Zinger Key Points
- One dose-limiting toxicity, febrile neutropenia (low white blood cell count), was observed in the dose level 1 cohort.
- FDA has accepted Verastem's plan to submit the clinical module in the second half of 2024 to complete the NDA application.
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Thursday, Verastem Oncology VSTM announced the initial interim safety and efficacy results from the ongoing RAMP 205 Phase 1/2 trial evaluating avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel in the first-line in patients with metastatic pancreatic cancer.
The initial interim results will be presented at the upcoming American Society of Clinical Oncology Annual Meeting.
As of May 14, patients receiving the combination of avutometinib and defactinib with gemcitabine and Nab-paclitaxel in dose level 1 cohort achieved a confirmed overall response rate (ORR) of 83% (5/6).
Of the 26 patients in all cohorts who have had the opportunity to have their first scan while on treatment, 21 have experienced a reduction of the change in target lesion sum of diameters.
One dose-limiting toxicity, febrile neutropenia (low white blood cell count), was observed in the dose level 1 cohort. The cohort was cleared after additional patients were evaluated.
In the additional dose cohorts enrolled more recently (-1, 1a, and 2a), follow-up is ongoing, and most patients remained on treatment at the data cutoff.
Verastem Oncology has established clinical collaborations with Amgen Inc AMGN and Bristol-Myers Squibb Co BMY Mirati to evaluate Lumakras (sotorasib) in combination with avutometinib and defactinib and Krazati (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the Phase 1b/2 RAMP 203 and RAMP 204 trials, respectively.
Friday, Verastem Oncology initiated the rolling submission of a New Drug Application (NDA) to the FDA seeking accelerated approval of the combination of avutometinib and defactinib for adult patients with recurrent KRAS mutant (KRAS mt) low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy.
FDA has accepted Verastem’s plan to submit the clinical module in the second half of 2024 to complete the NDA application.
The company plans to request a priority review of the NDA. Currently, there are no FDA-approved treatments specifically for recurrent LGSOC.
The company is currently enrolling patients and activating sites for RAMP 301, an international confirmatory Phase 3 trial, evaluating the avutometinib and defactinib combination versus standard of care chemotherapy or hormonal therapy for KRAS mt and KRAS wt recurrent LGSOC.
Price Action: VSTM shares are down 59% at $4.99 during the premarket session at last check Friday after it surged as high as $19.74.
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