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Pharmacyclics's PCI-32765 - A novel approach to treat B-cell malignancies Product Image

Pharmacyclics's PCI-32765 - A novel approach to treat B-cell malignancies

  • Published: February 2011
  • Region: Global
  • 37 Pages
  • LifeTech Research

Pharmacyclics’ PCI-32765 is an oral irreversible inhibitor of Btk, a tyrosine kinase involved in the activation of B lymphocytes via the B cell receptor (BCR) signaling pathway. PCI-32765 is in clinical development for B-cell non-Hodgkin’s lymphomas (NHL). Molecular experiments indicate that abnormal BCR signaling can contribute to the genesis of NHL, and support the use of BCR signaling inhibitors as a therapeutic approach. Compounds against various targets along the BCR pathway are in development.

A phase I trial of PCI-32765 showed impressive anti-tumor activity in a variety of B-cell NHLs. The company plans to initiate a broad clinical program in mantle cell lymphoma, chronic lymphocytic leukemia and diffuse large B-cell lymphoma. In this report, we review the scientific rationale, the early data, regulatory precedents and the likelihood of further success. Other BCR inhibitors in development provide proof of concept, but also represent competition. Yet, the market opportunity is fairly large and so is the unmet need.

INTRODUCTION

B-CELL RECEPTOR (BCR) SIGNALING AND CANCER

B-CELL MALIGNANCIES

1. Chronic lymphocytic leukemia/small lymphocytic lymphoma
- Many factors influence a CLL patient’s prognosis
- A role for BCR signaling
- Treatment management

2. Mantle Cell Lymphoma

3. Diffuse large B-cell lymphoma
- A role for BCR signaling
- Treatment management

PCI-32765 IN ONCOLOGY

1. Bruton’s Tyrosine Kinase (Btk)

2. Preclinical rationale

3. Clinical Development
- Phase Ia
- Phase Ib/II in CLL/SLL

4. Phase III enabling program
- Timeline for approval

OPINION

1. The rationale for targeting BCR signaling

2. Btk as a target for BCR signaling inhibition

3. Anti-tumor activity in early studies

4. Other BCR signaling inhibitors provide external validation to this approach

5. The unmet medical need in lymphomas

6. Lymphocytosis – should it be a concern?

7. What can we learn from prior approvals in CLL?

8. Insights from the ofatumumab approval in CLL

9. Safety profile

COMPETITION

MARKET

CONCLUSIONS

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