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 its 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
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 the LGSOC Initiative’s American research partner STAAR Ovarian Cancer.
Updates to this article
25 May 2023
5 July 2023
6 November 2023
December 13 2023
