CLAIM #6225 · Amgen Inc (AMGN) · 2025Q2 earnings call · Aug 5, 2025 · due Dec 31, 2025
“we remain on track to initiate a potentially registration-enabling study in both adults and adolescents later this year.”
Jay Bradner · EVP R&D
In context
“se I studies evaluating IMDELLTRA in combination with novel agents to potentially further improve patient outcomes. We are also focused on enhancing patient convenience by evaluating less frequent dosing and subcutaneous delivery. We continue to investigate our CD19- directed BiTE medicine, BLINCYTO in earlier treatment settings while also advancing a subcutaneous formulation. In June, Phase Ib and II subcutaneous blinatumomab data were presented and simultaneously published in the Lancet Hematology, demonstrating 89% to 92% remission rates and manageable safety in adults with relapsed/refractory CD19-positive Philadelphia chromosome-negative B- cell precursor acute lymphoblastic leukemia. Subcutaneous blinatumomab has the potential to improve both the patient experience and efficacy, and we remain on track to initiate a potentially registration-enabling study in both adults and adolescents later this year. Our first-in-class STEAP1 CD3 bispecific T cell engager xaluritamig is advancing in Phase III clinical development. We are also exploring xaluritamig in combination therapy and in earlier stages of prostate cancer with multiple Phase Ib studies ongoing. Collectively, IMDELLTRA, BLINCYTO and xaluritamig exemplify the significant growth potential of our robust bispecific T cell engager platform and reinforce our commitment to bringing groundbreaking treatments to cancer patients worldwide. Beyond our T cell engagers, in June, we announced data from the Phase III FORTITUDE-101 study of first-line bemarituzumab, our first-in-class fibroblast growth factor receptor 2b directed monoclonal antibody. Bemarituzumab plus mFOLFOX6 chemotherapy met its primary endpoint of overall survival at a prespe”
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SEC filings for AMGN ↗ · Claim quote is verbatim from the 2025Q2 earnings call.