This medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited.

LOTIS-2: Summary of results for the whole patient population after 2-years¹

ZYNLONTA trial administration²

A heterogeneous and highly refractory patient population²

20% primary refractory
58% refractory to last line of treatment
26% received prior SCT or CAR-T

Select baseline patient and disease characteristics

Results of 2-year follow-up analysis¹

48.3% (n=70) of patients had a response¹
24.8% (n=36) of patients had a CR¹
- 31% (11/36) of these had no disease progression or death at ≥2 years¹

ZYNLONTA efficacy mDOR

ZYNLONTA as a single agent achieves effective responses at 2-year follow up¹

2-year duration of response for patients who responded (n=70)

2-year follow-up of patients achieving complete response^1,c,d

ZYNLONTA overall and progressive-free survival

ZYNLONTA achieves long-term OS and PFS for patients with a complete response at 2-years1

Progression-free survival at 2-years chart

*median OS and PFS not reached for patients achieving CR; 9.5 and 4.9 months, respectively, for overall population

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard (for United Kingdom) and www.hpra.ie (for Republic of Ireland). Adverse events should also be reported to Swedish Orphan Biovitrum Ltd at [email protected] or Telephone +44 (0) 800 111 4754.

^a Of patients with a CR. Event-free defined as no progressive disease or death starting from day 1, cycle 1 of ZYNLONTA treatment.
^b Updated 2-year analysis. Median follow-up: 7.8 months (range, 0.3–42.6) in the all-treated population and 35.0 months (range, 4.4–42.6) in patients with a CR.1
^c Of patients with a CR. Event-free defined as no progressive disease or death starting from day 1, cycle 1 of ZYNLONTA treatment.
^d Each bar represents 1 of the 36 patients with a CR in the study. Response was determined by an independent reviewer.
^e Reasons for censoring patients with a CR included study discontinuation in 15 (41.7%) patients, SCT in 10 (27.8%) patients, and start of new anticancer therapy in 5 (13.9%) patients; 3 (8.3%) patients each experienced progressive disease and death.

Abbreviations:
CR: complete response, OR: overall response, ORR: overall response rate, PR: partial response, mDOR: median duration of response, CI: confidence interval, NR: not reached, OS: overall survival, PFS: progression-free survival

References:
1. Caimi PF et al. Haematologica 2024;109:1184-1193. 2. Caimi PF et al. Lancet Oncol 2021; 22: 790-800. 3. ZYNLONTA SmPC GB. 4. Caimi PF et al. Oral presentation at: 17th International Congress on Malignant Lymphoma, June 13-17, 2023.

LOTIS-2: Summary of results for the whole patient population after 2-years1

ZYNLONTA trial administration2

A heterogeneous and highly refractory patient population2

Results of 2-year follow-up analysis1