Long-Term Follow-Up Data Reinforce Continued Overall Survival Benefit of BAVENCIO® (avelumab) First-Line Maintenance Treatment in Patients with Advanced Urothelial Carcinoma

Not intended for UK-based media 38-month median follow-up data from the Phase III JAVELIN Bladder 100 trial demonstrated prolonged median OS of 23.8 months with BAVENCIO plus best supportive care (BSC) in the first-line maintenance setting versus a median OS of 15.0 months with BSC alone BAVENCIO continues to be the first and only immunotherapy to improve survival in the first-line setting in locally advanced or metastatic UC in a Phase III study EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany, in the US and Canada, today announced the results of an exploratory analysis from the Phase III JAVELIN Bladder 100 trial with 19 additional months of follow-up data from the initial primary analysis. This analysis reinforced the original results and showed that BAVENCIO® (avelumab) plus best supportive care (BSC) in the first-line maintenance setting prolonged median overall survival (OS) by 8.8 months versus BSC alone for patients with locally advanced or metastatic urothelial carcinoma (UC) whose tumors had not progressed on a platinum-based chemotherapy. These results were presented at the 2022 American Society of Clinical Oncology’s annual Genitourinary Cancers Symposium taking place February 17-19, 2022. “Since the introduction of the first-line maintenance regimen of BAVENCIO plus best supportive care, it has been recommended with the highest level of evidence in the NCCN, ESMO, EAU and JUA guidelines, and BAVENCIO first-line maintenance has become a standard of care in the locally advanced and metastatic UC treatment setting. The results from this analysis further reinforce the benefit of first-line maintenance therapy, and of BAVENCIO as the only immunotherapy in the maintenance setting shown to improve survival in this disease,” said Thomas Powles, MBBS, MRCP, MD, Professor of Genitourinary Oncology, Lead for Solid Tumor Research at Barts Cancer Institute, Queen Mary University of London, and Director of Barts Cancer Centre, London, UK. At 38 months median follow-up, patients who received first-line maintenance BAVENCIO plus BSC showed consistent overall survival benefit over patients on BSC alone. Median OS was 23.8 months (95% CI, 19.9 to 28.8) vs 15.0 months (95% CI, 13.5 to 18.2) (HR 0.76; 95% CI, 0.631 to 0.915).1 43.7% of patients (95% CI, 38.2% to 49.0%) in the BAVENCIO arm were alive at 30 months vs 33.5% (95% CI, 28.4% to 38.7%) of patients who received BSC alone.1 In the population of patients with PD-L1+ tumors (n=358): Median OS was 30.9 months (95% CI, 24.0-39.8) vs 18.5 months (95% CI, 14.1-24.2) (HR 0.69; 95% CI, 0.521 to 0.901).1 More than half (51.3%; 95% CI, 43.7% to 58.4%) of patients who received BAVENCIO were alive at 30 months vs 38.5% (95% CI, 30.9% to 46.1%) in the BSC arm.1 Median overall survival was measured from the time of randomization, after completion of four to six cycles of platinum-based chemotherapy. The safety profile for BAVENCIO was consistent with the overall JAVELIN monotherapy clinical development program, with no new safety signals. Patients continued treatment until disease progression, unacceptable toxicity or any other criteria for withdrawal occurred. In the primary population of all randomized patients, 19.5% of patients received ≥2 years of treatment, with 10.2% of patients discontinuing due to treatment-related adverse event with onset after ≥12 months of treatment. “Locally advanced and metastatic urothelial carcinoma has a low five-year survival rate and high recurrence rate, requiring additional medicines to maintain the benefits of chemotherapy and improve survival rates. The continued improvement in survival in the JAVELIN Bladder 100 trial further supports the use of BAVENCIO as maintenance therapy in patients whose disease has not progressed on first-line platinum-containing chemotherapy and reinforces our commitment to further evaluation of BAVENCIO in advanced bladder cancer,” said Victoria Zazulina, MD, Head of Development Unit Oncology, Merck KGaA, Darmstadt, Germany.

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