Optimising the Duration of Therapy for Newly Diagnosed Transplant Ineligible Patients - Analysis of Long Term Follow up Data from the UK MRA Myeloma XI Trial

• Published in: Blood 2024-11, Vol.144 (Supplement 1), p.1987-1987
• Main Authors: Pawlyn, Charlotte, Davies, Faith E, Cook, Gordon, McIntyre, Heather, Richards, Jeanine, Jackson, Sharon, Hodson, Elizabeth, Olivier, Catherine, Hockaday, Anna, Jones, John R, Kaiser, Martin F, Jenner, Matthew W., Gregory, Walter Martin, de Tute, Ruth M, Owen, Roger G, Drayson, Mark, Cairns, David A., Morgan, Gareth, Jackson, Graham
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2024-205788

Introduction Ongoing therapy to progression has become a standard of care for newly diagnosed myeloma (NDMM) patients but this carries with it an increased burden of treatment administration and potential side effects. This may be of particular importance in the older, frailer, patient group due to increased co-morbidities and polypharmacy. Optimum duration may also differ in subgroups of patients, for example those at different levels of frailty. In a novel analysis, updated data for the transplant ineligible (TNE) pathway of the UKMRA/NCRI Myeloma XI trial after more than 8 years follow up were used to explore this question. Methods Myeloma XI was a phase III trial with a pathway for TNE NDMM patients who, after immunomodulatory agent-based induction therapy, were randomised between lenalidomide maintenance (Len, 10mg, 21/28 days planned to continue to disease progression) or observation (Obs). Progression-free survival (PFS) and overall survival (OS) data were analysed landmarked from multiple time points (2, 3, and 4 years) after the time of maintenance randomisation, including all patients who had not had an event prior to that time point. Data were analysed for all patients, and within UK-Myeloma Risk Profile groups (UK-MRP: based on WHO performance status, age, ISS and CRP, used as a surrogate for frailty), defined as MRP-low, med and high. Results In the TNE pathway 723 patients entered the maintenance randomisation and were allocated to observation (n=316) or lenalidomide (n=407). After a median of 101 months (m) of follow up lenalidomide maintenance was associated with a significantly prolonged median PFS in the TNE pathway (11 vs 26m, hazard ratio [HR] 0.49 [95%CI 0.42, 0.58], p