Amgen Advances Leukemia Strategy With Completed Blinatumomab Study in Japan

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

Study Overview

Amgen has completed a Phase 1b study titled “A Phase 1b Open-label Study to Investigate Safety, Tolerability and Pharmacokinetics of Intravenous Blinatumomab in Japanese Adult Subjects With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL).” The main goal was to see how safe and tolerable blinatumomab is in newly diagnosed Japanese adults with this aggressive blood cancer, and to gather early drug-activity data that could support broader use and future trials in frontline treatment.

Intervention/Treatment

The study tested blinatumomab, an anti-cancer drug delivered by intravenous (IV) infusion. It is designed to help the immune system target and kill leukemia cells in the blood and bone marrow. In this trial, all participants received blinatumomab to assess how well patients could handle the treatment and how the drug behaved in the body.

Study Design

This was an interventional, single-arm trial, meaning all participants were assigned to the same treatment group with no randomization to different therapies. The model was a single-group assignment and the study was open-label, so both doctors and patients knew they were receiving blinatumomab. The primary purpose was treatment-focused, aiming to understand safety and dosing patterns rather than to compare against a standard therapy.

Study Timeline

The study was first submitted on 17 October 2024, marking the formal start of public registration and signaling early-stage development in this population. The overall status is now listed as completed, indicating that treatment and follow-up planned for this phase have finished. While the primary completion and final completion dates are not listed in detail, the most recent update to the record was submitted on 7 January 2026, showing that Amgen has refreshed the trial information and likely locked in core data for further analysis.

Market Implications

For investors, this update reinforces Amgen’s strategy to expand blinatumomab into earlier treatment settings and specific regional markets such as Japan. Positive safety and tolerability in newly diagnosed adults would support potential label expansions over time, deepen usage in acute lymphoblastic leukemia, and strengthen Amgen’s oncology portfolio. While this is an early-phase, single-arm study and not yet a revenue driver by itself, clean safety data in a front-line population could improve confidence in longer-term value creation, especially when combined with larger, ongoing or future trials. Competitors in hematologic cancers, including major players in CD19-targeted therapies and CAR-T, are also working to move earlier in the treatment line; any favorable outcomes for blinatumomab could help Amgen defend and extend share in this niche. Overall, the completed status and fresh update may offer a modest positive signal for sentiment around Amgen’s leukemia franchise, though investors should wait for full data disclosures to gauge commercial impact.

The study has been completed and recently updated, with further details available on the ClinicalTrials portal.

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