"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, Head of Global R&D for EMD Serono. "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.
About JAVELIN Bladder 100
JAVELIN Bladder 100 (NCT02603432) is a Phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigating first-line maintenance treatment with BAVENCIO plus BSC versus BSC alone in patients with locally advanced or metastatic UC whose disease did not progress after completion of first-line platinum-containing chemotherapy. A total of 700 patients whose disease had not progressed after induction chemotherapy as per RECIST v1.1 were randomly assigned to receive either BAVENCIO plus BSC or BSC alone. The primary endpoint is OS in co-primary populations of all patients and patients with PD-L1–positive tumors. Secondary endpoints include progression-free survival, anti-tumor activity, safety, pharmacokinetics, immunogenicity, predictive biomarkers and patient-reported outcomes in the co-primary populations.
- At the planned interim analysis, Phase III JAVELIN Bladder 100 study met the primary endpoint of prolonging overall survival (OS) as a first-line maintenance treatment versus standard of care
- BAVENCIO is the first immunotherapy to significantly prolong OS in locally advanced or metastatic urothelial carcinoma (UC) in the first-line setting in a Phase III trial
References:
- Cancer.net. Bladder Cancer: Introduction. https://www.cancer.net/cancer-types/bladder-cancer/introduction. Accessed January 2020.
- SEER. Cancer Stat Facts: Bladder Cancer. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed January 2020.
- Bukhari N, et al. Update on the Treatment of Metastatic Urothelial Carcinoma. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6011065/. Accessed January 2020.
- Von der Maase H, et al. Comparing Gemcitabine Plus Cisplatin, With Methotrexate, Vinblastine, Doxorubicin, Plus Cisplatin in patients With Bladder Cancer. Journal of Clinical Oncology. 2005;23(21):4602-4608.
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