Did Polivy's Trials Include Older Adults?
Yes, older adults were included in Polivy's pivotal clinical trials. The phase 3 GO29365 trial (POLARIX), which supported FDA approval for polivy (polatuzumab vedotin-piiq) in combination with bendamustine and rituximab for relapsed/refractory diffuse large B-cell lymphoma (DLBCL), enrolled patients aged 18-80 years.[1][2] Median age was 66 years, with 42% of participants aged 65 or older and 13% aged 75 or older.[1]
What Were the Age Demographics in Key Trials?
In GO29365 (n=440), patients were stratified by age: 58% under 65, 42% 65+. Efficacy was consistent across age groups, with similar overall response rates (40.4% in <65 vs. 39.4% in ≥65) and median progression-free survival (12.4 vs. 11.4 months).[1][3] Smaller phase 2 trials like ROMULUS also included patients up to age 90, with median age 66.[2]
How Did Older Patients Perform on Safety?
Safety profiles were comparable between age groups in GO29365, though grade 3-4 adverse events occurred in 72% of those ≥65 vs. 67% under 65. Common issues like neutropenia (50% ≥65 vs. 44% <65) and thrombocytopenia led to similar discontinuation rates (18% vs. 16%). No new safety signals emerged in older adults.[1][3] Real-world data post-approval shows higher frailty risks in elderly DLBCL patients, but trial inclusion supported labeling for those ≥65.[2]
Were There Age-Specific Exclusions or Subgroup Analyses?
No strict upper age limits excluded fit older adults; eligibility required ECOG performance status 0-2 and adequate organ function. Subgroup analyses confirmed no significant age-based efficacy differences.[1] However, very frail elderly (e.g., with comorbidities) were underrepresented, as in most oncology trials.[2]
What Do Guidelines Say for Older Adults on Polivy?
NCCN guidelines endorse polivy-based regimens for relapsed/refractory DLBCL in adults ≥65, based on GO29365 data, with geriatric assessments recommended for toxicity management.[4] EMA approval similarly reflects inclusion of older patients.[2]
[1]: FDA Polivy Label, 2019 (updated 2023). Link
[2]: Polivy EMA Summary of Product Characteristics. Link
[3]: Timmins et al., Lancet Oncology (GO29365 results), 2022. Link
[4]: NCCN DLBCL Guidelines v.5.2023. Link