Ibrutinib Continues to Demonstrate Viability in Treatment of CLL

Based on the results of the first in-human clinical trial of ibrutinib in chronic lymphocytic leukemia (CLL) – conducted in 2010 at Weill Cornell Medicine/NewYork-Presbyterian Hospital and other centers – researchers led in part by Dr. Richard Furman moved forward with the first phase II trial of the drug. According to a five-year follow-up study recently published in the American Society of Hematology’s Blood journal, ibrutinib continues to demonstrate excellent efficacy and tolerability as a single agent therapy for people with previously untreated and relapsed or refractory CLL.

CLL is characterized by uncontrolled growth of mature B-cells that accumulate in the blood, bone marrow, lymph nodes and spleen. As CLL cells fill these various organs, they interfere with normal cell functions. Ibrutinib is an oral treatment that inhibits Bruton’s tyrosine kinase (BTK), an enzyme involved in B-cell development that plays a critical role in CLL cell survival.

Prior to the Food and Drug Administration (FDA) approval of ibrutinib for CLL in 2014, chemoimmunotherapy (CIT), typically with fludarabine, cyclophosphamide and rituximab (FCR), was one of the only treatment options available for people with CLL. Chemoimmunotherapy often generates deep responses that last a median of five to six years, but it is associated with significant toxicities. When patients relapse after CIT, their disease becomes more resistant to subsequent treatments, and due to the accumulation of toxicities, many patients are unable to receive further CIT. Given the associated toxicities, the use of CIT is limited in older patients with comorbidities – the cohort that comprises the majority of CLL patients.

The phase II study in which Dr. Furman was involved tested ibrutinib as a single agent in over 100 patients – some of whom received no prior therapy, and others who relapsed following initial treatment. Patients received daily oral doses of ibrutinib until their disease progressed or until the presence of side-effects warranted discontinuation of therapy.

Almost 90 percent of all patient participants demonstrated a response to treatment at the five-year mark, and complete remission rates increased over time with ongoing treatment. Ninety-two percent of treatment-naive patients and 44 percent of relapsed/refractory patients remained free of disease progression five years out from the start of treatment.

Side-effects, including infections, diarrhea, bleeding and low-blood counts, were mild. They did not prevent patients from remaining on treatment long-term and often improved with continued dosing.

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Dr. Richard Furman, M.D.

“These data demonstrate the excellent long-term outcomes for CLL patients treated with ibrutinib, especially those who receive ibrutinib as their first therapy,” says Dr. Furman.

Lymphoma Program Hosts Oncologists from Brazil for Hematologic Malignancies Update

A group of more than 20 Brazilian oncologists traveled to Weill Cornell Medicine and NewYork-Presbyterian Hospital from South America to attend the 2017 Update in Hematologic Malignancies, a two-day interactive educational symposium organized and presented by members of the Weill Cornell Lymphoma Program’s research and clinical faculty. BrazilianHeme

The meeting, directed by Dr. Sarah Rutherford, featured didactic lectures on chronic lymphocytic leukemia (CLL) and Richter’s Transformation (RT) by Drs. John Allan and Richard Furman, discussions of controversies and challenging cases in mantle cell, follicular and diffuse large B-cell lymphomas (MCL, FL, DLBCL) led by Drs. Rutherford and Peter Martin, a lymphoma-specific hematopathology update from Dr. Amy Chadburn, and a tour of Dr. Leandro Cerchietti’s research laboratory.

Programs like this one foster partnerships that can propel us toward our goal of improving health outcomes for the nearly 100,000 people around the world who are affected by lymphoma. Our team is able to establish collaborative international relationships to teach and learn from medical practitioners of a diverse background, all while solidifying our role as a trusted, global authority on lymphoma research and care.

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Dr. Sarah Rutherford

“The relationship we have established with the Brazilian oncologists is fulfilling for all of us,” says Dr. Rutherford. “We enjoy teaching them and helping to manage complex cases that they face in Brazil. We also remain in touch with them after the conference – providing guidance on patients and even traveling to Brazil to participate in meetings. We look forward to continuing this collaboration given our shared mission of providing the best possible care for patients with lymphoma.”

FDA Approves Subcutaneous Administration of Rituximab for Three Lymphoma Types

On June 22, 2017, the United States Food and Drug Administration (FDA) approved subcutaneous injection of rituximab plus hyaluronidase human for people with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL). Subcutaneous administration refers to the method of delivering a drug under the skin rather than directly into a vein as performed during intravenous (IV) administration.

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Administration of rituximab under the skin tends to take less than 10 minutes, whereas the traditional IV method can last several hours. The technique also allows for fixed dosing, which can reduce preparation time and excess drug waste, and may be more cost effective than IV infusion.

The approved treatment is to be employed only after patients have received at least one cycle of intravenous rituximab.

Approval comes based on the results of a series of clinical trials demonstrating comparable safety and efficacy outcomes across subcutaneous and intravenous administration.