RG6596/ZN-A-1041 (HER2 Kinase Inhibitor)

2026-05-19 — Genentech (Roche Group) announced it will present new data at the 2026 ASCO Annual Meeting (May 29–June 2, Chicago) across nine approved and investigational oncology medicines spanning 15+ indications, with a major focus on giredestrant (oral SERD) in ER-positive/HER2-negative breast cancer.

Key breast cancer updates include: (1) lidERA (Phase III, early breast cancer): follow-up analyses by menopausal status; Genentech cites prior December 2025 results showing a 30% reduction in risk of invasive disease recurrence or death and notes the lidERA data have been submitted to the U.S. FDA. (2) persevERA (Phase III, 1L metastatic/locally advanced): primary results for giredestrant + palbociclib; the study did not meet its primary endpoint, but showed a numerical improvement in progression-free survival in an endocrine-sensitive population. (3) evERA (Phase III): post-progression analyses of giredestrant + everolimus; Genentech notes the FDA has accepted an NDA based on positive evERA data.

Additional ASCO highlights include early Phase Ic expansion data for ZN-A-1041 (RG6596) aimed at brain-penetrant HER2 therapy, and updates for divarasib in KRAS G12C+ NSCLC and Lunsumio + Polivy in relapsed/refractory DLBCL, supporting Genentech’s clinical and regulatory momentum in oncology.