Trodelvy improved PFS by 34% in heavily pre-treated patientsFor comparison purposes - Gilead's Phase 3 TROPiCS-02 study of Trodelvy® (sacituzumab govitecan-hziy) versus physicians’ choice of chemotherapy (TPC) in heavily pre-treated HR+/HER2- metastatic breast cancer patients who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy improved 12 month PFS by 34% and was approved by the FDA for the treatment of HR+/HER2 - metastatic breast cancer on this result.
The study met its primary endpoint of progression-free survival (PFS) with a statistically significant and clinically meaningful 34% reduction in the risk of disease progression or death (median PFS 5.5 vs. 4 months; HR: 0.66; 95% CI: 0.53-0.83; P<0.0003) at 12 months versus physician's choice of chemotherapy.
https://www.gilead.com/news-and-press/press-room/press-releases/2022/6/trodelvy-improved-progressionfree-survival-by-34-in-heavily-pretreated-hrher2-metastatic-breast-cancer-patients
Similarly 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.