BMS shares promising Opdivo/Yervoy data for advanced bladder cancer
pharmafile | December 8, 2016 | News story | Research and Development | BMS, Yervoy, opdivo
BMS has revealed new efficacy data on the combination of its immunotherapies Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of advanced urothelial carcinoma.
A pair of monoclonal antibodies, both drugs are checkpoint inhibitors, designed to block protein receptors which prevent the body’s T-cells from fighting cancer; Opdivo targets PD-L1, while Yervoy targets CTLA-4. The combination of the two drugs blocks both receptors and enables the body’s immune system to recognise and destroy tumour cells.
The Phase 1/2 trial CheckMate -032 investigated the efficacy of the combination treatment in two groups of metastatic or locally advanced urothelial cancer patients who had previously received at least one line of platinum-based therapy.
It was found that the first group (nivolumab 1 mg/kg plus ipilimumab 3 mg/kg), followed for a median of 7.8 months, showed an objective response rate (ORR) of 38.5%, while the second group (nivolumab 3 mg/kg plus ipilimumab1 mg/kg), followed for a median of 16.7 months, displayed an ORR of 26.0%. Additionally, the incidence of Grade 3-4 treatment-related adverse events was 30.8% in the first group and 31.7% in the second.
The death of one patient was reported during the trial, with the cause being given as pneumonitis.
Concerning this new data, professor Thomas Powles, clinical professor of Genitourinary Oncology at Barts Cancer Institute commented: “Over the last 30 years, there has been very little improvement in survival for patients with advanced bladder cancer and the outlook for these people remains poor. We have already seen that this combination of nivolumab plus ipilimumab can work effectively in other cancers such as advanced melanoma and these results provide an early indication of how this combination could transform how we treat bladder cancer in the future.”
While not yet recommended for the treatment of advanced urothelial carcinoma, the same combination therapy was recommended by NICE in June for the treatment of advanced melanoma.
“At Bristol-Myers Squibb, we have made significant strides to further the scientific understanding of immunotherapy combinations for treating a range of tumour types. These latest data indicate the future potential of this innovative approach for patients who are in the advanced stages of bladder cancer,” said Sue Bailey, Disease Area Head, Oncology, Bristol-Myers Squibb, UK and Ireland. “Our goal is to change survival expectations in cancer and we hope that in the future, these data translate into improved expectations for patients with this disease.”
BMS CEO Giovanni Caforio has been vocal about the company’s desire to pursue the potential of a range of Opdivo/Yervoy treatments following the former’s shock failure in its pivotal Phase 3 trial earlier this year.
The most common form of bladder cancer, urothelial carcinoma accounts for around nine out of ten cases, with only 10% of patients surviving for five years or more after diagnosis.
Matt Fellows
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