- Pembrolizumab (Keytruda) achieved superior OS compared with paclitaxel (Taxol), docetaxel (Taxotere, Docefrez), or vinflunine (Javlor), in patients with advanced urothelial cancer (UC) that progressed during or after platinum-based chemotherapy.
- Pembrolizumab had a better safety profile.
Why this matters
- This patient group has poor prognosis and limited treatment options.
- These findings support the study of pembrolizumab in earlier stages of UC.
- KEYNOTE-361 is studying pembrolizumab with/without platinum-based combination chemotherapy vs chemotherapy alone in UC.
- Benefit of pembrolizumab may be independent of programmed death ligand 1 (PD-L1) expression.
- Of 542 patients, 266 received pembrolizumab and 255 received chemotherapy (paclitaxel/docetaxel/vinflunine) during median follow-up of 14.1 mo.
- Pembrolizumab achieved superior median OS vs chemotherapy (10.3 mo vs 7.4 mo; HR for death, 0.73; P=.002).
- In patients with tumor PD-L1 combined positive score ≥10%, pembrolizumab was superior to chemotherapy (HR for death, 0.57; P=.005).
- Fewer treatment-related adverse events were reported with pembrolizumab vs chemotherapy (overall, 60.9% vs 90.2%; grade ≥3, 15.0% vs 49.4%, respectively).
- Phase 3, KEYNOTE-045 study evaluated patients with advanced UC after the failure of platinum-based chemotherapy.
- Funding: Merck Sharp & Dohme Corp.
- Open-label study.