Herzog explained 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.
Trial design
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.
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“There is a high unmet clinical need for treatment of patients with platinum-resistant ovarian cancer, and the ARTISTRY-7 trial provides a pathway to meet those unmet needs by incorporating cutting edge scientific advancements in targeted cancer therapy in a treatment regimen in combination with pembrolizumab,” said Herzog, deputy director of the University of Cincinnati Cancer Center, clinical director and Paul and Carolyn Flory Professor in Gynecologic Oncology in the UC College of Medicine and a UC Health gynecologic oncologist.
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.
“Nemvaluekin alfa is a drug that works with your body’s immune system to expand the cancer fighting immune cell,” Herzog said. “It is based on an established immune pathway which has shown promise in certain cancer types.”
Herzog 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. Herzog said 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, and Herzog said the preliminary evidence has been promising. Alkermes is the sponsor of the trial, and Herzog helped design the study for the specific patient population it will target.
Trial locations have already opened in Florida and New York, and Herzog said UC will soon begin enrolling patients and serve as a trial site as well.
“If this trial is successful, patients will have a novel treatment option where limited options exist, and it allows a break from repetitive chemotherapy, thereby potentially having better efficacy and safety profiles,” he said.
Source: Eurekalert
