Neoadjuvant Talimogene Laherparepvec Plus Surgery for Melanoma: 1-Year Recurrence-Free Survival
Posted: Tuesday, August 6, 2019
According to interim results from a clinical trial presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract 9520) and published in the Journal of Clinical Oncology, patients diagnosed with melanoma who received neoadjuvant talimogene laherparepvec plus surgery had better recurrence-free survival rates than patients treated with upfront surgery. Reinhard Dummer, MD, of the University Hospital Zürich Skin Cancer Center, and colleagues presented their results as part of reportedly the largest randomized neoadjuvant trial to date of resectable stage IIIB to IVM1a melanoma.
In this open-label phase II study (ClinicalTrials.gov identifier NCT02211131), the investigators enrolled 150 patients diagnosed with resectable stage IIIB/C/IVM1a melanoma who had one or more injectable cutaneous, subcutaneous, or nodal lesions; all of these patients had no systemic treatment 3 months prior to enrollment. The patients were split into two groups: Arm 1 (76 patients) received 6 doses of talimogene laherparepvec over 12 weeks followed by surgery, and arm 2 (74 patients) received upfront surgery alone.
A total of 1 year after treatment, 33.5% of patients in arm 1 remained free of recurrence, compared with 21.9% of patients in arm 2 (hazard ratio = 0.73). From a sensitivity analysis conducted, the investigators found that 55.8% of patients in arm 1 were free of recurrence after 1 year, versus 39.3% of patients in arm 2 (hazard ratio = 0.63).
In the group that received talimogene laherparepvec plus surgery, the overall survival rate was 95.9%, compared with 85.8% in the upfront surgery cohort. For patients who received subsequent adjuvant therapy—8 in arm 1 and 20 in arm 2—immunotherapy was the most common treatment (8.2% and 11.6%, respectively).
The authors noted that a future analysis of recurrence-free survival after 2 years in this patient population is expected.
Disclosure: The study authors’ disclosure information may be found at ascopubs.org.