Juan W. Valle, Chief Medical Officer of Cholangiocarcinoma Foundation, shared on LinkedIn:
“What did we learn from 3 key randomized phase III trials involving 1,451 patients at ESMO 2026?
1. Harmoni-GI1 (first-line, advanced disease): the addition of a VEGF-targeted to chemoimmunotherapy improves overall survival in Chinese patients with advanced biliary tract cancer. Interim results showed the combination of CisGem with ivonescimab (which targets both PD-1 and VEGF) was superior to CisGem with durvalumab (median OS 14.9 vs. 12.1 months, HR 0.75, p=0.0031). This promising development is now being evaluated in a US first-line study (NCT07765433).
You can also read: HARMONi-GI1 at ESMO 2026: Ivonescimab Plus Chemotherapy in Advanced Biliary Tract Cancer.
2. COMPANION-002 (second-line, advanced disease): targeting VEGF and DLL4 met its primary endpoint. Tovecimig (a dual VEGF- and DLL4-inhibitor) in combination with paclitaxel improved response rate (18.0% vs 5.3% with paclitaxel alone, p=0.028). PFS was also improved (median 4.7 vs. 2.6 months, HR 0.44, p<0.0001). There was no difference in overall survival, noting high cross-over rate (54%).
Title: COMPANION-002: A Randomized Phase 2/3 Trial of Tovecimig Plus Paclitaxel versus Paclitaxel Alone as a Second-line Therapy in Patients with Advanced Biliary Tract Cancer
Authors: Nilofer S Azad, Ian Hu, Priyadarshini Pathak, Ilyas Sahin, Olivia Aranha, Renuka Iyer, Gregory Heestand, Chih-Yi Liao, Howard S. Hochster, Aparna Kalyan, Anthony El-Khoueiry, Andrew Scott Paulson, Robin Kate Kelley, Mitesh Borad, Lipika Goyal, Cynthia A. Sirard, Thomas J. Schuetz, Milind Javle
You can also read: Press Release: COMPANION-002 Trail – Tovecimig Plus Paclitaxel Improves PFS in Biliary Tract Cancer.
3. ACTICCA-1 (adjuvant): combination chemotherapy is not superior to monotherapy. Cisplatin and gemcitabine chemotherapy failed to show an improvement in disease-free survival following curative resection of BTC, compared to capecitabine alone (24-month DFS 52% vs. 44%, HR 0,82, p=0.058), or overall survival.
We thank all patients, caregivers, and investigators for bringing these important results to our whole community.”
Title: Adjuvant chemotherapy with cisplatin and gemcitabine compared to standard of care after curative intent resection of cand muscle invasive gallbladder carcinoma (ACTICCA-1/AIO-HEP-0112 trial)
Authors: A Stein, J Bridgewater, H-J Klümpen, T Gruenberger, J Shannon, L Fornaro, L H Jensen, D Arnold, J Primrose, D Goldstein, A W Lohse, J Wilmink, U Pession, D P Modest, S Kasper, H S Wasan, D Palmer, J de Vos-Geelen, G Folprecht, A Möhl, A Pepić, E Vettorazzi, H Wege
You can also read: ACTICCA-1 at ESMO 2026: Adjuvant Gemcitabine Plus Cisplatin vs Capecitabine in Resected Biliary Tract Cancer.
