In clinical trials who typically uses polivy age wise?

Polivy Approval and Trial Demographics

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, targets adults. Clinical trials enrolled patients 18 years and older, with no pediatric use.[1]

Age Breakdown in Key Trials

In the pivotal Phase 2 GO29365 trial (n=80 efficacy-evaluable patients), the median age was 67 years (range: 29–86). Most participants were over 60:
- Under 65: 46%
- 65–74: 29%
- 75+: 25%

The Phase 3 GO29365 trial (n=435) showed a similar profile, with median age 69 years (range: 18–87):
- Under 65: 38%
- 65–74: 33%
- 75+: 29%

Older patients (≥65) comprised about 62% across trials, reflecting DLBCL's incidence peak in those over 60.[2][3]

Why Mostly Older Adults?

DLBCL primarily affects people aged 60+, aligning with trial demographics. Trials excluded those under 18 due to rarity in children and lack of pediatric data. Real-world use follows this, with post-approval studies confirming median ages around 68–70.[4]

Exceptions and Younger Patients

Younger adults (18–64) made up 35–46% of trial participants, often with aggressive or relapsed disease. No patients under 18 were included; polivy lacks approval or data for pediatrics.[1]

Sources:
[1]: FDA Polivy Label
[2]: GO29365 Phase 2 Results (Lancet Oncology)
[3]: GO29365 Phase 3 Results (NEJM)
[4]: Real-World Evidence (JCO)