{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T08:38:03Z","timestamp":1792831083934,"version":"4.5.0"},"reference-count":0,"publisher":"American Society of Clinical Oncology (ASCO)","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"abstract":"<jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Patients with previously treated biliary tract cancer (BTC) have a short median overall survival (OS), and few treatment options. Tovecimig, a bispecific antibody to delta-like ligand-4 and vascular endothelial growth factor (VEGF)-A, was evaluated in combination with paclitaxel in COMPANION-002, a randomized phase 2\/3 study in pretreated patients with advanced BTC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Patients with advanced BTC with one prior systemic therapy were randomized to paclitaxel (80 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ; days 1, 8 and 15) with or without tovecimig (10 mg\/kg; days 1 and 15). The primary endpoint was RECIST v1.1-defined objective response rate (ORR) as assessed by blinded independent central review (BICR). Secondary endpoints included progression-free survival (PFS) and OS. Crossover from the paclitaxel control arm to tovecimig plus paclitaxel was permitted following BICR-confirmed progression.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      168 patients were randomized 2:1 to tovecimig+paclitaxel (n=111) or paclitaxel alone (n=57). Tovecimig+paclitaxel significantly improved BICR-assessed ORR (18.0% vs 5.3%;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =.0228) and PFS (4.7 vs 2.6 months; hazard ratio [HR], 0.44;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;.0001). Among 31 patients (54%) who crossed over, post-progression PFS (time from crossover to subsequent second progression) exceeded initial PFS (PFS from randomization to initial progression on paclitaxel; 3.5 vs 1.9 months; HR, 0.40;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =.0035). Overall, 142 patients (85%) received tovecimig; no difference in OS was observed (HR, 1.05;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =.779). The most common treatment-emergent adverse events (TEAEs) with tovecimig+paclitaxel were hypertension (69.4%) and fatigue (66.7%). Grade \u22653 TEAEs occurred in 93.5% and 64.2% of patients treated with tovecimig+paclitaxel and paclitaxel alone, respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Tovecimig combined with paclitaxel significantly improved ORR and PFS versus paclitaxel alone as second-line therapy for patients with BTC.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-26-02188","type":"journal-article","created":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T08:25:06Z","timestamp":1792830306000},"update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":0,"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"],"prefix":"10.1200","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9613-3988","authenticated-orcid":false,"given":"Nilofer S","family":"Azad","sequence":"first","affiliation":[{"name":"Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-8605-0036","authenticated-orcid":false,"given":"Ian","family":"Hu","sequence":"additional","affiliation":[{"name":"MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Priyadarshini","family":"Pathak","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2070-9319","authenticated-orcid":false,"given":"Ilyas","family":"Sahin","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital, Boston, MA"},{"name":"University of Florida Health, Gainesville, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Aranha","sequence":"additional","affiliation":[{"name":"Washington University, Siteman Cancer Center, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3643-8621","authenticated-orcid":false,"given":"Renuka","family":"Iyer","sequence":"additional","affiliation":[{"name":"Roswell Park Comprehensive Cancer Center, Buffalo, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory","family":"Heestand","sequence":"additional","affiliation":[{"name":"Stanford Cancer Center, Stanford, CA 94305"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chih-Yi","family":"Liao","sequence":"additional","affiliation":[{"name":"University of Chicago Medical Center, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9893-1529","authenticated-orcid":false,"given":"Howard S.","family":"Hochster","sequence":"additional","affiliation":[{"name":"Rutgers Cancer Institute, New Brunswick, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aparna","family":"Kalyan","sequence":"additional","affiliation":[{"name":"Northwestern University Robert H. Lurie Comprehensive Cancer Center, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9053-3841","authenticated-orcid":false,"given":"Anthony","family":"El-Khoueiry","sequence":"additional","affiliation":[{"name":"USC Norris Comprehensive Cancer Center, Los Angeles, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-6023-670X","authenticated-orcid":false,"given":"Andrew Scott","family":"Paulson","sequence":"additional","affiliation":[{"name":"Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1984-2430","authenticated-orcid":false,"given":"Robin Kate","family":"Kelley","sequence":"additional","affiliation":[{"name":"Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2700-2658","authenticated-orcid":false,"given":"Mitesh","family":"Borad","sequence":"additional","affiliation":[{"name":"Mayo Clinic Arizona, Phoenix, AZ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9777-6221","authenticated-orcid":false,"given":"Lipika","family":"Goyal","sequence":"additional","affiliation":[{"name":"Stanford Cancer Center, Stanford, CA 94305"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4856-4457","authenticated-orcid":false,"given":"Cynthia A.","family":"Sirard","sequence":"additional","affiliation":[{"name":"Compass Therapeutics, Brighton, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas J.","family":"Schuetz","sequence":"additional","affiliation":[{"name":"Compass Therapeutics, Brighton, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9158-0941","authenticated-orcid":false,"given":"Milind","family":"Javle","sequence":"additional","affiliation":[{"name":"MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","published-online":{"date-parts":[[2026,10,24]]},"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO-26-02188","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T08:25:07Z","timestamp":1792830307000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO-26-02188"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,24]]},"references-count":0,"alternative-id":["10.1200\/JCO-26-02188"],"URL":"https:\/\/doi.org\/10.1200\/jco-26-02188","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,24]]},"assertion":[{"value":"2026-08-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-10-16","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-10-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"10.1200\/JCO-26-02188"}}