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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

Tumor-Agnostic targeted and immune therapies

3 evidence topics · 4 sources

Frequency of tumor-agnostic targets in biliary tract cancer

“Disease-agnostic approved agents are available for tumors with BRAF V600E mutations (4–5% frequency in BTC), NTRK fusions (<1%), RET fusions (<1%), and/or microsatellite instability (1–2%)” (opens the source at this quote in a new tab)

“NTRK fusions occur in <0.1% of BTC cases.” (opens the source at this quote in a new tab)

“Because of the very low prevalence of these alterations, the respective inhibitors have only been evaluated in basket trials.” (opens the source at this quote in a new tab)

Guideline recommendations for BRAF, NTRK, RET, MSI-H, and TMB-high disease

“Dabrafenib-trametinib is recommended for the treatment of patients with BRAFV600E mutations who have progressed after ≥1 prior line of systemic therapy [III, A; ESMO-MCBS v1.1 score: 3; ESCAT score: I-B; FDA approved, not EMA approved]” (opens the source at this quote in a new tab)

“NTRK inhibitors are recommended in patients with NTRK fusions who have progressed on or are intolerant to prior treatment [III, A; ESCAT score: I-C]” (opens the source at this quote in a new tab)

“Selpercatinib can be considered in patients with RET fusions who have progressed on or are intolerant to prior treatment [III; A; ESMO-MCBS v1.1 score for solid tumours with a RET fusion: 3; ESCAT score: I-C; FDA approved, not EMA approved]” (opens the source at this quote in a new tab)

“Pembrolizumab is recommended in patients with MSI-H/dMMR who have progressed on or are intolerant to prior non-immune checkpoint inhibitor-containing treatment [III, A; ESMO-MCBS v1.1 score: 3; ESCAT score: I-C]” (opens the source at this quote in a new tab)

“Pembrolizumab can be considered in patients with TMB-H tumours who have progressed on or are intolerant to prior non-immune checkpoint inhibitor-containing treatment [IV; A; ESMO-MCBS v1.1 score for pembrolizumab in TMB-H solid tumours: 3; ESCAT Score: I-C]” (opens the source at this quote in a new tab)

“Entrectinib (ESMO-MCBS v1.1 score: 3), larotrectinib (ESMO-MCBS v1.1 score: 3) and repotrectinib (not EMA or FDA approved) are recommended in patients with NTRK fusions who have progressed on or are intolerant to prior treatment [III, A; ESCAT score: I-C].” (opens the source at this quote in a new tab)

“Selpercatinib should be considered in patients with RET fusions who have progressed on or are intolerant to prior treatment [III, A; ESMO-MCBS v1.1 score: 3; ESCAT score: I-C].” (opens the source at this quote in a new tab)

Dabrafenib plus trametinib: ROAR biliary tract cancer cohort

“An investigator-assessed overall response was achieved by 22 (51%, 95% CI 36-67) of 43 patients.” (opens the source at this quote in a new tab)

“An independent reviewer-assessed overall response was achieved by 20 (47%, 95% CI 31-62) of 43 patients.” (opens the source at this quote in a new tab)

“The median duration of response in 22 patients with an investigator-assessed overall response was 9 months (95% CI 6–14).” (opens the source at this quote in a new tab)

“Median progression-free survival by investigator assessment was 9 months (95% CI 5–10; figure 2A). Overall survival was 84% (95% CI 69–92) at 6 months, 56% (38–71) at 12 months, and 36% (19–53) at 24 months.” (opens the source at this quote in a new tab)

“15 (35%) patients had adverse events that led to dose reduction, 24 (56%) patients had adverse events that led to dose interruption” (opens the source at this quote in a new tab)