BAVENCIO Significantly Improved Overall Survival in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Merck and Pfizer Inc. (NYSE: PFE) today announced the Phase III JAVELIN Bladder 100 study met its primary endpoint of overall survival (OS) at the planned interim analysis. In this study, patients with previously untreated locally advanced or metastatic urothelial carcinoma (UC) whose disease did not progress on induction chemotherapy and who were randomized to receive first-line maintenance therapy with BAVENCIO^® (avelumab)* and best supportive care (BSC) lived significantly longer than those who received BSC only. A statistically significant improvement in OS was demonstrated in the BAVENCIO arm in each of the co-primary populations: all randomized patients and patients with PD-L1–positive tumors. The safety profile for BAVENCIO in the trial was consistent with that in the JAVELIN monotherapy clinical development program. The results of the study will be submitted for presentation at an upcoming medical congress and shared with the US Food and Drug Administration (FDA) and other health authorities.

"BAVENCIO is the first immunotherapy to demonstrate in a clinical trial a statistically significant improvement in overall survival as a first-line treatment for patients with advanced urothelial carcinoma," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "These latest positive data from the JAVELIN clinical development program add to the body of evidence for BAVENCIO in the treatment of genitourinary cancers, and we look forward to discussing these results with health authorities."

UC accounts for about 90% of all bladder cancer.¹ When bladder cancer is metastatic, the five-year survival rate is 5%.² Combination chemotherapy is currently the first-line standard of care for patients with advanced disease, but despite high initial response rates, durable and complete responses following first-line chemotherapy are uncommon, and most patients will ultimately experience disease progression within nine months after initiation of treatment.^3,4

"Our unique maintenance approach with BAVENCIO has significantly prolonged survival for patients with locally advanced or metastatic urothelial carcinoma in this trial," said Luciano Rossetti, M.D., Executive Vice President, Head of Global R&D for the Biopharma business of Merck. "We believe this approach could become part of routine clinical practice, as these results are a major advance on the existing standard of care." 

In 2017, the FDA approved BAVENCIO for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response and duration of response. JAVELIN Bladder 100 is the confirmatory study for the conversion to full approval.

*BAVENCIO is under clinical investigation for the first-line maintenance treatment of advanced UC. There is no guarantee that BAVENCIO will be approved for first-line maintenance treatment of UC by any health authority worldwide.

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