Amgen Advances Blinatumomab Franchise With New Phase 3 Subcutaneous Trial

Amgen Inc (AMGN) announced an update on their ongoing clinical study.

Amgen Inc. (AMGN) has filed an update for a new Phase 3 trial titled “A Phase 3, Open-label, Randomized, Controlled Trial of Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukaemia.” The study aims to show that a simpler, under‑the‑skin form of blinatumomab works as well as the current continuous IV infusion in extending survival.

The trial tests two forms of the same cancer drug, blinatumomab, alongside standard HyperCVAD chemotherapy. One group receives blinatumomab as a continuous IV drip in the hospital, while the other gets subcutaneous shots. The goal is to keep treatment power while making care easier and more convenient for patients in remission.

The study is interventional and Phase 3, with participants randomly split between IV and subcutaneous treatment arms. It is open label, meaning doctors and patients know which route is used, and the main intent is treatment, focused on survival outcomes in adults with this aggressive leukemia.

The trial was first submitted on Oct. 29, 2025, marking the formal start of regulatory tracking for this program. The latest update was filed on Mar. 2, 2026, which signals active planning and setup, though the trial is still listed as “not yet recruiting,” so patient enrollment has not begun.

For investors, this update reinforces Amgen’s push to defend and extend the blinatumomab franchise in acute lymphoblastic leukemia. A successful switch to subcutaneous delivery could support pricing power, longer product life, and easier uptake versus emerging competitors, though clinical and execution risks remain high at this early stage.

The study remains active in setup with updated details available on the ClinicalTrials.gov portal, where investors can track future changes as the program advances.

To learn more about AMGN’s potential, visit the Amgen Inc drug pipeline page.