Health Disparities in Multiple Myeloma. Kenneth R. Bridges, M.D. Senior Medical Director Onyx Pharmaceuticals, Inc.

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1 Health Disparities in Multiple Myeloma Kenneth R. Bridges, M.D. Senior Medical Director Onyx Pharmaceuticals, Inc.

2 Multiple Myeloma Overview Multiple myeloma (MM) is a type of blood cancer that develops in the bone marrow and is the second most common blood cancer, after non- Hodgkin s lymphoma. In the U.S., more than 6, people are living with MM 1 and 21,7 new cases will be diagnosed in The cause of MM is unknown, although certain acquired genetic defects are common in people with the disorder. 3, 4 Higher risk of MM occurs with: 5 Black ethnicity Male gender Increasing age Family history Obesity 6 2

3 Health Disparity in Multiple Myeloma The basis of the higher incidence of multiple myeloma in blacks relative to the whites is unknown. 1 Lower socioeconomic status measured by income, occupation or education correlates with higher MM incidence in blacks. 2, 3 A high rate of obesity 4, 5 combines with ethnicity to increase the risk of MM in blacks. 3

4 Health Disparity in the US Health disparity is an issue of immense proportions with health, economic, social and environmental impact for the nation. Disparities in the burden of illness and premature death experienced by racial and ethnic minorities, lowincome, and rural populations, apply to a broad spectrum of disease types. The causes of and solutions to health disparities are multidimensional and require multidimensional approaches to improve health and eliminate the disparities. John Ruffin, Ph.D., Director National Institute on Minority Health and Health Disparities Senate Subcommittee on Labor-HHS-Education Appropriations May 11, 211 4

5 Incidence of Multiple Myeloma. Males Females White Black White Black 5 22 SEER Age-adjusted incidence rates per 1,

6 Death from Multiple Myeloma. Males Females White Black White Black 6 22 SEER Age-adjusted death rates per 1,

7 Lifetime Risk of Death due to Multiple Myeloma. Males Females 1 1 % %.5.5 White Black White Black SEER Lifetime Risk of Dying from Multiple Myeloma

8 Evolving MM Treatment Landscape Melphalan Prednisone Auto Stem Cell Transplant Intense Chemo Auto Stem Cell Transplant Reduced Chemo Vincristine Doxorubicin Dexamethasone Thalidomide bortezomib Lenalidomide Doxil Novel Therapies Older Therapies Newer Therapies 8

9 Health Disparities in MM Treatment Hematopoietic stem cell transplant (HSCT) is equally effective in blacks and whites. 1,2 However, blacks receive HCST at half the rate of whites. 3 Between 1973 and 25, new MM treatments significantly increased survival rates in whites but not in blacks. 4 9

10 Hematopoietic Stem Cell Transplants Odds in Whites relative to Blacks Odds Ratio > 1 means greater probability of transplant in whites than blacks HSCT (Overall) Auto HSCT HLA Ident. Sib Unrelated 1 Joshua et al. Cancer. 21 July 15; 116(14):

11 FDA Guidance for Industry Demographic Rule on investigational new drug (IND) applications and new drug applications (NDAs) The Demographic Rule requires IND holders to tabulate in their annual report the number of subjects enrolled in clinical studies of drugs and biologic products by age, race, and gender, and sponsors of NDAs to include summaries of effectiveness and safety data for important demographic subgroups, including racial subgroups. 11

12 Black Subjects Enrolled in Carfilzomib Pivotal Trials Exceeds the US Population Average % Enrollment of Black Subjects 21 US Census: N= 46 N= 95 Black persons, 12.6% 2 N= N= A 3-A1 4-part 1 4-part 2 Safety data set 12

13 Relapsed, Refractory MM- Race-specific Responses to Carfilzomib and Adverse Events 6 % 5 4. Response Rate to Carfilzomib White Black Event White % Black % Other CHF 23/ / Peripheral Neuropathy Adverse Events with Carfilzomib Treatment 55/ / /48 Fatigue 219/ / Dyspnea 134/ / Peripheral Edema 89/ / Creatinine Increase 92/ / A1 4-Pt 2 Safety data set N= 266 Safety data set N= 7 Lymphopenia 19/ / Chest wall pain 49/ / Dehydration 2/ / Pruritis 23/ Safety data set N=

14 Black Subjects Enrolled in KeyTrials of Newer Drugs for MM % Enrollment of Black Subjects 21 US Census: 2 Black persons, 12.6% 15 N= 22 1 N= 12 5 bortezomib (SUMMIT) lenalidomide (26) 14

15 Side Effects and MM Treatment in Blacks Hypertension and diabetes with poor glucose control in blacks increase susceptibility to chronic kidney disease (CKD) 1, 2, 3, 4 CKD incidence/mortality in blacks exceeds that of whites 5,6,7 CKD and kidney failure are common in MM 8,9 With CKD, reduced doses are used with some MM drugs. The combined risk factors of ethnicity, hypertension and diabetes make blacks particularly susceptible to CKD and possible reductions in MM treatment intensity. 1 The combined risk factors of ethnicity, obesity and diabetes make blacks particularly susceptible to treatment-induced peripheral neuropathy and consequent reductions in MM treatment intensity

16 Road Forward in Health Disparities Bridge Clinical Research, Inc. a CRO experienced in promoting ethnically inclusive clinical trials has provided Onyx with a roadmap that includes: Clinical Research Networking Minority Investigator Identification, Recruitment and Retention Minority Patient Recruitment and Retention Community Outreach Programming 16

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