Foundation Medicine Announces Collaboration with Karyopharm Therapeutics to Develop FoundationOne®CDx as a Companion Diagnostic for XPOVIO® (selinexor)

Today Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, announced a global collaboration with Karyopharm Therapeutics Inc. to develop FoundationOne®CDx as a companion diagnostic for selinexor, which is being evaluated as a front-line maintenance therapy following systemic therapy in patients with advanced or recurrent TP53 wild-type endometrial cancer.

Endometrial cancer is the most common cancer of the female reproductive organs in the U.S.¹ Roughly 50% of patients with advanced or recurrent disease have p53 wild-type tumors.² Karyopharm’s phase 3 study (EC-042; NCT03555422) is a multicenter, blinded, placebo-controlled, randomized study evaluating the efficacy and safety of selinexor as a maintenance therapy following systemic therapy in patients with advanced or recurrent TP53 wild-type endometrial cancer. The study is utilizing Foundation Medicine's tissue-based next generation sequencing test to identify and enroll patients whose tumors are TP53 wild-type.

“We’re looking forward to partnering with Karyopharm as they work to advance this exciting new treatment option for patients living with advanced endometrial cancer,” said Sanket Agrawal, Chief Biopharma Business Officer, Foundation Medicine. “Our deep understanding of cancer biology and global regulatory expertise, combined with their innovative approach to developing cancer therapies puts us in a strong position to help more patients living with this devastating condition.”

Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offers physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. If approved, FoundationOne CDx would be the first companion diagnostic to identify patients with TP53 wild-type endometrial cancer who may be eligible for selinexor.

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.

About FoundationOne®CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

About XPOVIO® (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds to be approved for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications XPOVIO (also known as NEXPOVIO® in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, China, South Korea, Canada, Israel and Taiwan. XPOVIO and NEXPOVIO is marketed by Karyopharm's partners, Antengene, Menarini, Neopharm and FORUS in China, South Korea, Singapore, Australia, Hong Kong, Germany, Austria, Israel and Canada. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications.

XPOVIO ® is a registered trademark of Karyopharm Therapeutics Inc.

Source: Foundation Medicine

¹ American Cancer Society, About Endometrial Cancer: https://www.cancer.org/cancer/endometrial-cancer/about/key-statistics.html (accessed January 19, 2022)

² “Mutated p53 portends improvement in outcomes when bevacizumab is combined with chemotherapy in advanced/recurrent endometrial cancer: An NRG Oncology study”, Leslie, Kimberly K. et al. Gynecologic Oncology, Volume 161, Issue 1, 113 – 121

View source version on businesswire.com: https://www.businesswire.com/news/home/20230110005421/en/