Which patient groups were part of polivy's trials?

Which patient groups were part of Polivy’s trials?

Polivy (polatuzumab vedotin-piiq) was evaluated in adults with diffuse large B-cell lymphoma (DLBCL) and other aggressive B-cell lymphomas.

How did the trials select patients by prior treatment status?
Most participants had received at least one prior therapy. The pivotal phase 2 study (GO29365) enrolled patients with relapsed or refractory DLBCL after one or more lines of treatment, while the phase 3 POLARIX study (NCT04665765) included newly diagnosed patients who had received no prior systemic therapy.

What age and performance-status criteria were used?
Eligibility was restricted to adults 18 years and older. Patients needed an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, reflecting the ability to carry out light daily activity.

Were patients with central nervous system involvement allowed?
Individuals with known CNS lymphoma at screening were excluded from both the relapsed and frontline trials to reduce confounding safety signals.

Did the trials include patients with specific molecular subtypes?
GO29365 and POLARIX enrolled all DLBCL subtypes without mandatory biomarker stratification. Retrospective analyses later examined outcomes in activated B-cell-like (ABC) versus germinal-center B-cell-like (GCB) subtypes, but subtype was not an entry criterion.

How were patients with comorbidities handled?
Key exclusions were significant cardiac disease, active hepatitis B or C, HIV with uncontrolled viremia, and severe neuropathy. Mild-to-moderate renal or hepatic impairment was permitted if laboratory values met protocol-defined thresholds.

What follow-up duration was planned for the frontline study?
POLARIX is following patients for a minimum of five years to assess progression-free survival, overall survival, and long-term safety.