Karyopharm is currently developing selinexor, an investigational treatment for recurrent or advanced endometrial cancer. They had planned to submit a supplemental New Drug Application (sNDA) to the FDA, but now these plans are changing.
Based on recent conversations with the FDA, Karyopharm has learned that the data they have compiled will not be sufficient for sNDA approval. Now, the pharmaceutical company has to decide what their next steps are.
FDA Comments on sNDA for Selinexor
Karyopharm has already completed a Phase 3 trial, titled SIENDO, investigating selinexor as a treatment for endometrial cancer. Specifically, this study evaluated the efficacy and safety of the drug and used progression-free survival as its primary endpoint. However, the FDA did not find that the data gathered during this study was sufficient for sNDA approval.
Looking deeper into the FDA’s comments, we see that the regulatory agency did not agree on the overall clinical benefit or significance of the study data in regard to the entirety of the endometrial cancer patient population. They pointed out that more information was necessary surrounding patients with p53 wild-type endometrial cancer.
Karyopharm’s Response
Karyopharm has taken all of this feedback and is applying it to their next steps. They will continue to work on the analysis of SIENDO data, along with initiating a new trial to focus specifically on p53 wild-type endometrial cancer. Specifically, this trial will be randomized and placebo-controlled, with top-line data predicted to be released in the first half of 2024.
In addition, the pharmaceutical company is moving with a sense of urgency. They recognize the unmet need that the endometrial cancer patient population faces, and they’re doing the best that they can to fill this need.
About Endometrial Cancer
Endometrial cancer is the most common form of cancer that forms in the uterus. Specifically, it begins to develop in the uterine lining. Medical professionals are unsure as to why this happens, but they have identified a number of risk factors: never being pregnant, later menopause, earlier menstruation, older age, obesity, changes in female hormones, hormone therapy administered for breast cancer, and an inherited colon cancer syndrome.
Regardless of cause or risk factors, symptoms of this cancer include vaginal bleeding in between periods, pelvic pain, and vaginal bleeding that occurs after menopause. Treatment for this cancer typically means removing the Fallopian tubes, uterus, and ovaries. If this cannot occur, other treatment options include chemotherapy, targeted drug therapy, radiation, immunotherapy, hormone therapy, and supportive care.
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