BRENTUXIMAB VEDOTIN IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS WITH NEWLY DIAGNOSED CD30‐POSITIVE PERIPHERAL T‐CELL LYMPHOMAS: REAL‐WORLD DATA

Abstract

Background: Based on the results of ECHELON-2 trial, Brentuximab vedotin (BV) in combination with cyclophosphamide, doxorubicin and prednisone (CHP) has been approved by EMA for the treatment of newly diagnosed systemic anaplastic large cell lymphoma (ALCL) and become the standard of care for this patient population. In Czech Republic, BV plus CHP is approved as 1st line treatment for CD30-positive peripheral T-cell lymphomas (PTCL), including non-ALCL PTCL since 8/2020. The aim of this analysis is to provide real world data with this combination. Methods: Using the prospective observational NiHiL project (NCT03199066), we identified patients (pts) ≥ 18 years of age with histologically confirmed CD30+ PTCL (diagnosed between August 2020 to October 2022), who received BV in combination with chemotherapy as 1st line treatment. Results: A total of 63 pts were recruited; 31 (49%) had ALCL (12 ALK+, 19 ALK-) and 32 (51%) had non-ALCL PTCL (16 with PTCL NOS, 14 with AITL, and 2 with EATL). Median age was 60 years (range; 19-82). Most pts showed adverse clinical features at lymphoma diagnosis, including Ann Arbor stage III-IV (n = 46; 73%) or elevated LDH (n = 34; 54%). Of note, 18 (29%) pts had ECOG performance status ≥ 2 (incl. 6 pts ECOG 3 and 1 pt ECOG 4). By IPI, 16 (25%), 18 (29%), 12 (19%), and 17 (27%) pts belonged to low, low-intermediate, high-intermediate, and high-risk groups, respectively. The most common chemotherapy backbone was CHP administered in 45 (71%) pts, followed by CHP + etoposide administered in 13 (21%) pts. Five (8%) pts received attenuated regimen. Nine (14%) pts underwent pre-planned consolidative autologous stem cell transplant. Sixty (95%) pts received G-CSF prophylaxis. The most common grade ≥3 adverse events were neutropenia (49%), anaemia (30%), febrile neutropenia (19%), thrombocytopenia (19%), and infections (18%). Neuropathy (all grades) occurred in 21 pts (33%); grade 3 neuropathy in 3 pts (5%). Grade 5 AE occurred in 2 (3%) pts, sepsis in both cases. Out of 63 there were 56 (89%) pts evaluable for response (PET/CT) at the time of database lock. The overall objective response rate (ORR) was 80% with 63% complete response (CR). The ORR/CR rates in ALCL (n = 26) versus non-ALCL (n = 30) pts were 89%/73% versus 73%/53%, respectively. The median follow-up of surviving pts is 16.6 months (range; 4.3- 31.3). The overall 18-months PFS and OS probability were 61.8% and 73.7%, respectively (Figure 1). By lymphoma subtype, the 18-months PFS and OS probability were 77.6% and 83.5% in ALCL and 50.3% and 65.9% in non-ALCL, respectively (Figure 1). Evaluation of the relationship between % of CD30+ neoplastic cells and clinical outcome is ongoing. The research was funded by: The study is supported by the Cooperation Program, research area “Oncology and Haematology” and NU20-03-00253 and NU22-03-00370. Keywords: Aggressive T-cell non-Hodgkin lymphoma, Combination Therapies Conflicts of interests pertinent to the abstract A. Sykorova Other remuneration: ROCHE, GILEAD, TAKEDA H. Mocikova Consultant or advisory role Takeda, Roche, Astra Zeneca, Janssen, Abbvie D. Belada Other remuneration: Roche, Gilead Sciences M. Trneny Consultant or advisory role Takeda Honoraria: Takeda