An Incyte drug for the treatment of rare types of anal cancer still has a chance to obtain FDA approval, but the company needs to obtain more clinical data from larger studies to support its application.
Regulators Friday be rejected The documents submitted by Incyte are based on data from the second phase of the study. The complete response letter sent by the FDA to the company is not public. According to Incyte, based in Wilmington, Delaware, the letter states that regulators need to see more data to prove the clinical benefit of the drug in treating patients with advanced or spreading anal squamous cell carcinoma (SCAC) . The company said it is reviewing the letter and will discuss the next steps for the drug with the agency.
Retifanlimab is an antibody drug that blocks PD-1, a protein on the surface of T cells that prevents them from killing tumors. Blocking this so-called checkpoint protein clears the way for patients’ immune cells to track cancer. Incyte drugs are given by intravenous infusion every four weeks.
Anal cancer is much rarer than cancer that affects the rectum or colon.according to American Cancer SocietyThe biggest risk factor for anal cancer is human papillomavirus infection. There is no FDA-approved therapy for SCAC, which is used to treat patients whose disease has progressed after chemotherapy.
The phase 2 clinical trial evaluating retivalizumab is an open-label, single-arm study. The 94 patients in the study had anal cancer that progressed while receiving chemotherapy, or the patients were not suitable or unable to tolerate chemotherapy. The main goal is to measure the objective response rate to treatment.
according to Provided data Last September, during the 2020 meeting of the European Society of Medical Oncology, an independent review confirmed that 1 patient had a complete response to the drug treatment, 12 patients had a partial response, and 33 patients were in stable condition. These results translate into an objective response rate of 14% and a disease control rate of 49%.
FDA rejects retivalizumab to follow 13 to 4 advisory committee vote Last month it was recommended to postpone the regulatory decision on the drug until more data is obtained from the confirmatory study of the drug. The study is ongoing and the goal is to recruit 300 patients. A double-blind clinical trial is testing the effects of Incyte’s drug plus chemotherapy on chemotherapy and placebo.
Incyte CEO Hervé Hoppenot said in a prepared statement: “There is currently no approved treatment for SCAC patients who progress after first-line chemotherapy.” “Although we are not surprised by the FDA’s decision, because [advisory committee] Recommended, we were disappointed. We will continue to work to advance science and find solutions for patients with unmet medical needs, and we will ensure close coordination with the FDA to process feedback and determine the next steps for the review of retifanlimab. “
Incyte obtained a license for retifanlimab from MaroGenics in 2017 and paid US$150 million in global rights for the biotech company. In addition to anal cancer, Incyte is evaluating the drug as a monotherapy for endometrial cancer with high microsatellite instability and Merkel cell carcinoma. The company is also testing the drug in combination with chemotherapy in non-small cell lung cancer.
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