Verastem Oncology Announces Multiple Data Presentations at Society of Gynecologic Oncology 2025 Annual Meeting on Women’s Cancer
Verastem Oncology (VSTM) announced multiple presentations at the upcoming Society of Gynecologic Oncology 2025 Annual Meeting. The key highlight is an oral presentation of additional analyses from the Phase 2 RAMP 201 trial, which evaluates avutometinib plus defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC). This data served as the basis for their NDA currently under FDA Priority Review.
The presentations include subgroup analyses by KRAS mutational status, an investigator-sponsored study of the same drug combination in gynecologic mesonephric cancer, and a preclinical poster on treatment resistance. The company will also maintain an exhibition booth (#622) at the conference, which takes place March 14-17 in Seattle.
Verastem Oncology (VSTM) ha annunciato numerose presentazioni in occasione del prossimo Congresso Annuale della Società di Oncologia Ginecologica 2025. Il punto saliente è una presentazione orale di ulteriori analisi del trial di Fase 2 RAMP 201, che valuta avutometinib più defactinib in pazienti con cancro ovarico seroso a basso grado ricorrente (LGSOC). Questi dati hanno costituito la base per la loro NDA attualmente in fase di Revisione Prioritaria da parte della FDA.
Le presentazioni includono analisi di sottogruppo in base allo stato di mutazione di KRAS, uno studio sponsorizzato da ricercatori sulla stessa combinazione di farmaci nel cancro mesonefrico ginecologico e un poster preclinico sulla resistenza al trattamento. L'azienda avrà anche uno stand espositivo (#622) alla conferenza, che si svolgerà dal 14 al 17 marzo a Seattle.
Verastem Oncology (VSTM) anunció múltiples presentaciones en la próxima Reunión Anual de la Sociedad de Oncología Ginecológica 2025. El aspecto más destacado es una presentación oral de análisis adicionales del ensayo de Fase 2 RAMP 201, que evalúa avutometinib más defactinib en pacientes con cáncer de ovario seroso de bajo grado recurrente (LGSOC). Estos datos sirvieron como base para su NDA actualmente bajo Revisión Prioritaria de la FDA.
Las presentaciones incluyen análisis de subgrupos por estado de mutación de KRAS, un estudio patrocinado por investigadores de la misma combinación de fármacos en cáncer mesonéfrico ginecológico, y un póster preclínico sobre resistencia al tratamiento. La empresa también mantendrá un stand de exhibición (#622) en la conferencia, que se llevará a cabo del 14 al 17 de marzo en Seattle.
Verastem Oncology (VSTM)는 다가오는 2025년 부인종양학회 연례 회의에서 여러 발표를 할 예정이라고 발표했습니다. 주요 하이라이트는 재발성 저급 세포성 난소암(LGSOC) 환자에서 avutometinib과 defactinib의 추가 분석에 대한 구두 발표입니다. 이 데이터는 현재 FDA의 우선 심사 중인 NDA의 기초가 되었습니다.
발표 내용에는 KRAS 돌연변이 상태에 따른 하위 그룹 분석, 동일한 약물 조합에 대한 연구자 주도 연구, 치료 저항성에 대한 전임상 포스터가 포함됩니다. 회사는 또한 3월 14일부터 17일까지 시애틀에서 열리는 회의에서 전시 부스(#622)를 유지할 것입니다.
Verastem Oncology (VSTM) a annoncé plusieurs présentations lors de la prochaine Réunion Annuelle de la Société d'Oncologie Gynécologique 2025. Le point fort est une présentation orale d'analyses supplémentaires de l'essai de Phase 2 RAMP 201, qui évalue avutometinib plus defactinib chez des patientes atteintes d'un cancer de l'ovaire séreux de bas grade récidivant (LGSOC). Ces données ont servi de base à leur NDA actuellement en cours de Révision Prioritaire par la FDA.
Les présentations incluent des analyses de sous-groupes selon le statut de mutation de KRAS, une étude parrainée par des chercheurs sur la même combinaison de médicaments dans le cancer mésonéphrique gynécologique et un poster préclinique sur la résistance au traitement. L'entreprise disposera également d'un stand d'exposition (#622) lors de la conférence, qui se déroulera du 14 au 17 mars à Seattle.
Verastem Oncology (VSTM) hat mehrere Präsentationen auf dem bevorstehenden Jahresmeeting der Gesellschaft für Gynäkologische Onkologie 2025 angekündigt. Das Hauptaugenmerk liegt auf einer mündlichen Präsentation zusätzlicher Analysen aus der Phase-2-Studie RAMP 201, die avutometinib plus defactinib bei Patienten mit rezidivierendem niedriggradigem serösem Ovarialkarzinom (LGSOC) untersucht. Diese Daten dienten als Grundlage für ihre NDA, die sich derzeit im FDA-Prioritätsprüfungsverfahren befindet.
Die Präsentationen umfassen Subgruppenanalysen nach KRAS-Mutationsstatus, eine von Forschern initiierte Studie zur gleichen Arzneimittelkombination bei gynäkologischem mesonephrotem Krebs und ein präklinisches Poster zur Therapie-Resistenz. Das Unternehmen wird auch einen Ausstellungsstand (#622) auf der Konferenz haben, die vom 14. bis 17. März in Seattle stattfindet.
- NDA under FDA Priority Review for avutometinib plus defactinib in LGSOC
- Multiple data presentations at major medical conference demonstrating clinical progress
- None.
Insights
The upcoming presentations at SGO 2025 represent a important milestone for Verastem Oncology's development program. The Priority Review status for their NDA is particularly significant, as it typically reduces the FDA review period from 10 months to 6 months, potentially accelerating market entry for their avutometinib plus defactinib combination therapy.
The RAMP 201 trial's subgroup analyses by KRAS mutational status are strategically important. KRAS mutations occur in approximately 20-30% of LGSOC cases, and understanding treatment efficacy in different molecular subgroups could help define optimal patient populations for targeted therapy. This precision medicine approach could provide Verastem with a competitive advantage in the LGSOC market, where current treatment options are and often ineffective.
The inclusion of data from gynecologic mesonephric cancer, a rare KRAS-mutation-rich cancer type, demonstrates Verastem's broader strategy in targeting RAS/MAPK pathway-driven cancers. This expansion beyond LGSOC could open additional market opportunities and strengthen the company's pipeline diversity.
The preclinical research on resistance mechanisms is particularly noteworthy, as it investigates combinations with established treatments like fulvestrant. This proactive approach to addressing treatment resistance could enhance the long-term commercial viability of Verastem's therapeutic strategy and potentially lead to new combination approaches that extend treatment durability.
Oral presentation of RAMP 201 trial results including updated subgroup analyses in recurrent low-grade serous ovarian cancer
Oral presentation of investigator-sponsored study of avutometinib plus defactinib in gynecologic mesonephric cancer, a rare grouping of cancers that generally harbor KRAS mutations
“The presentation of the RAMP 201 primary analysis, which served as the basis of the acceptance of our NDA that is under Priority Review with the FDA, includes additional subgroup analysis by KRAS mutational status,” said Dan Paterson, president, and chief executive officer of Verastem Oncology. “We look forward to sharing these learnings with many of the world’s leading gynecologic oncologists at SGO as part of our continued commitment to people living with recurrent low-grade serous ovarian cancer. We also recognize the importance of these findings to the broader cancer community as part of our growing pool of data reinforcing the potential to change expectations in managing RAS/MAPK pathway-driven cancers.”
Oral Presentation:
- Abstract Title: Avutometinib + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer (ENGOT-ov60/GOG-3052/RAMP 201): Dose Intensity and Subgroup Analysis
- Presenter: Rachel Grisham, M.D.
- Session: Focused Forum XV: Ongoing IMPACT
- Date/Time: Monday, March 17, 2025, 9:15 am PST
Oral Presentation – Investigator-Sponsored Trial:
- Abstract Title: A Phase II Study of Avutometinib and Defactinib in Advanced or Recurrent Gynecologic Mesonephric Cancer: Interim Results
- Presenter: Rachel Grisham, M.D.
- Session: Focused Forum IV: Finding IMPACT: The Needle in the Haystack
- Date and Time: Saturday, March 15, 2025, 4:15 pm PST
Preclinical Virtual Poster:
- Abstract Title: Preclinical Efficacy of the Estrogen Receptor Degrader Fulvestrant in Combination with RAF/MEK clamp Avutometinib and FAK Inhibitor in Low-Grade Serous Ovarian Cancer with Acquired Resistance to Chemotherapy and Aromatase Inhibitor
- Study Author: Cem Demirkiran, M.D.
About the Avutometinib and Defactinib Combination
Avutometinib is an oral RAF/MEK clamp that potently inhibits MEK1/2 kinase activities and 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 the MEK-only inhibitors.
Defactinib is an oral, selective inhibitor of focal adhesion kinase (FAK) and proline-rich tyrosine kinase-2 (Pyk2), the two members of the focal adhesion kinase family of non-receptor protein tyrosine kinases. FAK and Pyk2 integrate signals from integrin and growth factor receptors to regulate cell proliferation, survival, migration, and invasion. FAK activation has been shown to mediate resistance to multiple anti-cancer agents, including RAF and MEK inhibitors.
Verastem Oncology is currently conducting clinical trials with avutometinib with and without defactinib in RAS/MAPK-driven tumors as part of its Raf And Mek Program or RAMP. Verastem is currently enrolling patients and activating sites for RAMP 301 (GOG-3097/ENGOT-ov81/NCRI) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC).
Verastem was granted Priority Review and a Prescription Drug User Fee Act (PDUFA) date of June 30, 2025, for its New Drug Application (NDA) to the
Verastem Oncology has established a clinical collaboration with Amgen to evaluate LUMAKRAS™ (sotorasib) in combination with avutometinib and defactinib in both treatment-naïve patients and in patients whose KRAS G12C mutant non-small cell lung cancer progressed on a G12C inhibitor as part of the RAMP 203 trial (NCT05074810). Verastem has received Fast Track Designation from the FDA for the triplet combination in April 2024. 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, is supported by the PanCAN Therapeutic Accelerator Award. FDA granted Orphan Drug Designation to the avutometinib and defactinib combination for the treatment of pancreatic cancer.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a late-stage development biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition and KRAS G12D inhibition. For more information, please visit www.verastem.com and follow us on LinkedIn.
Forward-Looking Statements
This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “may,” “believe,” “estimate,” “forecast,” “goal,” “project,” and other words of similar meaning. Such forward-looking statements address various matters about, among other things, Verastem Oncology’s programs and product candidates, strategy, future plans and prospects, including statements related to the potential for and timing of commercialization of product candidates, the anticipated timing for the IND application for VS-7375/GFH375, the expected outcome and benefits of the Company’s collaboration with GenFleet Therapeutics (
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Source: Verastem Oncology
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