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BioNTech SE and DualityBiologics announced that their global Phase 3 clinical trial, DYNASTY-Breast02, evaluating trastuzumab pamirtecan in patients with HR+/HER2-low metastatic breast cancer, has met its primary endpoint.
BioNTech and DualityBio announced that their Phase 3 DYNASTY-Breast02 trial met its primary endpoint, showing statistically significant but moderate improvement in progression-free survival for Trastuzumab Pamirtecan versus chemotherapy in HR+/HER2-low metastatic breast cancer patients. However, the trial observed a higher rate of interstitial lung disease than previous studies, and the companies concluded the potential patient benefit appears limited given currently available treatment options.
BioNTech and DualityBio announced that their Phase 3 DYNASTY-Breast02 trial met its primary endpoint, showing statistically significant but modest improvement in progression-free survival with trastuzumab pamirtecan versus chemotherapy in HR+/HER2-low metastatic breast cancer patients. However, a higher rate of interstitial lung disease was observed, and the companies noted limited potential benefit in the current treatment landscape.
BioNTech SE and Bristol Myers Squibb announced initial data from the global Phase 2 ROSETTA Lung-107 study, showing an objective response rate of 36.7% for the bispecific immunomodulator Pumitamig in combination with docetaxel.
ImmunityBio has completed the database lock for Cohort A of its QUILT-2.005 registrational trial, which evaluates ANKTIVA in combination with BCG for BCG-naïve non-muscle invasive bladder cancer.
Database lock completed for Cohort A of QUILT-2.005 (NCT02138734), a randomized, controlled registrational trial comparing ANKTIVA® plus BCG with BCG alone in 366 patients with BCG-naïve non-muscle invasive bladder