medwireNews: The preliminary analysis of the real-world AVENANCE study bolsters the recommendation for avelumab maintenance in people with advanced urothelial carcinoma (UC) that has not progressed after first-line platinum-based chemotherapy.
Presenting the results in a poster at the ESMO Congress 2022 in Paris, France, the study authors said that “[t]hese first real-world data […] support the findings of the JAVELIN Bladder 100 trial,” which showed a significant improvement in survival with the addition of maintenance avelumab to best supportive care in this patient population and led to the approval of the PD-L1 inhibitor “in various countries worldwide.”
The AVENANCE study – which the authors describe as ambispective, that is, retrospective and prospective – is an ongoing study in France, which enrolls patients with locally advanced or metastatic UC who have previous, ongoing, or planned avelumab maintenance after achieving a complete or partial response or stable disease following first-line chemotherapy.
In the poster, they reported on the 267 participants who initiated avelumab at least 6 months before data cutoff. Patients were aged a median of 73.1 years and the majority were men (81.3%) and had metastatic disease (90.2%). The ECOG performance status at the start of chemotherapy was 0–1 in 85.9% and 2–3 in 14.1%.
Over half (57.6%) of the participants had received carboplatin plus gemcitabine chemotherapy, while 31.8% had received cisplatin plus gemcitabine, and 10.6% had received another regimen. A total of 21.8% had a complete response to chemotherapy, 55.9% had a partial response, and 20.3% had stable disease.
Patients received avelumab for a median of 5.8 months and 34.5% were continuing to receive the PD-L1 inhibitor at the time of analysis, which was conducted at a median follow-up of 13.5 months.
The primary endpoint of overall survival (OS) from the start of avelumab treatment was a median of 20.7 months. The 12-month OS rate from the initiation of avelumab was 66.9%, while it was 79.1% from the start of chemotherapy.
The median progression-free survival (PFS) from the start of avelumab was 5.7 months, which was “comparable to results from the JAVELIN Bladder 100 trial,” and the PFS rate at 12 months was 36.9%, reported Philippe Barthélémy, from Institut de Cancérologie Strasbourg Europe in France, and co-researchers.
They continued: “The safety profile was consistent with that observed in other studies of avelumab monotherapy, and no new safety concerns were identified.”
In all, 38.2% of patients experienced treatment-related adverse events (TRAEs), with serious TRAEs occurring in 5.2%. TRAEs led to temporary or permanent discontinuation of treatment in 9.7% of participants and to death in one case.
“These early results […] confirm the clinical activity and acceptable safety profile of avelumab in a heterogeneous population outside of a clinical trial setting,” said Barthélémy and colleagues.
And they concluded: “These results further support the recommendation of avelumab [first-line] maintenance as standard of care for patients with [locally advanced or metastatic] UC that has not progressed with [first-line] platinum-based chemotherapy.”
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This independent news story was supported by an educational grant from Pfizer and Merck Healthcare KGaA, Darmstadt, Germany