FDA Approves Pembrolizumab for Advanced or Metastatic Urothelial Carcinoma
The FDA granted regular approval to pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following chemotherapy.
The US Food and Drug Administration (FDA) granted regular approval to pembrolizumab for 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.1
Also granted was accelerated approval for first-line use of pembrolizumab in patients with locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy.
The approval for the second-line indication was based on results from the phase 3, open-label KEYNOTE 045 trial (ClinicalTrials.gov Identifier: NCT02256436). The study randomly assigned 542 patients to pembrolizumab 200 mg or investigator's choice of paclitaxel, docetaxel, or vinflunine every 3 weeks.
Median overall survival was 10.3 months in the pembrolizumab arm vs 7.4 months in the chemotherapy arm. Data from a planned survival analysis to be presented at the 2017 American Society of Clinical Oncology (ASCO) annual meeting confirm these findings; at a median follow-up of 18.5 months, the overall survival remained at 10.3 vs 7.4 months, respectively.2
The objective response rate, a secondary end point, was 21% for pembrolizumab and 11% for chemotherapy (P = .002). No significant difference in progression-free survival between the 2 arms was observed.
Accelerated approval for the first-line indication was based on data from the single-arm, open-label KEYNOTE 052 trial (ClinicalTrials.gov Identifier: NCT02335424) in 370 patients treated with pembrolizumab 200 mg every 3 weeks.
RELATED: Pembrolizumab May Effectively Treat Mediastinal B Cell Lymphoma
At a median follow-up of 7.8 months, the objective response rate was 28.6% and the median response duration was not reached (range 1.4+, 17.8+ months).
According to the FDA, “an additional trial is required to confirm clinical benefit of pembrolizumab for the first-line indication.”
- Pebrolizumab (Keytruda): advanced or metastatic urothelial carcinoma [news release]. Silver Spring, MD: US Food and Drug Administration; May 18, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ ApprovedDrugs/ucm559300.htm. Accessed May 18, 2017.
- Bajorin DF, De Wit R, Vaughn, DJ, et al. 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. 2017;35(suppl; abstract 4501).