Researchers have suggested that a new clinical trial studying the effectiveness of a combination of immunotherapy treatments could be more effective for patients with ovarian cancer who are resistant to traditional interventions.
Researchers explain that ovarian cancer can be a difficult disease to recognize and diagnose at first due to vague and mild symptoms, which in turn makes it difficult to treat. Treatments include surgery and platinum-based chemotherapies, which contain the chemical element platinum as part of their molecular make-up and form structures that prevent cancer cells from growing or cause them to die.
A majority of patients’ cancers will eventually develop resistance to platinum-based chemotherapy, one of the researchers said. For platinum-resistant ovarian cancers, the standard of care is a non-platinum chemotherapy, but this treatment offers a low likelihood of long-term effectiveness.
The trial will examine the effectiveness of a combination of two immunotherapy drugs called nemvaluekin alfa and pembrolizumab, compared to the standard of non-platinum based chemotherapy. Immunotherapy helps boost and train the body’s own immune system to identify and kill diseased cells.
Pembrolizumab, sold under the brand name Keytruda, is a well-established immunotherapy drug used to treat a variety of cancers. Nemvaleukin alfa is a novel drug created by drug company Alkermes that received Food and Drug Administration fast track designation last fall to accelerate the review of the drug’s safety and effectiveness.
Researchers said the trial will enroll and randomly assign 376 patients into one of four study arms. One group of patients will receive both immunotherapy drugs, one group will receive nemvaluekin alfa only, another group will receive pembrolizumab only and the final group will receive standard chemotherapy treatments.
The solo immunotherapy arms will be monitored for ineffectiveness early in the trial, with an option to close these groups before full enrollment if they prove futile. Single immunotherapy treatments for platinum-resistant ovarian cancer have not shown to be effective in the past, and he is excited to see if the combination immunotherapy approach can provide a new treatment option for patients.
ARTISTRY-7 is a Phase 3 trial, meaning it is designed to confirm preliminary evidence from previous trials that the treatment option is safe, beneficial and effective for the patient population.
Trial locations have already opened in Florida and New York, and UC will soon begin enrolling patients and serve as a trial site as well.