{"entity":{"id":"ramp-201","kind":"trial","name":"RAMP 201","aka":[],"tldr":"RAMP 201 produced the first approved treatment designed for low-grade serous ovarian cancer, a slow-growing type driven by the RAS pathway that shrugs off chemotherapy.","summary":"In KRAS-mutant tumours, the confirmed response rate was 44% with median PFS 19.6 months and median duration of response 31.1 months; response was lower in KRAS-wild-type disease (Targeted Oncology, 2025). FDA accelerated approval 8 May 2025 for KRAS-mutated recurrent LGSOC after prior systemic therapy. The confirmatory RAMP 301 phase 3 versus chemotherapy or endocrine therapy is ongoing.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04625270","url":"https://clinicaltrials.gov/study/NCT04625270"},{"label":"MSK on approval","url":"https://www.mskcc.org/news/fda-approves-avutometinib-defactinib-combination-for-treating-recurrent-low-grade-serous-ovarian-cancer-with-kras-mutation"}],"tags":[],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["kras"],"drugs":["avutometinib-defactinib"],"companies":["verastem"],"institutions":[],"pathways":["ras-mapk"],"terms":["lgsoc"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04625270","phase":"2","setting":"Recurrent low-grade serous ovarian cancer: avutometinib (RAF/MEK clamp) + defactinib (FAK inhibitor)","sponsor":"Verastem","result":"ORR 44%, median PFS 19.6 months in KRAS-mutant LGSOC.","started":"2020-12-21","startedType":"actual","yearReported":2024,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (KRAS-mutant)","primary":true,"unit":"%","arms":[{"name":"Avutometinib + defactinib","value":44}],"source":"https://www.targetedonc.com/view/avutometinib-plus-defactinib-gains-fda-approval-in-kras-ovarian-cancer"},{"endpoint":"Progression-free survival (KRAS-mutant)","unit":"months","arms":[{"name":"Avutometinib + defactinib","value":19.6}],"source":"https://www.targetedonc.com/view/avutometinib-plus-defactinib-gains-fda-approval-in-kras-ovarian-cancer"}]},"route":"/trials/ramp-201/","neighbours":{"cancer":[{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"}],"drug":[{"id":"avutometinib-defactinib","kind":"drug","name":"Avutometinib + defactinib","route":"/drugs/avutometinib-defactinib/"}],"company":[{"id":"verastem","kind":"company","name":"Verastem Oncology","route":"/companies/verastem/"}],"pathway":[{"id":"ras-mapk","kind":"pathway","name":"RAS / RAF / MEK / ERK (MAPK)","route":"/pathways/ras-mapk/"}],"term":[{"id":"lgsoc","kind":"term","name":"Low-grade serous ovarian cancer (LGSOC)","route":"/terms/lgsoc/"}],"paper":[{"id":"paper-ramp-201-avutometinib-defactinib-lgsoc-jco-2025","kind":"paper","name":"RAMP 201: avutometinib with or without defactinib in recurrent low-grade serous ovarian cancer","route":"/key-papers/paper-ramp-201-avutometinib-defactinib-lgsoc-jco-2025/"}]}}