FDA Alignment on use of PFS as Primary Endpoint in Ph 3 VERSATILE-003 Trial Announced
“Submission of the amended protocol is an exciting next step in our mission to make this promising treatment available to patients in need,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We believe that including PFS as a primary endpoint offers an important opportunity to shorten the duration of VERSATILE-003. The amendment retains mOS and safety as requirements for full FDA approval, and based on the dialogue we had with the agency in December, we are confident that we have a pathway to potentially accelerate our regulatory submission.”
Share:
More News
Dr. Michael Ge, CEO of Kelun-Biotech said, “We are delighted to see the acceptance of the fifth indication application for sac-TMT. Compared to immunotherapy alone, the ADC combination with KEYTRUDA® as first-line treatment for PD-L1-positive NSCLC has achieved not only positive results in PFS, but also a trend toward benefit
“We are excited to work with Merck to advance this promising investigational combination in RAS-driven cancers,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “RAS mutations activate the RAS/MAPK pathway and promote an immunosuppressive environment. Non-clinical data suggest that targeting the pathway with ERAS-0015 may complement PD-1 blockade
“Dosing the first patient in the ASPENOVA Phase 3 clinical trial represents a significant milestone in our development of azenosertib for patients with platinum-resistant ovarian cancer,” said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. “With DENALI Part 2 progressing toward a year-end readout that may support accelerated approval and
“The depth, durability, and consistency of responses observed across both the total population and BTKi-treated subsets underscore iopofosine’s potential as a meaningful new treatment option in WM and differentiate it from currently available therapies,” said Jarrod Longcor, chief operating officer of Cellectar Biosciences. “With the completion of at least 12-month