The Phase III TOWER study of Amgen's bispecific CD19-directed CD3 T cell engager (BiTE) Blincyto (blinatumomab) has been halted early after a pre-specified analysis showed that it has already met the primary overall survival endpoint in Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
The Phase III TOWER study of Amgen's bispecific CD19-directed CD3 T cell engager (BiTE) Blincyto (blinatumomab) has been halted early after a pre-specified analysis showed that it has already met the primary overall survival endpoint in Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
The randomized, open-label TOWER study was evaluating its efficacy versus standard of care (SOC) in adult patients, and was required...
Deal Snapshot: Bayer will take over development of the asset once Kumquat completes a Phase Ia clinical trial, but the biotech firm may opt in to share US profits and losses.
The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.
The US FDA approved Hernexeos for previously treated HER2-mutant NSCLC, making it the first oral option in a setting where drugs like AstraZeneca/Daiichi Sankyo’s Enhertu dominate.
The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.
The US FDA approved Hernexeos for previously treated HER2-mutant NSCLC, making it the first oral option in a setting where drugs like AstraZeneca/Daiichi Sankyo’s Enhertu dominate.
Novartis has strengthened its argument that ianalumab, its BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate, has PIP potential with successful topline results in two Phase III Sjögren’s syndrome trials, after recently dropping the product in hidradenitis suppurativa.
The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.
