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Correlation of circulating PD-L2 levels with outcomes of therapy with the anti-PD-1 antibody pembrolizumab (P) in patients (pts) with advanced soft tissue sarcomas (STS): Biomarker analysis of SARC028.

Publication ,  Conference
Burgess, MA; Roszik, J; Van Tine, BA; Hu, J; Schuetze, S; D'Angelo, SP; Attia, S; Priebat, DA; Okuno, SH; Riedel, RF; Davis, LE; Movva, S ...
Published in: Journal of Clinical Oncology
March 1, 2017

60 Background: The activity of the anti-PD-1 antibody P in pts with advanced STS was evaluated in a prospective multicenter Phase II study conducted by the Sarcoma Alliance for Research through Collaboration (SARC). SARC028 enrolled 40 patients with advanced soft tissue sarcoma. Pembro had an ORR of 19% and PFS rate at 12 weeks of 55%, suggesting clinical activity. We investigated biomarkers of response to P. Methods: The primary endpoint was Objective Response Rate (ORR) by RECIST 1.1. Secondary endpoints included progression-free survival (PFS), overall survival, and biomarkers of response in blood and tumor. Pre- and on-treatment biopsies were required and obtained from over 90% and 72% of pts respectively. Serum was obtained from all pts at baseline and at multiple time points on therapy (pre-, week 8, and every 12 weeks). Sera were examined for candidate circulating biomarkers by Affymetrix Luminex platform array, including PD-L2. To determine whether there is a statistically significant difference between different conditions, we used Mann-Whitney and two-tailed t tests. Log-rank p-values in Kaplan-Meier survival analyses were calculated using the "survival" R package. Results: Forty pts with STS were enrolled into 4 cohorts (10 each) based on histological subtype including undifferentiated pleomorphic sarcoma (UPS), dedifferentiated liposarcoma (LPS), synovial sarcoma (SS), and leiomyosarcoma (LMS). 4 pts with UPS, 2 pts with LPS, and one pt with SS achieved a response. Six of seven responses were durable at the time of this analysis. Circulating levels at baseline or after therapy of PD-1, PD-L1, 4-1BB, IDO, BTLA, CTLA-4, LAG-3, and TIM-3 did not correlate with outcome. However, pre-treatment and week 8 PD-L2 levels correlated best with clinical outcome: high PD-L2 levels were associated with better PFS (p=0.019) in STS. Conclusions: P has clinical activity in specific histologic subtypes of STS, namely UPS and LPS. Pre-treatment circulating PD-L2 levels correlated with progression-free survival and is a novel and promising predictor of improved clinical outcome of PD-1 therapy in STS.

Duke Scholars

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

March 1, 2017

Volume

35

Issue

7_suppl

Start / End Page

60 / 60

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

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Burgess, M. A., Roszik, J., Van Tine, B. A., Hu, J., Schuetze, S., D’Angelo, S. P., … Butterfield, L. H. (2017). Correlation of circulating PD-L2 levels with outcomes of therapy with the anti-PD-1 antibody pembrolizumab (P) in patients (pts) with advanced soft tissue sarcomas (STS): Biomarker analysis of SARC028. In Journal of Clinical Oncology (Vol. 35, pp. 60–60). American Society of Clinical Oncology (ASCO). https://doi.org/10.1200/jco.2017.35.7_suppl.60
Burgess, Melissa Amber, Jason Roszik, Brian Andrew Van Tine, James Hu, Scott Schuetze, Sandra P. D’Angelo, Steven Attia, et al. “Correlation of circulating PD-L2 levels with outcomes of therapy with the anti-PD-1 antibody pembrolizumab (P) in patients (pts) with advanced soft tissue sarcomas (STS): Biomarker analysis of SARC028.” In Journal of Clinical Oncology, 35:60–60. American Society of Clinical Oncology (ASCO), 2017. https://doi.org/10.1200/jco.2017.35.7_suppl.60.
Burgess MA, Roszik J, Van Tine BA, Hu J, Schuetze S, D’Angelo SP, et al. Correlation of circulating PD-L2 levels with outcomes of therapy with the anti-PD-1 antibody pembrolizumab (P) in patients (pts) with advanced soft tissue sarcomas (STS): Biomarker analysis of SARC028. In: Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2017. p. 60–60.
Burgess, Melissa Amber, et al. “Correlation of circulating PD-L2 levels with outcomes of therapy with the anti-PD-1 antibody pembrolizumab (P) in patients (pts) with advanced soft tissue sarcomas (STS): Biomarker analysis of SARC028.Journal of Clinical Oncology, vol. 35, no. 7_suppl, American Society of Clinical Oncology (ASCO), 2017, pp. 60–60. Crossref, doi:10.1200/jco.2017.35.7_suppl.60.
Burgess MA, Roszik J, Van Tine BA, Hu J, Schuetze S, D’Angelo SP, Attia S, Priebat DA, Okuno SH, Riedel RF, Davis LE, Movva S, Reed DR, Baker LH, Reinke DK, Maki RG, Patel S, Tawbi HA-H, Butterfield LH. Correlation of circulating PD-L2 levels with outcomes of therapy with the anti-PD-1 antibody pembrolizumab (P) in patients (pts) with advanced soft tissue sarcomas (STS): Biomarker analysis of SARC028. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2017. p. 60–60.

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

March 1, 2017

Volume

35

Issue

7_suppl

Start / End Page

60 / 60

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences