Keytruda for bladder cancer – pro
Pembrolizumab is the first immunotherapy to demonstrate superior survival over chemotherapy in patients with advanced urothelial carcinoma after failure of platinum-based chemotherapyas had been reported form the second interim analysis findings for overall survival (OS) of Keynote_45 study, determined after a median of 14 months, resulting in US FDA approval for pembrolizumab in patients with locally advanced or metastatic urothelial carcinoma. These were pateints who progressed after paltimum, and different from previous studies which were in non-cisplain treated patients.
The latest findings, from data cutoff in January 2017, gave a median OS of 10.3 months for the 270 patients randomly assigned to receive pembrolizumab 200 mg every 3 weeks. This was significantly longer than the 7.4 months achieved by the 272 patients given a paclitaxel, docetaxel or vinflunine regimen. Pembrolizumab-treated patients had a higher OS rate at 12 months (44.4 vs 30.2%) and 18 months (36.1 vs 20.5%) than their chemotherapy counterparts, and this OS benefit occurred across subgroups of patients based on factors such as primary tumor site, pattern of metastases, or programmed cell death ligand 1 (PD-L1) combined positive score.
It is currently FDA approved indication: “KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.”
References:
Planned survival analysis from KEYNOTE-045: Phase 3, open-label study of pembrolizumab (pembro) versus paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC). J Clin Oncol 35, 2017 (suppl; abstr 4501)
Prescribing Information Keytruda 2017