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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

IDH1 inhibition

3 evidence topics · 3 sources

Guideline recommendation for ivosidenib

“Ivosidenib is recommended for the treatment of patients with CCA and IDH1 mutations who have progressed after ≥1 prior line of systemic therapy [I, A; ESMO-MCBS v1.1 score: 2; ESCAT score: I-A; FDA approved, not EMA approved]” (opens the source at this quote in a new tab)

Ivosidenib versus placebo: ClarIDHy progression-free survival

“Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).” (opens the source at this quote in a new tab)

Ivosidenib versus placebo: ClarIDHy final overall survival

“Median OS was 10.3 months (95% CI, 7.8-12.4 months) with ivosidenib vs 7.5 months (95% CI, 4.8-11.1 months) with placebo (hazard ratio, 0.79 [95% CI, 0.56-1.12]; 1-sided P = .09).” (opens the source at this quote in a new tab)

“When adjusted for crossover, median OS with placebo was 5.1 months (95% CI, 3.8-7.6 months; hazard ratio, 0.49 [95% CI, 0.34-0.70]; 1-sided P < .001).” (opens the source at this quote in a new tab)