RE:Trodelvy improved PFS by 34% in heavily pre-treated patientsAs a reminder ... "ONCY's Phase 2 Bracelet-1 study demonstrated that pelareorep as a single agent improved met the surrogate endpoint of PFS with a clinically meaningful reduction in the risk of diseae progression or death by 32.8%. (HR: 0.29; 95% CI: 0.11.7-0.924) in the same heavily pre-treated patient groups as Trodelvy, namely patients who received prior endocrine therapy, CDK4/6 inhibitors and at least two lines of chemotherapy.
Consequently it would appear that ONCY's pelareorep as a single agent would adequately meet the FDA's Accelerated Approvable requirements, given their earlier decision to approve Gilead's Trodolvey in the same groups of patients.
https://www.oncolyticsbiotech.com/press-releases/detail/601/oncolytics-biotech-announces-updated-randomized-phase-2
The result was Trodely's approval by the FDA based on this 34% improvement in PFS at 12 months. "