The reality of cancer clinical trials in Latin America

Transcription

1 The reality of cancer clinical trials in Latin America Gustavo Werutsky Latin American Cooperative Oncology Group (LACOG) 18 April 2018, Mexico City, Mexico

2 None Conflicts of Interest

3 Cancer in Latin America

4 Cancer incidence and outcomes vary significantly across the region

5 Slide 15

6 Globalization of Clinical Trials

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8 Top 30 Countries Ranked By Average Relative Annual Growth Rates Nature Reviews Drug Discovery 2008; 7: 13-14

9 Phase I-III Cancer Clinical Trials Worldwide April, 2018 N= % US 4.3 % Latin America Source:

10 Number of Research Sites Region Number of Trial Sites (per 1M Population) US 82 Western Europe 11 Central / Eastern Europe 8 Latin America 2 Asia Pacific < 1 Source: Raps Focus, 2009, Latin American CTAs

11 Recruitment profile of LA sites 77% foreign patients and 54% foreign sites

12 FDA INSPECTIONS IN LATIN AMERICA

13 Pharmaceutical Markets IMS expects drug spending in emerging markets to grow by 10-13% a year until 2017.

14 Abstracts presented at ASCO by Nationality Majority of abstracts are from US and Europe 41% Saad ED. Ann Oncol. 2010, (3):627-32

15 Progression-free survival 5.8 months CP vs 2.8 months P (HR = 0.46, P <.001) Overall survival 9.3 months CP vs 5.3 P (hazard ratio [HR] = 0.62, P =.001) Mauro Zukin et al. JCO 2013;31:

16 Cooperative Groups Worldwide

17 All Stage Stage 0-II Stage III-IV N=3142 Sites=28 17

18 Oscar Arrieta, et. al. J Thorac Oncol. 2011;6:

19 LACOG Structure and Facilities LACOG Coordinating Office Porto Alegre, Brazil CRF and Data base Study design Statistics Communication Regulatory process Monitoring audits 5

20 LACOG Membership Status 250 members 150 sites 16 countries 8

21 Potential of Accrual LACOG Members Institutions Number of new cases per month = Breast Cancer Prostate Cancer Lung Cancer Colorectal Cancer Gastric Cancer Esophageal Cancer 1981 Uterine Cancer Cervical Cancer Kidney Cancer Sarcoma Hepatocellular Carcinoma Pancreatic Cancer CNS Cancer Melanoma Nonmelanoma Skin Cancer Laryngeal Cancer Thyroid Cancer Other types of Head and Neck Cancer Non-Hodgkin Lymphoma Hodgkin Lymphoma Acute Leukemia Multiple Myeloma 9

22 LACOG (Brazil/LA) GECOPERU (Peru) GAICO (Argentina) Gomez H et. al. Clin Breast Cancer Feb;16(1):38-44

23 A STUDY TO OBSERVE PATIENTS CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER IN LATIN AMERICA - LATINABREAST (MO LACOG 0615) Prinicipal Investigators: G. Werutsky N=4500 ELIGIBILITY Newly diagnosed stage I to IV breast cancer (recurrent or de novo) no more than 3 months prior to data extraction, although they can have received anti-cancer treatment during that time Male or Female >= 18 years BASELINE Patient demographics Medical History BC diagnosis and treatment Disease status and outcome FOLLOW-UP (5 years) Changes / Sequence of BC treatment Disease status and outcome Medical History Safety Primary Objectives: describe patients characteristics, breast cancer subtypes at diagnosis, outcomes and build a electronic plataform/database Countries: Argentina, Brazil, Chile, Colombia, Costa Rica, Cuba, Guatemala, Mexico, Peru, Venezuela (Uruguay).

24 LACOG BREAST CANCER GROUP STUDIES Epidemiológico - Fertilidade Ensaio Clínico - PALLAS (fase 3) - LORELEI (fase 2) - IMPASSION (fase 3) Epidemiológico - Metastático sequência tto Epidemiológico - AMAZONA III - Cancer de mama em homem - LATINA BREAST

25 Phase II randomized study of Abiraterone acetate plus ADT versus APALUTAMIDE versus Abiraterone and APALUTAMIDE in patients with advanced prostate cancer with non-castrate testosterone levels (LACOG 0415) N = 126 Prostate adenocarcinoma Biochemical relapse M0 or M1 and de novo PSA >= 2 ng/dl Indication to ADT (testosterone level >= 230 ng/dl0 R Abiraterone + ADT Abiraterone + Apalutamide Apalutamide Primary Objectives: proportion of patients who achieves an undetectable PSA level, defined as 0.2 ng/ml at week 25 week in each of three arms Countries: Brazil

26 CHALLENGES FOR CANCER CLINICAL RESEARCH IN LATIN AMERICA

27 Regulatory Timeline Around the World 5-12 months CANADA 3-4 months 5 months REINO UNIDO SUÉCIA 3 months 4-5 month s UNITES STATES 3 months FRANÇA 12 months MÉXICO 3 4 months COLOMBIA PERU 4 5 months BRAZIL months 3 months 4 months AUSTRÁLIA CHILE ARGENTINA 4 4,5 months 9 months 4 months Adapted from: Hurley D. GCP Journal March st Annual Drug Information Association Meeting, 2005.

28 Bureaucracy behind the scene

29 In March, the federal government announced that it was slashing the proposed 2017 science budget by 44%, bringing it to the lowest level in 12 years 2.8 billion reais (US$888 million). Although cuts were made across almost all federal ministries, the reduction in science spending hit particularly hard because the budget had already been chopped every year since 2013.

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31 Contribution of Latin American Countries to Cancer Research and Patent Generation: Recent Patents. 12,989 items published and 244 patent applications Brazil, Mexico, Argentina, Chile and Peru were highest contributors in cancer research. Brazil, Mexico, Cuba and Argentina were highest contributors in cancer patent applications. To Date No Device or Drug Developed in LA was Implemented in Clinical Practice Perez-Santos M. Recent Pat Anticancer Drug Discov. 2017;12(1):81-93.

32 Information about clinical trials for patients source:

33 Initiative for funding academic cancer research

34 How and Where I can learn about clinical trials Clinical Research Center your institution Clinical Research Fellowships Institutions and Organisations in Europe and US Clinical Trials Workshops ICTW ASCO / Methods EORTC

35 Thank you Gustavo Werutsky