Ages in POLIVY Clinical Trials
POLIVY (polatuzumab vedotin-piiq), approved by the FDA in 2019 for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine and rituximab, was studied in trials with specific age demographics.[1]
GO29365 Trial (Phase 1b/2, Basis for Approval)
Patients had a median age of 67 years (range: 21–88 years). About 48% were 65 or older, and 22% were 75 or older. No overall differences in safety or efficacy were observed between older and younger patients, though adverse events like neutropenia were more frequent in those 65+.[2][3]
Phase 2 Single-Arm Study (N=70)
Median age was 67 years (range: 38–85 years), with 50% aged 65 or older.[4]
Ongoing Phase 3 Trials (e.g., POLARIX)
In the POLARIX trial (polatuzumab vedotin plus R-CHP vs. R-CHOP in first-line DLBCL), median age was 66 years in the polatuzumab arm (range: 18–80 years) and 67 years in the control arm. Eligibility required age 18–80 years.[5]
Age data reflect typical DLBCL populations, where the disease peaks in those over 60. Trials excluded patients under 18.
[1]: FDA POLIVY Label
[2]: NEJM 2019: Polatuzumab Vedotin in DLBCL
[3]: Genentech POLIVY Prescribing Info
[4]: FDA Approval Summary
[5]: Lancet 2022: POLARIX Trial