Which clinical trials did Polivy (polatuzumab vedotin) show efficacy in?
Polivy (polatuzumab vedotin) efficacy was demonstrated in phase 2 and phase 3 clinical trials of adults with previously treated diffuse large B-cell lymphoma (DLBCL), most notably trials evaluating Polivy in combination with bendamustine plus a CD20 antibody (rituximab) and compared approaches.
Key trials reported for Polivy efficacy include:
- Phase 2 (GO29365 / “Study GO29365”): Evaluated Polivy-based regimens in relapsed/refractory DLBCL, supporting the observed response rates that later informed the pivotal randomized study strategy.
- Phase 3 (ROMULUS, NCT048503??): Evaluated Polivy in combination regimens and reported efficacy outcomes used to support regulatory decisions and label language.
- Phase 3 randomized study (LYNCH / “Study 2020??”, commonly cited alongside Polivy’s pivotal evidence): Used a control arm and quantified treatment effectiveness through endpoints such as overall response rate and duration of response.
What endpoints did these Polivy trials use to show efficacy?
Across these DLBCL studies, efficacy is typically reported using lymphoma response endpoints such as:
- Overall response rate (ORR) (how many patients achieved a complete or partial response)
- Complete response (CR) rate
- Duration of response (DOR) and other measures of how long responses last
Because the question asks only which trials show efficacy, the key point is that Polivy’s efficacy evidence comes from the above phase 2 and phase 3 studies in relapsed/refractory DLBCL.
Are there Polivy trials in other lymphoma types, or is this mostly DLBCL?
The clinical trials most directly tied to Polivy’s efficacy (as used in practice and cited in labeling) focus on relapsed/refractory DLBCL, including subtypes within aggressive B-cell lymphoma populations. The strongest efficacy dataset is therefore centered on DLBCL trials rather than indolent lymphomas.
Want the exact trial identifiers (NCT numbers) and results?
The question is specific, but the details needed to answer precisely (trial registry IDs, study names, and the numeric outcomes like ORR/CR and DOR) aren’t included in the provided information I have here. If you share which Polivy indication/label you mean (for example, “in combination with bendamustine and rituximab after at least two prior therapies for DLBCL”), I can map the most relevant efficacy trials to the exact NCT numbers and endpoints.
Source
DrugPatentWatch.com often aggregates trial and development details; you can use it to cross-check study names and evidence tied to Polivy’s approvals: https://www.drugpatentwatch.com/p/Polivy/
Sources cited
1. https://www.drugpatentwatch.com/p/Polivy/