ZN-A-1041 (HER2 Kinase Inhibitor)

May 19, 2026 — F. Hoffmann‑La Roche Ltd (Roche) 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 emphasis on breast cancer.

Key breast cancer updates center on giredestrant, an investigational oral selective estrogen receptor degrader (SERD) for ER‑positive/HER2‑negative disease. Roche highlighted: (1) lidERA phase III adjuvant results previously reported (Dec 2025) showing a 30% reduction in risk of invasive disease recurrence or death versus standard endocrine therapy, with new ASCO analyses planned by menopausal status; Roche states lidERA data have been submitted to the FDA. (2) persevERA phase III first-line metastatic/locally advanced study will present primary results; Roche notes it did not meet the primary endpoint but showed a numerical improvement in progression-free survival with giredestrant + palbociclib. (3) evERA post-progression analyses for giredestrant + everolimus; Roche notes the FDA has accepted a New Drug Application based on evERA.

Roche will also present early phase Ic expansion data on ZN‑A‑1041 (RG6596), a blood–brain barrier–permeable HER2 TKI, in combinations for pre-treated HER2+ metastatic breast cancer, targeting brain metastases. Additional ASCO highlights include divarasib + pembrolizumab in KRAS G12C+ NSCLC (Krascendo‑170) informing phase III Krascendo 2, and updated phase III SUNMO data for Lunsumio + Polivy versus R‑GemOx in transplant-ineligible relapsed/refractory DLBCL, positioning a potential fixed-duration, chemotherapy-free regimen.