ADC Therapeutics' Zynlonta Faces Competition, Poised for Potential Second-Line DLBCL Approval
Key Insights
ADC Therapeutics' Zynlonta (loncastuximab tesirine-Ipyl (search)) is a CD19 (search)-directed antibody-drug conjugate approved for relapsed/refractory large B-cell lymphoma (search).
An analyst estimates Zynlonta's peak revenue in the third-line treatment setting could reach $110 million in the U.S. by 2032.
Positive results from LOTIS-5 and LOTIS-7 clinical trials could lead to Zynlonta's approval for second-line treatment of diffuse large B-cell lymphoma (search) (DLBCL (search)).
ADC Therapeutics is navigating a competitive oncology market with its lead asset, Zynlonta (loncastuximab tesirine-Ipyl (search)), while also pursuing expansion into new treatment settings. The company is focused on developing antibody-drug conjugates (ADCs) for hematological malignancies and solid tumors.
Zynlonta, a CD19 (search)-directed ADC with a pyrrolobenzodiazepine (PBD) payload, received accelerated FDA approval in January 2021 for adult patients with relapsed/refractory (r/r) large B-cell lymphoma (search) (DLBCL (search)) after two or more lines of systemic therapy. However, the drug has faced stiff competition, impacting its market performance. At its peak in the first quarter of 2023, Zynlonta reached an annualized revenue run rate of approximately $80 million but has since struggled to maintain that level.
Market Analysis and Future Projections
An analyst projects that Zynlonta's peak revenue in the third-line treatment setting will reach $110 million in the U.S. by 2032. This outlook is contingent on the drug receiving approval for use in the second-line treatment of diffuse large B-cell lymphoma (search) (DLBCL (search)), based on positive results from the LOTIS-5 and LOTIS-7 clinical trials.
Preclinical data suggest that combining Zynlonta with rituximab, an anti-CD20 (search) antibody, may improve tumor control and provide longer-lasting results. The company is exploring expanding Zynlonta’s use to treat second-line DLBCL (search) and indolent lymphomas, either alone or in combination with other treatments.
Competitive Landscape and Efficacy Data
The second-line DLBCL (search) market is highly competitive, with numerous treatment options available. However, Zynlonta demonstrates promising efficacy, with an 80% overall response rate and a 50% complete response rate. The analyst estimates that Zynlonta could generate approximately $172 million in revenue from second-line DLBCL by 2032 if approved.
Pipeline Expansion
Beyond Zynlonta, ADC Therapeutics has a broad pipeline of antibody-drug conjugates (ADCs) targeting other solid tumor indications, providing multiple opportunities for growth. This diversified pipeline could mitigate the risks associated with relying solely on Zynlonta's performance in the DLBCL (search) market.