ESMO 2019: Neoadjuvant Talimogene Laherparepvec in Advanced Resectable Melanoma
Posted: Wednesday, October 30, 2019
According to the 2-year results of a phase II trial, showcased at the 2019 European Society for Medical Oncology (ESMO) Congress in Barcelona (Abstract LBA66), neoadjuvant therapy with talimogene laherparepvec may improve overall and relapse-free survival for patients with resectable stage IIIB to IVM1a melanoma. The findings, presented by Reinhard Dummer, MD, of the University of Zurich, and colleagues, are the result of reportedly the largest randomized trial of the intralesional immunotherapy in patients with advanced melanoma.
“T-cell influx and PD-L1 upregulation after talimogene laherparepvec treatment support a role for the adaptive immune system consistent with the mechanisms of action,” the authors concluded.
In this multicenter, open-label trial, the investigators enrolled 150 patients previously diagnosed with resectable stage IIIb to IVM1a melanoma who had one or more injectable cutaneous, subcutaneous, or nodal lesions. The patients were treated with either six doses of talimogene laherparepvec for 12 weeks followed by surgery or with surgery alone.
After a median follow-up of 31.2 months, 29.5% of patients treated with talimogene laherparepvec remained free of recurrence at 2 years, whereas 16.5% of those who received surgery were free of recurrence at 2 years. In the additional sensitivity analysis, just more than half (50.5%) of patients treated with talimogene laherparepvec were free of recurrence at 2 years, compared with 30.2% of those who did not receive the treatment.
The 2-year overall survival rates were 88.9% and 77.4% for those treated with and without talimogene laherparepvec, respectively. The authors reported that the use of talimogene laherparepvec resulted in a threefold increase in intratumoral CD8-positive cell density and an increase in PD-L1 expression. CD8-positive density and PD-L1 H-scores were also higher after treatment for those who received talimogene laherparepvec than for those who had surgery alone. A sensitivity analysis revealed that intratumoral CD8-positive density levels after treatment correlated with longer recurrence-free survival for patients treated with talimogene laherparepvec.
Disclosure: For full disclosures of the study authors, visit esmo.org.