Efficacy

Efficacy of Zynlonta (loncastuximab tesirine-lpyl) in Lymphoma

Zynlonta (loncastuximab tesirine-lpyl) is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The efficacy of Zynlonta was evaluated in a multicenter, single-arm, open-label clinical trial known as LOTIS-2. In this study, a significant proportion of patients achieved an objective response rate (ORR), which is a combined measure of complete responses (CR) and partial responses (PR). The therapy has shown promising results, particularly in a patient population with limited treatment options and a poor prognosis.

The LOTIS-2 trial results demonstrated that Zynlonta led to a 48.3% ORR with a 24.1% complete response rate in the overall study population. These results are notable considering the advanced stage of disease in the participants, who had previously undergone multiple lines of therapy, including stem cell transplantation in some cases. The median duration of response (DoR) for those who achieved a response was also clinically significant, providing a period of disease control that is valuable in the relapsed or refractory setting.

Efficacy of Brukinsa (zanubrutinib) in Lymphoma

Brukinsa (zanubrutinib) is a Bruton's tyrosine kinase (BTK) inhibitor that is used for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. It is also being studied in other B-cell malignancies. The approval of Brukinsa for MCL was based on overall response rate in clinical trials. In a pivotal trial known as BGB-3111-206, zanubrutinib demonstrated a high ORR in relapsed or refractory MCL patients, with a majority of patients achieving a partial or complete response to therapy.

Additional studies have reinforced the efficacy of Brukinsa in MCL and its potential in other forms of B-cell lymphoma. For instance, in the multicenter, open-label, single-arm Phase 2 trial (BGB-3111-AU-003), patients treated with zanubrutinib achieved an ORR of 84%, with a 59% complete response rate. The median DoR was not reached at the time of data cut-off, suggesting sustained responses in a significant number of patients. Moreover, ongoing studies are evaluating the efficacy of Brukinsa in various subtypes of lymphoma, including Waldenström's macroglobulinemia and marginal zone lymphoma, indicating its broader potential in lymphoma treatment.