Jazz Pharmaceuticals to Present Solid Tumor Oncology Advancements at ESMO 2024

Jazz Pharmaceuticals has announced its intention to present five abstracts at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona. The presentations will include new and updated data from ongoing trials involving zanidatamab and Zepzelca® (lurbinectedin).

One of the key highlights is the new data from a Phase 2 trial of zanidatamab, an investigational dual HER2-targeted bispecific antibody, combined with chemotherapy for the first-line treatment of HER2-positive metastatic gastroesophageal adenocarcinoma (mGEA). This data will include longer follow-up and overall survival findings. Additionally, data from another Phase 2 study will be revealed, showing the effects of zanidatamab combined with chemotherapy and bevacizumab as a first-line treatment for HER2-positive metastatic colorectal cancer. This study has demonstrated promising antitumor activity and will be discussed in a mini-oral presentation at the congress.

Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals, expressed enthusiasm about presenting the new and mature data from their oncology solid tumor clinical development program at the ESMO Congress. He highlighted the importance of advancing the clinical development program for zanidatamab in gastroesophageal adenocarcinoma, with a Phase 3 clinical trial expected to yield results by the second quarter of 2025, which could potentially support global regulatory submissions.

The congress will also feature data on Zepzelca. Specifically, findings from a Phase 2 trial will be presented, which evaluated the safety and efficacy of lurbinectedin combined with irinotecan for patients with relapsed small cell lung cancer (SCLC) who have a Chemotherapy-Free Interval (CTFI) of 30-90 days. These patients typically have a poor prognosis. The findings lend support to the rationale for this combination in the ongoing LAGOON confirmatory trial.

Zanidatamab is a HER2-targeted bispecific antibody designed to bind simultaneously to two distinct sites on HER2, which is termed biparatopic binding. This design enhances its binding and results in multiple mechanisms of action, including HER2 and HER3 signal inhibition, removal of HER2 protein from the cell surface, and enhanced immune functions such as complement-dependent cytotoxicity (CDC), leading to significant antitumor activity. This investigational drug is being developed through various clinical trials for patients with solid tumors expressing HER2. Jazz Pharmaceuticals, in collaboration with BeiGene, Ltd., is developing zanidatamab under licenses from Zymeworks, which initially developed the molecule.

In the U.S., zanidatamab has received priority review from the FDA for its Biologics License Application (BLA) for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC), with a target action date of November 29, 2024. The FDA has also granted Breakthrough Therapy designation for zanidatamab in previously treated HER2 gene-amplified BTC and two Fast Track designations: one for use as a single agent for refractory BTC and another in combination with standard chemotherapy for first-line gastroesophageal adenocarcinoma. Furthermore, zanidatamab has received Orphan Drug designations from both the FDA and the European Medicines Agency for various indications, including BTC and gastric cancer. In China, the Center for Drug Evaluation (CDE) has also granted zanidatamab Breakthrough Therapy designation.

Meanwhile, Zepzelca, an alkylating drug approved under accelerated approval by the FDA in June 2020, is used to treat adult patients with metastatic SCLC who have experienced disease progression following platinum-based chemotherapy. The approval was based on the overall response rate and duration of response observed in clinical studies. In December 2021, Jazz and PharmaMar initiated the LAGOON Phase 3 clinical trial to confirm the efficacy of Zepzelca.