AbbVie Inc. ABBV presented encouraging results on Imbruvica and its experimental multiple myeloma candidate, venetoclax, at the annual meeting of the American Society of Hematology (ASH).
Presented Multiple Data on Imbruvica
AbbVie announced that results from the phase III study (RAY) showed Imbruvica significantly prolonged progression-free survival (the primary endpoint) and improved overall response rates (ORR) – a key secondary endpoint – in patients with relapsed or refractory mantle cell lymphoma (MCL) compared with Torisel (temsirolimus). Imbruvica resulted in a reduction in the risk of disease progression or death by 57% after a median follow-up of 20 months. Data was also published online in The Lancet.
The company also announced that data from a multicenter, open-label phase II study showed that Imbruvica plus Rituxan (rituximab) was found to be well tolerated and demonstrated an ORR of 82% in treatment-naive patients with follicular lymphoma (FL). The company also presented phase I dose-escalation data on Imbruvica in combination with Rituxan and Revlimid (lenalidomide) in treatment-naive FL patients.
Moreover, preliminary data from the ongoing dose-escalation phase I/IIb study showed that Imbruvica plus Kyprolis (carfilzomib) with or without dexamethasone resulted in an initial ORR of 62% in relapsed or refractory multiple myeloma patients. Overall, the combination was found to be well tolerated with no dose-limiting toxicities observed during the dose escalation phase.
Meanwhile, results from a head-to-head phase III study (RESONATE-2) in treatment-naive patients (aged 65 years and above) with chronic lymphocytic leukemia (CLL) showed that Imbruvica reduced the risk of progression or death by 84% with an estimated survival rate of 98% at 24 months when compared to Leukeran. The results were simultaneously published online in The New England Journal of Medicine.
We note that AbbVie has submitted a supplemental new drug application to the FDA for the use of Imbruvica in treatment-naïve patients with CLL.
Imbruvica is currently approved in the U.S. for the treatment of patients with MCL or CLL who have received at least one previous therapy and for CLL patients with del 17p. It is also approved for the treatment of patients with Waldenström's macroglobulinemia. We remind investors that Imbruvica was added to AbbVie’s portfolio following the Pharmacyclics acquisition in May 2015. AbbVie has an agreement with Johnson & Johnson’s JNJ Janssen Biotech for Imbruvica.
Venetoclax Hits Phase II Primary Endpoint
AbbVie announced results from a multicenter, open label phase II study conducted to evaluate the efficacy and safety of venetoclax monotherapy in relapsed/refractory CLL patients with 17p deletion. Data revealed that venetoclax monotherapy achieved the primary endpoint of the study with an ORR of 79.4% and 84.7% having sustained duration of response.
Data from the study have been submitted to the FDA and European Medicines Agency as part of a new drug application and a marketing authorization application, respectively, in patients with relapsed/refractory CLL. Moreover, AbbVie announced new data from a phase I study showing some patients with relapsed/refractory CLL when treated with venetoclax experienced a response, including complete responses. Data was published online in The New England Journal of Medicine.
We note that AbbVie has an agreement with Roche Holding AG RHHBY for venetoclax.
AbbVie is a Zacks Rank #3 (Hold) stock. Baxalta Incorporated BXLT is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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