A phase 3 trial will analyze a novel drug combination in certain patients with ovarial cancer.
A phase 3 trial analyzing the treatment combination of avutometinib and defactinib compared with standard chemotherapy or endocrine therapy for patients with recurrent low-grade serous ovarian cancer (LGSOC) has been initiated, according to a news release from Verastem Oncology, the manufacturer of avutometinib and defactinib, two MEK inhibitors.
Specifically, the phase 3 trial called RAMP 301 is expected to have 270 patients who will be randomly assigned to one of two groups: avutometinib plus defactinib or a type of chemotherapy chosen by the trial’s researchers.
The trial’s primary endpoint (main result measured at the end of a study to see if treatment worked) was set to be progression-free survival (length of time during and after treatment when a patient lives with cancer but does not worsen).
Secondary endpoints for the study are objective response rate (ORR; percentage of patients in a study who show a partial or complete response to treatment), duration of response (length of time when a tumor responds to treatment without worsening) and disease control rate.
Other secondary endpoints include safety and tolerability, patient-reported outcomes and overall survival (length of time from diagnosis or the start of treatment when a patient is still alive).
“Based on my experience treating women with LGSOC, it’s clear that we need better therapeutic options,” Dr. Susana Banerjee, lead European investigator for the RAMP 301 trial, said in the news release. “I am pleased this phase 3 trial, following the initial positive results from the phase 2 RAMP 201 trial, is enrolling patients to potentially address the significant limitations we have seen with other available therapies.”
Banerjee is a consultant medical oncologist and research lead for the gynecological unit at The Royal Marsden NHS Foundation Trust in England and team leader in women’s cancers at The Institute of Cancer Research in London.
With the initiation of the RAMP 301 trial, the manufacturing company aims to submit an Accelerated Approval New Drug Application with the Food and Drug Administration. The submission of this application is based on data from a previous phase 2 trial, RAMP 201.
“Patients and treating physicians have advocated for more research and development in support of LGSOC. At Verastem Oncology, we are moving with urgency to offer a phase 3 study specifically directed at this disease in an effort to address this need,” Dan Paterson, president and chief executive officer, Verastem Oncology, said in the news release.
“Based on our Breakthrough Therapy Designation, the initiation and expected progress of this trial, along with the FRAME study data and mature RAMP 201 data, we plan to file for Accelerated Approval in the first half of next year, moving us a significant step closer to addressing the treatment needs of patients living with LGSOC,” said Paterson.
READ MORE: Ongoing Trial Shows Positive Response Rates With MEK Inhibitor Combo in Ovarian Cancer Subset
The manufacturing company established that the ORR from the RAMP 201 trial was 45% and the safety profile remained consistent with prior studies.
The RAMP 301 trial aims to continue providing effective treatment for patients with LGSOC.
“LGSOC has a unique molecular, histologic, and clinical profile that differs dramatically from the most common type of ovarian cancer. Response rates to standard of care treatments are disappointing, and there are still no FDA-approved treatments specifically for LGSOC,” Dr. Rachel Grisham, section head, ovarian cancer and director, gynecologic medical oncology at Memorial Sloan Kettering Cancer Center in Westchester, NY and RAMP 301 global lead investigator, said in the news release.
“The combination of avutometinib and defactinib continues to show promise in recurrent LGSOC, and I am looking forward to leading this confirmatory trial with the goal of establishing a new standard of care for people with this rare form of ovarian cancer,” Grisham said.
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