Bladder Cancer Coverage from Every Angle

Combination Immunotherapy for Urothelial Carcinoma: Phase Ib Interim Analysis

By: Kelly M. Hennessey, PhD
Posted: Tuesday, January 5, 2021

An interim analysis of the dose-expansion part of the JAVELIN IL-12 study was undertaken by Jean-Laurent Deville, MD, of La Timone Hospital, Marseille, France, and colleagues. They investigated the efficacy and safety of the anti–PD-L1 monoclonal antibody avelumab with immunocytokine M9421 in patients with advanced urothelial carcinoma. Their results, which were presented during the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting (Abstract 265) and published in the Journal for ImmunoTherapy of Cancer, revealed the combination did not meet a predefined efficacy criterion to proceed to phase II.

A total of 16 patients with locally advanced or metastatic urothelial cancer that had progressed on first-line therapy were included in the single-arm of this phase Ib study. Patients received 800 mg of avelumab once weekly in combination with 16.8 μg/kg of M9241 for the first 12 weeks and then continued with avelumab once every 2 weeks. An interim futility analysis based on the best overall response established whether the randomized controlled part of the study would commence.

At the time of data cutoff, no complete or partial responses were seen. Of the 16 patients, 2 had stable disease, 13 had progressive disease, and 1 was not evaluable. Treatment-related adverse events of any grade occurred in 93.8% of patients (n = 15), including pyrexia (50.0%), nausea (37.5%), asthenia (31.3%), anemia (25.0%), and hyperthermia (25.0%). No treatment-related adverse events led to death. Although the combination of avelumab with M9421 was well tolerated overall, the study was unsuccessful in meeting the necessary efficacy criterion to proceed to phase II.

Disclosure: For full disclosures of the study authors, visit

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