08:25 AM EDT, 05/24/2024 (MT Newswires) -- Verastem Oncology (VSTM) late Thursday reported that an ongoing phase 1/2 clinical trial evaluating avutometinib and defactinib in combination with gemcitabine and nab-paclitaxel in 41 patients with metastatic pancreatic cancer reached an interim partial response rate of 83%.
Of 26 patients in all the trial cohorts who have had their first scan while undergoing treatment, 21 have experienced a reduction in the size of their lesions. As of May 14, 12 patients in the trial experienced serious adverse reactions and two discontinued treatments.
Separately, the company on Friday also said it began a rolling submission of a New Drug Application to the US Food and Drug Administration for accelerated approval of the combination of avutometinib and defactinib for adults with recurrent KRAS mutant low-grade serous ovarian cancer who have one other previous therapies.
The company also said it plans to request a priority review of the New Drug Application.
The initial submission will be nonclinical studies with a plan to submit clinical results in H2, the company said, adding that a final submission of the clinical component may be expanded to include other indications if Verastem ( VSTM ) provides data showing substantial improvement over available therapies.
The company is currently enrolling patients for a Phase 3 trial of the drug combo.
The FDA has granted the drug combination Breakthrough Therapy Designation for the treatment of patients with the rare ovarian cancer type and Orphan Drug Designation for certain related indications, the company said.
Shares of the company were down more than 60% in recent Friday premarket activity
Price: 5.00, Change: -7.18, Percent Change: -58.95