On March 11, 2024 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported multiple oral and poster presentations, including a late-breaking oral presentation of avutometinib and defactinib combination from the RAMP 201 Part A trial in heavily pretreated patients with low-grade serous ovarian cancer (LGSOC), at the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer, to be held on March 16-18 in San Diego, California (Press release, Verastem, MAR 11, 2024, View Source [SID1234641038]). Verastem will have an exhibition booth (#420) at the meeting to provide an overview of its ongoing cancer research.

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"Important subgroup analyses from Part A of the Phase 2 RAMP 201 clinical trial evaluating avutometinib and defactinib demonstrate how our research in low-grade serous ovarian cancer continues to elucidate the potential use of this combination in a heavily pretreated patient population, including patients who received a prior MEK-only inhibitor," said Dan Paterson, president and chief executive officer of Verastem Oncology. "In addition, the plenary oral presentation highlighting preclinical efficacy of avutometinib in combination with a FAK inhibitor reinforces the potential of this combination in low-grade serous ovarian cancer regardless of KRAS status. Furthermore, the oral presentation from the LGSOC Patient Impact Survey, that is supported by Verastem Oncology, highlights the negative social and emotional impact patients experience living with this rare ovarian cancer."

Key Data Presentations:

Late-Breaking Oral Presentation

Title: Avutometinib plus defactinib in recurrent, low-grade serous ovarian cancer: A subgroup analysis of ENGOT-ov60/GOG-3052/RAMP 201 Part A
Session: Scientific Plenary IV: Late Breaking Abstract Session 1
Date/Time: Sunday, March 17, 2024, 4:15 – 5:30 p.m. PDT
Presenter: Dr. Susanna Banerjee, BBS, MA, PhD, FRCP
Focused Plenary Oral Presentation

Title: Preclinical efficacy of RAF/MEK clamp avutometinib in combination with FAK inhibition for low grade serous ovarian cancer
Session: Focused Plenary V: Rare Cancer: Updates in Uncommon Cancers
Date/Time: Sunday, March 17, 2024, 1:45 – 2:45 p.m. PDT
Presenter: Michelle Greenman, MD, MPH
Oral Poster Presentation

Title: Voices of women with low-grade serous ovarian cancer: Results from a multinational survey
Session: Poster Session II
Date/Time: Monday, March 18, 2024, 11:45 a.m. – 12:45 p.m. PDT
Presenter: Charlotte C. Sun, DrPH, MPH
Trials in Progress Poster Presentation

Title: A phase III, randomized trial evaluating avutometinib plus defactinib compared with investigator’s choice of therapy in patients with recurrent low-grade serous ovarian cancer: GOG-3097/ENGOT-ov81/NCRI/RAMP 301
Session: Poster Session II
Date/Time: Monday, March 18, 2024, 11:45 a.m. – 12:45 p.m. PDT
Presenter: Rachel N. Grisham, MD
Drs. Banerjee and Grisham are paid consultants for Verastem Oncology. The multinational survey is supported by Verastem Oncology.

About the Avutometinib and Defactinib Combination

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS/MAPK pathway inhibition. In contrast to currently available MEK-only inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other MEK-only inhibitors. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK clamp avutometinib, with defactinib, a selective FAK inhibitor, for the treatment of all patients with recurrent LGSOC regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy. Avutometinib alone or in combination with defactinib was also granted Orphan Drug Designation by the FDA for the treatment of LGSOC.

Verastem Oncology is currently conducting clinical trials with its RAF/MEK clamp avutometinib in RAS pathway-driven tumors as part of its (Raf And Mek Program). RAMP 301 (NCT06072781) is a Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent LGSOC. RAMP 201 (NCT04625270) is a Phase 2 registration-directed trial of avutometinib in combination with defactinib in patients with recurrent LGSOC and has completed enrollment in the dose optimization and expansion phases and is enrolling for low-dose evaluation.

Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and KRAZATI (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 (NCT05074810) and RAMP 204 (NCT05375994) trials, respectively. Supported by the "Therapeutic Accelerator Award" Verastem Oncology received from PanCAN, Verastem Oncology is conducting RAMP 205 (NCT05669482), a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer.