Verastem Oncology Announces RAMP VS-6766 Clinical Trials and Corporate Updates

Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced an update on its RAMP (Raf And Mek Program) clinical trials.

RAMP 201 in Patients with Recurrent Low Grade Serous Ovarian Cancer (LGSOC)

Verastem recently conducted a second planned interim analysis of the ongoing RAMP 201 trial among patients with recurrent LGSOC. Based on the results, including independently confirmed responses and no new safety signals, the Company is planning to meet with the U.S. Food and Drug Administration (FDA) in the fourth quarter to review the data set, discuss the go forward treatment regimen selection and align on a regulatory path forward.

“We are pleased with the encouraging results to date from our RAMP 201 trial in patients with recurrent low-grade serous ovarian cancer as we continue to see independently confirmed response rates, no new safety signals and a majority of patients still on treatment,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “As part of our Breakthrough Therapy Designation status and ongoing communications with the FDA, we look forward to our upcoming meeting to align on a regulatory path forward to advance this potential option for patients with LGSOC, who have a high unmet need and no approved therapies to treat their disease.”

Since the first interim analysis announced in June, the trial has been continuing with all four cohorts (VS-6766 ± defactinib in KRAS mutant and KRAS wild type patient populations) with full enrollment based on the study protocol expected by the end of the year. Interim results will not be released at this time to ensure the integrity of this ongoing, registration-directed clinical trial.The Company will provide an update after the upcoming meeting with the FDA.

RAMP 202 in Patients with KRAS G12V-Mutant Non-Small Cell Lung Cancer

In a planned analysis of the Part A data from the RAMP 202 trial among patients with KRAS G12V NSCLC treated with the combination of VS-6766 and defactinib (n=19), the confirmed overall response rate (ORR) by independent review was 11% (2 of 19) with a disease control rate of 37%. The ORR with non-G12V KRAS mutations was 5% (2 of 37) (one confirmed and one unconfirmed by independent review) with a disease control rate of 54%, and no subtype was identified for further clinical evaluation of VS-6766 with defactinib in this trial. Verastem plans to present the Part A results of RAMP 202 at an upcoming medical congress.