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Jazz Pharmaceuticals to Present Pivotal Phase 3 Results of Ziihera at ASCO GI Symposium 2026

In an eagerly anticipated announcement, Jazz Pharmaceuticals plc, trading under the Nasdaq symbol JAZZ, has confirmed that two significant abstracts pertaining to Ziihera® (zanidatamab-hrii) will be unveiled at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). This important event is scheduled to take place from January 8 to January 10, 2026, in San Francisco. The upcoming presentation will showcase pivotal findings from the Phase 3 HERIZON-GEA-01 trial, focusing on patients with first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA).

Late-Breaking Presentation Highlights

The HERIZON-GEA-01 trial represents a crucial advancement in treating aggressive forms of GEA, a type of cancer linked with poor prognoses and significant patient morbidity. The trial investigates the efficacy of Ziihera in combination with chemotherapy, with or without the PD-1 inhibitor Tevimbra® (tislelizumab), to assess whether it can surpass the current standard of care in first-line treatments. Notably, results from this trial will be presented as a late-breaking abstract, underscoring the significance of the findings within the oncology community.

Dr. Rob Iannone, M.D., M.S.C.E., who serves as the executive vice president and chief medical officer of Jazz Pharmaceuticals, expressed excitement over presenting the impactful results at ASCO GI. Advanced HER2+ GEA has long been associated with limited treatment advancements, and the forthcoming results from this trial could potentially redefine the existing treatment landscape.

Promising Results and Future Perspectives

Initial reports from the HERIZON-GEA-01 trial have indicated highly significant and clinically meaningful improvements in progression-free survival (PFS) when Ziihera is combined with chemotherapy compared to the control arm using trastuzumab plus chemotherapy. Additionally, the combination of Ziihera and tislelizumab has shown promising outcomes in overall survival (OS) metrics, reinforcing Ziihera's position as a leading candidate in HER2-targeted therapies.

Meanwhile, Jazz Pharmaceuticals will also present new insights from a post-hoc OS analysis conducted as part of the HERIZON-BTC-01 Phase 2b trial, focusing on patients with previously treated HER2-positive biliary tract cancer (BTC). This research lends further credence to the therapeutic potential of Ziihera across various malignancies associated with HER2.

Event Details and Further Information

For those interested, Jazz Pharmaceuticals is set to host an investor webcast on January 9, 2026, at 6:30 a.m. PT/9:30 a.m. ET. During this session, key executives will discuss the data presented at ASCO GI, including insights from Dr. Geoffrey Ku, an esteemed physician associated with the Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center.

Participants are encouraged to register early to ensure seamless access to the webcast, which will subsequently be available for replay. Specifics regarding the presentations will be published online, including the abstract numbers and a guide to the session schedules for ASCO GI.

Ziihera, as a bispecific HER2-directed antibody, has showcased a unique ability to target two extracellular sites on the HER2 receptor, thereby inhibiting tumor growth effectively. Its significance in treating advanced HER2-positive GEA and BTC not only emphasizes its approval by the U.S. FDA but also positions it for expansive applicability in solid tumors that express HER2.

Conclusion

The upcoming presentation at ASCO GI signifies a critical leap forward in the fight against HER2-positive gastroesophageal cancers. By providing new data on the efficacy of Ziihera, Jazz Pharmaceuticals is contributing to the collective effort to improve outcomes for patients afflicted by these challenging forms of cancer. Stakeholders eagerly await the insights that will emerge from this pivotal symposium, highlighting the importance of innovative treatments in oncology management.