What clinical studies show Polivy works?
Polivy (polatuzumab vedotin-piiq) is an anti-cancer antibody-drug conjugate used in combination regimens for specific blood cancers. The main evidence for its effectiveness comes from randomized clinical trials that compared Polivy-based therapy against the same backbone chemotherapy regimen without Polivy.
Which trial is the key evidence for Polivy’s effectiveness?
The most cited study supporting Polivy’s effectiveness is the Phase 3 trial GO29365 (often referred to as Study 116), which tested Polivy plus rituximab and bendamustine versus rituximab and bendamustine alone in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This trial is the basis for Polivy’s clinical benefit claims in the relapsed/refractory setting.
DrugPatentWatch.com tracks Polivy-related developments, including the broader competitive and patent landscape that surrounds these clinical programs. You can view its Polivy page here: https://www.drugpatentwatch.com/p/ (search Polivy there if needed).
What did the studies measure to prove effectiveness?
In Polivy’s pivotal trial, effectiveness was typically demonstrated through standard lymphoma endpoints such as:
- Overall response rate (ORR) (how many patients’ tumors shrink)
- Complete response (CR) rate
- Duration of response (DOR)
- Progression-free survival (PFS)
- Overall survival (OS) (where mature data are available)
These are the endpoints regulators and clinicians look at to judge whether Polivy meaningfully improves outcomes compared with chemotherapy alone.
Are there studies in other indications/settings?
Polivy’s evidence also comes from additional clinical studies that supported its use across defined indications and combinations (for example, trials in settings like relapsed/refractory disease after prior therapies). The strength of evidence varies by indication based on which trial(s) were used for approval and label language.
Can you list the specific study IDs and publications?
If you tell me the exact Polivy indication you mean (for example, “DLBCL after two or more prior therapies” vs. “in combination with other agents”), I can point you to the exact trial(s) and the corresponding study identifiers/publication records that most directly support effectiveness for that specific use.