Japan’s Ministry of Health, Labour and Welfare approved Taiho Pharmaceutical Co. Ltd.’s Lytgobi (futibatinib) for unresectable biliary tract cancer harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions that has progressed after chemotherapy.
HER2-targeting bispecific antibody zanidatamab, in development by Jazz Pharmaceuticals plc and Zymeworks Inc., produced better antitumor responses than current standard of care when used as a second-line treatment for biliary tract cancer (BTC) in a pivotal phase IIb study, bringing it closer to becoming the first therapy to target HER2-expressing BTC.
Top-line results of a phase II study of RXC-004, a porcupine inhibitor for treating certain Wnt ligand-dependent cancers, are not good enough to continue development as a monotherapy for biliary tract cancer, according to Redx Pharma plc. Despite the monotherapy arm not hitting progression-free survival at six months, the Porcupine2 study continues with its other treatment arm, this one using Keytruda (pembrolizumab, Merck & Co. Inc.). Data from that arm are set to come in the second half of 2023.
Jazz Pharmaceuticals plc in-licensed regional rights to Zymeworks Inc.’s HER2- targeted bispecific antibody zanidatamab in a deal potentially worth $1.76 billion, plus royalties. Jazz wants to expand its oncology portfolio with the deal, which covers the U.S., Europe, Japan and all other territories except Asia Pacific markets previously licensed by Zymeworks to Beigene Ltd.
Less than two months after scrubbing a phase III non-small-cell lung cancer trial of the bifunctional fusion protein immunotherapy bintrafusp alfa, Merck KGaA said a phase II test of the candidate in another indication, biliary tract cancer, has missed a predefined threshold that would have enabled a regulatory filing for it. Both studies are part of a rich alliance between Merck and licensee Glaxosmithkline plc.
HONG KONG – Singaporean drugmaker Aslan Pharmaceuticals Ltd. announced top-line data from its pivotal phase III TreeTopp (treatment opportunity with varlitinib (ASLAN-001) in biliary tract cancer) study in second-line biliary tract cancer patients, which failed to meet co-primary endpoints of progression-free survival (PFS) and overall response rate (ORR).
HONG KONG – Singaporean drugmaker Aslan Pharmaceuticals Ltd. announced top-line data from its pivotal phase III TreeTopp (treatment opportunity with varlitinib (ASLAN-001) in biliary tract cancer) study in second-line biliary tract cancer patients, which failed to meet co-primary endpoints of progression-free survival (PFS) and overall response rate (ORR).
