A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1)

Summary

Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50.

Timeline

Start

2020-08-18

Primary completion

2022-05-31

Completion

2022-05-31

Outcome

Missed primary endpoint

paper 20 (47%) of 43 patients had a pathological complete response by central assessment (lower bound of the one-sided 95% CI 33%), thus the null hypothesis (40% pathological complete response) could not be rejected (p=0·22). PMID 40318646 ↗

Publications

• Kuemmel S, Graeser M, Schmid P, Reinisch M, Feuerhake F, Volk V, Armeanu-Ebinger S, Schutz L, Kelemen O, Schroeder C, Ossowski S, Jozwiak K, Kostara A, Scheffen I, Ludtke-Heckenkamp K, Hilpert F, Kentsch A, Ziske C, Depenbusch R, Braun M, Blohmer JU, Zu Eulenburg C, Christgen M, Bartels S, Kreipe HH, Wuerstlein R, Biehl C, Pelz E, Hartkopf A, Harbeck N, Gluz O; West German Study Group investigators. Chemotherapy-free neoadjuvant pembrolizumab combined with trastuzumab and pertuzumab in HER2-enriched early breast cancer (WSG-KEYRICHED-1): a single-arm, phase 2 trial. Lancet Oncol. 2025 May;26(5):629-640. doi: 10.1016/S1470-2045(25)00097-X.

Drugs

Indications