Aktis Oncology Expands Phase 1b Trials for AKY-2519, Targeting NSCLC…

Event summary

Aktis Oncology has initiated a second Phase 1b clinical trial (BActinium-2) for AKY-2519, targeting non-small cell lung cancer (NSCLC) and other B7-H3 expressing tumors.
The BActinium-1 trial for metastatic castration-resistant prostate cancer (mCRPC) is already enrolling, with preliminary data expected in 2027.
First-in-human clinical imaging and dosimetry data presented at ASCO in May 2026 showed robust tumor uptake and limited normal tissue exposure for AKY-2519.
Aktis is also conducting a Phase 1b NECTINIUM-2 trial for AKY-1189, targeting Nectin-4 expressing tumors, with preliminary data expected in Q1 2027.

The big picture

Aktis Oncology is strategically expanding its clinical trials for AKY-2519, aiming to address a broad spectrum of solid tumors. The company's proprietary miniprotein radioconjugate platform is designed to maximize anticancer activity while minimizing exposure to normal tissues, positioning it as a potential leader in targeted radiopharmaceuticals. The initiation of multiple Phase 1b trials underscores Aktis' commitment to developing differentiated therapeutic options for large patient populations.

What we're watching

Clinical Efficacy: How the preliminary data from the BActinium-1 and BActinium-2 trials will shape the future development and potential approval of AKY-2519.
Market Differentiation: Whether AKY-2519 can establish a differentiated profile compared to existing radiopharmaceuticals, leveraging its wide therapeutic window.
Pipeline Progression: The pace at which Aktis can advance its pipeline, particularly with the ongoing NECTINIUM-2 trial for AKY-1189, and the potential for multi-indication approvals.