What are the next steps for the registrational Phase 3 study for PDAC, following the positive May 22, 2025 RAMP 205 results?

Following the positive updated results from the RAMP 205 Phase 1/2 trial for metastatic pancreatic ductal adenocarcinoma (PDAC) announced on May 22, 2025, Verastem Oncology is actively planning for a registrational Phase 3 study. The company anticipates initiating this Phase 3 trial in frontline metastatic PDAC in 2026.

Key next steps include:

• Completion of RAMP 205 Enrollment The expansion cohort of the RAMP 205 study is expected to complete enrollment in the third quarter of 2025.
• Regulatory Interactions Verastem plans further interactions with regulatory bodies to align on the design and pathway for the planned Phase 3 study.
• Potential Indications The company aims to evaluate avutometinib plus defactinib in two potential treatment indications: newly diagnosed metastatic PDAC and newly diagnosed borderline resectable PDAC.
• Investor Webcast Verastem hosted an investor webcast on June 2, 2025, to provide a comprehensive review of the updated RAMP 205 data.

The positive results from RAMP 205, which evaluated avutometinib plus defactinib in combination with standard-of-care chemotherapy, showed an overall response rate (ORR) of 83% (10/12) in the selected recommended Phase 2 dose (RP2D) cohort for frontline metastatic PDAC.