U.S. FDA analysis of enrollment of Asian patients from India in cancer clinical trials leading to approval from 2010 to 2022.

e13779 Background: There are an estimated 4.4 million Indian Americans (Asian Indian), constituting 1.35% of the United States (US) population. Indian Americans enrolled in clinical trials are identified under the broad race category of Asian which includes Asians within the US and outside of US (Ex-US). Although cancer is the leading cause of death for Asians in US, they are under-represented in cancer clinical trials. Enrollment of Asian patients from India (API) in multiregional oncology clinical trials may provide important data regarding intrinsic and extrinsic factors impacting the etiology of cancer as well as response to anti-cancer treatment in Indian Americans. Common cancers reported amongst Asians in US are breast, prostate, colorectal, and lung, and in India are breast, head and neck, cervical and lung. Methods: We analyzed data from ~96,000 patients in 164 cancer therapeutic trials that led to an FDA approval for breast, prostate, colorectal, lung, liver, gastric, head and neck and cervical cancer indications from 2010-2022, and identified country for enrollments for all Asians. Results: Descriptive statistics of Asian patients enrolled within US, Ex-US and from India enrolled in breast, prostate, colorectal, lung, liver, gastric, head and neck, and cervical cancer trials that led to an FDA approval from 2010-2022 are summarized (Table). Enrollment of Asian patients within US was ≤1% (except liver and cervical cancer), from India was ≤2.1% of all Asians enrolled outside of US and ≤0.7% of all enrolled patients. Conclusions: It is difficult to accurately characterize the exact number of Indian Americans enrolled but are likely under-represented in cancer clinical trials leading to FDA approval.Sponsors should collect more granular information regarding enrollment of Asian patients in clinical trials. Enrollment of patients from India is extremely low relative to the population size. Efforts to increase enrollment of Indian Americans as well as patients from India in oncology clinical trials can bolster the evidence that supports FDA drug approval and its applicability to Indian Americans. Table: see text