Median overall survival was 26.7 months in patients who received 80% or more of scheduled injections.
Major Finding: Median overall survival was 26.7 months in patients who received 80% or more of scheduled injections.
Concept: Among all 57 patients treated in this phase II trial, there were no adverse events grade 3 or higher.
Impact: This virus treatment is now being studied in other tumor types and with immune checkpoint blockade.
Intratumoral oncolytic virus treatment—which is thought to work via direct virus-mediated cancer cell lysis and indirect recruitment of tumor-infiltrating lymphocytes—has shown promise for a variety of solid tumor types, and one oncolytic virus (talimogene laherparepvec, or T-VEC) has been approved for the treatment of unresectable melanoma. Coxsackievirus A21 (V937) is another candidate for melanoma treatment, with potential advantages being lack of need for attenuation and absence of stimulation of the cGAS–STING pathway, which could otherwise lead to viral clearance and reduced efficacy. Andtbacka and colleagues conducted a phase II, open-label, single-arm clinical trial of V937 in 57 patients with unresectable, stage IIIC or IV melanoma. Among the 40 patients who received 80% or more of scheduled injections, the median progression-free survival was 11.1 months, and the median overall survival was 26.7 months. However, among the 17 patients who received fewer than 80% of scheduled injections, the median progression-free survival and median overall survival were 1.4 months and 10.5 months, respectively. Regression of both injected and noninjected lesions was observed, with 49.4% and 26.7%, respectively, exhibiting reductions in size. Notably, there were no treatment-emergent adverse events of grade 3 or higher; the most common treatment-emergent adverse events were injection site pain, fatigue, and chills. In summary, the results of this trial demonstrate that V937 is an agent of interest in the treatment of metastatic melanoma, not only because of the responses observed, but also because of the favorable safety and toxicity profile. Building on the results of this work, V937 is now being tested in other cancer types and in combination with immune checkpoint inhibitors.
Andtbacka RHI, Curti B, Daniels GA, Hallmeyer S, Whitman ED, Lutzky J, et al. Clinical responses of oncolytic Coxsackievirus A21 (V937) in patients with unresectable melanoma. J Clin Oncol 2021 Aug 31 [Epub ahead of print].
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