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Updated Results of Two Phase 2 Ibrutinib Studies in Patients with Mantle Cell Lymphoma or Diffuse Large B-cell Lymphoma
Date:6/16/2013

Consultant Haematologist in the Department of Haematology at the Derriford Hospital in Plymouth, United Kingdom, presented the results of this study at the EHA Congress today. He explained, "To see these results from a single agent among MCL patients is quite significant and very promising. The fact that response rates continued to increase over time, with no new safety signals, is particularly reassuring."

In the second study among relapsed/refractory DLBCL patients, investigators examined whether ibrutinib would be more active in the Activated B-cell-like (ABC) subtype of DLBCL compared to the Germinal Center B-cell-like (GCB) subtype. The ABC subtype of DLBCL is dependent on the B-cell antigen receptor (BCR) pathway, of which BTK is a key element. Ibrutinib selectively inhibits BTK, with the aim of inhibiting malignant B-cell growth and proliferation. Results of this study show that:

  • Patients with the ABC subtype showed a preferential response to ibrutinib monotherapy compared to those with the GCB subtype (ORR = 41% vs 5%, respectively, p=0.007, Fisher's exact test).
  • Median overall survival (OS) was 9.7 months for the ABC subtype, compared to 3.35 months for the GCB subtype.
  • Safety data from 70 patients identified no new safety signals. Grade 3 or higher AEs were seen in greater than 3% of patients and included fatigue (9%), hyponatremia (9%), pneumonia (7%), dehydration (4%), and pleural effusion (4%).

"These results indicated that ibrutinib monotherapy was an effective treatment for some study patients who had ABC-subtype DLBCL," noted presenting investigator Sven de Vos, M.D., Ph.D., Associate Professor in the Department of Medicine at the UCLA Medical Center, Los Angeles, U.S.A., who presented the results at the EHA Congress today. "Given that patients wit
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SOURCE Pharmacyclics, Inc.
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