Ps1096 Interim Update From a Multi‐center Study of Pralatrexate in Asian Patients With Relapsed or Refractory(r/R) Peripheral T‐cell Lymphoma (Ptcl)

Abstract

subsequent infusions in patients with no serious complications from their first infusion. Rapid infusion of rituximab has been shown to be generally well-tolerated, with an IRR rate of 8.8% reported in a recent meta analysis (Polwart, 2017); however, there are limited data on the safety of rapid infusion of 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. Methods: This non-interventional post-authorisation safety study is in progress in four European countries (United Kingdom [UK], Spain, France, Italy) and involves collection of data from the medical records of consenting adult patients with NHL or CLL who received rapidly-infused CT-P10 (i.e. a total infusion time of 90 minutes or less) during standard clinical care. The index date (day 1) is the date of the first rapid CT-P10 infusion, given in the second or a subsequent treatment cycle. Safety and effectiveness data are being collected for a 6 month observation period from the index date (or to death, if sooner). The primary outcome is incidence of IRRs on day 1 or day 2 post-index. Response to CT-P10 is as documented by the local investigator. Interim results are presented, based on a data cut on 18 January 2019. Where n is less than the total number of patients, data were missing. Results: The interim analysis includes 110 patients enrolled from the UK and Spain. Ninety-eight patients (90%) have NHL (68 [62%] diffuse large B-cell lymphoma [DLBCL], 30 [28%] follicular lymphoma [FL]) and 11 (10%) have CLL (n = 1 diagnosis missing). Other patient characteristics at index date: 66 (60%) male; median age 68 years (interquartile range [IQR] 59-74) (n = 109); median disease duration 0.2 years (IQR 0.1-0.3) (n = 109); 22 (20%) patients with prior NHL/CLL treatment recorded (n = 109); Eastern Cooperative Oncology Group performance status (n = 71): 0 (n = 34, 48%), 1 (n = 27, 38%), 2 (n = 3, 8%), 3 (n = 6, 8%) or 4 (n = 1, 1%); Ann Arbor stage for NHL (n = 52): I (n = 4, 8%), II (n = 5, 10%), III (n = 7, 13%) or IV (n = 36, 69%); Binet stage for CLL (n = 7): A (n = 4, 57%), B (n = 1, 14%) or C (n = 2, 29%). Eight of 106 patients with data available (8%) had IRRs recorded on day 1 or 2 post-index. Ten IRRs were reported (fatigue [n = 3], oropharyngeal pain, vomiting, nausea, rash, headache, generalized oedema, peripheral oedema [all n = 1]), of which 8 were grade 1 (mild), 1 was grade 2 (moderate) and 1 was grade 3 (severe [oropharyngeal pain during cycle 2, unlikely to be related to CT-P10 according to local investigator opinion]). Best responses to CT-P10 during the observation period are shown in Fig. 1. Summary/Conclusion:This is the first multi-country study to investigate the safety and effectiveness of rapidly infused CT-P10 in a real world setting. Early results suggest that the IRR rate for rapidly infused CT-P10 is similar to rates previously reported for reference rituximab.