NORTH CHICAGO, Ill., Dec. 5, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data from the Phase 2 CAPTIVATE (PCYC-1142) clinical trial evaluating IMBRUVICA® (ibrutinib) in combination with VENCLEXTA®/VENCLYXTO® (venetoclax) in previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) during an oral presentation session at the virtual 2020 American Society of Hematology (ASH) Annual Meeting (Abstract #123). The one-year disease-free survival (DFS) rate in patients randomized to placebo or ibrutinib after completing the combination regimen provides data to support a fixed-duration treatment that can offer CLL/SLL patients remission and time off treatment.

"These results show the ibrutinib plus venetoclax combination providing continued disease-free survival for CLL patients once treatment is complete," said Dr. William Wierda, M.D., Professor, Department of Leukemia, University of Texas MD Anderson Cancer Center and principal study investigator. "It will be really exciting for patients to have a potential option in the future that can put them into remission and time off treatment."

These findings build on the previously reported results showing that this first-line combination regimen for CLL resulted in high rates of undetectable minimal residual disease (uMRD) in both peripheral blood (PB) (75% of patients) and in bone marrow (BM) (72% of patients). Undetectable MRD is defined as little to no cancer cells found after treatment. In the Confirmed uMRD group, one-year DFS rate was not significantly different for patients randomized to placebo (95.3%; 95% CI 82.7-98.8) versus ibrutinib (100%; 95% CI 100-100) (P=0.1475).

During the overall study period across all-treated patients (with median treatment duration of 29 months), most common grade 3/4 adverse events (≥5% of patients) were neutropenia (36%), hypertension (10%), thrombocytopenia (5%), and diarrhea (5%). The safety profile of the combination was consistent with known adverse events for ibrutinib and venetoclax individually and no new safety signals emerged.

"IMBRUVICA and VENCLEXTA/VENCLYXTO, individually, have truly transformed the way CLL and some other blood cancers are treated. Today, CLL can be treated without chemotherapy in the form of an oral pill, which is a remarkable advancement, compared to standards of care over the last decade," said Mohamed Zaki, M.D., Ph.D., vice president and global head of oncology development, AbbVie. "The results from this study will add to the evidence required for the development of this combination regimen as a potential new treatment option for CLL."

CLL is one of the two most common forms of leukemia in adults and is a type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells (called lymphocytes).1 While these cancer cells start in the bone marrow, they then later spread into the blood. The prevalence of CLL is approximately 115,000 patients in the U.S. with approximately 20,000 newly diagnosed patients every year.2,3 CLL is predominately a disease of the elderly, with a median age at diagnosis ranging from 65-70 years.4

According to the Leukemia & Lymphoma Society, MRD refers to the small number of cancer cells that remain in the body after treatment.5 The number of remaining cells may be so small that they do not cause any physical signs or symptoms and often cannot even be detected through traditional methods, this is known as undetectable MRD (uMRD). Doctors use MRD/uMRD to measure the effectiveness of treatment and to predict which patients are at risk of relapse.

There are additional ongoing company-sponsored trials exploring the potential of ibrutinib and venetoclax in combination for CLL treatment, including the Phase 3 GLOW study. Results from the ongoing GLOW study, assessing the ibrutinib plus venetoclax combination in comparison to chlorambucil plus obinutuzumab for first-line treatment of patients with CLL or SLL (NCT03462719), will be presented at an upcoming congress.

About CAPTIVATEThe CAPTIVATE study MRD cohort evaluated 164 patients between the ages of 18 and 70 years old with previously untreated CLL/SLL. Patients received 3 cycles of ibrutinib lead-in followed by 12 cycles of ibrutinib + venetoclax (Ibr 420 mg/day PO; Ven ramp-up to 400 mg/day PO). Patients with confirmed uMRD (defined as uMRD serially over ≥3 cycles, and in both PB and BM) after 12 cycles of ibrutinib + venetoclax were randomized 1:1 to receive double-blind treatment with placebo or ibrutinib. Patients who did not meet the definition of confirmed uMRD were randomized 1:1 to receive open-label treatment with ibrutinib or continued ibrutinib + venetoclax. Primary endpoint was 1-year DFS rate in the confirmed uMRD patients randomized to placebo vs ibrutinib; DFS was defined as survival without progression or MRD relapse (which was defined as an MRD level of 10-2). Key secondary endpoints were rates of uMRD (