Major R&D Pipeline: 3ADCs
DS-3201 (EZH1/2 inhibitor):
Presented interim results of NHL Ph1 study at EHA
DS3201-A-J101; NCT02732275
Patients with R/R NHL
Age ≥20 (Japan) or ≥18 (US) years
ECOG PS 0 or 1
Patients with ATL: positive test
result for HTLV-1
Primary endpoints
.
.
·
Safety (including DLTS, TEAEs)
Recommended phase 2 dose
Pharmacokinetics
Secondary endpoints
Part 1: Dose Escalation
Japan
R/R NHL (all-comers) b
300 mg PO, QD
RDE
250 mg PO, QD
200 mg PO, QD
150 mg PO, QD
Part 2: Dose Expansion
Japan and US
R/R ATL
Valemetostat 200 mg PO, QD
R/R PTCL
Valemetostat 200 mg PO, QD
•
Safety analysis: all NHL (N=77)
•
Safety and efficacy analyses: T-cell NHL (n=58)
·
Safety
•
Antitumor effecta
o PTCL (n=44)
o ATL (n=14)
a According to the 2007 revised International Working Group Criteria for Malignant Lymphoma or "Definition, prognostic factors, treatment, and response criteria of adult T-cell leukemia-lymphoma: a proposal from an
international consensus meeting." b Each dosage was tested with 3 patients.
ATL: adult T-cell leukemia/lymphoma, EHA: European Hematology Association, NHL: non Hodgkin's lymphoma, PTCL: peripheral T-cell lymphoma, R/R: relapsed/refractory
Daiichi-Sankyo
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