Product information and disease descriptionPlace of product in therapyApproaches to treatment
Place in treatment, anticipated use, and care setting
5 evidence topics · 6 sources
Summary: anticipated position of tovecimig
Tovecimig is investigational and has no marketing authorization. Its anticipated population is the population enrolled in COMPANION-002: adults with unresectable advanced, metastatic, or recurrent biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma, who have radiologically documented progression after one prior gemcitabine and platinum containing regimen and who have an Eastern Cooperative Oncology Group performance status of 0 or 1. The trial randomized 168 participants 2:1 to tovecimig plus paclitaxel or paclitaxel alone and allowed crossover after centrally confirmed progression.
No positive biomarker is required for selection. Molecular testing is nonetheless relevant to eligibility, because the trial excluded participants who were eligible for a molecularly targeted therapy on a labelled regimen after first-line chemotherapy. The sponsor frames the target population as the approximately 85% of participants whose tumors do not harbor an actionable mutation with an approved targeted therapy, for whom there is no FDA-approved second-line treatment. In current guidelines that population receives FOLFOX, with irinotecan-based or liposomal irinotecan-based regimens as alternatives, so tovecimig plus paclitaxel would enter second-line treatment as an alternative to fluoropyrimidine-based chemotherapy rather than displacing a biomarker-directed option.
The regimen is entirely parenteral and requires an infusion setting. Paclitaxel 80 mg/m2 is given intravenously on days 1, 8, and 15 of each 28-day cycle, and tovecimig 10 mg/kg is given intravenously on days 1 and 15 of each 28-day cycle, so participants attend three infusion visits per 28-day cycle. Regulatory status as of September 2026 is pre-submission: the sponsor reported in August 2026 that it expected FDA feedback in the third quarter of 2026 and planned to include the COMPANION-002 data in a Biologics License Application later in 2026, with the full dataset selected for oral presentation at the October 2026 ESMO Congress.
Unmet need the sponsor identifies in the second-line setting
Eligibility without positive biomarker selection
Care setting: intravenous administration in the COMPANION-002 regimen
| Field | Registry record |
|---|---|
| Official title | “A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination With Paclitaxel Versus Paclitaxel Alone in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen” |
| Intervention description, CTX-009 | “IV infusion on day 1 and 14 of every 28 day cycle” |
| Intervention description, paclitaxel | “IV infusion on day 1, 8, and 15 of every 28 day cycle” |
| Comparator arm description | “Patients randomized to receive paclitaxel only have the option to crossover to the CTX-009 plus paclitaxel arm after documented disease progression per RECIST v1.1.” |
| Overall status | “Active, not recruiting” |