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

April 10, 2014

Emerging Therapies are Not Expected to Offer Improvements in Safety and Tolerability Attributes, According to Findings from Decision Resources Group

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."

About Decision Resources Group

Decision Resources Group offers best-in-class, high-value information and insights on critical issues within the healthcare industry. Clients rely on this analysis and data to make informed decisions. Find out more at www.DecisionResourcesGroup.com.

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For more information, contact:

Decision Resources Group

Christopher Comfort



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