AstraZeneca Plc has reported trial data for a new combination therapy directed against muscle-invasive bladder cancer which showed improvements in event-free survival for the patients concerned. The muscle-invasive disease is estimated to affect one in four people with bladder cancer and arises when a tumour invades the bladder’s muscle wall. The standard treatment for these patients is surgery, with or without an adjuvant treatment. However surgery has not stopped the disease from recurring in about half of patients who receive it, the company said in a statement issued on 14 May.
In the Phase 3 VOLGA trial, patients with muscle invasive bladder cancer were randomised to receive the checkpoint inhibitor, Imfinzi (durvalumab), with or without Imjudo (tremelimumab), in combination with the antibody-drug conjugate Padcev (enfortumab vedotin). The comparator arm was surgery with or without an approved adjuvant therapy. The trial enrolled 695 patients. At the interim analysis, the combination therapy showed a statistically significant and clinically meaningful improvement in event free survival and a favourable trend for overall survival. However the overall survival data were not statistically significant at the interim period and will be formally reassessed at a subsequent analysis. In a statement, Susan Galbraith, head of oncology haematology R&D at AstraZeneca said: “This interim analysis from the VOLGA trial highlights the benefit of perioperative Imfinzi with neoadjuvant enfortumab vedotin compared to surgery, a novel regimen that optimises treatment options for patients.”
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