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Uterine Cancer Drug Gets Fast-Track Approval

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A new drug – tulmimetostat – has been given fast-track approval by the US Food and Drug Administration (FDA) to treat some endometrial cancers – a type of uterine cancer.

A next-generation cancer drug

Endometrial cancers are the most common cancers of the female reproductive system and are the 15th overall most common cancer, accounting for over 400,000 new cases worldwide in 2020.

Life expectancy for those with localized disease – meaning the cancer has not spread outside the uterus – is favorable, with 96% surviving for 5 years after diagnosis. However, once the disease has spread to distant parts of the body like the lungs or liver, 5-year survival drops to just 20%.

Drugs that target a protein called enhancer of zeste homolog 2 (EZH2) are a relatively new part of the oncologist’s arsenal to treat endometrial cancers. EZH2 plays an important role in cancer development and has become a sought-after target for anti-cancer drugs.

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Representing the next generation of EZH2 inhibitors, tulmimetostat – produced by biopharmaceutical company MorphoSys – targets both EZH2 and its related protein EZH1 in order to reactivate silenced tumor suppressor genes. It was designed to be an improvement upon first-generation drugs, with increased potency and a longer half-life offering the potential to increase anti-tumor activity.

Preliminary trial results “promising”

The FDA’s fast-tracked approval has come off the back of pre-clinical studies and preliminary, unpublished results of an ongoing Phase 1/2 clinical trial. This study is investigating tulmimetostat as a once-daily oral monotherapy in patients with advanced solid tumors or lymphomas, including endometrial cancers with mutations in the gene ARID1A (AT-rich interacting domain-containing protein 1A). Previous studies have shown that inhibiting EZH2 in ARID1A-mutated tumors can suppress cancer cell growth and promote programmed cell death (apoptosis).

“Receiving fast-track designation from the FDA for tulmimetostat in ARID1A-mutated endometrial cancer underscores this investigational therapy’s potential in a patient population with limited treatment options,” said Dr. Tim Demuth, chief research and development officer at MorphoSys. “The preliminary results from our Phase 1/2 study of tulmimetostat are very promising. We will continue to generate data from this study across tumor types to inform our future development plans for tulmimetostat, both as a monotherapy and in combination with other treatments.”

This article is a rework of a press release issued by MorphoSys. Material has been edited for length and content.

This article is based on research findings that are yet to be peer-reviewed. Results are therefore regarded as preliminary and should be interpreted as such. Find out about the role of the peer review process in research here. For further information, please contact the cited source.