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Anatomic Location Predicts Response Rates: Real World Outcomes with Over 1,100 Cycles of Talimogene Laherparepvec (TVEC)
*Gray B. Peery
1, *Kristen E. Dougherty
1, *Chris B. Agala
1, *Veronica P. Pham
1, *Morgan E. Gwynn
2, *Michael O. Meyers
1, *Karyn B. Stitzenberg
1, *Jonathan D. Sorah
3, *Patricia K. Long
1, *Frances A. Collichio
3,
David W. Ollila11Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC; 2Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC; 3Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC
Objective: TVEC is the first FDA-approved injectable oncolytic virus to treat unresectable stage IIIB-IVA metastatic melanoma patients. Previously published real-world outcomes demonstrated a 39% complete response (CR) rate to TVEC (JACS, 2019). We hypothesized that anatomic location of metastatic melanoma is associated with the degree of therapeutic response to TVEC.
Methods: A prospective single-center melanoma database of patients treated with TVEC from December 2015-December 2023 was analyzed. We assessed patient demographics, clinicopathologic characteristics, TVEC treatment data, other immunotherapy received, side effects, and outcomes. Patients were categorized into groups based on treated anatomic sites. Side effects were categorized based on the National Cancer Institute Criteria for Adverse Events. Patient characteristics were summarized using frequencies, means, medians, comparisons, and tests of proportions using chi-square, Fisher’s exact, and Wilcoxon rank sum tests. We used unadjusted generalized estimating equation models with repeated measures to estimate relative risk ratios for local treatment response and anatomic sites. In all statistical tests, p<0.05 was considered statistically significant.
Results: 173 patients were included: median age 75 years [interquartile range (IQR)] (30-95); majority male (n=112, 64.7%) and white (n=170, 98.3%). We analyzed 190 therapeutic plans of TVEC with a total of 1,133 cycles, median 6 cycles/patient (1-18). 17 patients received 2 therapeutic plans of TVEC. Median follow-up was 41 months (11-107). Of the anatomic sites treated, 73 were head/neck (38.4%), 73 lower extremity (38.4%), 25 torso (13.2%), and 19 upper extremity (10%). CR was seen in 79 (41.6%), partial response (PR) in 41 (21.6%), mixed response/stable disease in 37 (19.5%), and disease progression in 33 (17.4%). In the CR group, 40 (50.6%) responses were head/neck, 24 (30.4%) lower extremity, 11 (13.9%) torso, and 4 (5.1%) upper extremity. Furthermore, 69.6% (55/79) patients had a durable CR (?6 months, as per OPTiM trial definition) with no evidence of disease at last follow-up, median follow-up 26 months (IQR:13-49). Patients were 3.9 and 3.3 times more likely to have CR vs stable disease in head/neck than lower and upper extremity, respectively. Similarly, they were 1.6 and 5.0 times more likely to have CR vs mixed response for treatments in neck/head vs lower and upper extremities. The majority (n=178, 93.7%) had no side effects or only grade 1 toxicities, 12 (6.3%) had grade 2-4 and none had grade 5 (difference=87.2%, 95% CI: 0.82-0.92, p<0.0001).
Conclusions: This is the largest prospective cohort evaluating real-world outcomes of metastatic melanoma patients treated with TVEC based on anatomic location. TVEC is a well-tolerated, durable treatment for advanced staged melanoma. Our findings demonstrate head/neck metastases have the greatest CR rate and should be strongly considered as first-line therapy for these patients.
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