Loncastuximab tesirine in Chinese patients with relapsed or refractory diffuse large B-cell lymphoma: a multicenter, open-label, single-arm, phase II trial

Patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) have a poor prognosis. Loncastuximab tesirine (Lonca), an antibody conjugate targeting CD19, has demonstrated significant clinical benefit in R/R DLBCL in a global phase II LOTIS-2 study. In the China bridging pivotal phase II OL-ADCT-402-001 study, eligible patients aged ≥18 years with R/R DLBCL who had failed ≥2 lines of systemic therapies were enrolled and treated every 3 weeks with 150 μg/kg Lonca for two cycles; then 75 μg/kg for subsequent cycles (up to 1 year). The primary endpoint was overall response rate (ORR) assessed by an independent review committee. Primary analyses for efficacy and safety were performed on the patients who received at least one treatment and had at least 6 months of follow-up following an initial documented response. As of data cutoff, 64 patients received Lonca (median 4.0 cycles; range, 1-17). The median number of prior lines of therapies was 3.0 (range, 2-12). The ORR was 51.6% (95% confidence interval [CI]: 38.7-64.2), and the complete response rate was 23.4%. Hematological events accounted for the majority of the most common (≥15%) grade ≥3 treatment-emergent adverse events (TEAE), in which increased γ-glutamyltransferase (25.0%), and hypokalaemia (18.8%) also were reported. Serious TEAE were reported in 35 of 64 patients with four fatal TEAE. In conclusion, Lonca monotherapy demonstrated clinically meaningful efficacy and was well-tolerated in heavily pretreated Chinese patients with R/R DLBCL, which was consistent with the results of the LOTIS-2 study in Caucasian patients.

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Publication Details

Journal
Haematologica
Published
2024-09-05
DOI
https://doi.org/10.3324/haematol.2024.284973
Citations
3
Primary Topic
Lymphoma Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
1.27
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article

Loncastuximab tesirine in Chinese patients with relapsed or refractory diffuse large B-cell lymphoma: a multicenter, open-label, single-arm, phase II trial

Jie Jin, Jun Zhu, Ye Guo, Liqun Zou et al.
3 citations
Haematologica
Lymphoma Diagnosis and Treatment
1.27
article

Loncastuximab tesirine in Chinese patients with relapsed or refractory diffuse large B-cell lymphoma: a multicenter, open-label, single-arm, phase II trial

Jie Jin, Jun Zhu, Ye Guo, Liqun Zou, Rong Zhu, Dan Song, Keshu Zhou, Qingqing Cai, Haiyan Yang, Wei Yang, Xiuhua Sun, Wenyu Li, Lihong Liu, Yao Liu, Hui Zhou, Liling Zhang, Zhenguang Wang, Feng Luo, Yuqin Song, Lei Yang, Ningjing Lin, Kai Hu
article en
3 citations

Abstract

Patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) have a poor prognosis. Loncastuximab tesirine (Lonca), an antibody conjugate targeting CD19, has demonstrated significant clinical benefit in R/R DLBCL in a global phase II LOTIS-2 study. In the China bridging pivotal phase II OL-ADCT-402-001 study, eligible patients aged ≥18 years with R/R DLBCL who had failed ≥2 lines of systemic therapies were enrolled and treated every 3 weeks with 150 μg/kg Lonca for two cycles; then 75 μg/kg for subsequent cycles (up to 1 year). The primary endpoint was overall response rate (ORR) assessed by an independent review committee. Primary analyses for efficacy and safety were performed on the patients who received at least one treatment and had at least 6 months of follow-up following an initial documented response. As of data cutoff, 64 patients received Lonca (median 4.0 cycles; range, 1-17). The median number of prior lines of therapies was 3.0 (range, 2-12). The ORR was 51.6% (95% confidence interval [CI]: 38.7-64.2), and the complete response rate was 23.4%. Hematological events accounted for the majority of the most common (≥15%) grade ≥3 treatment-emergent adverse events (TEAE), in which increased γ-glutamyltransferase (25.0%), and hypokalaemia (18.8%) also were reported. Serious TEAE were reported in 35 of 64 patients with four fatal TEAE. In conclusion, Lonca monotherapy demonstrated clinically meaningful efficacy and was well-tolerated in heavily pretreated Chinese patients with R/R DLBCL, which was consistent with the results of the LOTIS-2 study in Caucasian patients.

HaematologicaVol. 110(3)
Hebei Medical University (CN), Sun Yat-sen University (CN), Sichuan University (CN), West China Medical Center of Sichuan University (CN), Zhengzhou University (CN), Zhejiang Cancer Hospital (CN), Second Affiliated Hospital of Dalian Medical University (CN), Fourth Hospital of Hebei Medical University (CN), Hunan Cancer Hospital (CN), Sichuan Cancer Hospital (CN), Shanghai East Hospital (CN), Teva Pharmaceuticals (United States) (US), Henan Cancer Hospital (CN), Sun Yat-sen University Cancer Center (CN), Ministry of Education (ET), Guangdong Provincial People's Hospital (CN), Chongqing Cancer Hospital (CN), First Affiliated Hospital Zhejiang University (CN), Huazhong University of Science and Technology (CN), China Medical University (CN)
Openalex Percentile: Top 20%
Lymphoma Diagnosis and Treatment
1.27
DOIOpen Access PDFOpenAlex
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