On May 25, 2023 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will host a webcast to review the zanidatamab biliary tract cancers (BTC) data being featured in an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 2, 2023 (Press release, Jazz Pharmaceuticals, MAY 25, 2023, View Source [SID1234632111]). Previously disclosed positive top-line findings from the pivotal Phase 2b trial of zanidatamab as a monotherapy demonstrated a confirmed objective response rate (cORR) of 41.3% and median duration of response of 12.9 months in patients with previously treated HER2-positive BTC. The ASCO (Free ASCO Whitepaper) presentation will provide additional safety and efficacy data.
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Shubham Pant, M.D., MBBS, a professor in the Department of Gastrointestinal Medical Oncology with a joint appointment in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, will provide an overview of new data from the trial and Jazz senior management will discuss the development and commercialization of zanidatamab.
"There are currently no HER2-targeted therapies approved for patients with BTC; disease control with front-line therapy is modest and patients need treatment options after progression.i,ii Zanidatamab, a novel HER2-targeted bispecific antibody, is one of the most exciting and near-term programs in our pipeline, and the presentation at ASCO (Free ASCO Whitepaper) demonstrates its compelling anti-tumor effects in HER2-positive BTC. We are committed to advancing this program as rapidly as possible to potentially transform the lives of patients in critical need," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "With our impressive portfolio of oncology therapeutics approaching $1 billion in annual revenue, we remain focused on further enhancing our capabilities, advancing our pipeline and delivering treatments for difficult-to-treat cancers."
Webcast Details
The webcast will start on June 2, 2023, at 6:45 p.m. CT / 7:45 p.m. ET / 12:45 a.m. IST (June 3). Interested parties may register for the webcast in advance here or via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast.
A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.
About Zanidatamab
Zanidatamab is an investigational bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks, along with collaborators Jazz and BeiGene, Ltd. (BeiGene), are developing zanidatamab in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2.
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancers (BTC), and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of gastric cancer. Zanidatamab was also granted Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) in China.