Tanja Obradovic
May 21, 2025, 17:12
Tanja Obradovic: Issue of Trial Data Applicability to US Patient Population is Resurfacing Again at FDA
Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn:
“Issue of trial data applicability to US patient population is resurfacing again at FDA. It serves as a reminder that when designing registrational clinical trials global plans need to be done to be fitting with ultimate filing goals.
Yesterday the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8 to 1 against the applicability of the patient population and results from the phase 3 STARGLO trial (NCT04408638) to the US population of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
In STARGLO trial patient populations acros geographies were not balanced. Only 9% of patients (n = 25) were from North America, 32% of patients (n = 88) were from Europe, 11% of patients (n = 30) were from Australia, and 48% of patients (n = 131) were from Asia so with large differences between US and Asia populations in overall survival (OS) ODAC vote was not a surprise.
Important to note is that proper balancing projections of patient populations or even separate geographical trials may be needed not only due to possible biological population differences but also because of increasingly diverging global treatments in the first/second+ lines in cases of relapsed/refractory populations in some tumors.”
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