The FDA granted an accelerated approval to Zynlonta, a novel Anitbody Drug Conjugate for the treatment relapsed/refractory large B-cell lymphoma.1
About Non-Hodgkin Lymphoma
Lymphoma is a cancer of the cells of the lymphatic system, which is composed of tissues and organs that produce, store, and carry white blood cells that fight infections and other diseases. The two main types of lymphocytes are B-cells and T-cells. There are B-cell lymphomas (about 85 percent) and T-cell lymphomas (about 15 percent). The most frequent locations for lymphoma development—the lymph nodes, liver, spleen, and bone marrow—all contain large amounts of lymphoid tissue.
More than 600,000 Americans have lymphoma. An estimated 75,000 people in the United States are diagnosed annually and since 1997 death rates for NHL have steadily decreased annually by 3% in men and 3.7% in women due to significant advances in treatment. Despite these recent advances some patients develop refractory disease and 22,000 still succumb to their disease each year.
Zynlonta is an antibody drug conjugate (ADC), a type of precision cancer medicine that targets the CD19 antigen on B cells. The antibody is attached to pyrrolobenzodiazeprine dimer, a cytotoxic (cancer cell killing) agent that is is internalized following attachment to the CD19 antigen where it blocks cancer cells’ division and causes the cells to die. DNA - cross linking agents are significantly more potent than systemic chemotherapy.
The FDA approval was based on data from the pivotal LOTIS-2 clinical trial which included transplant eligible and ineligible patients and patients who previously received stem cell transplant or CAR-T cell therapy. All patients had relapsed/refractory DLBCL and had received 2 or more previous lines of systemic treatment. In this trial Zynlonta was administered as a 30-minute infusion once every 3 weeks for 1 year, or until disease progression, unacceptable toxicity.2
In 145 treated patients the overall response rate was 48.3% which included a 24.1% complete response rate in patients with relapsed/refractory disease who had received 2 or more previous lines of systemic treatment. The median duration response achieved with was 10 months. The most common significant side effects reported were anemia and low white blood cell and platelet counts.
A phase 3 confirmatory LOTIS 5 trial (NCT04384484) is assessing the combination of loncastuximab tesirine and rituximab (Rituxan) vs chemoimmunotherapy in patients with relapsed/refractory DLBCL.
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- ADC Therapeutics SA (ADCT) Announces FDA Approval of ZYNLONTA™ (loncastuximab tesirine-lpyl) in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. News release. ADC Therapeutics. April 23, 2021. Accessed April 23, 2021. https://bit.ly/3tI7330
- ADC Therapeutics announces maturing data from pivotal phase 2 clinical trial and phase 1/2 combination clinical trial of loncastuximab tesirine (Lonca) in patients with relapsed or refractory diffuse large B-cell lymphoma. News release. ADC Therapeutics SA. June 12, 2020. Accessed November 20, 2020.
- American Cancer Society. Types of B-cell Lymphoma. Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html. Accessed March 2021.