Loncastuximab Tesirine

7.1 The PBAC did not recommend loncastuximab tesirine for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received two or more prior lines of therapy. Due to limitations in the evidence the PBAC considered the claim of superior comparative effectiveness was highly uncertain but likely reasonable.PSD · Mar 2026

7.2 The PBAC considered the primary reason for this outcome was due to the economic evaluation provided.PSD · Mar 2026

6.55 The submission presented a stepped economic evaluation of loncastuximab tesirine versus chemoimmunotherapy (R-ICE as proxy for all rituximab-based chemoimmunotherapy), based on indirect evidence from LOTIS-2 and CORAL extension studies via the MAIC.PSD · Mar 2026

Table 12: Summary of model structure, key inputs and rationale Component Summary Treatments Loncastuximab tesirine vs chemoimmunotherapy (R-ICE as proxy) 30 years in the model base case versus up to 40 months of follow-up in LOTIS-2.PSD · Mar 2026

6.51 The submission described loncastuximab tesirine as superior in terms of effectiveness compared to chemoimmunotherapy. The evaluation considered this claim was not adequately supported by evidence presented in the submission. The key issues were:PSD · Mar 2026

• The pivotal evidence presented for loncastuximab tesirine was derived from a small, single arm, open label study, LOTIS-2. While the efficacy evidence was promising, the lack of RCT evidence adds a degree of uncertainty around the magnitude of the benefit. The PSCR stated that the use of single-arm studies is well established in R/R DLBCL and noted that in the absence of head to head evidence a MAIC had been undertaken.PSD · Mar 2026

6.96 The submission acknowledged the expected uptake rate of loncastuximab tesirine in the 3L setting is uncertain, and indicated the Sponsor is willing to work with the Department of Health to manage uncertainty of listing for loncastuximab tesirine and closely monitor PBS usage data and pharmacovigilance activities post-listing to better understand real-world uptake and utilisation patterns. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Mar 2026