Ph 3 POD1UM-304 trial of Retifanlimab (Zynyz®) + Chemo met primary endpoint of OS and all secondary endpoints in patients with 1L metastatic NSCLC
“The positive POD1UM-304 trial results provide additional proof of retifanlimab’s safety and efficacy profile in solid tumors,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “We look forward to leveraging these results to advance our pipeline, particularly in hard-to-treat cancers like NSCLC, and to submitting a supplemental Biologic License Application for this indication to the U.S. Food and Drug Administration next year.”
Share:
More News
“Our goal is not simply to complete a Phase 1 trial; it is to deliver a re-sensitization solution that changes the post-progression treatment paradigm and positions Kairos as the essential complement to the EGFR-targeted therapy market with this clean safety profile now confirmed across 13 patients,” said Dr. John Yu,
Dr. Michael GE, CEO of Kelun-Biotech, stated: “We are delighted to see that sac-TMT combined with pembrolizumab has achieved exciting positive results compared with immunotherapy plus chemotherapy in the first-line treatment of patients with PD-L1-negative NSCLC. This ADC plus immunotherapy regimen has previously demonstrated superior efficacy over immunotherapy monotherapy in
“This Fast Track designation represents another important regulatory milestone for Oncolytics and reflects the significant progress we have made over the past twelve months in advancing pelareorep toward potential registration,” said Jared Kelly, Chief Executive Officer of Oncolytics. “During that time, we have received Fast Track designation in both metastatic
“These findings build upon the well-established role of KEYTRUDA in endometrial cancer, one of the few cancers with rising incidence rates,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “We are committed to helping women facing this disease by advancing potential treatment options. We thank the