A new clinical trial studying the effectiveness of a combination of immunotherapy treatments may be more effective for ovarian cancer patients who are resistant to conventional interventions.
Herzog explained that ovarian cancer can be a difficult disease to recognize and diagnose at first because of vague and mild symptoms, which make it difficult to treat. Treatments include surgery and platinum-based chemotherapy, which contain the chemical element platinum as part of their molecular makeup and form structures that stop cancer cells from growing or cause them to die.
Herzog said most patients’ cancers will eventually develop resistance to platinum-based chemotherapy. For platinum-resistant ovarian cancer, the standard of care is a non-platinum chemotherapy, but this treatment offers little chance of long-term effectiveness.
The trial will examine the effectiveness of a combination of two immunotherapy drugs, called nemevalukin alfa and pembrolizumab, compared to standard non-platinum-based chemotherapy. Immunotherapy helps boost and train the body’s own immune system to identify and kill diseased cells.
“There is a highly unfulfilled clinical need for the treatment of patients with platinum-resistant ovarian cancer, and the ARTISTRY-7 trial seeks to address those unfulfilled needs by incorporating cutting-edge scientific advances in targeted cancer therapy into a treatment regimen. combination with pembrolizumab,” said the Paul and Caroline Flory Professor in Gynecological Oncology at UC College of Medicine, deputy director of the University of Cincinnati Cancer Center and a UC Health gynecological oncologist. Told.
Pembrolizumab, sold under the brand name Keytruda, is a well-established immunotherapy drug used to treat a variety of cancers. Nemvaleukin alfa is a new drug made by the pharmaceutical company Alkermes, which has received a Food and Drug Administration Fast Track designation for expediting reviews of the drug’s safety and effectiveness.
“Nameleukin 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 that has shown promise in certain types of cancer.”
Herzog said the trial would enroll and randomly assign 376 patients to one of four study arms. One group of patients would receive both immunotherapy drugs, one group would receive only nemavalukin alfa, the other group would receive only pembrolizumab and the last group would receive standard chemotherapy treatment.
Single immunotherapy arms will be monitored for ineffectiveness at the start of the trial, with the option to discontinue these groups prior to full enrollment if they prove fruitless. Herzog said single immunotherapy treatments for platinum-resistant ovarian cancer have not been shown to be effective in the past, and he is excited to see whether the combination immunotherapy approach could provide a new treatment option for patients.
ARTISTRY-7 is a phase 3 trial, which means 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 is promising. are. Alkermes is a sponsor of the trial, and Herzog helped design the study for the specific patient population he would target.
Trial locations in Florida and New York have already opened, and Herzog said UC will soon begin enrolling patients and also serve as a testing site.
“If this trial is successful, patients will have a novel treatment option where limited options exist, and it allows a break from repetitive chemotherapy, potentially leading to improved efficacy and safety profiles.”
Herzog will present his poster, “Artistry-7: A Phase 3, Multicentre Study of Nemevelucin Alfa in Patients (PT) of Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Combination of Pembrolizumab versus Chemotherapy,” during the ASCO. 2022 Gynecological Cancer Poster Session on June 4 from 1:15-4:15 CDT.
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