Durvalumab plus pazopanib combination in patients with advanced soft tissue sarcomas: a phase II trial

Hee Jin Cho, Kum-Hee Yun, Su-Jin Shin, Young Han Lee, Seung Hyun Kim, Wooyeol Baek, Yoon Dae Han, Sang Kyum Kim, Hyang Joo Ryu, Joohee Lee, Iksung Cho, Heounjeong Go, Jiwon Ko, Inkyung Jung, Min Kyung Jeon, Sun Young Rha and Hyo Song Kim ()
Additional contact information
Hee Jin Cho: CMRI, Kyungpook National University
Kum-Hee Yun: Yonsei University College of Medicine
Su-Jin Shin: Yonsei University College of Medicine
Young Han Lee: Yonsei University College of Medicine
Seung Hyun Kim: Yonsei University College of Medicine
Wooyeol Baek: Yonsei University College of Medicine
Yoon Dae Han: Yonsei University College of Medicine
Sang Kyum Kim: Yonsei University College of Medicine
Hyang Joo Ryu: Yonsei University College of Medicine
Joohee Lee: Yonsei University College of Medicine
Iksung Cho: Yonsei University College of Medicine
Heounjeong Go: University of Ulsan College of Medicine
Jiwon Ko: University of Ulsan College of Medicine
Inkyung Jung: Yonsei University College of Medicine
Min Kyung Jeon: Yonsei University College of Medicine
Sun Young Rha: Yonsei University College of Medicine
Hyo Song Kim: Yonsei University College of Medicine

Nature Communications, 2024, vol. 15, issue 1, 1-10

Abstract: Abstract We aimed to determine the activity of the anti-VEGF receptor tyrosine-kinase inhibitor, pazopanib, combined with the anti-PD-L1 inhibitor, durvalumab, in metastatic and/or recurrent soft tissue sarcoma (STS). In this single-arm phase 2 trial (NCT03798106), treatment consisted of pazopanib 800 mg orally once a day and durvalumab 1500 mg once every 3 weeks. Primary outcome was overall response rate (ORR) and secondary outcomes included progression-free survival (PFS), overall survival, disease control rate, immune-related response criteria, and safety. The ORR was 30.4% and the trial met the pre-specified endpoint. The median PFS was 7.7 months (95% confidence interval: 5.7–10.4). The common treatment-related adverse events of grades 3–4 included neutropenia (9 [19.1%]), elevated aspartate aminotransferase (7 [14.9%]), alanine aminotransferase (5 [10.6%]), and thrombocytopenia (4 [8.5%]). In a prespecified transcriptomic analysis, the B lineage signature was a significant key determinant of overall response (P = 0.014). In situ analysis also showed that tumours with high CD20+ B cell infiltration and vessel density had a longer PFS (P = 6.5 × 10−4) than those with low B cell infiltration and vessel density, as well as better response (50% vs 12%, P = 0.019). CD20+ B cell infiltration was identified as the only independent predictor of PFS via multivariate analysis. Durvalumab combined with pazopanib demonstrated promising efficacy in an unselected STS cohort, with a manageable toxicity profile.

Date: 2024
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DOI: 10.1038/s41467-024-44875-2

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