Phase 2 trial of avelumab in combination with gemcitabine in advanced leiomyosarcoma as a second‐line treatment (EAGLES, Korean Cancer Study Group UN18‐06)
Year: 2024
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: In this single-arm, multicenter, phase 2 trial, the authors evaluated the efficacy and safety of avelumab plus gemcitabine in patients with leiomyosarcoma (LMS) who failed on first-line chemotherapy. METHODS: on days 1, 8, and 15 of a 28-day cycle until they developed disease progression or intolerable toxicity. The primary end point was the objective response rate (ORR). RESULTS: In total, 38 patients were enrolled. Of these, 35 patients were evaluable, and the ORR was 20% (95% confidence interval; [CI], 8%-37%). The disease control rate was 71%, and the median duration of response was 21.8 months (range, 7.6 to ≥43.3 months). The median progression free-survival was 5.6 months (95% CI, 4.5-6.8 months), and the median overall survival was 27.5 months (95% CI, 20.4-34.6 months). Grade 3-4 adverse events occurred in 70% of patients, of which neutropenia was the most common (54%). Immune-mediated adverse events occurred in five patients (14%; hypothyroidism, n = 3; hepatitis, n = 2). Patients who had a higher density of tumor-infiltrating lymphocytes (greater than the median) exhibited better ORR (35% vs. 8%; p = .104), progression-free survival (median, 7.3 vs. 3.3 months; p = .024), and overall survival (median, not reached vs. 21.5 months; p = .027). CONCLUSIONS: The combination of avelumab and gemcitabine demonstrated promising efficacy and manageable safety in patients with advanced LMS who progressed on first-line therapy. Tumor-infiltrating lymphocyte density may be an important factor in predicting the response to combining immunotherapy with chemotherapy.
Source: Cancer
DOI: 10.1002/cncr.35609
Authors: Miso Kim, Yu Jung Kim, Yu Jung Kim, Koung Jin Suh, Se Hyun Kim, Jeong Eun Kim, Juhyeon Jeong, Jung Yong Hong, Jeeyun Lee, Su Jin Lee, Sung Yong Oh, Jung Hoon Kim, Gyeong‐Won Lee, Mi Sun Ahn, Wonyoung Choi, Yoon Ji Choi, Taebum Lee, Chiyoon Oum, Jeongkyu Kim, Young Saing Kim, Young Saing Kim, Jin‐Hee Ahn
Institutions: Seoul National University, Seoul National University Hospital, Gachon University, Seoul National University Bundang Hospital, Gachon University Gil Medical Center, Asan Medical Center, University of Ulsan, KoreaBio, Pusan National University Yangsan Hospital, Samsung Medical Center, Sungkyunkwan University, Ewha Womans University, Ewha Womans University Medical Center, Dong-A University Hospital, Dong-A University, Gyeongsang National University, Gyeongsang National University Hospital, Ajou University Hospital, Ajou University, National Cancer Center, Korea University Anam Hospital, Lunit (South Korea)
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,740
Funder: Merck KGaA
Award: G1670422463
OpenAlex ID: W4403539284