Overall survival was significantly improved in patients with locally advanced or metastatic urothelial cancer who received first-line maintenance treatment with avelumab versus standard of care, meeting the primary end point of the phase III JAVELIN Bladder 100 study, Pfizer announced in a press release.
Overall survival (OS) was significantly improved in patients with locally advanced or metastatic urothelial cancer who received first-line maintenance treatment with avelumab (Bavencio) versus standard of care, meeting the primary end point of the phase III JAVELIN Bladder 100 study, Pfizer announced in a press release.
The statistically significant OS results will be shared with the FDA and submitted for presentation at an upcoming medical conference. The safety profile of avelumab was consistent with that observed in the JAVELIN monotherapy clinical development program, which involves over 10,000 patients evaluated across more than 15 different tumor types.
“Bavencio is the first immunotherapy to demonstrate in a clinical trial a statistically significant improvement in OS as a first-line treatment for patients with advanced urothelial carcinoma,” said Chris Boshoff, MD, PhD, 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.”
The multicenter, multinational, open-label, parallel-arm, phase III clinical trial is investigating avelumab plus best supportive care (BSC) versus BSC alone in patients with locally advanced or metastatic urothelial cancer whose disease did not progress after completion of first-line platinum-containing chemotherapy. The study recruited 700 participants to assess the primary end point in addition to secondary end points including progression-free survival, antitumor activity, safety, pharmacokinetics, immunogenicity, predictive biomarkers, and patient-reported outcomes in the co-primary populations.
“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.”
Patients were eligible to enroll in the study if they had histologically confirmed, unresectable locally advanced or metastatic urothelial cancer that was stage IV at the start of first-line chemotherapy. Patients were required to have measurable disease as determined by RECIST v1.1 prior to beginning first-line chemotherapy. Patients must have had at least 4 cycles of prior first-line chemotherapy but no more than 6 cycles of gemcitabine plus cisplatin and/or gemcitabine plus carboplatin. Patients could not have progressive disease following completion of first-line chemotherapy.
Individuals are excluded from the study if they have had prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization. Patients who have had prior immunotherapy with IL-2; IFN-α; an antiPD-1, anti–PD-L1, anti–PD-L2, anti-CD137, or CTLA-4 antibody; or with another antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways were also excluded. Patients with persisting toxicity related to prior therapy, known symptomatic central nervous system metastases requiring steroids, and those with other malignancies diagnosed within 5 years prior to randomization were also excluded from the study.
Avelumab was approved by the FDA in 2017 for the treatment of patients with urothelial cancerwhohave 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. The approval was an accelerated approval based on tumor response and duration of response observed with the drug. The phase III JAVELIN Bladder 100 study is a confirmatory study for conversion to full FDA approval. The study is active with an estimated study completion date of June 3, 2021.
Bavencio Significantly Improved Overall Survival in Patients With Locally Advanced or Metastatic Urothelial Carcinoma [news release]. Rockland, Massachusetts and New York, New York: Merck KGaA and Pfizer Inc; January 6, 2020. https://prn.to/36EBko5. Accessed January 6, 2020.