Zymeworks announces positive Phase 3 results for Ziihera in first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma.
Results show significant improvement in PFS and OS with Ziihera plus chemotherapy.
Impacts indicate Ziihera's potential as the HER2-targeted agent of choice in this indication.
Significant Improvements in PFS
Ziihera plus chemotherapy showed statistically significant enhancements in progression-free survival compared to trastuzumab and chemotherapy.
Positive OS Results
Ziihera plus Tevimbra and chemotherapy demonstrated improvements in overall survival compared to standard treatment options.
Broad OS Benefit
Both PD-L1 positive and negative subgroups showed benefits in overall survival with Ziihera combinations.
Secondary Endpoints Success
Ziihera combinations displayed better objective response rates and duration of response supporting primary efficacy outcomes.
Favorable Safety Profile
Safety profile of Ziihera in combination with chemotherapy showed no new safety signals supporting its benefit-risk profile.
- The results mark a turning point for HER2+ gastroesophageal adenocarcinoma patients with limited treatment options and poor outcomes.
- Ziihera's success in the trial signals a significant advancement in care for this challenging indication.
- Jazz Pharmaceuticals plans for Ziihera to be a first-line treatment option with potential global impact.
- The data from HERIZON-GEA-01 trial highlight the strength of Zymeworks' platform and partnership strategy.
The Phase 3 results for Ziihera present a promising shift in the treatment landscape for HER2-positive gastroesophageal adenocarcinoma, offering hope for improved outcomes and establishing a new standard of care. The collaboration between Zymeworks, Jazz, and BeOne shows a commitment to advancing therapies for difficult-to-treat diseases.