Merck KGaA and Pfizer said Monday that a Phase III study of Bavencio (avelumab) as a first-line maintenance therapy for patients with previously untreated locally advanced or metastatic urothelial carcinoma met its primary endpoint of overall survival (OS) at the planned interim analysis. The companies noted that the anti-PD-L1 agent is the first immunotherapy to significantly prolong OS in this setting.
The JAVELIN Bladder 100 trial randomised 700 patients with locally advanced or metastatic urothelial carcinoma, whose disease did not progress after completion of first-line platinum-containing chemotherapy, to receive first-line maintenance therapy with Bavencio plus best supportive care (BSC) or BSC alone. The study's main goal is OS in the co-primary populations of all patients and those with PD-L1–positive tumours, while secondary endpoints include progression-free survival and antitumour activity.
According to Merck and Pfizer, a significant improvement in OS was demonstrated in the Bavencio arm in each of the co-primary populations. The drugmakers added that the results will be submitted for presentation at an upcoming medical congress and shared with the FDA and other health authorities.
"Our unique maintenance approach with Bavencio has significantly prolonged survival for patients with locally advanced or metastatic urothelial carcinoma in this trial," remarked Luciano Rossetti, head of global R&D for Merck's EMD Serono division. Rossetti added "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 granted accelerated approval to 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. The clearance was based on tumour response and duration of response data from the Phase I JAVELIN Solid Tumor trial, with the JAVELIN Bladder 100 study conducted to confirm the findings.
Bavencio, which is also authorised for use in patients with metastatic Merkel cell carcinoma and in combination with Inlyta (axitinib) as a first-line treatment for advanced renal cell carcinoma, generated sales of €29 million ($32 million) in the third quarter of last year. In November, the companies reported that a Phase III trial of Bavencio as a first-line maintenance treatment in certain patients with gastric or gastroesophageal junction cancer had failed to meet its primary endpoints.
To read more Top Story articles, click here.