TOPLINE:
The oncolytic viral immunotherapy talimogene laherparepvec (T-VEC; Imlygic) was associated with a significant improvement in 5-year survival outcomes, including overall survival, compared with surgery alone in patients with advanced resectable melanoma, new data suggest.
METHODOLOGY:
- This phase 2, open-label randomized clinical trial enrolled 150 patients with resectable stage IIIB to IVM1a melanoma and one or more injectable cutaneous, subcutaneous, or nodal lesions.
- Patients were randomly assigned to receive six doses of neoadjuvant T-VEC followed by surgery (group 1), or immediate surgery alone (group 2). Investigators could provide their choice of adjuvant therapy.
- T-VEC was delivered as an intralesional injection on day 1 of weeks 1, 4, 6, 8, 10, and 12 until surgery, no remaining injectable tumors, or intolerance.
- The primary endpoint was recurrence-free survival; other endpoints included overall survival, event-free survival, and distant metastasis-free survival.
- The two groups exhibited similar disease stages at baseline; 13.7% in group 1 and 31.9% in group 2 received adjuvant therapy.
TAKEAWAY:
- Over a median follow-up of 63.3 months, 5-year recurrence-free survival was 22.3% in group 1 and 15.2% in group 2 (hazard ratio [HR], 0.76).
- Patients in group 1 also demonstrated "durable" improvements in 5-year event-free survival (43.7% vs 27.4%; HR, 0.57) and 5-year overall survival (77.3% vs 62.7%; HR, 0.54).
- Group 1 showed improvements in distant metastasis-free survival as well (HR, 0.73; 80% CI, 0.57-0.94).
IN PRACTICE:
"These results demonstrate that neoadjuvant T-VEC plus surgery improves cancer-related outcomes vs surgery alone, with acceptable safety," the authors concluded, adding that the improvement in survival outcomes "is likely the result of an induced systemic immunologic antitumor effect, as shown by elevated CD8+ density after T-VEC treatment."SOURCE:
The study, led by Reinhard Dummer, MD, Department of Dermatology, University Hospital of Zurich, Switzerland, was published online in JAMA Oncology on August 10.
LIMITATIONS:
- The study is limited by the definition and assessment of recurrence-free survival in the trial design, which does not account for disease progression during the neoadjuvant period.
- Overall, 14.5% of patients in group 1 (n = 11) did not undergo surgery owing to disease progression; 16 discontinued T-VEC.
DISCLOSURES:
The study was sponsored and funded by Amgen. Dummer declared relationships with Novartis, Merck Sharp & Dohme, Bristol Myers Squibb, Roche, Amgen, Takeda, and Pierre Fabre, among others.
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