The US FDA (United States Food and Drug Administration) granted its approval to a novel drug avelumab (Bavencio) as maintenance therapy for patients suffering from locally advanced or metastatic urothelial carcinoma that has not yet advanced with first-line platinum-containing chemotherapy on 30 June 2020.
A randomized, multicenter, phase 3, open-label, parallel-arm (JAVELIN Bladder 100) study was conducted to explore the efficacy of avelumab plus BSC (best supportive care) as first-line maintenance treatment of urothelial carcinoma. Overall, 700 adult subjects with locally advanced or metastatic urothelial carcinoma were recruited in this analysis.
Patients were randomly assigned in a 1:1 ratio to receive either an intravenous infusion of avelumab every 2 weeks plus BSC or BSC alone. Within 4-10 weeks, treatment was initiated after the last chemotherapy dose. The primary outcome measure was the estimation of OS (overall survival) in all randomized patients and patients with PD-L1 (Programmed death-ligand 1)-positive tumors.
The study results depicted that the median OS in the overall population treated with avelumab plus BSC was more compared to BSC alone as shown in the following table:
Avelumab + BSCBSC aloneMedian OS21.4 months14.3 months
Among patients with PD-L1-positive treated with avelumab (n=358), the risk of death declined by 44% in comparison with BSC alone. Among patients with PD-L1-positive tumors, the hazard ratio for OS was found to be 0.56. Moreover, in an exploratory analysis of PD-L1-negative patients, the OS hazard ratio was 0.85 as shown in the following table:
Patients with PD-L1-positive tumors (51%)Patients with PD-L1-negative tumors (39%) OS hazard ratio0.560.85
Regarding safety, the most commonly noted adverse reactions in patients receiving avelumab included rash, fatigue, musculoskeletal pain, and urinary tract infection. One participant with sepsis died. Serious adverse reactions were witnessed in 28% of patients treated with avelumab.
The dose of avelumab is recommended to be 800 mg given intravenously over 60 minutes every 2 weeks until unacceptable toxicity or disease progression. Thus, for managing patients having advanced bladder cancer, avelumab can be utilized as a first-line maintenance treatment.
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Source: US FDA
Original title of the article FDA approves avelumab for urothelial carcinoma maintenance treatment