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On Saturday 15th June, Dr. Mark Roschewski, National Cancer Institute, Bethesda, MD presented at the 24th annual congress of the European Hematology Association (EHA), Amsterdam, NL. He reported the results of a phase Ib/II clinical trial using HU5F9-G4 (5F9) and rituximab combination therapy in DLBCL and iNHL. 1
5F9 is a first-in-class antibody targeting CD47, a macrophage immune checkpoint that cancer cells exploit to avoid phagocytosis. The study aimed to determine the safety and efficacy of 5F9 and rituximab combination in patients with iNHL and relapsed/refractory (R/R) DLBCL. The initial dose escalation results in R/R DLBCL showed the objective (OR) and complete response (CR) rates of 40% and 33% respectively, and 71% and 43% in refractory FL, with good safety profile. The data presented at the session were a follow up of phase Ib cohort and a preliminary results from phase II.
Characteristics |
All |
DLBCL |
iNHL N=45 (%) |
---|---|---|---|
Median age (range) |
67 (21–88) |
69 (21–88) |
60 (28–87) |
Medium number of prior therapies (range) |
3 (1–10) |
3 (1–10) |
3 (1–9) |
ECOG performance status 0 1 2 Missing |
50 (43) 58 (50) 5 (4) 2 (2) |
22 (31) 43 (61) 5 (7) 0 |
28 (62) 15 (33) 0 2 (4) |
Stage at diagnosis I–II III–IV Unknown |
17 (15) 68 (59) 30 (26) |
12 (17) 19 (56) 19 (27) |
5 (11) 29 (64) 11 (24) |
Rituximab refractory Any regimen Last regimen |
98 (85) 83 (72) |
62 (89) 52 (74) |
36 (80) 31 (69) |
Refractory to last regimen |
82 (71) |
49 (70) |
33 (73) |
Primary refractory |
- |
41 (59) |
- |
Prior autologous transplant |
27 (24) |
17 (24) |
10 (22) |
Response |
Total |
DLBCL |
iNHL |
---|---|---|---|
Overall response rate (ORR) |
44 (45%) |
21 (36%) |
23 (61%) |
Complete response (CR) |
18 (19%) |
9 (15%) |
9 (24%) |
Partial response (PR) |
26 (27%) |
12 (20%) |
14 (£7%) |
Stable disease (SD) |
16 (17%) |
7 (12%) |
9 (24%) |
Progressive disease (PD) |
37 (38%) |
31 (53%) |
6 (16%) |
The 5F9 and rituximab combination is well tolerated and shows efficacy in R/R DLBCL and refractory FL. The lower response rate in the phase II cohort of patients is likely to be due to heavy pre-treatment and predominance of R/R CAR T ineligible patients. CD47 is highly expressed in DLBCL and FL patients and potential correlation analysis of the expression levels with the response are ongoing.
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