Maximum Age Reported in POLIVY Trials
The highest age of any patient enrolled across POLIVY (polatuzumab vedotin-piiq) clinical trials is 88 years old. This comes from the pivotal phase 2 GO29365 trial (also called ROMULUS), where participants ranged from 22 to 88 years.[1][2]
Age Demographics in Key Approval Trials
In GO29365, the trial supporting FDA approval for relapsed/refractory diffuse large B-cell lymphoma (DLBCL), median age was 66 years, with 41% of 80 patients aged 65-75 and 35% over 75. No upper age cap was specified in eligibility criteria, allowing enrollment up to 88.[1][3]
The phase 3 POLARIX trial (n=880, frontline DLBCL) had a median age of 66, with patients up to 80 years old reported in demographics; 43% were 65 or older.[2][4]
Smaller studies like phase 1/2 trials (e.g., NCT01290549) enrolled patients up to 86 years.[5]
Why No Strict Upper Age Limit?
Trial protocols focused on performance status (ECOG 0-2) rather than age cutoffs, reflecting POLIVY's use in elderly unfit patients. This enabled inclusion of octogenarians, though frailty influenced outcomes—older patients (>75) had higher adverse event rates like neuropathy (45% vs. 36% overall).[1][3]
Outcomes for Elderly Patients
In GO29365, complete response rates were similar across ages (75+ group: 44% vs. 45% overall), but progression-free survival trended shorter in those over 75 (7.5 vs. 9.5 months).[1] POLARIX showed consistent efficacy in patients 65+, with no age subgroup failures highlighted in approvals.[2]
Ongoing Trials and Real-World Data
Current trials like NCT03671018 (phase 2, elderly/newly diagnosed) and NCT04182204 (phase 3, transplant-ineligible) continue enrolling patients over 80 where fit.[6] Real-world studies report median ages around 70, with some 85+ patients tolerating POLIVY combos.[7]
[1]: FDA POLIVY Label
[2]: NEJM POLARIX Study
[3]: Sehn et al., Lancet Oncol 2019
[4]: ClinicalTrials.gov NCT02692952
[5]: ClinicalTrials.gov NCT01290549
[6]: ClinicalTrials.gov Search for POLIVY
[7]: PubMed Real-World POLIVY Reviews