Page 210 - Haematologica Vol. 109 - July 2024

ARTICLE - S-DVd in RRMM patients V. González-Calle et al. AB
CD
Figure 4. Kaplan-Meier survival curves in part 1 and 2 of the study. Panel (A) shows progression-free survival for (PFS) the inten- tion-to-treat (ITT) population in part 1 and part 2. Panel (B) shows overall survival for the ITT population in part 1 and part 2. Panel (C) shows PFS for patients according to number of prior lines (PL) of therapy; Panel (D) shows PFS according to lenalido- mide refractoriness (len-ref) in part 2 of the trial.
CI: NE-NE), with a 2-year OS rate of 71.7% (Figure 4B). In the post hoc subgroup analysis, median PFS for those relapsing after one PL, two PL and three PL were 27.5 months (95% CI: 22.3-32.7), 31.6 months (95% CI: NE-NE), and 12.3 months (95% CI 3.2-21.3), respectively (Figure 4C). Median OS for these patients according to PL of treatment was not reached (95% CI: NE-NE), 31.6 months (95% CI: NE-NE) (P=0.8), and 22.8 months (95% CI: 15.7-29.9) (P=0.1), respectively. Notably, PFS (22.8 months vs. 31.6 months, hazard ratio [HR] =1.5; 95% CI: 0.6-3.7; P=0.4) and OS (30.0 months vs. not reached, HR=1.4; 95% CI: 0.4-4.8; P=0.6) were comparable between patients refractory and not refractory to len, respectively (Figure 4D). Importantly, no differences were found across other subgroups like ISS staging score, R-ISS or the presence of high-risk cytogenetic abnormalities but this comparison is limited due to small sample size.
Safety
Hematological AE were the most frequently reported AE in both parts of the study, overall, 47 (82.4%) of patients had at least one hematological AE. Thrombocytopenia was the most common AE present in 70.2% of patients (grade 3-4 in 45.6%) followed by neutropenia in 38.6% of the patients (grade 3-4 in 29.8%). Infection was the most frequent non-hematological AE and occurred in 42 (73.6%) of patients (grade 3-4 in 31.6%). Regarding gastrointestinal AE, diarrhea was reported in 38.6% (grade 3-4: 3.5%) and nausea or vomiting in 35.1% (grade 3-4: 8.8%). Peripheral neuropathy occurred in ten (17.5%) patients, without any grade 3 or 4 events. No differences in safety have been observed between part 1 or 2 of the study. There was a trend toward a higher percentage of patients with throm- bocytopenia (83.3% vs. 60.6%, respectively; P=0.06) and
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