Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director, Gyo Sagara; 'ONO') and Bristol-Myers Squibb K.K. today announced that the companies have received approval in Japan for the following combination therapies of Opdivo intravenous Infusion, a human anti-programmed death-1 (PD-1) monoclonal antibody, and Yervoy Injection, a human monoclonal antibody against cytotoxic T-lymphocyteassociated antigen 4 (CTLA-4) for the first-line treatment of unresectable, advanced or recurrent nonsmall cell lung cancer, for a partial change in approved items of the manufacturing and marketing approval in Japan.

Combination therapy with Opdivo and Yervoy (ONO/BMSKK)

Combination therapy with Opdivo, Yervoy plus chemotherapy (ONO/BMSKK)

Combination therapy with Opdivo and chemotherapy (ONO)

Note: The companies' names in the brackets show those which received the approval. (ONO: Opdivo and BMSKK: Yervoy)

These approvals are based on the results from the following clinical studies conducted by ONO and Bristol Myers Squibb (NYSE: BMY; 'BMS'): 1) and 3): CheckMate -227 Study: a global, multi-center, multi-part, randomized, open-label Phase III study evaluating Opdivo, or Opdivo plus Yervoy, or Opdivo plus platinum-doublet chemotherapy compared to platinum doublet chemotherapy in patients with previously untreated unresectable advanced or recurrent non-small cell lung cancer (NSCLC), 2): CheckMate -9LA Study: a global multi-center, randomized, open-label Phase III study evaluating Opdivo plus Yervoy in combination with platinum-doublet chemotherapy (two cycles) compared to platinum-doublet chemotherapy alone in patients with previously untreated unresectable advanced or recurrent NSCLC

About CheckMate -227 study

This study is a global, multi-center, multi-part, randomized, open-label Phase III clinical study, evaluating Opdivo, or Opdivo plus Yervoy, or Opdivo plus platinum-doublet chemotherapy compared to platinum-doublet chemotherapy in patients with previously untreated unresectable advanced or recurrent NSCLC. This study consists of the following 3 Parts:

Part 1a: Evaluating the efficacy and safety of Opdivo, or Opdivo plus Yervoy in patients whose tumors express PD-L1 1

Part 1b: Evaluating the efficacy and safety of Opdivo plus Yervoy, or Opdivo plus platinum-doublet chemotherapy in patients whose tumors express PD-L1

(C) 2020 Electronic News Publishing, source ENP Newswire