Updated Results from Phase 2 low-grade serous ovarian cancer clinical trial

Cure Our Ovarian CancerNews

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Verastem has released interim results from their Phase 2 low-grade serous clinical trial called RAMP 201. The results indicate that the combination treatment of avutometinib (a RAF/MEK inhibitor) AND defactinib (a FAK inhibitor) is more effective at shrinking low-grade serous ovarian cancer than avutometinib on its own.

A reported 28% of women in the interim analysis who received the combination treatment experienced tumour shrinkage. This was four times better than in the group who received avutometinib on its own, with an overall disease control rate (people who had stable disease or tumour shrinkage for a period of time) in the combination treatment group of over 90%. Responses were seen in both the KRAS mutation and KRAS wildtype (normal) groups. 9% of women discontinued the treatment due to side effects.

“The interim positive data from RAMP 201 are encouraging and indicate the combination of avutometinib and defactinib remains a promising approach for treating patients with recurrent LGSOC.”

– Rachel N. Grisham, M.D., Section Head, Ovarian Cancer and Director, Westchester Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center NY, the study’s principal US investigator

Pending mature data and finalisation of a confirmatory study – Verastem intends to apply for accelerated FDA application asking for the combination of avutometinib and defactinib to be approved for recurrent low-grade serous ovarian cancer regardless of mutation status.

If Verastem is successful in their application to the FDA, avutometinib and defactinib will be the first FDA treatment specifically approved for low-grade serous ovarian cancer.

The RAMP 201 trial remains open for recruitment in the combination arm. For further information on the trial visit: www.ramp201study.com

Read the full press release from Verastem: https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-announces-positive-data-and-regulatory-update

Avutometinib is also known as VS-6766

Dr Grisham is a leading low-grade serous ovarian cancer researcher who was awarded a research grant in 2022 through Cure Our Ovarian Cancer’s American research partners STAAR Ovarian Cancer. To learn more about STAAR visit staaroc.org

Published 27th January 2023

Updates:

May 25th 2023: Updated Data from Part A of Verastem Oncology’s RAMP 201 Trial Show an Objective Response Rate of 45% in Patients with Recurrent Low-Grade Serous Ovarian Cancer Treated with Avutometinib and Defactinib

July 5th 2023: Verastem Oncology Announces Design for Confirmatory Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer

November 6th 2023: Verastem Oncology Announces Efficacy and Safety Data of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) in Heavily Pretreated Patient Population

December 13 2023: Verastem Oncology Announces Initiation of a Confirmatory Phase 3 Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer