Efficacy

In Study 3, an objective disease response rate (CR+CRu+PR) of 26% (34/130) was achieved1

Response rates in clinical study 3

a95% confidence interval.
Response rates above are rounded to the nearest whole number.

A complete response rate of 15% (20/130) was achieved1

Similar CR achieved in Study 41

  • The percentage of patients achieving CR/CRu in Study 4 was similar to that in Study 3

response-rates-chart-1a

ISTODAX was studied in patients with relapsed or
refractory PTCL across subtypes, including
34 patients in Studies 3 and 4 with AITL.1

SERIOUS ADVERSE REACTIONS

  • Infections were the most common type of serious adverse events reported. In Study 3, 26 patients (20%) experienced a serious infection, including 6 patients (5%) with serious treatment-related infections. In Study 4, 11 patients (23%) experienced a serious infection, including 8 patients (17%) with serious treatment-related infections
  • Serious adverse reactions reported in ≥2% of patients in Study 3 were pyrexia (8%), pneumonia, sepsis, vomiting (5%), cellulitis, deep vein thrombosis, (4%), febrile neutropenia, abdominal pain (3%), chest pain, neutropenia, pulmonary embolism, dyspnea, and dehydration (2%)
  • In Study 4, serious adverse reactions in ≥2 patients were pyrexia (17%), aspartate aminotransferase increased, hypotension (13%), anemia, thrombocytopenia, alanine aminotransferase increased (11%), infection, dehydration, dyspnea (9%), lymphopenia, neutropenia, hyperbilirubinemia, hypocalcemia, hypoxia (6%), febrile neutropenia, leukopenia, ventricular arrhythmia, vomiting, hypersensitivity, catheter-related infection, hyperuricemia, hypoalbuminemia, syncope, pneumonitis, packed red blood cell transfusion, and platelet transfusion (4%)

In Study 3, 60% (12/20) of complete responses were known to exceed 11.6 months1

Duration of complete response in study 3

  • Responses in 12 out of 20 patients achieving CR/CRu were known to exceed 11.6 months1
  • Follow-up was discontinued in the remaining 8 patients prior to 8.5 months1
  • Patients had received a median of 2 prior systemic therapies (range: 1-8)1

ISTODAX is a 2nd-line treatment for PTCL.1
- Regardless of subtype, transplant eligibility,
and number of prior treatments

SERIOUS ADVERSE REACTIONS (cont’d)

  • Reactivation of hepatitis B virus infection has occurred in 1% of patients with PTCL patients in clinical trials in Western population enrolled in Study 3 and Study 4
  • Deaths due to all causes within 30 days of the last dose of ISTODAX occurred in 7% of patients in Study 3 and 17% of patients in Study 4
  • In Study 3, there were 5 deaths unrelated to disease progression that were due to infections, including multi-organ failure/sepsis, pneumonia, septic shock, candida sepsis, and sepsis/cardiogenic shock
  • In Study 4, there were 3 deaths unrelated to disease progression that were due to sepsis, aspartate aminotransferase elevation in the setting of Epstein Barr virus reactivation, and death of unknown cause

In Study 3, median time to objective disease response (CR+CRu+PR) was 56 days (1.8 months)1,16

Median time to complete response in Study 3 (N=130)

Median time to complete response in Study 3 (20/130)1,16

  • The median time to complete response was 105.5 days (3.5 months; ~4 cycles) for patients who achieved a CR/CRu

Romidepsin (ISTODAX) has a category 2A recommendation
from the NCCN Clinical Practice Guidelines in Oncology
(NCCN Guidelines®) for PTCL based on Study 3 and
Study 4.18-20

DISCONTINUATIONS

  • Discontinuation due to an adverse event occurred in 19% of patients in Study 3 and in 28% of patients in Study 4
  • In Study 3, thrombocytopenia and pneumonia were the only events leading to treatment discontinuation in at least 2% of patients
  • In Study 4, events leading to treatment discontinuation in ≥2 patients were thrombocytopenia (11%), anemia, infection, and alanine aminotransferase increased (4%)
NEXT: ADVERSE REACTIONS

Important Safety Information

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

Peripheral T-Cell Lymphoma

The most common Grade 3/4 adverse reactions (>5%) regardless of causality in Study 3 (N=131) were thrombocytopenia (24%), neutropenia (20%), anemia (11%), asthenia/fatigue (8%), and leukopenia (6%), and in Study 4 (N=47) were neutropenia (47%), leukopenia (45%), thrombocytopenia (36%), anemia (28%), asthenia/fatigue (19%), pyrexia (17%), vomiting (9%), and nausea (6%).

Infections were the most common type of serious adverse event reported in Study 3 (N=131) and Study 4 (N=47). In Study 3, 26 patients (20%) experienced a serious infection, including 6 patients (5%) with serious treatment-related infections. In Study 4, 11 patients (23%) experienced a serious infection, including 8 patients (17%) with serious treatment-related infections.

The most common adverse reactions regardless of causality in Study 3 (N=131) were nausea (59%), asthenia/fatigue (55%), thrombocytopenia (41%), vomiting (39%), diarrhea (36%), and pyrexia (35%), and in Study 4 (N=47) were asthenia/fatigue (77%), nausea (75%), thrombocytopenia (72%), neutropenia (66%), anemia (62%), leukopenia (55%), pyrexia (47%), anorexia (45%), vomiting (40%), constipation (40%), and diarrhea (36%).

DRUG INTERACTIONS

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