POLIVY® Trial Results

POLIVY helped improve response rates in people with relapsed or refractory DLBCL

People who received POLIVY+BR had a complete remission or a partial remission more often compared with those who received BR by itself.

63% of the people who received POLIVY+BR had a complete or partial remission at some point in the study (25 out of 40), compared with 25% of those who received BR by itself (10 out of 40).

More people had complete remission with POLIVY+BR after finishing treatment*:

POLIVY® (polatuzumab vedotin-piiq) DLBCL complete remission rates

*Doctors in the study checked response to treatment 6 to 8 weeks after Day 1 of cycle 6 or last study treatment.

Nearly 1 in 2 people who responded to treatment with POLIVY+BR were in remission for a year or more.

Duration of response (DoR) in people who responded to treatment with POLIVY+BR:

POLIVY® (polatuzumab vedotin-piiq) median duration of response

Of the 10 people who responded to BR treatment by itself, 20% had a DoR of at least 12 months (2 out of 10), and 30% had a DoR of at least 6 months (3 out of 10).

Duration of response (DoR) is the length of time a person is in remission, from where they first respond to treatment to when the disease gets worse. DoR includes people who have had a complete remission or partial remission at any time in the study.

Talk with your doctor for additional data about POLIVY+BR and what it may mean for your prognosis

How POLIVY was studied

POLIVY plus a chemotherapy regimen of bendamustine and a rituximab product (POLIVY+BR) was compared with BR by itself in a clinical trial. It was studied in 80 patients with R/R DLBCL. 

POLIVY® (polatuzumab vedotin-piiq) patient study design for GO29365 clinical trial

Patients received either POLIVY+BR or BR by itself every 21 days for 6 treatment cycles. Both patients and healthcare providers knew which treatment had been given.

Patients in the study were randomized (or sorted) by the length of time they responded to a previous treatment (also known as duration of response, or DoR).

The study included patients with R/R DLBCL who:

  • Had already received at least one prior treatment for their DLBCL
  • Were not candidates for a type of stem cell transplantation called HSCT
  • Were 30 to 86 years old (average age 69 years)

The study did not include people
who had:

  • A history of moderate to severe nerve problems in their arms or legs
  • Prior treatment with certain types of stem cell transplantation
  • Central nervous system lymphoma* or transformed lymphoma

HSCT=hematopoietic stem cell transplantation.
*Central nervous system lymphoma is a rare non-Hodgkin lymphoma in which cancer cells from other parts of the body form in the brain and/or spinal cord.
Transformed lymphoma occurs when a slow-growing lymphoma develops into a more aggressive one.

Please talk to your doctor about whether POLIVY is right for you

POLIVY® (polatuzumab vedotin-piiq) icon for how it may work

How POLIVY works

Learn more about how POLIVY may work

POLIVY® (polatuzumab vedotin-piiq) icon for infusion process

Glossary of Terms

See the terms and definitions for R/R DLBCL

POLIVY® (polatuzumab vedotin-piiq) icon for infusion process

How is POLIVY Administered?

See the infusion process and dosing schedule for POLIVY+BR

Important Safety Information and Indication

POLIVY® is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large B-cell lymphoma in adults who have progressed after at least 2 prior therapies.

The conditional approval of POLIVY is based on a type of response rate. There are ongoing studies to establish how well the drug works.

Possible serious side effects

Everyone reacts differently to POLIVY therapy, so it’s important to know what the side effects are. Some people who have been treated with POLIVY have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.

  • Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
  • Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
  • Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you POLIVY, which may prevent some infections, and will monitor your blood counts throughout treatment with POLIVY. Treatment with POLIVY can cause severe low blood cell counts
  • Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
  • Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
  • Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication

Side effects seen most often

The most common side effects during treatment were

  • Low blood cell counts (platelets, red blood cells, white blood cells)
  • Nerve problems in arms and legs
  • Tiredness or lack of energy
  • Diarrhea
  • Nausea
  • Fever
  • Decreased appetite
  • Infections

POLIVY may not be for everyone. Talk to your doctor if you are

  • Pregnant or think you are pregnant: Data have shown that POLIVY may harm your unborn baby
  • Planning to become pregnant: Women should avoid getting pregnant while taking POLIVY. Women should use effective contraception during treatment and for at least 3 months after their last POLIVY treatment. Men taking POLIVY should use effective contraception during treatment and for at least 5 months after their last POLIVY treatment
  • Breastfeeding: Women should not breastfeed while taking POLIVY and for at least 2 months after the last dose

These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of POLIVY treatment.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see the full Prescribing Information for additional Important Safety Information.