Zymeworks

FDA grants accelerated approval to Ziihera® (zanidatamab-hrii) for treating previously treated, unresectable or metastatic HER2-positive biliary tract cancer, based on a 52% objective response rate and 14.9-month median duration of response from the HERIZON-BTC-01 trial. Ziihera is the first dual HER2-targeted bispecific antibody approved for this indication in the U.S., with ongoing regulatory reviews in China and Europe. Zymeworks receives a $25M milestone payment from Jazz Pharmaceuticals and remains eligible for up to $500M in regulatory milestones.

Jazz Pharmaceuticals' drug Ziihera, for HER2-positive biliary tract cancer, received FDA accelerated approval. It showed a 52% response rate in a study but caused serious adverse reactions in 53% of patients. Jazz aims to further research for HER2-expressing cancers.

Ziihera, a dual HER2-targeted bispecific antibody, received accelerated FDA approval for HER2-positive BTC, based on a 52% objective response rate and 14.9-month median duration of response. Zymeworks earned a $25M milestone payment and is eligible for up to $500M in regulatory milestones. Zanidatamab is also under regulatory review in China and Europe, and is being investigated in Phase 3 trials for gastroesophageal adenocarcinomas and metastatic breast cancer.

J.P.-G. consults for Lilly, Roche, Eisai, Daiichi Sankyo, AstraZeneca, Seattle Genetics, Gilead, MSD; receives travel compensation from Roche; employed by MEDSIR. G.A. receives honoraria from MEDSIR. M.G. receives travel support and honoraria from AstraZeneca, Gilead Sciences, Roche, Pfizer. A.L.-C. receives research support, consults, speaks, and travels for Roche, Lilly, Pfizer, Novartis, Merck Sharp & Dohme, Gilead, Daiichi Sankyo; owns MEDSIR, Initia-Research. J.C. consults, receives honoraria, research funding, stock, travel expenses, and patents for Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck Sharp & Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, HiberCell, BioInvent, GEMoaB, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies; holds patents for pharmaceutical combinations.

Zymeworks has initiated a Phase I clinical trial of ZW191, an investigational therapy targeting advanced solid tumours expressing folate receptor-α (FRα), including endometrial, ovarian, and non-small cell lung cancers. The trial, enrolling 145 patients globally, aims to assess ZW191's safety, tolerability, and anti-tumour activity, utilizing a novel payload developed by Zymeworks.

Zymeworks Inc. initiates a Phase 1 trial to assess ZW191's safety and tolerability in treating advanced FRα-expressing solid tumors, including ovarian, endometrial, and NSCLC cancers. The global study aims to enroll 145 patients across North America, Europe, and the Asia-Pacific region.

Zymeworks Inc. announced the first patient dosed in Phase 1 trial of ZW191 for advanced FRα-expressing solid tumors, including ovarian, endometrial, and NSCLC cancers, to evaluate safety and tolerability.

Cancer has become more manageable due to tailored treatments, with leaders in oncology pushing for genetic insights and data research. This year's Cancer Care Visionaries include Dr. Hesham Abdullah, Jason Bock, Arnon Chait, Raffaele Colombo, Dr. Yusri Elsayed, Mark Erlander, Dr. Marjorie Green, Raquel Izumi, Dr. Biljana Naumovic, Dr. Amita Patnaik, Dr. Mary Pinder-Schenck, Amoolya Singh, and AmirAli Talasaz, each contributing unique perspectives on cancer therapy and leadership.

Recent advancements in HCC and BTC treatment include targeted therapy combinations like atezolizumab plus bevacizumab for HCC and durvalumab with gemcitabine and cisplatin for BTC, improving survival outcomes. Liquid biopsies and precision medicine are also transforming early detection and treatment options.

October saw FDA approvals for Pfizer's Hympavzi, Astellas' Vyloy, and Iterum's Orlynvah, targeting hemophilia, gastric cancers, and UTIs respectively. November anticipates FDA decisions on drugs like Journey Medical's DFD-29 for rosacea, Merus' Zenocutuzumab for NRG1+ cancers, and PTC Therapeutics' Upstaza for AADC deficiency, among others, highlighting significant advancements in treatment options.