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Tovecimig (CTX-009)

Second-line advanced biliary tract cancer

Also known as ABL001
Last updated
89 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatmentCurrent treatment options and standard of care

FGFR2 Fusion-Directed inhibitors

5 evidence topics · 5 sources

Guideline recommendations for FGFR inhibition after progression

“Futibatinib [ESMO-Magnitude of Clinical Benefit (MCBS) v1.1 score: 3] and pemigatinib (ESMO-MCBS v1.1 score: 2) are recommended in patients with FGFR2 fusions or rearrangements who have progressed after one or more prior lines of systemic therapy [III, A; ESCAT score: I-B].” (opens the source at this quote in a new tab)

“These findings led to both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approval of pemigatinib and futibatinib.” (opens the source at this quote in a new tab)

“FGFR inhibitors are recommended for the treatment of patients with FGFR2 fusions who have progressed after ≥1 prior line of systemic therapy [III, A; ESMO-MCBS v1.1 score: 3; ESCAT score: I-B]” (opens the source at this quote in a new tab)

Prevalence of FGFR2 fusions and rearrangements and their detection

“Fibroblast growth factor receptor 2 (FGFR2) fusions or rearrangements occur in up to 14% of patients with intrahepatic cholangiocarcinoma.” (opens the source at this quote in a new tab)

“Exploratory ctDNA analysis identified FGFR2 fusions or rearrangements in 83 of the 95 patients (87%) evaluated” (opens the source at this quote in a new tab)

Pemigatinib: FIGHT-202 final analysis

“The ORR in cohort A was 37.0% (95% confidence interval 27.9% to 46.9%); complete and partial responses were observed in 3 and 37 patients, respectively.” (opens the source at this quote in a new tab)

“Median DOR was 9.1 (6.0-14.5) months; median PFS and OS were 7.0 (6.1-10.5) months and 17.5 (14.4-22.9) months, respectively.” (opens the source at this quote in a new tab)

“The most common TEAEs of any grade were hyperphosphatemia (58.5%), alopecia (49.7%), and diarrhea (47.6%).” (opens the source at this quote in a new tab)

Futibatinib: FOENIX-CCA2 phase 2 trial

“A total of 43 of 103 patients (42%; 95% confidence interval, 32 to 52) had a response, and the median duration of response was 9.7 months.” (opens the source at this quote in a new tab)

“At a median follow-up of 17.1 months, the median progression-free survival was 9.0 months and overall survival was 21.7 months.” (opens the source at this quote in a new tab)

“Common treatment-related grade 3 adverse events were hyperphosphatemia (in 30% of the patients), an increased aspartate aminotransferase level (in 7%), stomatitis (in 6%), and fatigue (in 6%).” (opens the source at this quote in a new tab)

“Overall, treatment-related adverse events led to dose interruptions in 52 patients (50%) and dose reductions in 56 patients (54%).” (opens the source at this quote in a new tab)

Acquired resistance to FGFR inhibition and next-generation agents

“Cholangiocarcinoma is a rare, aggressive cancer often driven by FGFR2 fusions, which are targetable with inhibitors such as pemigatinib and futibatinib. However, resistance frequently develops due to acquired FGFR2 mutations.” (opens the source at this quote in a new tab)

“Among 51 patients included in the efficacy evaluable set, the objective response rate was 6·3% (95% CI 0·2-30·2; one confirmed partial response) in cohort A1, 30·0% (6·7-65·3; three confirmed partial responses) in cohort A2, 23·1% (5·0-53·8; three confirmed partial responses) in cohort B, and 0% in cohort C.” (opens the source at this quote in a new tab)