Mette Bjerre

Avelumab for the treatment of relapsed or refractory extranodal NK/T-cell lymphoma: an open-label phase 2 study

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

DOI

  • Seok Jin Kim, Sungkyunkwan Univ, Sungkyunkwan University (SKKU), Samsung Medical Center, Sch Med, Samsung Med Ctr, Dept Orthoped Surg
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  • Jing Quan Lim, Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore; Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.
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  • Yurike Laurensia, Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore; Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.
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  • Junhun Cho, Sungkyunkwan Univ, Sungkyunkwan University (SKKU), Samsung Medical Center, Sch Med, Samsung Med Ctr, Dept Orthoped Surg
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  • Sang Eun Yoon, Sungkyunkwan Univ, Sungkyunkwan University (SKKU), Samsung Medical Center, Sch Med, Samsung Med Ctr, Dept Orthoped Surg
  • ,
  • Ji Young Lee, Samsung Advanced Institute for Health Sciences and Technology
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  • Kyung Ju Ryu, Samsung Advanced Institute for Health Sciences and Technology
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  • Young Hyeh Ko, Sungkyunkwan University
  • ,
  • Youngil Koh, Seoul Natl Univ Hosp, Seoul National University, Seoul National University Hospital, Dept Surg
  • ,
  • Duck Cho, Sungkyunkwan Univ, Sungkyunkwan University (SKKU), Samsung Medical Center, Sch Med, Samsung Med Ctr, Dept Orthoped Surg
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  • Soon Thye Lim, Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore; Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.
  • ,
  • Marie Beck Enemark
  • Francesco D'amore
  • Mette Bjerre
  • Choon Kiat Ong, Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore; Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.
  • ,
  • Won Seog Kim, Sungkyunkwan Univ, Sungkyunkwan University (SKKU), Samsung Medical Center, Sch Med, Samsung Med Ctr, Dept Orthoped Surg

This study aimed to assess the efficacy and safety of treatment with avelumab, an anti-programmed death ligand 1 (PD-L1) antibody, in patients with relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (ENKTL). In this phase II trial, 21 patients with relapsed or refractory ENKTL were treated with 10 mg/kg of avelumab on days 1 and 15 of a 28-day cycle (ClinicalTrials.gov Identifier: NCT03439501). The primary end point was the complete response (CR) rate based on the best response. Targeted sequencing and immunohistochemistry were performed using pretreatment tumor tissue, and blood samples were drawn pre- and post-treatment for measurement of cytokines and soluble programmed cell death protein 1 (PD1), PD-L1, and PD-L2. The CR rate was 24% (5/21) and the overall response rate was 38% (8/21). Although nonresponders showed early progression, five responders currently continue to receive treatment and have maintained their response. Most treatment-related adverse events were grade 1 or 2; no grade 4 adverse events were observed. Treatment responses did not correlate with mutation profiles, tumor mutation burden, serum levels of cytokines, or soluble PD1/PD-L1 and PD-L2. However, the response to avelumab was significantly associated with the expression of PD-L1 by tumor tissue (P = 0.001). Therefore, all patients achieving CR showed high PD-L1 expression, and their tumor subtyping based on PD-L1 expression correlated with treatment response. In conclusion, avelumab showed single-agent activity in a subset of patients with relapsed or refractory ENKTL. The assessment of PD-L1 expression on tumor cells might be helpful for identifying responders to avelumab.

OriginalsprogEngelsk
TidsskriftBlood
ISSN0006-4971
DOI
StatusE-pub ahead of print - 7 aug. 2020

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