drugs by IV: If a patient already receives other medications by IV, IV Opdivo rather than Opdivo Qvantig may be the most comfortable and convenient choice.
• Preference: About 10-20% of patients prefer IV administration.⁴

If a patient is starting Opdivo for the first time, the choice between subcutaneous and IV administration comes down to preference, convenience, and comfort. Dr. Dronca suggested discussing how a patient’s cancer type, stage, and overall treatment plan fit with the subcutaneous option.

Dr. Dronca encourages patients who are interested in subcutaneous administration of Opdivo to have a shared decision-making conversation that considers all of these issues. “Patients should feel comfortable discussing these options with their doctors. They should also ask about effectiveness, side effects, what the overall visit is like, at what type of facility the treatment is given, the time they will spend at the clinic, as well as insurance coverage and out-of-pocket expenses,” she explained.

Dr. Dronca stated, “patient-friendly Opdivo Qvantig gives patients options they didn’t have before and can lead to less time in the treatment chair and at the clinic and less anxiety.” She said that “subcutaneous administration represents a shift in cancer care from just thinking about effectiveness of a treatment to now including the patient’s perspective and quality of life.” With both subcutaneous and IV options for Opdivo, patients can be part of the decision-making process by telling their doctor their preferences.4 Opdivo Qvantig may give patients a sense of control and newfound time.