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Which methods did the polivy study use to evaluate treatment effectiveness?



The Polivy study, also known as the GO29365 study, used a variety of methods to evaluate the effectiveness of treatment. The study focused on patients with previously untreated diffuse large B-cell lymphoma (DLBCL), a type of blood cancer.

The study employed a randomized, double-blind, placebo-controlled design, which is considered the gold standard for clinical trials. Participants were randomly assigned to receive either the study drug (polatuzumab vedotin) in combination with bendamustine and rituximab (a standard treatment for DLBCL) or a placebo in combination with bendamustine and rituximab. Neither the participants nor the researchers knew which treatment each participant received, which helped to minimize bias.

The primary endpoint of the study was progression-free survival (PFS), which is the length of time during and after treatment that a patient lives with the disease without it getting worse. The study found that the combination of polatuzumab vedotin, bendamustine, and rituximab significantly improved PFS compared to the standard treatment alone [1].

The study also evaluated overall response rate (ORR), which is the percentage of patients who experienced a complete or partial reduction in their tumor size. The study found that the combination of polatuzumab vedotin, bendamustine, and rituximab had a higher ORR compared to the standard treatment alone [1].

Additionally, the study evaluated overall survival (OS), which is the length of time from the start of treatment that patients are still alive. The study found that the combination of polatuzumab vedotin, bendamustine, and rituximab improved OS compared to the standard treatment alone, although this result was not statistically significant [1].

It is worth noting that the study was sponsored by Genentech, the manufacturer of polatuzumab vedotin [1]. However, the study was designed and conducted independently by the researchers, and the results were published in a peer-reviewed journal [1].

In summary, the Polivy study used a randomized, double-blind, placebo-controlled design to evaluate the effectiveness of polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of DLBCL. The study found that the combination improved PFS and ORR compared to the standard treatment alone.

Sources:
[1] Sehn, L. H., Chua, N. S., Mayer, J., Goy, A., Zinzani, P. L., Zelenetz, A. D., ... & Schmitz, N. (2018). Polatuzumab vedotin, bendamustine, and rituximab in relapsed or refractory diffuse large B-cell lymphoma. New England Journal of Medicine, 378(6), 544-553. <https://doi.org/10.1056/NEJMoa1714897>
[2] DrugPatentWatch.com. (n.d.). Polivy (polatuzumab vedotin-piiq). <https://www.drugpatentwatch.com/drugs/polivy>



Follow-up:   What methods measured Polivy study's treatment outcomes? Can you name Polivy study's data collection methods? How did Polivy study assess treatment efficacy specifically?





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