1L HER2+ GEA OS and PFS results
Dual primary endpoint in 1L HER2+ GEA: OS in PD-L1 all comers
First regimen to surpass 2 years mOS in a pivotal phase 3 trial for 1L HER2+ unresectable locally advanced or metastatic GEA, regardless of PD-L1 status1-4
26.4 months median overall survival with TEVIMBRA + zanidatamab-hrii + chemotherapy vs 19.2 months with trastuzumab + chemotherapy, across the range of HER2 positivity1,2*
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TEVIMBRA + zanidatamab-hrii + chemotherapy (n=302) demonstrated 26.4 months median overall survival (95% CI: 21.5-30.3) vs 19.2 months (95% CI: 16.8-21.8) with trastuzumab + chemotherapy (n=308) [unprecedented hazard ratio: 0.72; 95% CI: 0.57-0.90; P=0.004].
The zanidatamab-hrii + chemotherapy arm (not pictured) did not achieve statistical significance for overall survival vs trastuzumab + chemotherapy at the first interim analysis2
Estimated using the Kaplan-Meier method.
The approved 1L HER2+ GEA indication for the zanidatamab-hrii + chemotherapy regimen is limited to patients with HER2 IHC 3+ expression.5
NCCN
preferred
1l her2+
gea
PD-L1 all comers
Dual primary endpoint in 1L HER2+ GEA: PFS in PD-L1 all comers
New milestone established in progression-free survival1,6
2.4x greater PFS rate at 2 years with TEVIMBRA + zanidatamab-hrii + chemotherapy vs trastuzumab + chemotherapy, across the range of HER2 positivity*
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At 24 months, the progression-free survival rate was 38.2% (95% CI: 31.4-45.0) with TEVIMBRA + zanidatamab-hrii + chemotherapy vs 15.6% (95% CI: 10.1-22.1) with trastuzumab + chemotherapy.
12.4 months mPFS (95% CI: 9.8-18.5) with TEVIMBRA + zanidatamab-hrii + chemotherapy (n=302) vs 8.2 months mPFS (95% CI: 7.0-8.9) with trastuzumab + chemotherapy (n=308); unprecedented HR: 0.63 (95% CI: 0.51-0.78; P<0.0001).
Estimated using the Kaplan-Meier method.
Subgroup analysis of OS in 1L HER2+ GEA
A consistent trend in overall survival favored TEVIMBRA + zanidatamab-hrii + chemotherapy across multiple key subgroups7
OS results generally favored the TEVIMBRA-containing regimen across multiple key subgroups and regardless of PD-L1 status7
Limitation: Subgroup analysis was not statistically powered and was descriptive only. No definitive conclusions can be drawn.
Frequently Asked Questions
What was the overall survival with TEVIMBRA in patients with 1L HER2+ advanced GEA?
*HER2 positivity defined as IHC 3+ or IHC 2+/ISH+.1
What was the progression-free survival with TEVIMBRA in patients with 1L HER2+ advanced GEA?
There was a 2.4x greater PFS rate at 2 years with TEVIMBRA + zanidatamab-hrii + chemotherapy vs trastuzumab + chemotherapy in patients with 1L HER2+ advanced GEA across the range of HER2 positivity. Median PFS was 12.4 months with TEVIMBRA + zanidatamab-hrii + chemotherapy vs 8.1 months with trastuzumab + chemotherapy, with an unprecedented hazard ratio of 0.63 (95% CI: 0.51-0.78; P<0.001).1,6
What were the results for TEVIMBRA across key subgroups in 1L HER2+ advanced GEA?
In a subgroup analysis, TEVIMBRA + zanidatamab-hrii + chemotherapy reported a consistent trend in overall survival vs trastuzumab + chemotherapy. OS results generally favored the TEVIMBRA-containing regimen across multiple key subgroups and regardless of PD-L1 status.7
Limitation: Subgroup analysis was not statistically powered and was descriptive only. No definitive conclusions can be drawn.
*HER2 positivity defined as IHC 3+ or IHC 2+/ISH+.1
1L, first line; ECOG, Eastern Cooperative Oncology Group; GEA, gastroesophageal adenocarcinoma; GEJ, gastroesophageal junction; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ISH, in situ hybridization; mOS, median overall survival, mPFS, median progression-free survival, OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; PS, performance status.
References: 1. TEVIMBRA. Prescribing Information. BeOne Medicines USA, Inc.; 2026. 2. Shitara K, Elimova E, Liu T, et al. N Engl J Med. 2026;394(20):2002-2014. doi:10.1056/NEJMoa2517729 3. Herceptin. Prescribing Information. Genentech, Inc.; 2026. 4. Keytruda. Prescribing Information. Merck & Co. Inc.; 2026. 5. Ziihera Prescribing Information. Jazz Pharmaceuticals, Inc.; 2026. 6. Elimova E, Rha SY, Shitara K, et al. Presented at: ASCO Gastrointestinal Cancers Symposium; 2026; San Francisco, CA. 7. Shitara K, Elimova E, Liu T, et al. N Engl J Med. Supplementary appendix. 2026;394(20):2002-2014. doi:10.1056/NEJMoa2517729