Double-Digit ORR announced in Each Cohort from the Ongoing ENVASARC Ph 2 Pivotal Trial

“We are pleased with the activity of the 600 mg dose of envafolimab that has demonstrated a double-digit objective response rate both as a single agent and in combination with Yervoy, even at this early 12-week time point,” said James Freddo, M.D., TRACON’s Chief Medical Officer. “We are also encouraged with the safety data showing that envafolimab monotherapy and in combination with Yervoy are well tolerated. This interim analysis is a positive milestone and we look forward to the next interim analysis which will be conducted after the 46th patient in each cohort has completed a minimum of 12 weeks of efficacy evaluations. Importantly, accrual in ENVASARC remains ahead of projections and we are excited by the emerging data and for envafolimab’s potential to become a differentiated treatment for sarcoma patients.”
Share:
More News
PharmaMar has submitted a Marketing Authorization Application to the European Medicines Agency for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The MAA submission
“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need,” said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. “Fore Bio is focused on resetting the
The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from
“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is