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On Wednesday 19 June at the International Conference on Malignant Lymphoma, Lugano, CH, Professor Umberto Vitolo, presented the first report of the global ROBUST phase III randomized trial (NCT02285062) of lenalidomide/R-CHOP (R2-CHOP) vs placebo/R-CHOP in previously untreated CD20+ activated B-cell (ABC)-type diffuse large B-cell lymphoma (DLBCL).
In the double-blind trial, investigators sought to determine whether the addition of lenalidomide to R-CHOP could improve outcomes compared with R-CHOP in 570 patients with ABC-type DLBCL. The study did not meet its primary endpoint of progression-free survival (PFS) for R2-CHOP versus placebo/ R-CHOP as frontline therapy in patients with ABC-type DLBCL.
N (%) |
|
R2-CHOP |
Placebo/R2-CHOP |
---|---|---|---|
International Prognostic Index (IPI) score
|
2 |
121 (42) |
120 (42) |
≥3 |
164 (58) |
165 (58) |
|
Bulky disease |
≥7 cm* |
97 (34) |
99 (35) |
Median age, y (range) ≥ 65 y* |
|
65 (21–82) 147 (52) |
65 (28–83) 148 (52) |
Male/female |
|
164 (58)/121 (42) |
143 (50)/142 (50) |
ECOG performance status |
0 |
129 (45) |
111 (39) |
1 |
104 (36) |
118 (41) |
|
2 |
52 (18) |
56 (20) |
|
Ann Arbor disease stage |
II |
37 (13) |
33 (12)† |
III |
80 (28) |
98 (34) |
|
IV |
168 (59) |
154 (54) |
|
Elevated LDH (> 234 U/L) |
|
177 (62) |
176 (62) |
Geographic distribution |
Europe |
124 (44) |
150 (53) |
Asia-Pacific |
111 (39) |
92 (33) |
|
North America |
24 (8) |
23 (8) |
|
Other |
26 (9) |
20 (7) |
Figure 1: Robust study design
The ROBUST trial was the first study to compare R2-CHOP with placebo/R‐CHOP in patients with previously untreated, prospectively selected, CD20+ ABC‐type DLBCL. Prof Vitolo concluded that overall, the ROBUST trial did not meet the PFS primary or key secondary endpoint for R2-CHOP vs placebo/R-CHOP. However, an encouraging trend for PFS supporting R2-CHOP was observed in patients with higher risk IPI ≥ 3. Prof Vitolo emphasized that analyses of ROBUST are still ongoing and future analyses will include the evaluation of pharmacokinetics/dosing, molecular classification, and mutational status.
Future clinical trials will investigate next-generation immunomodulatory agents for DLBCL.
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