Statistically Significant Final 2-Yr OS Data from Ph 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent Pulmonary Metastatic Osteosarcoma Announced
“The continued outperformance in overall survival of OST-HER2 when compared with historical control is exactly what we were hoping for when we started the Company in 2018,” said Paul Romness, MPH, Chairman & CEO of OS Therapies. “We have had highly productive regulatory meetings with the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA), the United States (US) Food & Drug Administration (FDA) and the European Medicines Agency’s (EMA) Dutch rapporteur. Representatives of all three regulatory agencies, in various ways, indicated that overall survival may be an appropriate clinical endpoint to support a conditional marketing authorization, especially when supported with biomarker data. The rationale for overall survival combined with biomarkers is largely a result of the compelling data recently published in canine osteosarcoma by researchers at the University of Pennsylvania.”
Share:
More News
“We are excited to have restarted our Phase 2 study in presurgical triple-negative breast cancer. Triple-negative is a deadly and aggressive form of breast cancer, and patients having local disease currently undergo a harsh six-month regimen whereby a small percentage can die from the SOC before their surgery,” said Intensity
“TRAVERSE represents a potential breakthrough for both Allogene and the broader CAR T field,” said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene. “CAR T has transformed hematologic malignancies while solid tumors have remained one of the field’s most difficult challenges. When we designed ALLO-316 with the
“We continue to be very encouraged by the longer-term data from our Phase 2 J201 study, and today’s announcement marks a pivotal step forward in our mission to bring safusidenib as a comprehensive treatment option for patients with all types of IDH1-mutant glioma,” said David Hung, M.D., Founder, President, and
“As the data continue to mature, we are increasingly encouraged by the preliminary findings emerging from both cohorts, particularly the overall survival trends observed in the cohort with MGMT unmethylated glioblastoma,” said Niven R. Narain, Ph.D., President and CEO of BPGbio. “These findings further reinforce our belief that targeting mitochondrial