- A combination of AbbVie's blood cancer drugs Imbruvica and Venclexta has delivered high response rates early into a mid-stage study, called CAPTIVATE, of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Around 90% of the first 14 study participants who completed a full treatment of 12 cycles of the combo regimen had no detectable cancer cells, according to data presented Sunday at the American Society of Clinical Oncology. Among the first 30 enrolled participants, 77% showed no detectable cancer cells after six treatment cycles.
- Grade 3 or higher adverse events included diarrhea, high blood pressure, and low platelet and white blood cell counts. Some of the less severe yet still common side effects were fatigue, joint pain and upper respiratory infections.
AbbVie made a name for itself in blood cancer treatment with the approval of Imbruvica (ibrutinib). Co-developed with Johnson & Johnson, the drug is one on a short list of first-line treatments for CLL, and sits as the second biggest revenue driver in AbbVie's portfolio.
Venclexta (venetoclax) is poised to further strengthen the pharma's place in this market.
The B-cell lymphoma-2 inhibitor secured a thumbs up in 2016 as a second-line therapy for CLL patients who have a certain kind of chromosomal abnormality. AbbVie is looking to expand that label, and has racked up data showing Venclexta works well as an initial therapy when paired with Imbruvica or more broadly in the second-line setting when combined with Roche's blockbuster Rituxan (rituximab).
Following positive initial data from the Phase 3 MURANO study, which tested the latter pairing in relapsed/refractory CLL, Cowen & Co. issued an investor note estimating AbbVie's Venclexta sales would reach $2.6 billion in 2024. In December, the North Chicago, Illinois-based company submitted a supplemental New Drug Application for the combo in that indication.
A month later, it filed another sNDA for Venclexta monotherapy in CLL patients who relapsed or proved refractory to B-cell receptor inhibitors.
Still, combination therapies appear particularly compelling for AbbVie and its blood cancer offerings. At ASCO, Johnson & Johnson unveiled an interim analysis of the Phase 3 INNOVATE study that found adding Imbruvica to Rituxan significantly reduced risk of disease progression or death in patients with a type of non-Hodgkin lymphoma called Waldenstrom macroglobulinemia.
The Phase 2 CAPTIVATE also received positive reactions. Recruitment is complete, with 164 treatment-naive CLL or SLL patients enrolled. In addition to the effect Imbruvica and Venclexta therapy has on minimal residual disease, investigators haven't seen any dose-limiting toxicities among those 14 participants who have gone through 12 cycles of the combo, according to AbbVie.
"This is the first data of the combo in first line CLL and suggests that ibrutinib + venclexta could have a role in [the first-line] setting and allow treatment holidays," analysts from Cowen wrote in the May 17 note, referring to data released in an abstract ahead of the ASCO meeting.
Such a role would likely lift up Venclexta sales, which thus far haven't been large enough for AbbVie to break out in its quarterly earnings filings with the Securities and Exchange Commission.
"With Venclexta, we are nearing the launch of a major label expansion in relapsed refractory CLL, which represents a meaningful market for AbbVie. We're already hearing positive feedback from [key opinion leaders] who view Venclexta as a potential game-changing new therapy for patients with CLL," AbbVie CEO Richard Gonzalez said during the company's most recent earnings call.