KEY TAKEAWAYS
- This Phase II study evaluated the five-year efficacy and safety of tafasitamab in R/R DLBCL patients.
- The trial’s primary endpoint was the best ORR. Secondary endpoints were DoR, PFS, OS, and safety.
- The 5-year L-MIND analysis showed durable responses in R/R DLBCL pts ineligible for ASCT, initially using tafasitamab and lenalidomide, followed by long-term tafasitamab monotherapy.
The L-MIND Phase II study resulted in fast-tracked approval in the US and conditional authorization in the EU for using tafasitamab with lenalidomide. This treatment is for relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) patients (pts) unsuitable for autologous stem cell transplant (ASCT).
In the study, pts (18 years and older) with ASCT-ineligible R/R DLBCL, 1–3 prior systemic therapies (including a CD20-targeting regimen), and Eastern Cooperative Oncology Group performance status 0–2 received tafasitamab (12 mg/kg) for ≤12 cycles with lenalidomide (25 mg). Following this, tafasitamab was continued as monotherapy until either the disease progressed or unacceptable toxicity.
The primary endpoint was the best objective response rate (ORR), which includes either a complete response (CR) or a partial response (PR) as determined by an independent radiology committee. Secondary outcomes assessed included duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. Further exploratory analyses also examined the treatment’s effectiveness based on the number of previous lines of therapy (pLoT) received by the pts.
In the complete analysis set of 80 pts, the ORR was 57.5% (95% CI: 45.9–68.5), with CR of 41.2% (30.4–51.6; n=33) and PR of 16.2% (8.9–26.2; n=13). These findings were consistent with previous analyses. The median DoR was not reached (NR), with a median follow-up (mFU) of 44.0 months (29.9–57.0). The median PFS was 11.6 months (5.7–45.7; mFU 45.6 [22.9–57.6]), and the median OS was 33.5 months (18.3–NR; mFU 65.6 [59.9–70.3]). In pts with one prior line of therapy (pLoT) (n=40), the ORR was higher at 67.5%, with 52.5% CR (n=21) and 15% PR (n=6), compared to pts with two or more pLoT (n=40), where the ORR was 47.5%, with 30% CR (n=12) and 17.5% PR (n=7). However, the median DoR was NR for both subgroups, showing similar long-term effectiveness for responders. Adverse events (AEs) were consistent with previous reports and were manageable. The frequency of AEs declined after the transition to tafasitamab monotherapy, with monotherapy exceeding two years.
The final 5-year analysis of the L-MIND trial showed prolonged durable responses in R/R DLBCL pts ineligible for ASCT. Combining tafasitamab and lenalidomide followed by long-term tafasitamab monotherapy was effective. No new safety signals were reported, confirming the treatment’s tolerability profile.
Source: https://clml-soho2023.elsevierdigitaledition.com/432/index.html
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02399085
Duell, J., Abrisqueta, P., Andre, M., Augustin, M., Gaidano, G., Barca, E.G., Jurczak, W., Kalakonda, N., Liberati, A.M., Maddocks, K.J., Menne, T., Nagy, Z., Tournilhac, O., Bakuli, A., Amin, A., Gurbanov, K., Salles, G. Five‑Year Efficacy and Safety of Tafasitamab in Patients With Relapsed or Refractory (R/R) Diffuse Large B‑Cell Lymphoma (DLBCL): Final Results From the Phase II L‑MIND Study.
