Phase 3 Trial Evaluating Imbruvica Plus Gazyva for CLL Patients Meets Primary Endpoint

iLLUMINATE trial meets primary endpoint of PFS in patients with previously untreated chronic lymphocytic leukemia compared with chlorambucil plus obinutuzumab.

Global biopharmaceutical company AbbVie has just announced that their phase 3 trial, dubbed iLLUMINATE, has met its primary endpoint of improvement in progression-free survival (PFS) in patients with chronic lymphocytic leukemia (CLL).

It is estimated that there will be over 60,000 new cases of leukemia in the United States in 2018; CLL accounts for about one-fourth of those cases, according to the American Cancer Society. Risk of getting CLL is about 1 in 175, and mainly older adults are affected by this cancer.

iLLUMINATE, a randomized, multicenter, open-label, phase 3 trial compared the use of IMBRUVICA (ibrutinib) in combination with GAZYVA (obinutuzumab) with chlorambucil plus obinutuzumab in CLL or small lymphocytic lymphoma (SLL) patients who had been previously untreated.

The study met its primary endpoint in that there was a clinically and statistically significant difference noted in PFS for those who received the combination therapy versus those who were given chlorambucil combined with obinutuzumab.

IMBRUVICA, is described as a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, and by blocking BTK, it is able to “move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs,” according to AbbVie’s Pharmacyclics LLC and Janssen Biotech, Inc., who developed and commercialized the therapy.

“We are optimistic about the topline results from the iLLUMINATE study and the fact that IMBRUVICA plus obinutuzumab demonstrated marked improvement in progression-free survival compared to obinutuzumab plus chlorambucil, a combination with is currently recommended by the National Comprehensive Cancer Network guidelines as a Category 1 treatment,” Danielle James, MD, MAS, head of clinical sciences at Pharmacyclics LLC, said in a recent statement.

After presenting primary analysis data from the iLLUMINATE study to regulatory authorities, the companies will either publish the data or share it in a medical congress.

Available in the United States since November 2013, IMBRUVICA has received approval from the US Food and Drug Administration (FDA) to treat 6 indications, including: mantle cell lymphoma (in those who received at least 1 prior treatment), CLL/SLL, CLL/SLL with 17p deletion, Waldenström macroglobulinemia, marginal zone lymphoma in those who require systemic therapy and have received specific prior treatment, and chronic graft versus host disease after 1 or more lines of systemic therapy have failed.

If approved by the FDA, the combination therapy could potentially be the first chemotherapy-free CD20 combination in first-line CLL treatment, according to the press release.

“This chemotherapy-free combination represents a potential new treatment option for patients with CLL,” lead investigator of the study John Gribben, MD, stressed in a recent statement. “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.”