Drug updated on 4/16/2024
| Dosage Form | Injection (intravenous; 10 mg powder for reconstitution) |
| Drug Class | CD19-directed antibody and alkylating agent |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.
Summary
- Loncastuximab tesirine-lpyl (Zynlonta) is a CD19-directed antibody-drug conjugate used for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
- The drug has shown antitumor activity and an acceptable toxicity profile in patients with high-risk disease characteristics, including those who have double-hit, triple-hit, transformed, or primary refractory diffuse large B-cell lymphoma (DLBCL).
- In the LOTIS-2 study involving 145 patients aged 18 years and above suffering from DLBCL that was either relapsed or refractory after at least two prior therapies; loncastuximab tesirine improved health-related quality of life over time as measured by EQ VAS overall health score.
- Two randomized controlled trials were reviewed which showed that Zynlonta had substantial single-agent antitumor activity producing durable responses with an acceptable safety profile potentially offering a new therapeutic option for heavily pretreated patients with relapsed/refractory DLBCL.
- Common grade 3 or higher treatment-emergent adverse events reported during these studies included neutropenia (26% of participants), thrombocytopenia (18%), and increased gamma-glutamyltransferase levels(17%). Serious adverse events were reported in approximately 39% of participants but none were considered related to Zynlonta use.
- Elderly patient findings mirrored those found within the general population studied suggesting similar efficacy across different age groups when using loncastuximab tesirine-lpyl(Zynlonta).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zynlonta (loncastuximab tesirine-lpyl) Prescribing Information. | 2022 | ADC Therapeutics America, Murray Hill, New Jersey |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Health-related quality of life, symptoms, and tolerability of loncastuximab tesirine in patients with relapsed or refractory diffuse large B-cell lymphoma. | 145Subjects F: 41% M: 59% | 2022 | Clinical Lymphoma, Myeloma & Leukemia |
| Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial. | 145Subjects F: 41% M: 59% | 2021 | The Lancet Oncology |
Sex Distribution:
F:41%
M:59%
145Subjects
Year:
2022
Source:Clinical Lymphoma, Myeloma & Leukemia
Sex Distribution:
F:41%
M:59%
145Subjects
Year:
2021
Source:The Lancet Oncology