RE:ONCY Q2-2024 earnings call Pelareorep as a backbone therapyAt the latest earnings call Tom Heineman commented on ONCY's mBC registration study design for pelareorep + nab-paclitaxel as similar to the model that Pfizer and Daiichi used for the CDK4/6 inhibitor and antibody drug conjugate (ADC), respectively, for their FDA approvals, Heineman stated that ... " the model that we're following is very similar to the approach that was used by Pfizer, for example, for their initial licensure of Ibrance and then subsequently, by Daiichi for the initial licensure of Enhertu."
Pfizer entitled their Ibrance (palbociclib - CDK4/6 inhibitor) cliical trial model in advanced breast cancer - Paloma -1 and Paloma-2 while Daiichi Sankyo entitled their series of breast cancer clinical trials Destiny-breast. Since the initial development and approval of palbociclib, first-in-class cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, for estrogen receptor–positive/human epidermal growth factor receptor 2–negative (ER+/HER2–) advanced breast cancer (ABC) on the basis of PALOMA-1 in 2015, the CDK4/6 inhibitor class has transformed the treatment landscape and, in combination with endocrine therapy (ET), has become the standard of care for the disease.5 PALOMA-2 confirmed the results of PALOMA-1 with statistically and clinically significant improvement in progression-free survival (PFS) for palbociclib plus letrozole versus placebo plus letrozole in ER+/HER2– ABC.
PALOMA-2 demonstrated statistically and clinically significant improvement in progression-free survival with palbociclib plus letrozole versus placebo plus letrozole in estrogen receptor–positive/human epidermal growth factor receptor 2–negative (ER+/HER2–) advanced breast cancer (ABC). https://ascopubs.org/doi/10.1200/JCO.23.00137
In Destiny the primary endpoint was progression-free survival by blinded independent central review. The key secondary endpoint was overall survival and this prespecified second overall survival interim analysis reports updated overall survival, efficacy, and safety results. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02420-5/fulltext https://www.daiichisankyo.com/media/press_release/detail/index_4088.html