Opdivo is set to become the market leader in gastric in gastro-oesophageal cancer following the latest data from two label expansion trials, which were noted to have met their primary endpoints. GlobalData expects Opdivo’s label expansions to gain approval in mid-2021 and revolutionize this indication as the first targeted therapy available in the adjuvant setting for all patients and in the first-line setting for HER2-negative patients.

Miguel Ferreira, MSc, Oncology and Hematology Analyst at GlobalData, comments: “Opdivo’s use in both the adjuvant and first-line metastatic HER2-negative settings would significantly improve survival rates and represent a milestone in a treatment setting where patients are currently only treated with chemotherapy. The drug is slowly going up the lines of treatment and will be available to more patients sooner. This is especially key in Europe, where this type of drug is not approved at all in this indication; the US where this drug’s main competitor is also trying to break into the first-line of treatment but lagging behind (Keytruda); and in Japan where adjuvant treatment is much more popular and this drug is already approved as a last line of treatment and therefore will be very popular upon approval.”

With the two Phase III trials, Checkmate-649 and Checkmate-577, scheduled for completion in mid-2021, GlobalData estimates approval will soon follow.

Ferreira concludes: “If both treatment settings are approved, Opdivo is set to become the leading therapy in gastric and gastro-oesophageal cancer, in front of other immunotherapies such as Merck’s Keytruda, as well as various targeted therapies such as Roche’s Herceptin and Eli Lilly’s Cyramza. Bristol-Myers Squibb may further look to bring Opdivo into pre-metastatic patient segments, eventually establishing this agent as part of the primary treatment backbone in perioperative and preoperative settings as well.”

To find out more, send your questions to Rebecca Panks, PR Executive at GlobalData (pr@globaldata.com)