{"doi":"10.1093/oncolo/oyaf069","title":"A phase II, multicenter, single-arm study of pemigatinib in patients with metastatic or unresectable colorectal cancer harboring FGFR alterations","abstract":"BACKGROUND: FGFR alterations are known to be driver alterations in several tumor types. We aimed to assess the efficacy of pemigatinib, an oral FGFR1-3 inhibitor, in patients with metastatic or unresectable colorectal cancer whose tumors harbored FGF/FGFR alterations. PATIENTS AND METHODS: The ACCRU-GI-1701 is a single-arm phase II trial which enrolled patients with previously treated FGF/FGFR-altered metastatic colorectal cancer to receive oral pemigatinib daily in 21-day cycles. The primary endpoint is objective response. Secondary endpoints include clinical benefit, progression-free survival, overall survival, quality of life, and adverse events (AEs). This trial was registered with ClinicalTrials.gov (NCT04096417). RESULTS: Of the 14 patients included in the interim analysis, the objective response rate as well as clinical benefit rate were 0%. Given these results, the trial closed to enrollment after stage one due to futility. A total of 42.9% of patients had at least one grade 3 or higher AE, the most common being anemia and fatigue. CONCLUSION: Pemigatinib monotherapy did not lead to objective responses in patients with chemorefractory metastatic colorectal cancer harboring FGF/FGFR alterations, although it was overall relatively well tolerated with no new safety signals. Notably, 93% (n = 13) of patients had only FGF/FGFR mutations and amplifications; one patient had an FGFR3-WHSC1 fusion at a low cfDNA percentage (0.02%).","journal":"The Oncologist","year":2025,"id":525983,"datarank":0.231829389509552,"base_score":1.3862943611198906,"endowment":1.3862943611198906,"self_citation_contribution":0.20794415416798362,"citation_network_contribution":0.023885235341568403,"self_endowment_contribution":0.20794415416798362,"citer_contribution":0.023885235341568403,"corpus_percentile":null,"corpus_rank":null,"citation_count":3,"citer_count":3,"citers_with_citation_signal":2,"citers_with_endowment":2,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.6158,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT04096417"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":556231,"name":"Tyler Zemla","orcid":"0009-0005-2390-3557","position":1,"is_corresponding":false},{"id":772954,"name":"Joleen M. Hubbard","orcid":"0000-0001-8250-4920","position":2,"is_corresponding":false},{"id":566299,"name":"John H. Strickler","orcid":"0000-0001-7579-1175","position":3,"is_corresponding":false},{"id":558415,"name":"Olumide B. Gbolahan","orcid":null,"position":4,"is_corresponding":false},{"id":1401064,"name":"L. R. Wilson","orcid":"0009-0008-9224-8543","position":5,"is_corresponding":false},{"id":1100727,"name":"Blake Waechter","orcid":null,"position":6,"is_corresponding":false},{"id":429763,"name":"Fang‐Shu Ou","orcid":"0000-0003-1267-8735","position":7,"is_corresponding":false},{"id":239530,"name":"Andrew B. Nixon","orcid":"0000-0003-3971-2964","position":8,"is_corresponding":false},{"id":105140,"name":"Tanios Bekaii‐Saab","orcid":"0000-0001-7721-1699","position":9,"is_corresponding":false},{"id":1368436,"name":"Kristen K. Ciombor","orcid":"0000-0002-5745-5909","position":10,"is_corresponding":false},{"id":1401507,"name":"Margaret C. Wheless","orcid":null,"position":0,"is_corresponding":true}],"reference_count":39,"raw_metadata":null,"created_at":"2026-07-19T02:50:25.860105Z","pmid":"40515475","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}