Jazz Pharmaceuticals (JAZZ) RBC Capital Markets Global Healthcare Conference 2026 summary

Zanidatamab program and clinical data

• Zanidatamab is a bispecific biparatopic antibody targeting two validated HER2 epitopes, causing receptor clustering and unique immune activation, including complement fixation and recruitment of NK cells and macrophages.

• Demonstrates superior activity to Herceptin and Perjeta in preclinical and clinical settings, with notable efficacy in biliary tract and breast cancer patients who progressed on prior HER2 therapies.

• Shows synergy with PD-1/PD-L1 inhibitors, especially in PD-L1 negative gastric cancer, potentially eliminating the need for PD-L1 testing and expanding patient eligibility.

• HERIZON-GEA-01 study revealed unprecedented survival benefits, with more than two years median OS in both arms and strong PFS, generating significant enthusiasm among oncologists.

• Regulatory pathway is supported by robust PFS and OS data, with a PDUFA date set for August 25 and priority review status granted by the FDA.

Commercial and launch readiness

• Commercial teams are prepared for launch, leveraging overlap in treating physicians between biliary tract and gastric indications.

• Label updates are anticipated following mid-year doublet data, with strong triplet OS results already supporting differentiation in the market.

• Medical science liaisons are actively educating oncologists, focusing on data dissemination and publication to support uptake.

Expansion into additional indications

• Zanidatamab is being explored in later-line breast cancer (303 trial), with rationale based on persistent HER2-driven disease and unmet need post-ADC therapy.

• Partnerships with Boehringer and Iambic are evaluating combinations with novel HER2 TKIs in breast cancer, aiming to enhance efficacy and immune response.

• Trials are planned or ongoing in first-line biliary tract cancer, neoadjuvant/adjuvant gastric cancer, colorectal cancer, and non-small cell lung cancer, targeting HER2 overexpression.