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Breakthrough therapy for low-grade serous ovarian cancer (LGSOC)! Combination of VS-6766 and defactinib: total remission rate of 52%, regardless of KRAS status!
Combination of VS-6766 and defactinib for LGSOC ovarian cancer. Verastem is a biopharmaceutical company dedicated to the development of new anti-cancer drugs. Recently, the company announced that the US Food and Drug Administration (FDA) has granted VS-6766 (RAF/MEK inhibitor) and defactinib (FAK inhibitor) combination therapy breakthrough drug designation (BTD) for the treatment of all relapses Patients with low-grade serous ovarian cancer (LGSOC), regardless of their KRAS status after one or more previous treatment regimens (including platinum-based chemotherapy).
BTD is a new drug review channel created by the FDA in 2012. It aims to accelerate the development and review of the treatment of serious or life-threatening diseases, and there is preliminary clinical evidence that the drug is in one or more of the existing therapeutic drugs. New drugs that have significantly improved clinically significant endpoints. BTD-obtained drugs can receive closer guidance including high-level FDA officials during development, ensuring that new treatment options are provided to patients in the shortest possible time.
Parallel pathway blocking: VS-6766 will become the backbone therapy for RAS pathway-driven tumors
Melissa Aucoin, CEO of the National Ovarian Cancer Alliance, said: “LGSOC patients urgently need better solutions because the current treatment methods have low response rates and tolerability issues. LGSOC patients often start dealing with this at a relatively young age. This highly recurring and far-reaching disease has been fighting for a long time. Therefore, the qualification of a breakthrough drug in this disease marks an important progress.”
The combination therapy of VS-6766 and defactinib is being evaluated in a Phase 1/2 FRAME trial initiated by the investigator. Recent results from the FRAME LGSOC cohort (n=24) showed that the overall response rate (ORR) was 52% (11 out of 21 remission evaluable patients), and the ORR in KRAS mutation patients was 70% (10 remission evaluable) There were 7 remissions among patients), the ORR in KRAS wild-type patients was 44% (4 out of 9 remission-evaluable patients), and the ORR in patients with undetermined KRAS status was 0% (2 remission-evaluable patients had 0 cases). The most common side effects in the study were skin rash, elevated creatine kinase, nausea, hyperbilirubinemia and diarrhea, most of which were grade 1/2 and were all reversible. Some patients have been treated for more than a year, which shows the potential for long-term benefit.
Low-grade serous ovarian cancer (LGSOC) is a recurrent, chemotherapy-resistant cancer with a high mortality rate. It accounts for 5-10% of serous ovarian cancers and 6-8% of all ovarian cancers. There are an estimated 6000 cases in the United States and an estimated 80,000 LGSOC patients worldwide. LGSOC is most common in women aged 45-55. The median survival of LGSOC is about 10 years, and 85% of patients relapse and endure severe pain and complications as the disease progresses. Chemotherapy is the standard care plan for the treatment of the disease.
RAS is the most common mutated oncogene, occurring in 30% of human cancers. These cancers are usually highly aggressive and recurrent, sending signals through the RAS pathway. VS-6766 is a new dual inhibitor of RAF/MEK signaling pathway. With this unique dual mechanism of action, VS-6766 has a vertical inhibitory effect on the RAS pathway in a single drug. Currently, VS-6766 is being evaluated for its combined effects with drugs targeting other nodes in the RAS pathway and drugs targeting parallel pathways to address multiple cancer indications and mutations, including KRAS mutant non-small cell lung cancer (NSCLC) And colorectal cancer, pancreatic cancer, endometrial cancer, uveal metastatic melanoma, etc.
Verastem is currently evaluating VS-6766 as a monotherapy and a Phase 2 registration guidance trial in combination with defactinib. RAMP 201 (Raf and Mek Project) (ENGOTov60/GOG3052) is an adaptive 2-part multicenter, parallel cohort, randomized, open-label trial designed to evaluate the efficacy of VS-6766 alone or in combination with defactinib in the treatment of patients with recurrent LGSOC And safety.
(source:internet, reference only)