RECENT APPROVALS by the Food and Drug Administration (FDA) open the door for existing immunotherapies to be given by injection, a shot under the skin given over a few minutes, rather than 30- to 60-minute infusions delivered into a vein.
In September 2024, the FDA approved Tecentriq Hybreza (atezolizumab and hyaluronidase), a subcutaneous injection, to treat all indications for which intravenous Tecentriq was already approved. It was the first injectable version of an anti-PD-L1 immunotherapy to be approved in the U.S.
The injectable formula can now be used for patients with several types of cancer, including non-small cell lung cancer (NSCLC), small cell lung cancer, liver cancer, melanoma and alveolar soft part sarcoma (ASPS).
Tecentriq Hybreza was evaluated in the IMscin001 clinical trial, in which 371 patients with advanced NSCLC who had disease progression following chemotherapy but had not previously undergone immunotherapy were given either the subcutaneous Tecentriq Hybreza or the previously approved intravenous Tecentriq formula.
No notable differences were observed in overall response rate, progression-free survival or overall survival for the two methods. The response rate was 9% in the group that received the subcutaneous injection and 8% in the intravenous group.
Injection or Infusion
The recommended dose for the new injection formula is a 15-milliliter shot given in the thigh over seven minutes. The original Tecentriq formula is given as an infusion, typically 30 to 60 minutes long. Researchers hope the injection option will make treatment easier for patients.
Federico Cappuzzo, director of medical oncology at the National Cancer Institute Regina Elena in Rome, was the lead investigator on the IMscin002 trial, a separate study that evaluated patient preferences for the two Tecentriq delivery methods, which found that 71% of patients preferred treatment through injection. He explains that the advantages of the injectable go beyond time saved.
“The reasons why patients prefer subcutaneous is because they spend less time in the clinic and the comfort for the patient is higher,” Cappuzzo says. “We also observed a significant reduction in the emotional distress of the patients.”
Patients undergoing immunotherapy want to get back to normal life quickly, Cappuzzo adds. “Many patients are also working, so it’s important, the timing, for the patients and their families,” he explains.
Another Immunotherapy Injection Approved
Though Tecentriq Hybreza was the first anti-PD-L1 immunotherapy to be approved as an injectable, another immunotherapy drug quickly followed suit. Injectable Opdivo Qvantig (nivolumab and hyaluronidase)—also an immune checkpoint inhibitor—was approved by the FDA in December 2024 to treat all adult solid-tumor indications for which the original intravenous formula was previously approved. The approval means the injectable can be used to treat certain types of lung cancer, melanoma, colorectal cancer, and others.
Learn more about the role of immune checkpoint inhibitors in treating non-small cell lung cancer.
Cappuzzo says he hopes administering immunotherapy as a subcutaneous injection becomes more widespread and is available to all eligible patients.
Mustafa Khasraw, a physician-scientist and deputy director of the Center for Cancer Immunotherapy at Duke Cancer Institute in Durham, North Carolina, notes other advantages to giving the immunotherapy drugs as shots rather than infusions. Besides faster administration time and greater convenience for patients, injectables could cost less because patients don’t need to spend extended time at infusion centers. There is even the potential for patient self-administration in the future.
However, he warns these promising subcutaneous injection formulas need more study to determine how well they work years after treatment is completed. “There is no data demonstrating that long-term outcomes will be the same as the IV route that has been more extensively studied,” he explains.
Khasraw also says there are situations where doctors might still recommend IV therapy, even when an injectable formula is an option. These may include when patients are already undergoing other IV treatments like chemotherapy or when they have skin conditions like scleroderma or lymphedema that may limit absorption of the drug.
Mary Jo Fidler, thoracic oncologist and section chief of medical oncology at RUSH MD Anderson Cancer Center in Chicago, notes that patients opting for injectables will still need to regularly see their health care teams to monitor for side effects, but time saved undergoing treatment can still be significant.
“Given the patient convenience, I am excited to offer them to my patients,” she says.
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