EMD Serono...today announced that the European Commission (EC) has approved BAVENCIO (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.

EMD Serono Canada...announced that Health Canada has approved BAVENCIO (avelumab) for the maintenance treatment of patients with unresectable locally advanced or metastatic UC whose disease has not progressed following first-line platinum-based chemotherapy.

Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.

BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for:..Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy....Patients with locally advanced or metastatic UC who:...Have disease progression during or following platinum-containing chemotherapy....Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Gemcitabine/carboplatin [II, B] followed by maintenance avelumab (in those tumours not progressing on ChT) for those not eligible for cisplatin-based therapy is the standard of care

Cisplatin-based ChT [I, A] followed by maintenance avelumab in those tumours not progressing on ChT is the standard of care

NON-SUPPORTIVE EVIDENCE: The use of avelumab for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy is not recommended by NICE following an announcement on May 6.

Gemcitabine/carboplatin [II, B] followed by maintenance avelumab (in those tumours not progressing on ChT) for those not eligible for cisplatin-based therapy is the standard of care

...the NCCN panel recommends pembrolizumab, atezolizumab, nivolumab, durvalumab, avelumab, or erdafitinib as preffered second-line systemic therapy options after platinum-based therapy.

Patients with advanced UC without progression after four to six cycles of platinum-based chemotherapy and a 4-10-wk interval after chemotherapy (n = 700) were randomized to receive avelumab + BSC or BSC alone....Avelumab maintenance treatment helped patients with advanced urothelial cancer without disease progression after at least four cycles of prior chemotherapy, and who started maintenance treatment at least 4 wk after chemotherapy, to live longer.

Median OS was 25.3 months (95% CI, 18.6 to not estimable [NE]) in the avelumab + BSC arm vs. 18.7 months (95% CI, 12.8-NE) in the BSC alone arm (hazard ratio [HR], 0.74 [95% CI, 0.43-1.26]); median PFS was 5.6 months (95% CI, 2.0-7.5) vs. 1.9 months (95% CI, 1.9-1.9), respectively (HR, 0.58 [95% CI, 0.38-0.86]).

In Japanese patients (n = 73) randomized to avelumab + BSC (n = 36) or BSC alone (n = 37), median OS was 24.7 months (95% CI, 18.2-not estimable) vs 18.7 months (95% CI, 12.8-33.0), respectively (HR, 0.81 [95% CI, 0.41-1.58])... Avelumab 1L maintenance treatment showed a favorable benefit-risk balance in Japanese patients, supporting avelumab 1L maintenance as a new standard of care in Japanese patients with advanced UC that has not progressed with 1L platinum-containing chemotherapy.

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc...today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO® (avelumab) as monotherapy for the first line maintenance treatment of adult patient with locally advanced or metastatic urothelial carcinoma (UC)...The opinion was based on positive findings from the Phase III JAVELIN Bladder 100 trial...BAVENCIO is the only immunotherapy to significantly prolong overall survival (OS) in locally advanced or metastatic UC in the first-line setting in a Phase III trial.

Overall survival at 1 year was 71.3% in the avelumab group and 58.4% in the control group (median overall survival, 21.4 months vs. 14.3 months; hazard ratio for death, 0.69; 95% confidence interval [CI], 0.56 to 0.86; P=0.001).