Karyopharm Provides U.S. Regulatory Update on Selinexor in Advanced or Recurrent Endometrial Cancer

Following Discussion with the FDA, Karyopharm Plans to Initiate a New Placebo-Controlled Randomized Study of Selinexor in the Advanced or Recurrent Endometrial Cancer p53 Wild-Type Population to Support a Future sNDA Submission as the Current Topline Data from the SIENDO Study are Unlikely to Support an sNDA Approval

Karyopharm is Encouraged by the SIENDO p53 Wild-Type Results and is Committed to Working with the FDA to Design and Initiate the New Study This Year Focused on the Patient Population Where Selinexor May Offer the Greatest Promise

Phase 3 SIENDO Data have been Selected for Presentation at ESMO’s Virtual Plenary on March 17, 2022 and at Society for Gynecologic Oncology 2022 Annual Meeting Taking Place March 18-21, 2022; Company to Host Investor Conference Call to Discuss the SIENDO Results in Mid-March

Excerpt from the Press Release:

NEWTON, Mass., March 1, 2022 /PRNewswire/ — Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today provided an update on its discussions with the U.S. Food and Drug Administration (FDA) regarding its previously planned supplemental New Drug Application (sNDA) submission based on the data from the Phase 3 SIENDO study evaluating selinexor as a front-line maintenance therapy following chemotherapy in patients with advanced or recurrent endometrial cancer.

During a productive meeting with the FDA, the Company received feedback that the current SIENDO study top-line results are unlikely to support an sNDA approval.  Karyopharm and the FDA participants had differing views on the study significance and overall clinical benefit for the whole population and discussed that further exploration of patients with advanced or recurrent endometrial cancer with p53 wild-type is warranted. The Company will continue to collect and analyze the SIENDO study data and work with the FDA to explore all regulatory pathways for patients with p53 wild-type. In addition, considering the FDA’s feedback, the Company intends to initiate a new placebo-controlled, randomized clinical study of selinexor in patients with p53 wild-type endometrial cancer and believes top-line data will be available in the first half of 2024. Karyopharm plans to rapidly initiate this study of selinexor in patients with p53 wild-type this year, working with the FDA as well as established networks and partners, including the European Network of Gynaecological Oncological Trial groups (ENGOT) and the Gynecologic Oncology Group Foundation, Inc. (GOG-F).

“We strongly believe in selinexor’s potential in patients with p53 wild-type and are excited to further evaluate it in this patient population to better understand its potential to address the unmet need in women with endometrial cancer,” said Sharon Shacham, Chief Scientific Officer of Karyopharm. “Given the significant need for new therapeutic options, we have a tremendous sense of urgency to design and enroll a new trial as quickly as possible and believe we are well-positioned to do so working with our existing SIENDO clinical trial sites.”

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