Change is on the Horizon for CLL Treatment, Expert Says

The treatment landscape for chronic lymphocytic leukemia (CLL) is going to drastically change over the next decade or so, says Jose Leis, M.D.
BY GINA COLUMBUS @ginacolumbusonc
Fludarabine, cyclophosphamide, and Rituxan (rituximab) (FCR) and allogeneic stem cell transplantation will continue to be the standard treatment approach for patients with chronic lymphocytic leukemia (CLL).

However, recent approvals of novel agents and ongoing developments of combination regimens are advancing the field into a realm of new, improved and individualized possibilities for patients, explains Jose Leis, M.D.

One clinical opportunity is a phase 2 study of Imbruvica (ibrutinib) — which was first approved as a treatment for patients with previously treated CLL in September 2014 and later as a frontline therapy in March 2016 — plus Venclexta (venetoclax) in patients with relapsed/refractory disease or high-risk untreated patients (NCT02756897). Venclexta was approved by the FDA in April 2016 in pretreated patients who have a 17p deletion (del[17p]).

Leis lectured on this shifting landscape of CLL during and interview with CURE.

“To be aware of your patient and really understand them is really going to be pivotal to what therapy you recommend for that patient,” said Leis. “It’s very clear that one medication — one therapy — does not fit all.”

Leis, a professor of Medicine and head of the Chronic Lymphocytic Leukemia Program at Mayo Clinic, spoke on the current state of the disease and pivotal clinical trial findings in CLL to be presented at the 2016 American Society of Hematology (ASH) Annual Meeting. Additionally, he provided insight into the potential of chimeric antigen receptor (CAR) T-cell therapies in CLL and how the treatment paradigm will look in the coming years.

How have we seen the field of CLL evolve?

The world of CLL therapy has just really dramatically changed in the last 20 years. I got interested in CLL because my father-in-law called while I was a young faculty member at Harvard and told me he had been diagnosed with CLL. In 1995, we didn’t know about prognostic factors; we didn’t really know anything about the clinical course of aggressive CLL. Unfortunately, within three years, he passed from his disease.

What we knew at that time really didn’t tell us what the basis of the disease was. The first major advance was that our understanding that cytogenetics made a difference. In a German study published in The New England Journal of Medicine in 2000, it showed that it’s really not one disease; it’s a broad spectrum of B-cell aggressiveness from the 17p deletion patients who literally have six months before they progress to needing treatment, to 13q deletion (del[13q]) patients who will go for a decade before they might progress. There is also the finding about the mutational status in immunoglobulin genes. That’s going to be a really important thing in the next 20 years.

The big advances started with the combination of chemoimmunotherapy, the FCR regimen by Dr. Michael Keating of The University of Texas MD Anderson Cancer Center in the early 2000s. That really improved the responses and the complete remission rates.

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