1L HER2+ GEA ORR and mDoR

Secondary endpoints in 1L HER2+ GEA: ORR and mDoR in PD-L1 all comers

Deep and durable responses observed with TEVIMBRA + zanidatamab-hrii + chemotherapy, across the range of HER2 positivity1,2*

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TEVIMBRA + zanidatamab-hrii + chemotherapy demonstrated ~1 year longer median duration of response vs trastuzumab + chemotherapy.

  • TEVIMBRA + zanidatamab-hrii + chemotherapy (n=302) improved overall response rate by 70.7% (complete response: 19.6%; partial response: 51.5%) and increased median duration of response to 20.7 months (n=198)
  • Zanidatamab-hrii + chemotherapy (n=304) improved overall response rate by 69.6% (complete response: 17.1%; partial response: 52.5%) and increased median duration of response to 14.3 months (n=195)
  • Trastuzumab + chemotherapy (n=308) improved overall response rate by 65.7% (complete response: 11.0%; partial response: 54.8%) and increased median duration of response to 8.3 months (n=186)
Secondary endpoints:
 
TEVIMBRA + zanidatamab-hrii + chemotherapy demonstrated an overall response rate of 67% (95% CI: 61-72) vs 63% (95% CI: 57-68) with trastuzumab + chemotherapy. Additionally, TEVIMBRA + zanidatamab-hrii + chemotherapy extended duration of response to 18.9 months (95% CI: 12.1-37.7) vs 8.3 months (95% CI: 6.8-10.1) with trastuzumab + chemotherapy.
 
The median duration of response with TEVIMBRA + zanidatamab-hrii + chemotherapy was more than 10 months longer than the responses with trastuzumab + chemotherapy.

Overall response rates:

  • 70.7% with TEVIMBRA + zanidatamab + chemotherapy (n=302); CR: 19.6%, PR: 51.1%
  • 69.6% with zanidatamab + chemotherapy (n=304); CR: 17.1%, PR: 52.5%
  • 65.7% with trastuzumab + chemotherapy (n=308); CR: 11.0%, PR: 54.8%

Frequently Asked Questions

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TEVIMBRA + zanidatamab-hrii + chemotherapy demonstrated an overall response rate* of 67% (95% CI: 61-72) vs 63% (95% CI: 57-68) with trastuzumab + chemotherapy in patients with 1L HER2+ advanced GEA. Additionally, TEVIMBRA + zanidatamab-hrii + chemotherapy extended duration of response* to 18.9 months (95% CI: 12.1-37.7) vs 8.3 months (95% CI: 6.8-10.1) with trastuzumab + chemotherapy.1

 

*ORR and DoR were secondary endpoints in this trial.1

View safety in 1L HER2+ GEA

*HER2 positivity defined as IHC 3+ or IHC 2+/ISH+.

†95% CI: 61-72.

‡95% CI: 12.1-37.7.

§95% CI: 57-68.

II 95% CI: 6.8-10.1.

1L, first line; CR, complete response; GEA, gastroesophageal adenocarcinoma; HER2, human epidermal growth factor receptor 2; mDoR, median duration of response; ORR, overall response rate; PD-L1, programmed death ligand 1; PR, partial response.

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

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