Emerging Therapies in Development for Relapsed/Refractory CLL/SLL are Expected to Offer Efficacy Benefits Over Currently Available Treatments

BURLINGTON, Mass., April 10, 2014 /PRNewswire/ -- Decision Resources Group finds that the effect of a therapy on overall survival and progression-free survival are attributes that most influence surveyed U.S. and European hematological oncologists' prescribing decisions for relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). In addition, U.S. and European hematological oncologists, as well as U.S. payers indicate that improving overall survival is one of the greatest unmet needs in R/R CLL/SLL. The novel mechanism of action of first-in-class kinase inhibitors ibrutinib (Johnson & Johnson/Janssen/Pharmacyclics' Imbruvica) and idelalisib (Gilead Sciences) has elicited great enthusiasm from interviewed experts. These experts perceive that ibrutinib and idelalisib offer a major advantage in efficacy compared with the current major-market sales and patient share leader, FCR*. It is expected that these agents will be added to rituximab-containing regimens, such as bendamustine (Teva Pharmaceutical Industries' Treanda, Mundipharma's Ribomustin/Levact, Symbio Pharmaceuticals/Eisai's Treakisym) in combination with rituximab, currently used in this difficult-to-treat patient population. Moreover, hematological oncologists express enthusiasm for Celgene's Revlimid, Roche/Genentech/Chugai/Glycart's Gazyva, and Roche/Genentech/AbbVie's ABT-199, with regard to their potential for overall survival improvement in this setting. 

* Fludarabine (Genzyme's Fludara, Bayer HealthCare's Fludara/Beneflur, generics) + cyclophosphamide (Bristol-Myers Squibb's Cytoxan, Pfizer's Cyclophospham, generics) + rituximab (Roche/Genentech/Chugai Seiyaku/Zenyaku Kogyo's Rituxan/MabThera)

Other key findings from the DecisionBase report entitled Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (Relapsed/Refractory): As the Relapsed/Refractory Treatment Setting for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Becomes More Crowded, What Key Attributes Will Differentiate Emerging Therapies According to Oncologists and Payers?: 

• Bendamustine in combination with rituximab (BR): reflecting available clinical data and the opinions of interviewed thought leaders, our report indicates that the BR regimen is the current gold-standard therapy for treatment of R/R CLL/SLL.
• Overall response rate: surveyed U.S. payers indicate that emerging therapies offering improvements in overall response rate over existing therapies are likely to be included on formularies.
• Ibrutinib: surveyed U.S. hematological oncologists indicate that they would prescribe ibrutinib in combination with BR to 50 percent of their R/R CLL/SLL patients.

Comments from Decision Resources Group Analyst Dana Gheorghe, Ph.D.:

• "The relapsed/refractory CLL/SLL setting is highly heterogenic, with age, fitness, performance status, cytogenetic profile, and time between the last treatment and disease progression all playing a role in the treatment algorithm; therapies such as FCR and BR have proven to be efficacious in this setting, but an improved overall survival remains an unmet need."
• "Ibrutinib monotherapy is now FDA-approved for R/R CLL, and the drug continues to generate tremendous interest as a result of its proven efficacy; the ibrutinib/BR combination has the potential to offer overall survival and disease progression improvements in the relapsed/refractory CLL/SLL setting."

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SOURCE Decision Resources Group