What Key Attributes Do Oncologists and Payers Believe Will Differentiate Emerging Therapies?

The first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) market is becoming increasingly crowded. In recent years, several new, high-priced therapies have been approved for use in this patient population, making this lucrative market more dynamic and competitive. The launch of ibrutinib (Johnson & Johnson/Janssen/Pharmacyclics’ Imbruvica) and idelalisib (Gilead Sciences’ Zydelig) in 2014 transformed the treatment algorithm and improved the outlook for patients. Nevertheless, clinical and commercial opportunity awaits emerging therapies that can provide greater survival benefits than the current standards of care and add minimal toxicities to the existing chemotherapy regimens used to treat first-line CLL/SLL.

Questions Answered in This Report:

  • Improved overall survival and delayed disease progression are key goals in the treatment of first-line CLL/SLL. What are the key primary and secondary clinical trial end points on which new therapies are evaluated? How do U.S. and European hematological oncologists weight specific efficacy end points and other drug attributes in their prescribing decisions for first-line CLL/SLL?

  • 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) (the FCR regimen) was the 2013 major-market sales leader for first-line CLL/SLL. What weaknesses in this regimen’s profile would allow emerging therapies to gain traction in the first-line CLL/SLL market? Have emerging therapies demonstrated strengths on the attributes that surveyed hematological oncologists indicate are most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that surveyed MCO PDs seek from new therapies?

  • Overall survival and progression-free survival are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new first-line CLL/SLL therapies. What trade-offs across these and other clinical attributes are U.S. hematological oncologists willing to make when considering the use of emerging therapies for the treatment of first-line CLL/SLL? Based on the trade-offs in price and performance across key drug attributes that U.S. hematological oncologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for first-line CLL/SLL?

  • Based on its clinical profile, ibrutinib is the current clinical gold standard in our Drug Comparator Model for first-line CLL patients (with 17p deletion or TP53 mutation). What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Will any therapies in development challenge ibrutinib as the future gold standard in 2018 or 2023?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for first-line CLL/SLL:

- Three-year overall survival rate

- Median progression-free survival

- Overall response rate

- Rate of grade ? 3 neutropenia

- Rate of grade ? 3 infection

- Rate of grade ? 3 tumor lysis syndrome

- Price per 28-day cycle

Attributes included in assessment of U.S. payers’ receptivity to new therapies for first-line CLL/SLL:

- Effect on progression-free survival

- Effect on complete response

- Incidence of grade ? 3 neutropenia

- Incidence of infections

Physicians surveyed: 60 U.S. and 30 European hematological oncologists.

Payers surveyed: 20 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- 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) (FCR)

- Bendamustine (Teva Pharmaceutical Industries’ Treanda, Mundipharma’s Ribomustin/Levact, SymBio Pharmaceuticals/Eisai’s Treakisym) + rituximab (Roche/Genentech/Chugai Seiyaku/Zenyaku Kogyo’s Rituxan/MabThera) (BR)

- Obinutuzumab (Roche/Genentech/Chugai Seiyaku/Glycart’s Gazyva/Gazyvaro) + chlorambucil (Aspen’s Leukeran/Techni-Pharma’s Chloraminophène)

- Ibrutinib (Johnson & Johnson/Janssen/Pharmacyclics’ Imbruvica)

- Ofatumumab (GlaxoSmithKline/Genmab’s Arzerra) + chlorambucil (Aspen’s Leukeran/Techni-Pharma’s Chloraminophène)

Emerging Therapies

- Idelalisib (Gilead Sciences’ Zydelig) + rituximab (Roche/Genentech/Chugai Seiyaku/Zenyaku Kogyo’s Rituxan/MabThera)

- Venetoclax (Roche/Genentech/AbbVie’s ABT-199) + obinutuzumab (Roche/Genentech/Chugai Seiyaku/Glycart’s Gazyva/Gazyvaro)

- Venetoclax (Roche/Genentech/AbbVie’s ABT-199) + bendamustine (Teva Pharmaceutical Industries’ Treanda, Mundipharma’s Ribomustin/Levact, SymBio Pharmaceuticals/Eisai’s Treakisym) + rituximab (Roche/Genentech/Chugai Seiyaku/Zenyaku Kogyo’s Rituxan/MabThera)

- Duvelisib (AbbVie/Infinity Pharmaceuticals’ IPI-145) + 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)

- Ibrutinib (Johnson & Johnson/Janssen/Pharmacyclics’ Imbruvica) + obinutuzumab (Roche/Genentech/Chugai Seiyaku/Glycart’s Gazyva/Gazyvaro)