|
Main | | |
| Brand | Lynparza, fka AZD2281 |
| Generic | olaparib |
| MOA | PARP1 inhibitor |
| Indication | aOC, mCRPC, pancreatic, mBC |
| Economics | MRK. Originally from KuDOS, acquired by AZN in 2006 |
| PK | LogP=1.9, MW=434, HBD=1, HBA=5, RB=4, TPSA=82. Capsule discontinued, Tablet replaced |
| IP | 7151102 first patent doesn't correspond to structure, expired |
| | 7449464 expires 2024 |
| | 8071579 expires 2027, MOU patent |
| | 8143241 expires 2027, MOU patent |
| | 8475842 expires 2029, formulation patent |
| | 8859562 expires 2031, ridiculous claim |
| | |
| Clinical Trials | |
| | Phase III SOLO-2 - NCT01874353 |
| | |
| | Phase III POLO |
| | |
| | Phase III "SOLO-1" n=391 1L aOC BRCA+ in PR/CR - NEJM 2018, NCT01844986 |
| | HR=0.30 TTP/OS |
| | |
| | Phase III "PROpel" 1L CRPC abiraterone+-olaparib - NEJM 2022, NCT03732820 |
| | mibPFS HR=0.66, OS=0.86 (p=0.29 immature) |
| | 24.8 months vs. 16.6 months mibPFS |