Avelumab (Bavencio) will be added to the PBS from 1 October as the first maintenance therapy for advanced urothelial carcinoma.
The anti-PD-L1 monoclonal antibody was recommended “for the maintenance treatment of Stage III or Stage IV urothelial carcinoma in patients whose disease has not progressed following first-line platinum-based chemotherapy” at the March 2021 PBAC meeting [link here].
“The PBAC considered that the appropriate comparator would be best supportive care with subsequent therapy with pembrolizumab on progression. The PBAC considered that, while the magnitude of the incremental benefit of the use of maintenance avelumab versus initiation of pembrolizumab on disease progression was uncertain, it was likely avelumab in this context would offer benefit to some patients.”
The decision follows the phase III JAVELIN Bladder 100 trial which randomised 700 patients with locally advanced or metastatic urothelial carcinoma who had not progressed following first-line, platinum-based chemotherapy to maintenance treatment with avelumab plus best supportive care versus best supportive care alone.
The study, published in the NEJM [link here], found 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).
Associate Professor David Pook, from Monash Health and Holmesglen Private Hospital, said the survival benefit of avelumab as first-line maintenance therapy versus best supportive care was clear.
“We are now moving from watch and wait following chemotherapy to active therapy to prevent cancer progression,” he said.
“When bladder cancer progresses, some patients become too sick to receive further treatment, so moving directly to maintenance improves the proportion of patients who receive both chemotherapy and immunotherapy.”
“As the first checkpoint inhibitor to show a survival advantage as maintenance therapy for locally advanced or metastatic urothelial cancer, Bavencio is now the standard-of-care for patients who complete chemotherapy without progression,” he said.