The study involved 263 patients in more than 100 centers based in Europe, North America, China and Israel.
Longer progression-free survival
The primary endpoint was an improvement in progression-free survival. That is the length of time patients live with the disease without it worsening and is a standard indicator to evaluate treatments in cancer studies.
“The prognosis of advanced endometrial cancer is very poor: patients typically relapse within 3 to 4 months of first-line chemotherapy and survive less than a year on average. The current standard of care is a ‘watch and wait’ approach, as no maintenance therapy exists,” says Dr. Vicky Makker, principal investigator in the US and medical oncologist at the Memorial Sloan Kettering Cancer Center.
Prof. Dr. Ignace Vergote, global principal investigator and gynecologist oncologist at University Hospitals Leuven in Belgium: “Our study showed that oral treatment with selinexor prolongs the time before patients relapse. The effect was especially large in the pre-specified, exploratory subgroup of patients with a working p53 gene (p53wt): their progression-free survival at the median was about 10 months longer. This is not a cure, but we are one step closer to offering patients a treatment option that can give them more time with their friends and family. The side effects were generally manageable with supportive care and dose modifications when needed. The global health status, physical functioning and symptoms were similar in both groups.”
Normally, the tumor suppressor gene p53 prevents the development of cancer. The gene is therefore also called ‘the guardian of the genome’. In cancer cells, p53 does not work sufficiently, partly because it is pulled out of the cells by transport proteins. The drug selinexor blocks those transport proteins, allowing p53 to perform its normal antitumor function.
Selinexor is already approved for hematological malignancies in Europe and the US.
The pharmaceutical company plans to initiate a new placebo-controlled, randomized study of selinexor in advanced or recurrent p53wt endometrial cancer to support a future supplemental new drug application (sNDA) with the FDA.
About endometrial cancer
Endometrial cancer is the most common cancer of the female reproductive organs and the fifth most common overall form of cancer in women. In 2020, there were approximately 130,000 new cases in Europe and 417,000 new cases worldwide. The majority of cases are diagnosed early and treated by surgically removing the tumor, but this is no longer an option for patients who have advanced or recurrent endometrial cancer.