RE:RE:RE:RE:RE:RE:RE: Pelareorep + Paclitaxel = ADC/HER2 failed breast cancerComparing Roche's inavolisib's + palbociclib and fulvestrant combination Phase 3 results to ONCY's pelareorep + paclitaxel Phase 2 results ...
The results showed the inavolisib-based regimen more than doubled progression-free survival (PFS), reducing the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001) in the first-line setting.
At a median follow up of 21.3 months, median investigator-assessed PFS was 15 months in the invavolisib arm and 7.3 months in the placebo arm. Investigator-assessed PFS at 6, 12, and 18 months in the invavolisib arm was 82.9%, 55.9%, and 46.2% vs 55.9%, 32.6%, and 21.1% in the placebo arm, respectively. OS results trended in favor of invavolisib (hazard ratio [HR] 0.64; 95% confidence interval 0.43 to 0.97; P = .0338). OS event-free rates at 12 and 18 months were 85.9% and 73.7% in the invavolisib arm and 74.9% and 67.5% in the placebo arm. Confirmed ORR was 58.4% in the invavolisib arm and 25% in the placebo arm.
Versus
June 2023 updated data from Phase 2 BRACELET-1 showed a median progression-free survival (mPFS) of 9.5 months in the paclitaxel plus pelareorep cohort vs. 6.3 months in the paclitaxel monotherapy cohort for a hazard ratio of 0.29 as of a March 3, 2023 cut-off date and reducing the risk of disease worsening or death by 71%. Confirmed overall response rate (ORR) in these cohorts was 37.5% and 13.3%, respectively.
ONCY's ORR surrogate endpoint would suggest that the FDA would be accelerating the approval of the biologic pelareorep in a manner that was in line or more favorable than Roche/Genentrech's small molecule drug inavolisib.
https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-announces-updated-randomized-phase-2-data-from-bracelet-1-metastatic-breast-cancer-trial-that-show-pelareorep-driving-robust-increases-in-progression-free-survival-and-confirm/