Age Groups in Polivy Clinical Trials
Polivy (polatuzumab vedotin-piiq), approved for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), was studied primarily in adults. Key trials like GO29365 (Phase 1b/2) enrolled patients aged 18 to 80 years.[1][2] The pivotal GO29365 trial, supporting FDA approval in 2019, included adults with a median age of 67 years (range: 29–80 years).[3]
What About Pediatric Participation?
No pediatric patients (under 18) participated in Polivy's registration trials. Genentech's clinical development focused on adults with aggressive lymphomas, as DLBCL is rare in children.[4] Ongoing studies remain adult-only.
Trial-Specific Age Breakdowns
- GO29365 (polatuzumab + bendamustine/rituximab): 80 patients; median age 67 (range 29–80).[3]
- Phase 1 dose-escalation: Adults only, typically 18+ with no upper limit specified beyond safety.[2]
- GO39975 (POLARGO): Adults aged 18–80; median 68 years.[5]
Eligibility often excluded those with significant comorbidities regardless of age.
Why No Younger Age Groups?
DLBCL incidence peaks in older adults (median diagnosis age ~67), so trials targeted this population. Pediatric lymphomas differ genetically, requiring separate studies.[6]
[1]: FDA Polivy Label
[2]: ClinicalTrials.gov GO29365
[3]: NEJM 2018;379:2291-2301
[4]: Genentech Polivy HCP Site
[5]: ClinicalTrials.gov GO39975
[6]: SEER Cancer Stats