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. 2018 May 18;6(1):38.
doi: 10.1186/s40425-018-0345-7.

Adjuvant NY-ESO-1 vaccine immunotherapy in high-risk resected melanoma: a retrospective cohort analysis

Michael Lattanzi  1   2 , Joseph Han  3 , Una Moran  4   5 , Kierstin Utter  6   5 , Jeremy Tchack  7   5 , Rachel Lubong Sabado  8   9 , Russell Berman  10   11   12 , Richard Shapiro  13   11   12 , Hsin-Hui Huang  14 , Iman Osman  15   2   5   12 , Nina Bhardwaj  16   9   17 , Anna C Pavlick  18   2   5   12
Affiliations

Adjuvant NY-ESO-1 vaccine immunotherapy in high-risk resected melanoma: a retrospective cohort analysis

Michael Lattanzi et al. J Immunother Cancer. .

Abstract

Background: Cancer-testis antigen NY-ESO-1 is a highly immunogenic melanoma antigen which has been incorporated into adjuvant vaccine clinical trials. Three such early-phase trials were conducted at our center among patients with high-risk resected melanoma. We herein report on the pooled long-term survival outcomes of these patients in comparison to historical controls.

Methods: All melanoma patients treated at NYU Langone Health under any of three prospective adjuvant NY-ESO-1 vaccine trials were retrospectively pooled into a single cohort. All such patients with stage III melanoma were subsequently compared to historical control patients identified via a prospective institutional database with protocol-driven follow-up. Survival times were calculated using the Kaplan-Meier method, and Cox proportional hazard models were employed to identify significant prognostic factors and control for confounding variables.

Results: A total of 91 patients were treated with an NY-ESO-1 vaccine for the treatment of high-risk resected melanoma. Of this group, 67 patients were stage III and were selected for comparative analysis with 123 historical control patients with resected stage III melanoma who received no adjuvant therapy. Among the pooled vaccine cohort (median follow-up 61 months), the estimated median recurrence-free survival was 45 months, while the median overall survival was not yet reached. In the control cohort of 123 patients (median follow-up 30 months), the estimated median recurrence-free and overall survival were 22 and 58 months, respectively. Within the retrospective stage III cohort, NY-ESO-1 vaccine was associated with decreased risk of recurrence (HR = 0.56, p < 0.01) and death (HR = 0.51, p = 0.01). Upon controlling for sub-stage, the adjuvant NY-ESO-1 clinical trial cohort continued to exhibit decreased risk of recurrence (HR = 0.45, p < 0.01) and death (HR = 0.40, p < 0.01).

Conclusions: In this small retrospective cohort of resected stage III melanoma patients, adjuvant NY-ESO-1 vaccine immunotherapy was associated with longer recurrence-free and overall survival relative to historical controls. These data support the continued investigation of adjuvant NY-ESO-1 based immunotherapy regimens in melanoma.

Keywords: Adjuvant; CTLA-4; Cancer Testis Antigen; Immunotherapy; Melanoma; NY-ESO-1; Nivolumab; PD-1; Tumor antigen; Vaccine.

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Conflict of interest statement

Ethics approval and consent to participate

The three adjuvant vaccine trials were conducted in accordance with all accepted standards for the ethical conduct of human subjects research; all three were approved by the NYU IRB, and all patients provided informed consent at the time of enrollment. The NYU melanoma registry is approved by the NYU IRB for the prospective collection of demographic, clinical, and pathologic data as well as biospecimens for research purposes. The present retrospective study was approved by the NYU IRB (s15–01258), which granted a waiver of informed consent.

Consent for publication

All patients consented to participate in either an adjuvant vaccine trial or the NYU melanoma registry.

Competing interests

The authors declare that they have no competing interest.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Recurrence-free (left, log-rank p = 0.98) and overall survival (right, log-rank p = 0.37) of all adjuvant stage III NY-ESO-1 vaccine clinical trial patients stratified by each of the three individual trials
Fig. 2
Fig. 2
Recurrence-free (left, p < 0.01) and overall survival (right, p = 0.01) among all stage III patients stratified by adjuvant NY-ESO-1 vaccine versus no adjuvant therapy
Fig. 3
Fig. 3
Recurrence patterns among retrospective stage III cohort stratified by vaccine versus no adjuvant therapy (left, p = 0.5) indicating the number of patients with resectable versus non-resectable recurrences, and specific sites of disease recurrence among the stage III adjuvant NY-ESO1 vaccine cohort (right, n = 35)
See this image and copyright information in PMC

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