(P 192) CURRENT SCENARIO OF SARCOMA CLINICAL TRIALS IN SOUTH AMERICA: A REPORT BY THE LACOG SARCOMA GROUP

Objective: Latin America represents 8% of the global burden of new cancer cases. The incidence of malignancies in this region is projected to grow from 1.5 million new cases in 2020 to more than 2.4 million by 2040. However, Latin America is underrepresented in oncology clinical trials—data shows that, in 2022, only 5.5% out of 75,084 registered clinical studies included countries from Latin America. We aim to describe the representation of South America in clinical trials for sarcoma, looking at ongoing trials and published studies that led to drug approvals.

Methods: Data on the number of clinical trials was retrieved from the National Institutes of Health (NIH) U.S. National Library of Medicine (ClinicalTrials.gov) as of May 28th, 2024. Using the "advanced search" option, we specified "sarcoma" as the condition or disease and selected "interventional studies (clinical trials)" under the study type. Each Latin American and Caribbean country was individually entered in the "location > country" field. Additionally, we reviewed the inclusion of patients from Latin America in clinical trials that led to the approval of drugs by the FDA or EMA from 2009 to 2024. Finally, we provide results of a survey to medical professionals who treat patients with sarcoma regarding specifically the availability of clinical trials for sarcoma in the hospital (the results for the complete survey are presented elsewhere).

Results: As of May, 2024, there were 407 interventional studies recruiting patients with sarcoma worldwide registered at clinicaltrials.gov. Only 6 (1.5%) of these studies were open to recruitment in South American Countries. Brazil led with 5 trials open for accrual, followed by Argentina with 3 trials actively enrolling patients with sarcoma. There were no trials open in the remaining countries in the region. Analyzing 13 drug approvals by the FDA or EMA specifically for sarcoma, only 2 trials enrolled patients in South American countries. The studies that recruited patients in South America were the ones leading to approval of Eribulin and Trabectedin. The trial leading to Trabectedin approval did not disclose the number of patients enrolled in each country, whereas in the trial evaluating eribulin only 5% of patients were from Latin America. Accordingly, in an online survey developed by LACOG, only 31% of 99 respondents reported interventional clinical trials opened that enrolled patients with sarcoma at their center in the past 2 years.

Conclusion: South America's representation in sarcoma clinical trials is low, with only 1.5% of global trials conducted in the region, primarily in Brazil and Argentina. Moreover, the minority of new drugs approved by the FDA in the past 15 years have been evaluated in trials that enrolled patients in South America. This underrepresentation underscores the need for increased efforts to promote oncology clinical trials in our region to allow for equitable access to novel treatments.