KEY TAKEAWAYS
- The phase III LYMA trial studied the efficacy and safety of rituximab maintenance post-ASCT in first-line for young patients with MCL.
- The LYMA trial’s first long-term analysis was conducted for a follow-up period of seven years ranging from 0.2 to 10 years.
- The study’s primary endpoint was a 3-year EFS.
- The median EFS and PFS were in favor of RM.
The LYMA trial showed that rituximab maintenance (RM) following autologous stem cell transplant (ASCT) was both effective and safe for young patients with mantle cell lymphoma (MCL). Researchers reported the initial long-term evaluation of the LYMA trial.
The study included 299 patients, with 240 randomly assigned to either receive three years of RM (n = 120) or no RM (observation; n = 120). The primary endpoint was a 3-year event-free survival (EFS), and recent updates have been made on the outcomes of all participating patients.
According to the current analysis, the follow-up period is 7 yrs (0.2 to 10). The median EFS and progression-free survival (PFS) exhibited a statistical advantage in favor of RM, where the EFS has not reached [NR] compared to 5.8 yrs, and the PFS was NR vs. 6.1 years in the observation arm. The estimated 7-year EFS and PFS rates were 76.2% (95% CI 67.4%–82.9%) and 78.5% (95% CI 69.9%–85.0%) for RM, respectively, while the observation arm had rates of 46% (95% CI 36.6%–54.9%) and 47.4% (95% CI 37.9%–56.3%), respectively (p < .0001). Twenty-two pts (18.3%) in the RM arm died compared to 33 (27.5%) in the observation arm, resulting in a 7-year overall survival (OS) estimate of 83.2% (95% CI 74.7.7%–89.0%) and 72.2% (95% CI 62.9%–79.5%) for RM and observation, respectively (p = 0.087).
The study established lymphoma as the cause behind fatalities in both groups, with no variation. Less than 10% of deaths were a consequence of infections. The cessation of RM failed to provoke an increase in the frequency of relapses. The RM group witnessed most progressions transpiring during the 3-year RM period17/21 (81%), with a meager 19% occurring after. Conversely, in the observation arm, 60% of progressions (32/53) took place during the 3-year maintenance period, with 40% taking place after. Pts in both the RM and observation groups were given varying amounts of anti-CD20 and BTK inhibitors as a salvage treatment, with a similar outcome. However, it is worth noting that previous RM significantly impacted post-relapse OS. Pts in the RM arm had a median OS-2 of 1.1 years (95% CI 0.7–2.1) compared to the 4.6 years (95% CI 2-NA) in the observation arm. The timing of relapses in the RM group shows how quickly the disease progresses during RM.
After seven years of follow-up, RM showed superior EFS and PFS but not OS. The cessation of RM did not lead to a higher relapse rate or infectious-related mortality, thereby establishing it as a safe standard of care for long-term follow-up. Patients who experienced a relapse during RM had a particularly poor outcome, highlighting an unmet medical need.
Source: https://onlinelibrary.wiley.com/doi/10.1002/hon.3163_100
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT00921414
Sarkozy, C., Thieblemont, C., Oberic, L., Moreau, A., Bouabdallah, K., Damaj, G., Gastine, T., Ribrag, V., Casasnovas, O., Haioun, C., Houot, R., Jardin, F., Den Neste, E. V., Cheminant, M., Morschhauser, F., Callana, M., Ghesquieres, H., Gressin, R., Hermine, O., Gouill, S. L. VERY LONG-TERM FOLLOW-UP OF RITUXIMAB MAINTENANCE IN YOUNG PATIENTS WITH MANTLE CELL LYMPHOMA INCLUDED IN THE LYMA TRIAL, A LYSA STUDY. Hematological Oncology, 41, 151-152. https://doi.org/10.1002/hon.3163_100
