The BioPharm Brief: HER2 Approvals, Deals, and Survival Data

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. Here’s what’s making headlines today.

First, the European Commission has approved Enhertu in combination with pertuzumab as a first-line treatment for adults with HER2-positive metastatic or unresectable breast cancer. The approval is based on Phase 3 DESTINY-Breast09 data, which showed the combination reduced the risk of disease progression or death compared with the current standard of care. The regimen gives patients a new first-line option in a treatment setting that has seen limited change in more than a decade.

In another major oncology development, Roche has licensed global rights to SIM0660, an investigational bispecific antibody from Simcere Zaiming, in a deal worth up to $1.53 billion. Roche will receive exclusive rights outside Greater China to the DLL3-targeted therapy, which is being developed for small cell lung cancer and other solid tumors. Simcere will receive $75 million upfront, with additional development, regulatory, and commercial milestone payments, along with tiered royalties.

And BeOne Medicines has reported positive second interim overall survival data for Ziihera in the Phase 3 RATIONALE 305 study. In patients with previously untreated HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma, the Ziihera-containing regimen demonstrated a statistically significant overall survival benefit compared with chemotherapy plus trastuzumab. The findings add to the clinical data supporting Ziihera in first-line HER2-positive gastroesophageal cancer.

That’s The BioPharm Brief for today. For analysis and expert insights, please visit BioPharmInternational.com.

Key takeaways:

• The EU approved Enhertu plus pertuzumab for first-line HER2-positive metastatic breast cancer.
• Roche licensed global rights to Simcere’s investigational SIM0660 in a deal worth up to $1.53 billion.
• BeOne reported positive overall survival data for Ziihera in first-line HER2-positive gastroesophageal cancer.