Currently Enrolling Trials
Polivy (polatuzumab vedotin-piiq) is an anti-CD79b antibody-drug conjugate (ADC).
Polivy is specifically indicated:
- in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater.
- in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies
Polivy supplied as a solution for intravenous injection. The recommended dose(s) is as follows:
Patients with Previously Untreated DLBCL, NOS or HGBL
The recommended dosage of Polivy is 1.8 mg/kg administered as an intravenous infusion every 21 days for 6 cycles in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone. Administer Polivy , cyclophosphamide, doxorubicin, and a rituximab product in any order on Day 1 after the administration of prednisone. Prednisone is administered on Days 1–5 of each cycle.
Patients with Relapsed or Refractory DLBCL, NOS
The recommended dosage of Polivy is 1.8 mg/kg administered as an intravenous infusion every 21 days for 6 cycles in combination with bendamustine and a rituximab product. Administer Polivy, bendamustine, and a rituximab product in any order on Day 1 of each cycle. The recommended dose of bendamustine is 90 mg/m2 /day on Days 1 and 2 when administered with Polivy and a rituximab product. The recommended dose of rituximab product is 375 mg/m2 intravenously on Day 1 of each cycle.
For All Indicated Patients
If not already premedicated, administer an antihistamine and antipyretic at least 30 minutes prior to Polivy . If a planned dose of Polivy is missed, administer as soon as possible. Adjust the schedule of administration to maintain a 21-day interval between doses.
Mechanism of Action
Polivy (polatuzumab vedotin-piiq) is an anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B-cells, an immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL). Polivy binds to CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells.
Adverse effects associated with the use of Polivy may include, but are not limited to, the following:
- low white blood cell count
- low platelet levels
- low red blood cell count
- tingling or pain in the hands and feet
- decreased appetite
Clinical Trial Results
Polivy in combination with BR was granted accelerated approval. Further clinical trials are required to verify and describe Polivy's clinical benefit.
The FDA approval of Polivy was based on complete response rates observed in the randomized, controlled phase Ib/II GO29365 study. The Phase II part of the study randomized 80 patients with heavily pre-treated R/R DLBCL to receive either BR, or BR in combination with Polivy for a fixed duration of six 21-day cycles. Patients enrolled had received a median of two prior therapies (a range of 1-7 prior therapies in the Polivy arm and range of 1-5 prior therapies in the BR alone arm). The primary endpoint was complete response (CR) at the end of treatment, as measured by positron emission tomography and assessed by an independent review committee (IRC). Results of the study showed that 40 percent of people treated with Polivy plus BR achieved a complete response, meaning no cancer could be detected at the time of assessment, compared to 18 percent with BR alone.
The FDA approval of Polivy plus R-CHP for the first-line treatment of DLBCL was based on pivotal data from POLARIX, an international Phase III, randomized, double-blind, placebo-controlled study that demonstrated a statistically significant and clinically meaningful improvement in PFS compared to R-CHOP. The risk of disease progression, relapse or death was reduced by 27% with Polivy plus R-CHP (n=440) compared with R-CHOP (n=439).