Rapid Infusion with CT-P10 in Patients with Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukaemia: Interim Six Month Follow-up from a European Non-Interventional Post-Authorisation Safety Study

Background: In February 2017, CT-P10 became the first rituximab biosimilar to be approved in Europe for treatment of rheumatic diseases and specific blood cancers including non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukaemia (CLL). More recently, CT-P10 was approved in the US for NHL. Although the recommended rituximab administration protocol is a slow initial infusion rate with gradual up-titration, rapid infusion protocols are used widely in patients with no serious complications from their first infusion. There are limited data on the safety of rapidly infused CT-P10. Aims: To evaluate the safety and effectiveness of rapidly infused CT-P10 in patients with NHL or CLL in a real world clinical setting over a 6 month follow up period. Methods: This non-interventional post-authorisation safety study is in progress in the United Kingdom (UK), Spain, France and Italy. It involves collection of data from the medical records of consenting adult patients with NHL or CLL who received rapidly-infused CT-P10 (total infusion time ≤90 minutes) during routine clinical practice. The index date (day 1) is the date of the first rapid CT-P10 infusion. Safety and effectiveness data have been collected over a 6 month observation period from the index date (or to death, if sooner). Early results from this study have been previously presented and showed the index IRR rate (the primary outcome) to be 8% (Bishton, 2019). Updated interim results with full 6 month follow-up are now available for 112 patients and are reported here, based on a data cut on 19 June 2019. Results: This interim analysis includes patients enrolled from the UK, Italy and Spain. Ninety four patients (84%) have NHL (68 [61%] diffuse large B-cell lymphoma [DLBCL], 26 [23%] follicular lymphoma [FL]) and 18 (16%) have CLL. Other patient characteristics at index date: 74 (66%) male; median age 67 years (interquartile range [IQR] 58.0-74.0); median disease duration 0.2 years (IQR 0.1-0.4); 20 (18%) patients with prior treatment recorded (n=111); Ann Arbor stage for NHL at index (n=58): I (n=7, 12%), II (n=7, 12%), III (n=8, 14%), IV (n=35, 60%) or other (n=1, 2%; recorded as ‘1E‘); Binet stage for CLL at index (n=11): A (n=5, 45%), B (n=4, 36%) or C (n=2, 18%). Patients had between 1 and 4 CT-P10 infusions prior to the index date, with first infusions given over a median of 4 hours (IQR 3.5-4.1 hours). Median CT-P10 dose at index was 375 mg/m2 (IQR 375.0-375.0 mg/m2) and a median of 5 infusions per p