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Copiktra

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    Report

  • 26 Pages
  • January 2019
  • Region: Global
  • Citeline
  • ID: 4775397
Drug Overview
Copiktra (duvelisib; Verastem/Yakult Honsha) is a highly selective small molecule inhibitor of the p110-delta and p110-gamma isoforms of the phosphoinositide 3-kinase (PI3K) enzyme. The PI3K-delta and PI3K-gamma enzymes are preferentially expressed in leukocytes, where they are responsible for the regulation of cell proliferation, cell migration, and cell activation. The inhibitory function of Copiktra blocks the growth and survival of malignant B cells.

Analyst Outlook
Copiktra (duvelisib; Verastem/Yakult Honsha) is a small molecule inhibitor targeting the phosphoinositide 3-kinase (PI3K) enzyme approved for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL) after at least two prior therapies. Results from the Phase III DUO trial revealed that heavily pretreated patients treated with Copiktra exhibited superior median progression-free survival (PFS) versus treatment with Arzerra (ofatumumab; Genmab/Novartis). Notably, patients with 17p deletion (del17p) CLL also exhibited responses to Copiktra. The presence of del17p is the strongest adverse prognostic factor for survival in CLL patients, and patients with this chromosomal abnormality remain an area of high unmet need. Ongoing Copiktra clinical trials continue to investigate the drug’s safety and efficacy in relapsed/refractory CLL, and several early-phase trials suggest that Verastem is looking to target the first-line setting

Table of Contents

OVERVIEW
Drug Overview
Product Profiles
Copiktra: Chronic lymphocytic leukaemia (CLL)
Copiktra: NHL: Follicular lymphoma (FL)
LIST OF FIGURES
Figure 1: The author's drug assessment summary of Copiktra for CLL
Figure 2: Copiktra sales for CLL across the US, Japan, and five major EU markets, by country, 2017–26
Figure 3: Copiktra for follicular lymphoma – SWOT analysis
Figure 4: The author's drug assessment summary of Copiktra for follicular lymphoma
Figure 5: Copiktra sales for follicular lymphoma across the US and five major EU markets, by country, 2017–26
LIST OF TABLES
Table 1: Copiktra drug profile
Table 2: Approval history of Copiktra for CLL in the US, Japan, and five major EU markets
Table 3: Trials of Copiktra for CLL
Table 4: Copiktra for CLL – SWOT analysis
Table 5: Copiktra drug profile
Table 6: Copiktra pivotal trial data in follicular lymphoma
Table 7: Copiktra sales for follicular lymphoma across the US and five major EU markets, by country ($m), 2017–26