ABC
1Main
2Brand NameOpdivo, fka BMS-936558
3Generic Name
4IndicationCancer
5MechanismAnti-PD-1 Antibody
6EconomicsOno has Japanese rights.
7Clinical Trials
8Phase III NSCLC versus Taxotere n=264
9Primary endpoint: ORR/OS
10
11Phase I "Study 301" n=296 in all cancers
12n=104 melanoma, n=122 NSCLC, n=34 RCC, n=17 CRPC, n=19 CRC
13Dose ranging from 0.3mg/kg to 10.0mg/kg
149/52 response rate in melanoma
152/17 in RCC
165/49 in NSCLC
171/17 in ovarian cancer
188/16 responses lasted longer than 1 year