Tumor Panel II: B-Cell Malignancies: Recent Advances, Remaining Challenges and Promising New Approaches March 17-18, 2015 New York, NY
Tumor Panel II: B-Cell Malignancies: Recent Advances, Remaining Challenges and Promising New Approaches Moderator: Mike Rice, MS, MBA, Senior Consultant, Defined Health Panelists: Omar Abdel-Wahab, MD, Hematologist/Oncologist, Memorial Sloan Kettering Cancer Center Stanley R. Frankel, MD, Adjunct Associate Professor of Medicine, Division of Hematology/Oncology, Columbia University College of Physicians and Surgeons William Grossman, MD, PhD, Therapeutic Area Lead, Oncology-Global Pharmaceutical R&D/Global Medical Affairs, AbbVie Thomas J. Kipps, MD, PhD, Evelyn and Edwin Tasch Chair in Cancer Research, Distinguished Professor & Deputy Director, Research Operations, Moores UCSD Cancer Center 2
B-Cell Malignancies Are a Heterogeneous Group of Lymphoproliferative Malignancies with Differing Patterns of Behavior and Responses to Treatment More Than 25 Types of B-Cell Malignancies (2008 WHO Criteria) Estimated new cases and deaths from NHL in the US in 2014: New cases: 70,800 Deaths: 18,990 B-Cell Malignancies Originate From Distinct Stages of B-Cell Differentiation in the Germinal Centers of Lymph Nodes NATURE REVIEWS CANCER VOLUME 5 APRIL 2005 Page 3
B-Cell Malignancies Are Far More Common and Somewhat Less Aggressive Than T-Cell Malignancies Median Age of Onset 80 70 60 50 40 30 20 ATLL NK/T-Cell Lymphoma Hodgkin s Lymphoma B-Cell NHLs TPL Plasma Cell Neoplasms BPL PTCL Burkitt Lymphoma DLBCL MCL T-LGL CLL/SLL WM/LL FL Hodgkin s Lymphoma MZL CTCL HCL 10 T-Cell NHLs 0 35% 45% 55% 65% 75% 85% 95% NCI SEER Database Statistics 2-Year Overall Survival Page 4
Rituximab, the CD20 Targeted mab, Impacted Treatment and Outcomes of B-Cell Lymphomas Novel Agents Poised to Continue Benefit The approval of the anti-cd20 monoclonal antibody rituximab for the treatment of CD20 + follicular lymphoma and diffuse large B-cell lymphoma has undoubtedly been one of the most impactful events in the history of NHL drug development Indeed, the initial FDA approval of rituximab in 1997 coincides with the beginning of a clear decline in the mortality rate of NHL, which had been rising steadily over the previous 20 years (see graph at right). Rituximab is typically used in combination with a polychemotherapy regimen such as R-CHOP. 14 12 10 8 6 4 2 0 US NHL Mortality Rate (Deaths per 100,000) Fludarabine Etoposide Cisplatin Rituximab Ibruvica Velcade Zydelig Revlimid Treanda Gazyva NCI SEER Database Statistics Page 5
The Combined B-Cell Malignancies Market Is Expected to Become One of the Largest Oncology Sectors WW Indication Sales ($M) 25,000 20,000 15,000 10,000 B-Cell Malignancy WW Sales By Indication 2005-2020 Waldenström's ALL CLL NHL 5,000 EvaluatePharma 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Page 6
2014 Marks an Inflection Point in the Value of the B-Cell Malignancies Market 25,000 Top 10 B-Cell Malignancy Products WW Indication Sales 2005-2020 WW Product Sales ($M) 20,000 15,000 10,000 5,000 CTL019 Adcetris Arzerra Sprycel Duvelisib Venetoclax Revlimid Zydelig KTE-C19 Gazyva Imbruvica Rituxan Other 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 EvaluatePharma Page 7
Imbruvica Appears to Be on Its Way to Become the Fastest Growing Cancer Drug in Terms of U.S. Sales Ibrutinib was awarded Breakthrough Therapy designation and accelerated approval for previously treated CLL under the trade name Imbruvica in February 2014 The drug was first FDA approved for R/R MCL in November 2013, R/R CLL in Feb 2014, frontline 17p CLL in July 2014 and Waldenstroms in Jan 2015 Costs for CLL is estimates at $8,774/month, or $105,288/year 2014 Imbruvica revenue was $463MM, 2015 sales expected to exceed $1B IMBRUVICA in Comparison to Best US Cancer Drugs (First Four Quarters) Phamacyclics Investor Presentation Dec 2014 Page 8
Tumor Panel II: B-Cell Malignancies: Recent Advances, Remaining Challenges and Promising New Approaches Moderator: Mike Rice, MS, MBA, Senior Consultant, Defined Health Panelists: Omar Abdel-Wahab, MD, Hematologist/Oncologist, Memorial Sloan Kettering Cancer Center Stanley R. Frankel, MD, Adjunct Associate Professor of Medicine, Division of Hematology/Oncology, Columbia University College of Physicians and Surgeons William Grossman, MD, PhD, Therapeutic Area Lead, Oncology-Global Pharmaceutical R&D/Global Medical Affairs, AbbVie Thomas J. Kipps, MD, PhD, Evelyn and Edwin Tasch Chair in Cancer Research, Distinguished Professor & Deputy Director, Research Operations, Moores UCSD Cancer Center 9