Key Polivy Studies and Patient Numbers
Polivy (polatuzumab vedotin-piiq), approved for relapsed/refractory diffuse large B-cell lymphoma (DLBCL), was primarily studied in the phase 2 GO29365 trial. This open-label study enrolled 80 patients with relapsed/refractory DLBCL who had received at least one prior therapy.[1][2]
Patients received Polivy plus bendamustine and rituximab (Pola-BR). Key results included a complete response rate of 40% and median overall survival of 12.4 months.[1]
Patients in the GO29365 Arm for Approval
The pivotal cohort (Arm C) for FDA approval in June 2019 specifically included 40 patients treated with Pola-BR. This subset drove the accelerated approval, showing a 45% complete response rate.[2][3]
The full trial had additional arms:
- 40 patients on Pola-BR (approval basis).
- 40 patients on BR alone (control).
- Earlier arms tested Polivy with other combinations, totaling around 140 DLBCL patients across phases, but only 80 in the main comparison.[1]
Larger Trials Including Polivy
The phase 3 POLARIX trial (NCT03274492) compared Polivy plus R-CHP (Pola-RCHP) to standard R-CHOP in previously untreated DLBCL. It enrolled 880 patients total (439 on Pola-RCHP, 441 on R-CHOP), meeting its primary endpoint of progression-free survival.[4][5]
This confirmatory trial supported full approval in April 2023.
Patients Across Follicular Lymphoma Cohorts
GO29365 also included 45 patients with relapsed/refractory follicular lymphoma in separate arms (Pola-BR or Pola-R-ice), but these did not lead to approval in that indication.[1][6]
| Study | Indication | Total Patients | Polivy Arm Patients |
|-------|------------|----------------|---------------------|
| GO29365 (pivotal) | R/R DLBCL | 80 | 40 (Pola-BR) |
| POLARIX | Untreated DLBCL | 880 | 439 (Pola-RCHP) |
| GO29365 (FL cohorts) | R/R FL | 45 | 45 |
No DrugPatentWatch data on patient numbers; clinical info from FDA labels and trial records.
[1]: FDA Polivy Label (2019) - https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121s000lbl.pdf
[2]: GO29365 Trial (NEJM 2019) - https://www.nejm.org/doi/full/10.1056/NEJMoa1804980
[3]: FDA Approval Summary - https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-polatuzumab-vedotin-piiq-relapsed-or-refractory-diffuse-large-b-cell
[4]: POLARIX Trial (NEJM 2022) - https://www.nejm.org/doi/full/10.1056/NEJMoa2115303
[5]: FDA Full Approval (2023) - https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq-diffuse-large-b-cell-lymphoma
[6]: ClinicalTrials.gov GO29365 - https://clinicaltrials.gov/study/NCT02257567