Final results from trial E1912 appeared in the New England Journal of Medicine in early August. The study, led by Tait Shanafelt, MD of Stanford Medicine, found the combination of ibrutinib plus rituximab was superior to standard treatment for patients age 70 and younger with previously untreated chronic lymphocytic leukemia (CLL).
The combination led to improvements in both progression-free survival (the length of time patients live before their disease worsens) and overall survival. Additionally, patients who received ibrutinib-rituximab were less likely to experience serious side effects than those who received standard treatment.
"These results are practice-changing and immediately establish ibrutinib and rituximab as the new standard of care for the initial treatment of CLL in patients age 70 and younger,” says Dr. Shanafelt.
The findings were initially presented as a late-breaking abstract at the American Society of Hematology (ASH) Annual Meeting in December 2018. Results from another NCI-supported trial on ibrutinib in patients with CLL, led by the Alliance for Clinical Trials in Oncology, were also presented at the same ASH meeting. Trial A041202 demonstrated that ibrutinib produces superior progression-free survival compared with standard chemoimmunotherapy (bendamustine plus rituximab) in previously untreated patients with CLL who are age 65 and older. The study found that adding rituximab to ibrutinib did not improve progression-free survival beyond ibrutinib alone.
“These two NCI-funded trials have collectively established ibrutinib-based therapy as the first line treatment for CLL patients of any age,” says Dr. Shanafelt.
Read the press release to learn more.