Enrollment completed in Ph 2 CRDF-004 Trial of Onvansertib in 1L RAS-mutated Metastatic CRC

“The successful completion of enrollment in our first-line trial for patients with RAS mutant mCRC represents an important milestone in our mission to develop new treatments for a population who have not seen meaningful treatment advancements for decades. We are deeply grateful for our patients, care-givers and clinical investigators, whose commitment to the trial has been integral in this achievement,” said Mark Erlander, Chief Executive Officer of Cardiff Oncology. “As we move forward, we are eager to continue accruing additional clinical data and advancing towards regulatory discussions with FDA with the goal of bringing this transformative therapy to 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