Ono Pharma Korea and Bristol-Myers Squibb Korea have presented four new clinical trial results regarding a combination treatment that uses Opdivo (Ingredient: nivolumab) and Yervoy (Ingredient: ipilimumab), at the European Society for Medical Oncology.
The trials involved were CheckMate-214, CheckMate-067, CheckMate-032 and CheckMate-142.
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.
With a minimum follow-up of 30 months, 36 percent of patients who received a combination treatment of Opdivo and Yervoy still survived and did not require subsequent therapy compared to the 16 percent of patients who received Sunitinib.
At two years after discontinuation of these treatments, Opdivo and Yervoy combination treatment and Sunitinib groups reported treatment-free survival (TFS) of 19 and 6 percent, while showing 42 and 12 percent for complete responses or partial responses, and 12 and 6 percent for stable disease, which means that the patients do not need any follow-up treatment.
The company also presented the results for the phase 3 clinical trial for CheckMate-067, which is the most extended follow-up to date. The trial continues to demonstrate durable, long-term survival benefits with the first-line combination of Opdivo and Yervoy versus Yervoy or Opdivo alone, in patients with advanced melanoma.
At a minimum follow-up of 48 months showed that Opdivo and Yervoy combination treatment group had a four-year overall survival rate and complete response rate of 53 and 21 percent, respectively, which was higher than the Yervoy group’s 30 and 5 percent and Opdivo group’s 46 and 18 percent.
According to the analysis of patients who survived the four-year period, the treatment-free status for patients was highest in the combination therapy with 71 percent.
Regarding Checkmate-032, which is a multi-center, open-label Phase 1/2 trial, evaluating the safety and efficacy of Opdivo as a single agent or in combination with Yervoy in 274 patients with previously treated locally advanced or metastatic urothelial carcinoma, the overall safety profile was consistent with prior studies.
At a minimum follow-up of 7.9 months for the expanded cohort of patients receiving 1 mg/kg of Opdivo and 3 mg/kg of Yervoy, the objective response rate (ORR) was 38 percent. For patients receiving 3 mg/kg of Opdivo and 1 mg/kg of Yervoy, at a minimum follow-up of 38.8 months the ORR was 27 percent, and for patients receiving Opdivo alone, at a minimum follow-up of 37.7 months the ORR was 26 percent.
Also, both combination treatment groups showed a higher median progression-free survival (PFS) and overall survival period than the Opdivo monotherapy group.
CheckMate-142 is an international Phase 2, multi-cohort, open-label, non-comparative trial of Opdivo, or Opdivo combinations, in recurrent or metastatic MSI-H and non-MSI-H colorectal cancer.
The trial showed the combination worked in patients who have received no prior treatment for MSI-high metastatic colorectal cancer.
The treatment showed an objective response rate of 60 percent, and complete response of seven percent. Also, after 12 weeks 84 percent of patients had tumor shrinkage, and at 12-months the progression-free survival and overall survival rates were 77 and 83 percent, respectively.
The company added that the median duration of response, progression-free survival, and overall survival has not yet been reached.