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EU panel backs label update for pembrolizumab in urothelial carcinoma


The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended adding data from the phase 3 KEYNOTE-361 trial to the label for pembrolizumab (Keytruda) for its indication for patients with advanced or metastatic urothelial carcinoma.1

Pembrolizumab is approved in Europe for the treatment of adult patients with advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (Combined Positive Score ≥10). This approval was supported by the single-arm KEYNOTE-052 trial and KEYNOTE-361 was subsequently launched as a post-marketing commitment.

The open-label, phase 3 KEYNOTE-361 trial (NCT02853305) randomized 1010 patients with advanced or metastatic urothelial carcinoma to frontline treatment with single-agent pembrolizumab (P), pembrolizumab plus chemotherapy (P + C), or chemotherapy (C) alone. Chemotherapy consisted of cisplatin or carboplatin plus gemcitabine. The coprimary end points for the trial were OS and PFS. Secondary end points were response, disease control rate, and safety.

It was previously reported that the study did not meet its coprimary end points. Despite this outcome, it was the conclusion of the CHMP that the “benefit-risk profile remains positive and that including data from KEYNOTE-361 in the label allows physicians to evaluate the potential benefit-risk of KEYTRUDA on an individual basis,” according to the Merck (MSD), the developer of pembrolizumab.

“Keytruda has become an important treatment option for certain patients with locally advanced or metastatic bladder cancer in the European Union and other countries around the world,” Scot Ebbinghaus, MD, vice president, clinical research, Merck Research Laboratories, stated in a press release. “We are pleased with today’s positive opinion by the CHMP, which fulfills our post-marketing requirement for Keytruda in these patients in the European Union and will enable continued access for patients in need of another treatment option.”

In the study, the media PFS was 8.3 months with P + C, compared with 3.9 months and 7.1 months with P alone and C alone, respectively.2 The hazard ratio for PFS for P + C versus C was 0.78 (P = .0033). The median OS was 17.0 months for P +C, compared with 15.6 months with P alone and 14.3 months with C alone. The hazard ratio for OS for P + C versus C was 0.86 (P = .0407). The objective response rates were 54.7%, 30.3%, 44.9% for P + C , P, and C, respectively.

Regarding safety, 75.1% of the P + C arm experienced grade 3-5 treatment-related adverse events, compared with 16.9% in the P arm and 71.6% in the C arm. The AE-related discontinuation rates of any drug were 30.9%, 15.9%, and 18.1% in the 3 arms, respectively.


1. Merck Receives Positive EU CHMP Opinion for Updated Label of KEYTRUDA® (pembrolizumab) To Include Results of Phase 3 KEYNOTE-361 Trial in Certain Adult Patients with Locally Advanced or Metastatic Urothelial Cancer. Published online March 30, 2021. Accessed March 30, 2021. https://bit.ly/3m5cIgw.

2. Alva A. LBA23 - Pembrolizumab (P) combined with chemotherapy (C) vs C alone as first-line (1L) therapy for advanced urothelial carcinoma (UC): KEYNOTE-361. Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

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