Polivy Trial Participant Age Range
Polivy (polatuzumab vedotin-piiq), approved for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), was studied in the Phase II GO29365 trial (also called ROMULUS). Participants ranged from 19 to 90 years old, with a median age of 67 years.[1][2]
How Did Age Affect Trial Eligibility?
Inclusion required patients to be 18 or older with confirmed DLBCL. No upper age limit was set, allowing enrollment up to 90. About 40% were 75 or older, reflecting real-world older DLBCL populations.[1][3]
Age Breakdown in Key Polivy Trials
| Trial | N | Age Range | Median Age | ≥75 Years (%) |
|-------|---|-----------|------------|---------------|
| GO29365 (Phase II, pivotal) | 80 | 19-90 | 67 | 40% [1][2] |
| GO29365 Arm C (Phase Ib/II) | 109 (polivy + BR) | 21-87 | 66 | 33% [4] |
Why Does Age Matter for Polivy Patients?
DLBCL peaks in those over 60, and Polivy trials matched this demographic. Older participants (≥75) showed similar response rates (complete response ~40%) to younger ones but higher rates of cytopenias and infections, per post-hoc analyses.[3][5]
What About Other Polivy Studies or Ongoing Trials?
Smaller studies like Phase I (N=17) had ages 31-80 (median 65).[6] Ongoing trials (e.g., NCT03385365 for frontline) target similar ranges, often ≥18 without upper caps.[7]
[1]: FDA Polivy Label
[2]: Sehn LH et al. Lancet Oncol 2019;20:612-622
[3]: Polivy PI, Genentech 2023
[4]: ClinicalTrials.gov NCT02257567
[5]: ASH 2020 Abstract
[6]: Palanca-Wessels et al. Clin Cancer Res 2015
[7]: ClinicalTrials.gov Search for Polivy