NEW YORK – The US Food and Drug Administration on Thursday granted accelerated approval to Verastem Oncology's combination treatment Avmapki Fakzynja Co-Pack (avutometinib and defactinib) for KRAS-mutant recurrent low-grade serous ovarian cancer patients that received prior systemic therapy.
The agency approved the treatment based on results from the Phase II RAMP 201 trial in this patient population. Among 57 patients in the trial, the combination of the RAF/MEK clamp Avmapki and FAK inhibitor Fakzynja demonstrated an overall response rate of 44 percent and a duration of response of between 3.3 months and 31.1 months.
Avmapki Fakzynja Co-Pack is the first treatment approved for KRAS-mutant ovarian cancer. According to Verastem, approximately 70 percent of low-grade serous ovarian cancers carry RAS pathway-associated mutations, with 30 percent of low-grade serous ovarian cancer patients having a KRAS mutation. Patients with these types of tumors currently have limited treatment options available.
Verastem is currently studying the combination in a Phase III confirmatory trial, called RAMP 301, which is comparing it to investigators' choice of treatment, including chemotherapy or hormone therapy. That trial will enroll approximately 270 patients with KRAS-mutant recurrent low-grade serous ovarian cancer.
"The approval of avutometinib plus defactinib brings a much-needed therapeutic option to patients and establishes this combination as the new standard of care for women with recurrent low-grade serous ovarian cancer harboring a KRAS mutation," Rachel Grisham, section head for ovarian cancer at Memorial Sloan Kettering Cancer Center and global lead principal investigator of RAMP 301, said in a statement.