Polivy (polatuzumab vedotin-piiq)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved June 2019

Specific Treatments:

diffuse large B-cell lymphoma

Therapeutic Areas

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General Information

Polivy (polatuzumab vedotin-piiq) is an anti-CD79b antibody-drug conjugate (ADC).

Polivy is specifically indicated for use in combination with bendamustine plus Rituxan (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies.

Polivy is supplied as a solution for intravenous injection. The recommended dose is 1.8 mg/kg tadministered as an intravenous infusion every 21 days for 6 cycles in combination with bendamustine and rituximab product. Administer Polivy, bendamustine, and rituximab product in any order on Day 1 of each cycle. The recommended dose of bendamustine is 90 mg/m2/day on Day 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. If not already premedicated, administer an antihistamine and antipyretic at least 30 minutes prior to Polivy. Administer the initial dose of Polivy over 90 minutes. Monitor patients for infusion-related reactions during the infusion and for a minimum of 90 minutes following completion of the initial dose. If the previous infusion was well tolerated, the subsequent dose of Polivy may be administered as a 30-minute infusion and patients should be monitored during the infusion and for at least 30 minutes after completion of the infusion. If a planned dose is missed administer as soon as possible.  Adjust the schedule of administration to maintain a 21-day interval between doses.

Clinical Results

FDA Approval

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.

Side Effects

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

numbness

tingling or pain in the hands and feet

diarrhea

fever

decreased appetite

pneumonia

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.

Additional Information

For additional information regarding Polivy or diffuse large B-cell lymphoma, please visit https://www.polivy.com/