Jazz Pharmaceuticals is presenting new data on zanidatamab and Zepzelca (lurbinectedin) at the European Society for Medical Oncology (ESMO) Congress 2024, highlighting advancements in solid tumor oncology research.
Zanidatamab for HER2-Positive mGEA
Updated data from an ongoing Phase 2 trial of zanidatamab, a dual HER2-targeted bispecific antibody, in combination with chemotherapy for the first-line treatment of HER2-positive metastatic gastroesophageal adenocarcinoma (mGEA) will be presented. This includes longer follow-up data and overall survival findings. Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals, stated that the company looks forward to advancing the clinical development program for zanidatamab in GEA, including the Phase 3 clinical trial expected to read out in the second quarter of 2025, which could support global regulatory submissions.
Zanidatamab for HER2-Positive mCRC
Additional data from a Phase 2 study evaluating zanidatamab in combination with chemotherapy and bevacizumab as a first-line treatment in HER2-positive metastatic colorectal cancer (mCRC) will be presented as a mini-oral presentation. The data demonstrates encouraging antitumor activity.
Lurbinectedin and Irinotecan in Relapsed SCLC
Data on Zepzelca (lurbinectedin) will also be presented, including findings from a Phase 2 trial evaluating the safety and efficacy of lurbinectedin and irinotecan in relapsed small cell lung cancer (SCLC) patients, including those with a chemotherapy-free interval (CTFI) of 30-90 days. These findings support the rationale for this combination in the ongoing LAGOON confirmatory trial.
Regulatory Designations for Zanidatamab
The U.S. Food and Drug Administration (FDA) has granted priority review for the Biologics License Application (BLA) for zanidatamab for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC) with a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2024. The FDA has also granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations: one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA and the European Medicines Agency for the treatment of BTC and gastric cancer. Zanidatamab was also granted Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) in China.
