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
“FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies,” said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. “By combining cell-selective delivery with targeted protein degradation in a single molecule,
“We are excited to expand our clinical collaboration with Roche to evaluate a second KRAS combination with potential best-in-class MTA-cooperative PRMT5 inhibitor IDE892 for pancreatic cancer patients, where there remains a high unmet medical need. IDEAYA is advancing multiple rational combination strategies for the IDE892 program, including with MAT2A inhibitor
“These encouraging initial safety observations represent an important first step in the clinical evaluation of ZI-MA4-1 and our TCR-NK platform” said Namir Hassan, Chief Executive Officer of Zelluna. “The first patient received all three planned doses, and the independent committee’s recommendation enables us to continue recruitment at the first dose
“Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us