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Results from the RAMP 201 clinical trial are promising for patients with recurrent low-grade serous ovarian cancer.
The combination of avutometinib and defactinib has been found to be effective among patients with recurrent low-grade serous ovarian cancer (LGSOC), updated clinical trial data has shown.
Updated findings from the phase 2 RAMP 201 clinical trial, presented as part of the International Gynecologic Cancer Society 2024 Annual Meeting, showed that patients treated with the combination experienced a median progression-free survival (PFS) of more than a year, according to a news release from biopharmaceutical company Verastem Oncology.
PFS — The time a patient lives without their disease spreading or worsening.
KRAS-wild-type — When a tumor does not have a KRAS mutation.
ORR — Patients whose disease responded partially or completely to treatment.
DCR — Patients who experienced complete or partial response or stable disease.
Based on the findings of the RAMP 201 trial, Verastem Oncology plans to submit a New Drug Application to the Food and Drug Administration (FDA) in October 2024 for adults with recurrent KRAS-mutant LGSOC who have received at least one prior systemic therapy, and also plans to seek accelerated approval from the agency and will request priority review, according to the news release.
While the current standard of care for the cancer type includes hormone therapy and chemotherapy, Verastem Oncology president and chief executive officer Dan Paterson said in the news release that this would mark the first FDA-approved treatment for patients with recurrent KRAS-mutant LGSOC. The company hopes to make the treatment commercially available in the United States in 2025.
"In the mature data from the RAMP 201 trial, most patients achieved tumor reductions and a median progression-free survival that was greater than one year across both KRAS-mutant and KRAS-wild-type patient populations. These results reinforce our confidence in the potential of the combination of avutometinib and defactinib to change how patients with recurrent low-grade serous ovarian cancer are treated," stated Dr. John Hayslip, chief medical officer of Verastem Oncology, in the news release. "Encouraged by the durable clinical benefit seen in KRAS-wild-type patients in RAMP 201 and the poorer prognosis in this subset of patients that are treated with sub-optimal treatment choices today, we believe that this treatment combination will be the preferred treatment option for all subgroups of patients with recurrent low-grade serous ovarian cancer. We are committed to making the combination available to these patients, including working with the FDA to outline a path forward to expand the indication with additional data."
At a data cut-off of June 30, 2024, primary analysis of the RAMP 201 trial showed an objective response rate (ORR) in all evaluable patients with approximately 12 months of follow-up. The confirmed response was 44% among patients with KRAS-mutant LGSOC and 17% for patients with KRAS-wild-type LGSOC.
Among all patients, the median duration of response was 31.1 months, with it being 31.1 months in the KRAS-mutant patients and 9.2 months in patients with KRAS wild-type LGSOC.
Of note, the median PFS was 12.9 months among all patients, 22 months for patients with KRAS-mutant LGSOC and 12.8 months among those with KRAS wild-type LGSOC.
The disease control rate (DCR) at six or more months was 61% in all patients, 70% in patients with KRAS mutations and 50% in patients with the KRAS wild-type LGSOC.
The news release noted that there was a 10% discontinuation rate due to side effects, with no new safety signals observed. The most common side effects in all grades and grade 3 (severe) or higher were nausea (67%, 2.6%), diarrhea (58.3%, 7.8%) and increased blood creatine phosphokinase levels (60%, 24.3%).
"The notable response rates and low discontinuation rate seen with the combination of avutometinib and defactinib are significant. These updated results confirm the potential of this new combination therapy to change practice and be the new standard for care for recurrent low-grade serous ovarian cancer, which previously had limited effective treatment options," stated professor Susana Banerjee, global lead investigator of the study, consultant medical oncologist at The Royal Marsden NHS Foundation Trust and team leader in women’s cancers at The Institute of Cancer Research in London.
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