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Long-term outcomes with tafasitamab in R/R DLBCL
Results
Patients
Overall, 81 patients received at least one dose of either drug and were evaluated for safety. Of those, 80 patients received ≥1 dose of both tafasitamab and lenalidomide and were evaluated for efficacy (Figure 1). A total of 34 patients received tafasitamab monotherapy after discon- tinuing lenalidomide (30/34 patients had completed 12 cycles of tafasitamab plus lenalidomide and 4/34 had dis- continued lenalidomide prior to cycle 12 and continued tafasitamab). Fifteen of these 34 patients had discontin- ued tafasitamab treatment at the data cut-off for this analysis; thus, 19 patients were still receiving tafasitamab monotherapy. Of the 62/81 patients who had discontin- ued study treatment, 42 had died, 13 were alive and included in the survival follow-up and 7 had been lost to follow-up at the data cut-off for this report.
The full baseline characteristics of the patients in the L- MIND study have already been published.8 Briefly, the patients had a median age of 72 years (range, 41-86) at enrollment and had received a median of two (range, 1-4) prior lines of therapy. All patients had received R-CHOP or equivalent chemoimmunotherapy prior to study entry. With the availability of additional data from a central pathology review of two patients, the baseline patients’ characteristics for cell of origin by immunohistochem- istry and gene expression profiling have been updated since the primary analysis (Table 1). There was one patient each with double- and triple-hit DLBCL.
Patient subgroups of clinical interest included 15 patients (18.5%) with primary refractory disease, 33 patients (41.3%) with rituximab-refractory disease, and 35 patients (43.8%) who were refractory to their last ther-
apy. Most patients who were refractory to their last line of therapy had received two prior lines of treatment (71.4%), and the last prior line included chemotherapy in 94.4% and rituximab in 80.0% of cases. The baseline characteristics of patients in the refractory subgroups were generally comparable with those of the overall pop- ulation (Table 1), although patients in refractory sub- groups were more likely to have increased lactate dehy- drogenase and germinal center B cell of origin by immunohistochemistry.
Prior treatment regimens for patients refractory to their last treatment are shown in Online Supplementary Table S1.
Efficacy outcomes
After the primary analysis, the best responses for three patients were revised based on an IRC re-adjudication due to a disagreement between the two primary radiolo- gists. At this long-term data cut-off after at least 35 months’ follow-up, the IRC-assessed objective response rate was 57.5% (46/80; 95% confidence interval [95% CI]: 45.9-68.5), the CR rate was 40.0% (32/80) and the PR rate was 17.5% (14/80) (Table 2). Additionally, 16.3% of patients (13/80) had stable disease. The median time to response was 2.1 months (range, 1.7-34.7) and the medi- an time to CR was 6.8 months (range, 1.7-46.3). Thirty patients had completed the combination treatment phase of 12 cycles on both study drugs and achieved a best response of CR (n=24), PR (n=3), or stable disease (n=3) as per IRC.
Time-to-event endpoints are shown in Table 2 with Kaplan-Meier plots in Figure 2. The median IRC-assessed DoR was 43.9 months (95% CI: 26.1-not reached [NR]), and was not reached in patients who achieved a CR (95% CI: 43.9-NR). The median IRC-assessed PFS was 11.6
Figure 1. CONSORT (Consolidated Standards of Reporting Trials) diagram of the L-MIND study at the October 30, 2020 data cut-off.
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