Chemo-Free Combo Therapy for Chronic Lymphocytic Leukemia Wins in Phase 3 Trial

Results from the phase 3 iLLUMINATE (PCYC-1130) trial support ibrutinib (Imbruvica) in combination with obinutuzumab (Gazyva) as an effective therapy for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), according to a press release.

The study evaluated the combination therapy compared with chlorambucil plus obinutuzumab in previously untreated patients with CLL or SLL. According to the data, the trial met its primary endpoint of improvement in progression-free survival (PFS).

In the study, patients received either ibrutinib 420 mg continuously in combination with obinutuzumab 1000 mg intravenously over 6 cycles or chlorambucil on days 1 and 15 of each cycle plus obinutuzumab.

Ibrutinib is currently FDA-approved for all lines of CLL/SLL therapy, including patients with difficult-to-treat 17p deletion CLL. The drug mainly works by blocking a protein called Bruton’s tyrosine kinase (BTK), which is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells, according to the press release.

CLL is the most common form of leukemia in adults and the prevalence of CLL is approximately 115,000 patients in the United States with approximately 19,000 newly diagnosed patients every year, according to AbbVie.

“We’re pleased to see positive results for the combination of ibrutinib plus obinutuzumab. This chemotherapy-free combination represents a potential new treatment option for patients with chronic lymphocytic leukemia,” John Gribben, MD, lead trial investigator, said in the press release. “It’s exciting to see the blood cancer treatment paradigm continue to evolve—each advance moves us one step closer to a better standard of care for these patients.”

There are currently several other ongoing trials evaluating ibrutinib alone and in combination with other treatments for several blood and solid tumor cancers, and other serious illnesses.

References

IMBRUVICA® (ibrutinib) Plus GAZYVA® (obinutuzumab) Phase 3 iLLUMINATE Trial for First-Line Therapy of Chronic Lymphocytic Leukemia (CLL) Patients Met Primary Endpoint [news release]. AbbVie’s website. https://news.abbvie.com/news/imbruvica-ibrutinib-plus-gazyva-obinutuzumab-phase-3-illuminate-trial-for-first-line-therapy-chronic-lymphocytic-leukemia-cll-patients-met-primary-endpoint.htm. Accessed May 24, 2018.