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Avelumab Safe and Effective for Metastatic Urothelial Cancer
San Francisco, California—Administering avelumab therapy in patients with metastatic urothelial cancer yielded durable clinical activity and a safety profile that was manageable, according to results from a recent study presented at the 2019 ASCO Genitourinary Cancers Symposium.
“Avelumab, a human anti‒PD-L1 IgG1 antibody, is approved for the treatment of metastatic urothelial cancer…progressing after platinum chemotherapy in the US, Canada, and Israel,” explained lead investigator Andrea B. Apolo, MD, Head, Bladder Cancer Section, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, and colleagues, who shared updated findings from 2 cohorts of patients receiving avelumab in the JAVELIN Solid Tumor clinical trial.
Patients with metastatic urothelial cancer were eligible for inclusion in the JAVELIN Solid Tumor study if their disease progressed after platinum-based therapy or if they were cisplatin-ineligible. They were given avelumab 10 mg/kg every 2 weeks and had their tumors evaluated every 6 weeks.
The end points of the study included objective response rate (ORR), response duration, progression-free survival (PFS), overall survival (OS), and safety.
According to Dr Apolo and colleagues, 249 patients had received avelumab and had been followed-up with for ≥2 years (median 2.7 years) as of April 2018. The median duration of treatment was 12 weeks, and 12 (4.8%) patients are still receiving treatment.
Among 242 evaluable patients, the confirmed ORR was 16.5% (95% confidence interval [CI], 12.1%-21.8%), with 4.1% achieving a complete response. The median response duration was 20.5 months (95% CI, 9.7-not estimable), and the estimated 12-month response duration was 65.4% (95% CI, 47.0%-78.8%).
In addition, the median PFS and OS was 1.6 months (95% CI, 1.4-2.7 months) and 7.0 months (95% CI, 5.9-8.5 months), respectively. The estimated 12- and 24-month OS rates were 35.9% (95% CI, 29.9%-42.0%) and 20.1% (95% CI, 15.2%-25.4%), respectively.
Treatment-related adverse events of any grade occurred in approximately 70% of patients, with the most common being infusion-related reactions (24.1%), fatigue (18.1%), and rash (18.1%); of note, 29 (11.6%) patients had treatment-related adverse events grade ≥3. Overall, 10 (4 %) patients discontinued avelumab because of treatment-related adverse events; 1 treatment-related death occurred due to pneumonitis.
“Avelumab showed durable clinical activity and had a manageable safety profile in pts [patients] with mUC [metastatic urothelial cancer]. A phase 3 trial of avelumab in the maintenance setting after first-line platinum-based therapy for mUC is ongoing,” Dr Apolo and colleagues concluded.—Hina Khaliq
Apolo AB, Ellerton JA, Infante JR, et al. Avelumab treatment for metastatic urothelial carcinoma in the phase Ib JAVELIN Solid Tumor Study: Updated safety and efficacy analysis with ≥ two years of follow-up. Presented at: the 2019 Genitourinary Cancers Symposium; February 14-16, 2019; San Francisco, CA. Abstract 425.
