What was the POLIVY study?
The POLIVY study (GO29365) was a phase 1b/2 clinical trial evaluating polatuzumab vedotin (Polivy), combined with bendamustine and rituximab (BR), for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It compared Polivy plus BR against BR alone in a randomized phase 2 portion, with primary results published in 2018 and follow-ups through 2023.[1][2]
Primary endpoint for assessing treatment results
The main measure was complete response rate, defined as complete metabolic response by independent review committee using Lugano 2014 criteria (PET-CT scan showing no FDG-avid disease, bone marrow assessment if previously involved). This was assessed at the end of treatment.[1][3]
Key secondary endpoints
- Objective response rate (ORR): Complete plus partial response (partial metabolic response or non-FDG-avid PR on PET-CT).
- Progression-free survival (PFS): Time from randomization to disease progression (by independent review) or death.
- Overall survival (OS): Time from randomization to death from any cause.
- Duration of response (DOR): Time from first response to progression or death.
- Event-free survival (EFS): Time to progression, relapse, initiation of new anti-lymphoma treatment, or death.[1][2]
Imaging and response assessment methods
Responses relied on PET-CT scans (using 5-point Deauville score) performed at screening, end of treatment (6-8 weeks after last dose), and every 6 months up to 2 years, then annually. CT or MRI served as alternatives if PET unavailable. Independent central review used modified Lugano criteria for consistency.[3][4]
Safety and other assessments
Adverse events were graded per NCI CTCAE v4.04, monitored via physical exams, labs (CBC, chemistry), and patient-reported outcomes (FACT-Lym questionnaire for quality of life). Pharmacokinetics measured drug levels in blood.[1][5]
Sources
[1]: Polivy prescribing information (FDA)
[2]: NEJM 2018: Polatuzumab Vedotin in Relapsed/Refractory DLBCL
[3]: Lugano Classification (2014)
[4]: Lancet Oncology 2021 follow-up
[5]: ClinicalTrials.gov NCT02257567