84P Lack of diversity in clinical trials leading to Food and Drug Administration (FDA) approvals for gynaecological cancers

Clinical trials (CTs) leading to FDA approvals should give an estimation of investigational drugs' effect on enrolled patients (pts); however, enrollment criteria do not always accurately reflect a real-world population. As such, demographics and baseline characteristics of enrolled pts are essential to evaluating the applicability and safety of study drugs in the intended use population, particularly underrepresented minorities (URMs). We searched "Drugs@FDA" to identify CTs that led to FDA drug approvals for gynecological cancers (GynC) between 2006 and 2024. We assessed the demographics and baseline characteristics, including ECOG Performance Status (PS), older adults (OA), race, and ethnicity in the published CTs. Out of 437 FDA approvals for solid tumors, 30 (4.6%) were for GynC based on 23 CTs: 73.9% phase 3, 21.8% phase 2, and 4.3% phase 1. Of note, 91.2% (21/23) of CTs led to approvals granted after 2014. ECOG PS was reported in 82.6% (19/23) CTs, with only 26.1% (6/23) CTs allowing the enrollment of pts with ECOG PS up to 2; the median proportion of enrolled pts with ECOG PS of 2 was 6.4 % (IQR 5.6-7.1%). The proportion of enrolled OA was reported in 30% (7/23) of CTs, all of which were published on or after 2014. The median proportion of enrolled OA was 36.8% (IQR 16.9-43.7%). Race was reported in 52.2% (12/23) of CTs, with a median proportion of 78.9% white pts enrolled (IQR 72.3-85.5). Ethnicity was reported in 30.4% (7/23) trials, but only in 13% (3/23) of CTs was reported separately from the race. After years of limited therapeutic advancement, 2014 marked a new era for GynC treatment, with many FDA approvals. Despite the FDA's recommendations regarding data collection, demographics and baseline characteristics are still underreported. Data on traditionally URMs (non-white race, Hispanic or Latino ethnicity, and pts with a non-optimal PS) are often lacking and deserve further inclusion in future CTs to assess the applicability of new drugs in the real world. Actionable first steps to achieve this goal include expanding eligibility criteria, establishing engagement and partnerships with communities and institutions, and prioritizing diversity.