A potentially $1.76 billion oncology deal created a little more than three years ago between partners Jazz Pharmaceuticals plc and Zymeworks Inc. now has a more solid direction. New and positive top-line results for the phase III Herizon-GEA-01 study of the HER2-targeted bispecific antibody zanidatamab in locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) moved the stock and expectations for both companies.
More than a week ahead of its priority PDUFA date, the U.S. FDA has greenlit the first dual HER2-targeted bispecific antibody specifically for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The approval went to Jazz Pharmaceuticals plc for Ziihera (zanidatamab), an injection given to adults every two weeks. The treatment was designed to have a more favorable profile than competitors, where drugs targeting HER2 such as Astrazeneca plc’s Enhertu (trastuzumab deruxtecan) and Roche Holding AG’s Herceptin (trastuzumab) are options, as well as checkpoint inhibitors such as Merck & Co Inc.’s Keytruda (pembrolizumab).
The American Society of Clinical Oncology (ASCO) begins its 2024 annual meeting at the cavernous and labyrinthine McCormick Place convention center in Chicago Friday, May 31. It’s one of the world’s largest cancer research conferences and can be daunting to follow. More than 400 organizations will participate this year, with about 200 sessions ready to convene. The vast majority of the 5,000 abstracts that cover all aspects of cancer treatment have already been released, and they will be scrutinized by the more than 40,000 attendees from around the world.
The identification of novel immunotherapeutic targets for the treatment of biliary tract cancer (BTC) is still a need. It has been reported that galectin-9 (GAL-9) is expressed in BTC and induces immunosuppressive effects, such as inducing apoptosis in T cells when binding to its receptor TIM-3.
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).
