The introduction of the anti-CD20 monoclonal antibody (MAb) rituximab (Roche/Genentech/Chugai Seiyaku/Zenyaku Kogyo’s Rituxan/MabThera) profoundly revolutionized the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Although the MAbs alemtuzumab (Sanofi/Genzyme’s Campath/MabCampath) and ofatumumab (GlaxoSmithKline/Genmab’s Arzerra) have expanded treatment options for relapsed/refractory (R/R) CLL/SLL, this heterogenic patient population remains difficult to treat. The February 2014 approval of ibrutinib (Johnson Johnson/Janssen/Pharmacyclics’ Imbruvica) represents a significant milestone in the treatment of R/R CLL and will serve to increase competition in the market. Nevertheless, significant clinical and commercial opportunity remains for therapies that can provide survival benefits greater than those of current standards of care.
Attributes included in conjoint analysis based assessment of target product profiles for R/R CLL/SLL:
- Median overall survival.
- Median progression-free survival.
- Overall response rate.
- Rate of grade ≥ 3 neutropenia.
- Rate of grade ≥ 3 tumor lysis syndrome.
- Rate of grade ≥ 3 infection.
- Price per 28-day cycle.
Attributes included in assessment of U.S. payers’ receptivity to new therapies for R/R CLL/SLL:
- Improved effect on progression-free survival.
- Improved overall response rate.
- Lower incidence of grade ≥ 3 neutropenia.
- Lower incidence of infections.
Physicians surveyed: 62 U.S. and 31 European hematological oncologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- 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 [BR]
- Alemtuzumab (Sanofi/Genzyme’s Campath/MabCampath)
- Ofatumumab (GlaxoSmithKline/Genmab’s Arzerra)
- Chlorambucil (Aspen’s Leukeran, Techni-Pharma’s Chloraminophène) + rituximab
- Ibrutinib (Johnson & Johnson/Janssen/Pharmacyclics’ Imbruvica) + BR
- Idelalisib (Gilead Sciences) + BR
- Lenalidomide (Celgene’s Revlimid) + rituximab
- Obinutuzumab (Roche/Genentech/Chugai Seiyaku/Glycart’s Gazyva) + FC
Venetoclax (Roche/Genentech/AbbVie’s ABT-199) + rituximab