New data from the phase 3 Herizon-Gea-01 clinical trial signals a potential paradigm shift in the first-line treatment of HER2-positive gastroesophageal adenocarcinoma (GEA). The study suggests that the investigational agent Ziihera, developed by Jazz Pharmaceuticals, outperforms the current standard of care, Herceptin.
Significant survival milestones The trial evaluated different combination regimens in treatment-naive patients:
-
Triplet Regimen (Ziihera + Chemo + Tevimbra): Reduced the risk of disease progression or death by 37%. The median overall survival (OS) reached 26.4 months—the longest duration ever reported in a phase 3 GEA trial.
-
Doublet Regimen (Ziihera + Chemo): Showed a 35% improvement in progression-free survival (PFS) compared to the control group receiving Herceptin plus chemotherapy.
Breakthroughs in challenging patient subgroups A key highlight of the study is that Ziihera’s efficacy appeared consistent regardless of the patient’s PD-L1 expression status. In the PD-L1-negative subgroup—traditionally less responsive to standard PD-1 inhibitors—the combination showed a substantial trend toward reducing the risk of death. Oncology experts suggest that Ziihera’s unique dual-targeting mechanism may enhance immune activation, potentially turning “cold” tumors “hot” and expanding the utility of immunotherapy.
Despite a higher incidence of treatment-related adverse events in the triplet arm, researchers believe the unprecedented median duration of response (20.7 months) and significant survival gains will quickly influence clinical practice in oncology centers worldwide.
Source: https://www.fiercepharma.com/pharma/jazz-touts-ziihera-new-her2-agent-choice-stomach-cancer