Herbert A. Eradat, MD, associate professor, University of California, Los Angeles Medical Center, discusses the implications of the FDA approval of rituximab-pvvr (Ruxience), a biosimilar to rituximab (Rituxan), in patients with CD20-positive B-cell Non-Hodgkin lymphoma and chronic lymphocytic leukemia (CLL).

In July 2019, the FDA approved the biosimilar rituximab-pvvr for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma as a single agent or in combination with chemotherapy, or for patients with CD20-positive CLL in combination with chemotherapy.

The approval of rituximab-pvvr will lead to significant financial improvement for patients, explains Eradat. Although financial toxicity is not typically discussed with patients or during medical meetings, it is an important issue to address, he adds.

The hope is that more biosimilars, particularly in the context of CLL, will come down the pipeline. Having these products available to patients will reduce the cost of the regimen and increase its availability. The availability of these products will greatly improve access to care for these patients, concludes Eradat.

Videos

Herbert A. Eradat, MD, discusses the implications of the FDA approval of rituximab-pvvr (Ruxience), a biosimilar to rituximab (Rituxan) in patients with CD20-positive B-cell Non-Hodgkin lymphoma and chronic lymphocytic leukemia.

Dr. Eradat on Rituximab Biosimilar in CD20+ B-Cell Non-Hodgkin Lymphoma and CLL

Herbert A. Eradat, MD, associate professor, University of California, Los Angeles Medical Center, discusses data with acalabrutinib (Calquence) in chronic lymphocytic leukemia (CLL).

On August 14 2019, the FDA granted a breakthrough therapy designation to acalabrutinib for the treatment of patients with CLL. Acalabrutinib is a second-generation BTK inhibitor that is being evaluated in several ongoing clinical trials, says Eradat. The initial trials demonstrated promising activity with the agent, comparable to what has been seen with the first-generation inhibitor, ibrutinib (Imbruvica).

If the agent receives regulatory approval, it could become an alternative agent for patients, particularly for those who cannot tolerate ibrutinib, adds Eradat. These patients could potentially switch to acalabrutinib and have a continued response without the adverse events seen with ibrutinib. Notably, data that have been reported in the relapsed setting show similar efficacy to ibrutinib.

Dr. Eradat Discusses Data With Acalabrutinib in CLL

Herbert A. Eradat, MD, associate professor, University of California, Los Angeles Medical Center, discusses unprecedented aspects of the phase II CAPTIVATE trial in chronic lymphocytic leukemia (CLL).

Data from the trial were presented by William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, at the 2019 ASCO Annual Meeting. The trial evaluated the combination of ibrutinib (Imbruvica) and venetoclax (Venclexta) in treatment-naïve patients. One hundred percent of patients had a response to the treatment, marking the first time that deep responses leading to minimal residual disease (MRD) negativity had been observed.

With these combinations, the field may be able to start applying MRD testing to clinical practice and use the results to guide treatment discontinuation or reinitiation strategies, says Eradat. This would be similar to what is being done in chronic myeloid leukemia, he adds. The results of the trial may also shed light on when and how to reinitiate therapy, as well as when to test for resistance, Eradat concludes.

Dr. Eradat on the CAPTIVATE Trial in CLL

Herbert A. Eradat, MD, associate professor, University of California, Los Angeles Medical Center, discusses unmet needs in chronic lymphocytic leukemia (CLL).

A subset of patients with CLL harbor a 17p deletion or 

 mutation that causes a loss of p53 function, explains Eradat. Additionally, there are patients who have a complex karyotype or unstable genome. Although these patients respond to existing therapies, the durability of the response is poor.

Younger patients pose a particular challenge, says Eradat. This subgroup often presents with the same mutations but because of age, they may run out of therapy options more quickly than older patients.

Patients with Richter’s transformation are also an area of unmet need in CLL, concludes Eradat, because like patients with 

 mutations, those with Richter’s transformation have short responses to treatment.


Herbert A. Eradat, MD, associate professor, University of California, Los Angeles Medical Center, discusses unmet needs in chronic lymphocytic leukemia.

Dr. Eradat on the Unmet Needs in CLL

Herbert A. Eradat, MD, associate professor, University of California, Los Angeles Medical Center, compares novel therapies with cytotoxic chemotherapy in the treatment of patients with chronic lymphocytic leukemia (CLL).

CLL develops through 2 pathogenic mechanisms: one is that cells either do not die properly, or the cells are dependent on signals through the B-cell receptor, Eradat explains. Most novel therapies exploit those 2 pathogenic mechanisms, which is why they tend to be more effective and better tolerated than cytotoxic chemotherapy, according to Eradat.

With novel therapies, agents are attacking how the disease develops and thrives in the patient, whereas traditional cytotoxic chemotherapy is controlled administration of a poison that is supposed to control the disease, but is significantly toxic, concludes Eradat.

Herbert A. Eradat, MD, compares novel therapies with cytotoxic chemotherapy in the treatment of patients with chronic lymphocytic leukemia.

Herbert A. Eradat, MD

Articles

Dr. Eradat on Rituximab Biosimilar in CD20+ B-Cell Non-Hodgkin Lymphoma and CLL

Dr. Eradat Discusses Data With Acalabrutinib in CLL

Dr. Eradat on the CAPTIVATE Trial in CLL

Dr. Eradat on the Unmet Needs in CLL

Dr. Eradat on Novel Therapy Vs Chemotherapy in CLL