Table 3.
Parameter | Everolimus190 | Lenalido-mide193 | Panobinostat194 | Mocetinostat195 |
Entinostat196 |
Resminostat197 | Ruxolitinib198 | Idelalisib199 |
---|---|---|---|---|---|---|---|---|
Dosage | 10 mg/day p.o. continuously | 25 mg/day p.o., day 1–21/28 days | 40 mg p.o., t.i.w. continuously | 85 mg p.o. t.i.w. | 10 or 15 mg /2weeks or 15 mg/week ×3 weeks/28 days | 600–800 mg ×5 days/14 days | 20 mg b.i.d. p.o. continuously | 150 mg b.i.d. continuously |
Patients (n) | 57 | 38 | 129 | 28 | 49 | 37 | 33 | 25 |
Age [median (range) years] | 32 (19–77) | 34 (25–62) | 32 (18–75) | 34 (19–68) | 33 (19–73) | 34 (19–71) | 37 (19–80) | 42 (21–80) |
ECOG PS 0–1 (%) | 97 | 92 | NR | 100 | 100 | 94 | 79 | 95 |
Prior ASCT (%) | 67 | 87 | 100 | 82 | 80 | 57 | 70 | 72 |
Prior regimens [median (range) n] | 4 (1–17) | 4 (2–9) | 4 (2–7) | 5 (1–9) | 3 (1–10) | 6 (2–14) | 5 (1–16) | 5 (2–9) |
Time from diagnosis to last relapse/progression [median (range) mos] | 39 (7–221) |
NR | NR | NR | NR | NR | 55 (9–216) | |
ORR (%) | 46 | 19 | 27b | 26 | 12 | 34e | 19 | 20 |
CRR (%) | 9 | 3 | 4b | 0 | 0 | 3 | 0 | 4 |
DCR (%) | 81 | 33a | 82 | 69c | 51d | 37a | 53 | 48 |
DOR (median, mos) | 6.0 | 6.7 | 28.5 | 1.9 | 7.7 | 8.4 | ||
PFS (median, mos) | 7.3 | 4.0 | 6.1 | ~9.0 | 5.5 | 2.3 | 3.5 | 2.3 |
Median duration of drug exposure (months, range) | 4.1 (1 day–4.7 years) | 4 cycles (1–43+) | 4.3 (<1–20.2) | NR | 1.4 (0.2–8.0) | 4 (1–22) | 3.6 (0.5–25.2) | |
Prolonged drug administration (n, %) | 7 (12%) for ⩾1 year | 7 (19%) for ⩾1 year | 3 (3%) for ⩾1 year |
NR | 3 (6%) for ⩾1 year |
NR, but ↓↓ | 4 (12%) for ⩾1 year |
Generally, prior exposure to BV in these trials was minimal or absent, except for 82% in the ruxolitinib and 92% in the idelalisib trial.
ASCT, autologous stem-cell transplantation; BV, brentuximab vedotin; CRR, complete response rate; DCR, disease control rate; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status ; NR, not reported; ORR, overall response rates; PFS, progression-free survival.
Including SD for 6 months or more.
By CT/MRI (no PET).
Only 30% if only durable SD included.
Only 24% if only durable SD included.
Including 23% partial metabolic responses with SD.