Table 1.
Clinical trials evaluating emavusertib in non-hodgkin lymphomas.
| Clinical Trials.gov Identifier | Diseases Evaluated | Median Age, range | Median # of Prior Treatments, range | Any Grade Treatment Related Adverse Events | ≥Grade 3 Treatment Related Adverse Events | Response | RP2D |
|---|---|---|---|---|---|---|---|
| NCT03328078 |
Phase 1a
(Emavusertib monotherapy) DLBCL (n=14) MCL (n=2) MZL (n=2) WM (n=3) Transformed DLBCL (n=1) LPL (n=2) FL (n=6) |
68.5 (50-87) | 4 (1-8) | Fatigue (36%), Nausea (27%), Neutrophil count decreased (23%), Dizziness (18%), Hypercalcemia (18%), Hypophosphatemia (18%), Vomiting (18%). |
Rhabdomyolysis (25%; n=8) of patients treated with 400mg BID | Eight of 28 evaluable patients experienced overall tumor burden decreases of ≥20% from baseline | 300mg BID of Emavusertib |
|
Part 2a (Emavusertib + Ibrutinib 420mg or 560mg)
DLBCL (n=2) CLL(n=2) MCL (n=2) MZL (n=3) WM (n=2) PCNSL(n=2) |
66 (56-92) | 3 (1-8) | NR | NR | ORR=44.4% (n=4/9) CR=2 (PCNSL and MCL) PR=2 (MCL and CLL) 5=SD |
200mg BID of Emavusertib combined with Ibrutinib 420 or 560mg |
DLBCL, diffuse large B cell lymphoma; MCL, mantle cell lymphoma; MZL, marginal zone lymphoma; WM, Waldenstrom macroglobulinemia; LPL, lymphoplasmacytic lymphoma; FL, follicular lymphoma; CLL, chronic lymphocytic leukemia; PCNSL, primary CNS lymphoma; NR, not reported, ORR, overall response rate; CR; complete response; PR; partial response; SD, stable disease; RP2D, recommended phase II dose.
#, Number.