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Pembrolizumab Approved for Urothelial Cancer in US

Pembrolizumab (Keytruda, Merck & Co) has been approved for use in urothelial cancer, making it the fifth immunotherapy to be approved for this indication during the past year.

The other four are avelumab (Bavencio, EMD Serono Inc), atezolizumab (Tecentriq, Genetech Inc), durvalumab (Imfinzi, AstraZeneca), and nivolumab (Opdivo, Bristol-Myers Squibb). All act as inhibitors of the programmed cell death pathway.

These immunotherapies are "altering the landscape" for the treatment of bladder cancer, experts have commented.

The US Food and Drug Administration (FDA) granted pembrolizumab regular approval for second-line use in patients with locally advanced or metastatic urothelial carcinoma who have experienced disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In this indication, the drug has demonstrated a significant improvement in overall survival (OS) when compared to chemotherapy. The median OS was 10.3 months with pembrolizumab vs 7.4 months with chemotherapy (hazard ratio (HR), 0.73; P = .004). The overall response rate (ORR) was also significantly better with the immunotherapy, at 21% vs 11% for chemotherapy (P = .002). However, there was no statistically significant difference in progression-free survival between the two arms.

These results come from the KEYNOTE-045 trial, in which patients received either pembrolizumab 200 mg every 3 weeks (n = 270) or investigator's choice of a chemotherapy regimen (paclitaxel [n = 84], docetaxel [n = 84], or vinflunine [n = 87]) every 3 weeks (n = 272).

In addition, the FDA granted pembrolizumab accelerated approval for first-line use in patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

This accelerated approval was based on response rate data from a single-arm, open-label clinical trial, the KEYNOTE-052 trial. It involved 370 patients with locally advanced or metastatic urothelial carcinoma who were deemed ineligible for cisplatin-containing chemotherapy. All patients received pembrolizumab 200 mg every 3 weeks. With a median follow-up time of 7.8 months, the ORR was 28.6%; the median response duration was not reached (range, 1.4 -17.8 months).

The FDA notes that the most common adverse reactions reported for at least 20% of pembrolizumab-treated patients in either of the two trials were fatigue, musculoskeletal pain, pruritus, decreased appetite, nausea, diarrhea, constipation, and rash. Serious adverse reactions occurred in approximately 40% of pembrolizumab-treated patients. Immune-mediated adverse reactions reported in these trials included pneumonitis, colitis, hepatitis, and endocrinopathies.

The recommended pembrolizumab dose and schedule for the treatment of urothelial carcinoma is 200 mg as an intravenous infusion over 30 minutes every 3 weeks.

The drug is already marketed for use in several other tumor types, including melanoma and lung cancer.

Full prescribing information for pembrolizumab is available online.


Pembrolizumab Approved for Urothelial Cancer in US. Medscape. May 19, 2017.

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