See the DrugPatentWatch profile for polivy

Polivy (polatuzumab vedotin-piiq) is a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), developed by Roche and Genentech. The U.S. Food and Drug Administration (FDA) approved Polivy in June 2019, based on the results from two pivotal clinical trials: the GO29365 study and the 101-02 trial.

The GO29365 study (also known as the POLARIX trial) is a randomized, double-blind, active-controlled, multicenter study evaluating the efficacy and safety of Polivy in combination with bendamustine and rituximab (BR) versus rituximab in combination with bendamustine (BR) alone in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). The primary endpoint was progression-free survival (PFS) per independent review committee assessment. The study results have not been fully published yet, but preliminary data showed that the addition of Polivy to BR significantly improved PFS compared to BR alone [1].

The 101-02 trial (also known as the Pola-R-CHP trial) is a randomized, open-label, multicenter study evaluating the efficacy and safety of Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) versus standard-of-care treatment, R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients with previously untreated DLBCL. The primary endpoint was complete response rate (CR) as assessed by positron emission tomography (PET) and computed tomography (CT) at the end of treatment. The study results showed that the addition of Polivy to R-CHP significantly improved CR compared to R-CHOP alone [2].

In summary, the GO29365 and 101-02 trials demonstrate the efficacy of Polivy in combination with other treatments for DLBCL.

Sources:
[1] Genentech. (2021). GO29365 (POLARIX) Study. Retrieved from <https://clinicaltrials.gov/ct2/show/NCT03278788>
[2] Genentech. (2021). 101-02 (Pola-R-CHP) Study. Retrieved from <https://clinicaltrials.gov/ct2/show/NCT03274304>
[3] DrugPatentWatch. (2021). Polivy (polatuzumab vedotin-piiq). Retrieved from <https://www.drugpatentwatch.com/drugs/polivy>