Opdivo, Yervoy combo shows promising results in advanced form of bladder cancer
Bristol-Myers Squibb announced follow-up data evaluating Opdivo monotherapy and Opdivo in combination with Yervoy in patients with platinum-pretreated metastatic urothelial carcinoma. Results from the Phase 1/2 CheckMate -032 trial showed that patients who received the combination of Opdivo 1 mg/kg plus Yervoy 3 mg/kg experienced a higher objective response rate compared to those who received Opdivo 3 mg/kg plus Yervoy 1 mg/kg or Opdivo alone. Patients in the study were heavily pretreated, with most receiving at least two prior treatment regimens. At a minimum follow-up of 7.9 months for the expanded cohort of patients receiving O1:Y3, the ORR was 38%. For patients receiving O3:Y1, at a minimum follow-up of 38.8 months the ORR was 27%, and for patients receiving Opdivo alone, at a minimum follow-up of 37.7 months the ORR was 26%. Median progression-free survival and overall survival, secondary endpoints in the study, were numerically longer in the O1:Y3 treatment cohort compared to the O3:Y1 and Opdivo monotherapy cohorts. The overall safety profile was consistent with prior studies of Opdivo in combination with Yervoy with these dosing schedules. Grade 3 or 4 treatment-related adverse events occurred in 27%, 31% and 39% of patients treated with Opdivo monotherapy, O3:Y1 and O1:Y3, respectively; grade 5 TRAEs were observed in one patient each in the Opdivo monotherapy and O3:Y1 groups; no grade 5 TRAEs were observed in the O1:Y3 group. The combination of Opdivo plus Yervoy was also well tolerated, with 13% discontinuation rate due to TRAEs in the O1:Y3 group and 13% discontinuation rate in the O3:Y1 group. The discontinuation rate due to TRAEs in the Opdivo monotherapy group was 4%.