Tag: Richard Furman MD

Idelalisib Study for CLL Patients Ended Early Due to Positive Findings

On October 9, Gilead Sciences Inc., announced an exciting new development for CLL patients. An independent Data Monitoring Committee (DMC) recommended that a Phase 3 study of Idelalisib in previously-treated CLL patients be ended early, due to evidence of efficacy. As Gilead noted,

“This DMC recommendation is based on a predefined interim analysis showing highly statistically significant efficacy for the primary endpoint of progression-free survival in patients receiving idelalisib plus rituximab compared to those receiving rituximab alone. The safety profile of idelalisib was acceptable and consistent with prior experience in combination with rituximab in previously treated CLL. Gilead has informed the U.S. Food and Drug Administration (FDA) of the plan to end the study and will engage in a dialogue with the FDA regarding a regulatory filing in CLL.”

Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President , Research and Development and Chief Scientific Officer explained,

“This is the first Phase 3 study to report positive results for a new class of targeted therapies that inhibit B-cell receptor signaling as a major component of their mechanism of action, an important area of focus in the development of chemotherapy-free regimens in CLL and other B-cell malignancies. We extend thanks to the investigative sites and to the other research collaborators participating in this study, as well as to the patients who volunteered, and we look forward to sharing these data with the hematology community.”

Prominent researchers involved in this study include the Lymphoma Program’s Dr. Richard Furman. Further data from this study will be submitted for upcoming scientific conferences. Please look to this space to follow up with any further announcements regarding this new development.

 Gilead’s full press release can be found here.

Dr. Richard Furman Discusses Exciting New Treatments for CLL

While attending iwCLL 2013, Dr. Richard Furman, a nationally recognized CLL clinician and researcher here in the Lymphoma Program, sat down and gave his thoughts on the latest advances in CLL treatment, and how this will effect future patient outcomes.

The discussion can be found here.

Ibrutinib Promotes a High Frequency of Durable Response in Relapsed/Refractory and Older Treatment Naive CLL Patients

BTK is an essential mediator of B-cell receptor signaling in normal and malignant B-cells.  Ibrutinib (PCI-32765), an oral inhibitor of BTK, promotes apoptosis and inhibits proliferation, migration and adhesion in CLL cells. Chemoimmunotherapy (CIT) treatment approaches such as fludarabine, cyclophosphamide and rituximab have markedly improved outcomes of younger, fit patients as initial or second-line therapy. Unfortunately, fludarabine-based therapy is less well tolerated in the elderly and carries significant risk of cellular immune suppression, myelosupression, and subsequent myeloid neoplasia. Additionally, virtually all patients eventually relapse after fludarabine-based CIT, leading to the need for effective salvage regimens that induce durable remissions.

Recently, at the biennial international workshop on CLL (iwCLL), in Cologne, Germany, Dr. Richard Furman presented final results from a large (n=116 patients) multi-cohort Phase Ib/II trial of ibrutinib in treatment-naive (TN) or relapsed/refractory (RR) CLL/SLL.  Patients demonstrated a high frequency of durable responses extending beyond 24 months in both TN and RR CLL/SLL including those with high-risk genomic features.

Patients who were TN (all age ≥65 years) or RR (≥ 2 prior therapies including a purine analog and with  high-risk (HR) (relapsed within 2 years from combination CIT) were treated with  ibrutinib at fixed doses of 420mg or 840mg daily until disease progression (PD). The study’s primary objective was to determine the safety and response rates of both dosing regimens.  The overall response rates for the TN and RR patients were 84% and 88% respectively.  The progression free survival (PFS) estimated at 26 months for the 85 RR patients is 74% and for the 31 TN patients is 96%. Estimated 26 month overall survival (OS) for 85 RR patients is 78% and for the 31 TN patients is 97%.  Median duration of response, PFS, and OS have not been reached at the time of this analysis.

In conclusion, Ibrutinib monotherapy was found to be highly active, well tolerated, and induced durable responses in CLL patients with high-risk disease, R/R patients, and older TN patients. At present there are ongoing randomized trials comparing the safety profile of ibrutinib with other CLL therapeutic agents. Ongoing CLL trials at Weill Cornell Medical College can be found here.