Verastem Oncology Announces Positive Interim Results and FDA Submission for Cancer Therapies
核心洞察
Verastem Oncology reported an 83% overall response rate in a Phase 1/2 trial of avutometinib plus defactinib with chemotherapy for metastatic pancreatic cancer (搜索).
The company initiated a rolling NDA submission to the FDA for avutometinib and defactinib in recurrent KRAS (搜索) mutant low-grade serous ovarian cancer (搜索) (LGSOC).
A Phase 3 trial is underway comparing the combination therapy to standard chemotherapy or hormonal therapy for recurrent LGSOC.
Verastem Oncology (VSTM) has announced promising initial interim safety and efficacy results from its RAMP 205 Phase 1/2 trial. The trial evaluates avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel as a first-line treatment for patients with metastatic pancreatic cancer (搜索). These results will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting.
Promising Results in Pancreatic Cancer Trial
As of May 14, patients in the dose level 1 cohort receiving the combination therapy achieved a confirmed overall response rate (ORR) of 83% (5 out of 6 patients). Furthermore, among the 26 patients across all cohorts who had their first scan while on treatment, 21 experienced a reduction in the change in target lesion sum of diameters. One dose-limiting toxicity, febrile neutropenia, was observed in the dose level 1 cohort but was resolved after additional patient evaluations. Follow-up is ongoing in the additional dose cohorts (-1, 1a, and 2a), with most patients remaining on treatment at the data cutoff.
NDA Submission for Ovarian Cancer Treatment
Verastem Oncology has initiated a rolling submission of a New Drug Application (NDA) to the FDA, seeking accelerated approval for the combination of avutometinib and defactinib. The application targets adult patients with recurrent KRAS (搜索) mutant (KRAS mt) low-grade serous ovarian cancer (搜索) (LGSOC) who have received at least one prior systemic therapy. The FDA has accepted Verastem’s plan to submit the clinical module in the second half of 2024 to complete the NDA application, and the company plans to request a priority review. Currently, there are no FDA-approved treatments specifically for recurrent LGSOC, highlighting a significant unmet medical need.
Ongoing Phase 3 Trial
The company is actively enrolling patients and activating sites for the RAMP 301 trial, an international confirmatory Phase 3 study. This trial evaluates the avutometinib and defactinib combination versus standard of care chemotherapy or hormonal therapy for KRAS (搜索) mt and KRAS wt recurrent LGSOC.
Collaborations for NSCLC Therapies
Verastem Oncology has also established clinical collaborations with Amgen and Bristol-Myers Squibb (搜索) to evaluate Lumakras (sotorasib) in combination with avutometinib and defactinib, and Krazati (adagrasib) in combination with avutometinib in KRAS (搜索) G12C mutant NSCLC (搜索), as part of the Phase 1b/2 RAMP 203 and RAMP 204 trials, respectively.