VSTM - Verastem: Other Catalysts In 2024 Beyond NDA Rolling Submission Of Defactinib

2024-02-07 01:01:54 ET

Summary

• Rolling NDA submission of avutometinib + defactinib for the treatment of patients with low-grade serous ovarian cancer is expected in the 1st half of 2024, with possible commercialization in 2025.
• Results from two studies, RAMP-203 and RAMP-204, each using avutometinib with two different types of KRAS G12C inhibitors for the treatment of KRAS G12C NSCLC, expected mid-2024.
• The global non-small cell lung cancer market is expected to reach $38.8 billion by 2030; About 13% of NSCLC patients have the KRAS G12C mutation.
• One-third of human cancers are driven by the RAS pathway, which means there is an opportunity to expand either or both avutometinib + defactinib for other solid tumors with this pathway mutation.

The last time I mentioned Verastem ( VSTM ) was in a prior Seeking Alpha article entitled " Verastem: Potential Accelerated Approval Filing In H1 2024 ". In this article I noted that the company was gearing up to initiate the rolling submission of avutometinib and defactinib to the FDA for the treatment of patients with low grade serous ovarian cancer [LGSOC]. It is still on track to do this, with a possible expected commercial launch happening in 2025. However, this isn't the only catalyst for investors to keep an eye on this year. The company might be able to expand the use of these combination drugs [avutometinib + defactinib] to treat other patient populations. One such catalyst would be an initial data readout from the ongoing RAMP-205 trial, which is using this avutometinib combination plus standard of care [SOC] chemotherapy for the treatment of frontline metastatic pancreatic cancer....

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