Bristol-Myers Squibb (BMS) and Ono Pharma Korea have received an additional indication for using a combination treatment of Opdivo and Yervoy a first-line therapy in treating renal cell carcinoma (RCC), in Europe.
Opdivo is an anti-programmed cell death protein 1 (PD-1) immuno-chemotherapeutic agent that acts on protein PD-1 on the surface of immune cells.
The European Commission approved the use of Opdivo 3 mg/kg and low-dose Yervoy 1 mg/kg for the first-line treatment of patients with advanced mediastinal and poor risk advanced RCC without previous treatment, based on the result of CheckMate-214 on Jan. 14.
The decision is the first of its kind for immunotherapy to receive approval for treating patients with moderate to high-risk advanced RCC who have no prior treatment experience in the EU.
CheckMate-214 is a phase 3 randomized and placebo-controlled clinical study, which compared Opdivo and Yervoy combination treatment and Sunitinib in patients with moderate- and high-risk advanced RCC who did not have any treatment experience.
The study found that the combination of Opdivoand Yervoy reduced the risk of death by 37 percent compared to Sunitinib and the survival benefit was independent of PD-L1
Also, the company has not yet reached median overall survival (28.2 months and continuing) in the Opdivo and Yervoy treatment group, while the Sunitinib was 25.9 months.
The two companies also confirmed that Opdivo significantly improves overall survival (OS) compared to chemotherapy in treating esophagus cancer through ATTRACTION-3, a clinical trial into the drug.
In the trial, the company prescribed performed opioid and clinical chemotherapy (docetaxel or paclitaxel) to patients with advanced or recurrent esophageal cancer who were not able to undergo resection and who had difficulty in treating fluoropyrimidine and platinum-based chemotherapy.
The study showed that Opdivo significantly extended the primary endpoint and OS compared to fluoropyrimidine and platinum-based chemotherapy.
“Opdivo has demonstrated for the first time that OS improves statistically significantly in patients with advanced or recurrent esophageal cancer, which cannot be resected, regardless of PD-L1,” the company said. “The results of the study will be presented at a future academic conference.”
Although the companies received approval to use a combination treatment of Opdivo and Yervoy as the first-line immunotherapy to treat RCC last year, they have fallen short of gaining approval to treat esophagus cancer in Korea.