For Patients and Caregivers

Clinical Trial Information

POLIVY® was studied in a pivotal, randomized clinical trial in R/R DLBCL vs BR1

POLIVY was approved based on Study GO29365, a randomized, phase II, open-label clinical trial in patients with R/R DLBCL (N=80)1,3

  • Inclusion criteria: Patients received at least 1 prior regimen and were not candidates for autologous hematopoietic stem cell transplantation (HSCT) at study entry1
  • Exclusion criteria: Patients with Grade 2 or higher peripheral neuropathy, prior allogeneic HSCT, active central nervous system lymphoma, or transformed lymphoma1

Patients were randomized 1:1 to receive either POLIVY+BR or BR for six 21-day cycles.1

Study design flowchart

Following premedication with an antihistamine and an antipyretic, POLIVY was given by intravenous (IV) infusion at 1.8 mg/kg on Day 2 of cycle 1 and on Day 1 of cycles 2 to 6.1*
Bendamustine was dosed at 90 mg/m2 intravenously on Days 2 and 3 of cycle 1 and on Days 1 and 2 of cycles 2 to 6.1
A rituximab product was administered at a dose of 375 mg/m2 intravenously on Day 1 of cycles 1 to 6. Each cycle was 21 days in length.1

*Dosing protocol in Study GO29365.
Please see the Dosing page and full Prescribing Information for recommended dosing schedule.

Primary Endpoint1,3 Select Additional Endpoints1,3
  • Complete response (CR) as assessed by an independent review committee (IRC)
    • Measured by PET-CT at EOT†
  • Objective response rate at EOT (ORR; IRC assessed)
  • Best overall response of CR or partial response (PR)‡
  • Duration of response (DoR) as assessed by IRC


†EOT was defined as 6 to 8 weeks after Day 1 of cycle 6 or last study treatment.
‡PET-CT results were prioritized over CT results.
CT=computed tomography; EOT=end of treatment; PET-CT=positron emission tomography–computed tomography.

 

POLIVY+BR was studied in a broad range of patients with R/R DLBCL, including those who were primary refractory and/or double expressors1,3

Select Patient Characteristics3 POLIVY+BR (n=40)1,3 BR (n=40)1,3
Median age, years (range) 67 (33-86) 71 (30-84)
Gender, male 70.0% 62.5%
ECOG PS
0 or 1
2
82.5%
15.0%
77.5%
20.0%
World Health Organization 2016 Classification (central pathology review)§    
DLBCL, NOS
 95.0% 100.0%
DLBCL, NOS: ABC
 47.5% 47.5%
DLBCL, NOS: GCB
 37.5% 42.5%
DLBCL, NOS: other
 10.0% 10.0%
Double expressors (MYC and BCL2 overexpression)||
 27.5% 15.0%
Primary reasons patients were not candidates for HSCT    
Age
 32.5% 47.5%
Insufficient response to salvage therapy
 30.0% 22.5%
Prior transplant failure
 25.0% 15.0%
Median prior therapies, n (range) 2 (1-7) 2 (1-5)
1 prior therapy
 27.5% 30.0%
2 prior therapies
 27.5% 22.5%
≥3 prior therapies
 45.0% 47.5%
Prior treatments    
Anti-CD20
 97.5% 100%
Bendamustine
 2.5% 0%
Bone marrow transplant
 25.0% 15.0%
Refractory to last prior anti-lymphoma therapy 75.0% 85.0%
Primary refractory# 52.5% 67.5%

§Central pathology review incorporated results of NanoString cell of origin when available.
||Of patients tested for MYC/BCL2 overexpression, POLIVY+BR had 11 patients with double-expressor lymphoma (DEL) and 12 patients with non-DEL; BR had 6 patients with DEL and 13 patients with non-DEL. Not all patients were assessed for DEL.
Defined as no response, progression, or relapse within 6 months of last anti-lymphoma therapy end date.
#Patients were refractory to first prior anti-cancer therapy.
ABC=activated B-cell type; ECOG PS=Eastern Cooperative Oncology Group performance status; GCB=germinal center B-cell–like.

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Important Safety Information and Indication
Indication

POLIVY in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated 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.

POLIVY in combination with bendamustine and a rituximab product (BR) is indicated for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies.

Important Safety Information

Peripheral Neuropathy

POLIVY can cause severe peripheral neuropathy. Peripheral neuropathy occurs as early as the first cycle of treatment and is cumulative. POLIVY may exacerbate preexisting peripheral neuropathy.

In POLARIX, of 435 patients treated with POLIVY plus R-CHP, 53% reported new or worsening peripheral neuropathy, with a median time to onset of 2.3 months. Peripheral neuropathy was Grade 1 in 39% of patients, Grade 2 in 12%, and Grade 3 in 1.6%. Peripheral neuropathy resulted in dose reduction in 4% of treated patients and treatment discontinuation in 0.7%. Among patients with peripheral neuropathy after POLIVY, 58% reported resolution after a median of 4 months.

In Study GO29365, of 173 patients treated with POLIVY, 40% reported new or worsening peripheral neuropathy, with a median time to onset of 2.1 months. Peripheral neuropathy was Grade 1 in 26% of patients, Grade 2 in 12%, and Grade 3 in 2.3%. Peripheral neuropathy resulted in POLIVY dose reduction in 2.9% of treated patients, dose delay in 1.2%, and permanent discontinuation in 2.9%. Sixty-five percent of patients reported improvement or resolution of peripheral neuropathy after a median of 1 month, and 48% reported complete resolution.

The peripheral neuropathy is predominantly sensory; however, motor and sensorimotor peripheral neuropathy also occur. Monitor for symptoms of peripheral neuropathy such as hypoesthesia, hyperesthesia, paresthesia, dysesthesia, neuropathic pain, burning sensation, weakness, or gait disturbance. Patients experiencing new or worsening peripheral neuropathy may require a delay, dose reduction, or discontinuation of POLIVY.

Infusion-Related Reactions

POLIVY can cause severe infusion reactions. Delayed infusion-related reactions as late as 24 hours after receiving POLIVY have occurred.

With premedication, 13% of patients (58/435) in POLARIX reported infusion-related reactions after the administration of POLIVY plus R-CHP. The reactions were Grade 1 in 4.4% of patients, Grade 2 in 8%, and Grade 3 in 1.1%.

With premedication, 7% of patients (12/173) in Study GO29365 reported infusion-related reactions after the administration of POLIVY. The reactions were Grade 1 in 4.6% of patients, Grade 2 in 1.7%, and Grade 3 in 0.6%.

Symptoms occurring in ≥1% of patients included chills, dyspnea, pyrexia, pruritus, rash, and chest discomfort. Administer an antihistamine and antipyretic prior to the administration of POLIVY, and monitor patients closely throughout the infusion. If an infusion-related reaction occurs, interrupt the infusion and institute appropriate medical management.

Myelosuppression

Treatment with POLIVY can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia.

In POLARIX, 90% of patients treated with POLIVY plus R-CHP had primary prophylaxis with granulocyte colony-stimulating factor (G-CSF). Grade 3–4 hematologic adverse reactions included lymphopenia (44%), neutropenia (39%), febrile neutropenia (15%), anemia (14%), and thrombocytopenia (8%).

In Study GO29365, in patients treated with POLIVY plus BR (n = 45), 42% received primary prophylaxis with G-CSF. Grade 3 or higher hematologic adverse reactions included neutropenia (42%), thrombocytopenia (40%), anemia (24%), lymphopenia (13%), and febrile neutropenia (11%). Grade 4 hematologic adverse reactions included neutropenia (24%), thrombocytopenia (16%), lymphopenia (9%), and febrile neutropenia (4.4%). Cytopenias were the most common reason for treatment discontinuation (18% of all patients).

Monitor complete blood counts throughout treatment. Cytopenias may require a delay, dose reduction, or discontinuation of POLIVY. Administer prophylactic G-CSF for neutropenia in patients receiving POLIVY plus R-CHP. Consider prophylactic G-CSF administration in patients receiving POLIVY plus bendamustine and a rituximab product.

Serious and Opportunistic Infections

Fatal and/or serious infections, including opportunistic infections such as sepsis, pneumonia (including Pneumocystis jiroveci and other fungal pneumonia), herpesvirus infection, and cytomegalovirus infection have occurred in patients treated with POLIVY.

In POLARIX, Grade 3–4 infections occurred in 14% (61/435) of patients treated with POLIVY plus R-CHP, and infection-related deaths were reported in 1.1% of patients.

In Study GO29365, Grade 3 or higher infections occurred in 32% (55/173) of patients treated with POLIVY, and infection-related deaths were reported in 2.9% of patients within 90 days of last treatment.

Closely monitor patients during treatment for signs of infection. Administer prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus. Administer prophylactic G-CSF for neutropenia as recommended.

Progressive Multifocal Leukoencephalopathy (PML)

PML has been reported after treatment with POLIVY plus bendamustine and obinutuzumab in Study GO29365 (0.6%, 1/173). Monitor for new or worsening neurological, cognitive, or behavioral changes. Hold POLIVY and any concomitant chemotherapy if PML is suspected, and permanently discontinue if the diagnosis is confirmed.

Tumor Lysis Syndrome

POLIVY may cause tumor lysis syndrome. Patients with high tumor burden and rapidly proliferative tumor may be at increased risk of tumor lysis syndrome. Monitor closely and take appropriate measures, including tumor lysis syndrome prophylaxis.

Hepatotoxicity

Serious cases of hepatotoxicity that were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, have occurred in patients treated with POLIVY.

In recipients of POLIVY plus R-CHP, Grade 3–4 elevation of ALT and AST developed in 1.4% and 0.7% of patients, respectively.

In Study GO29365, Grade 3 and Grade 4 transaminase elevations each developed in 1.9% of patients.

Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk of hepatotoxicity. Monitor liver enzymes and bilirubin level.

Embryo-Fetal Toxicity

Based on the mechanism of action and findings from animal studies, POLIVY can cause fetal harm when administered to a pregnant woman. The small molecule component of POLIVY, monomethyl auristatin E, administered to rats caused adverse developmental outcomes, including embryo-fetal mortality and structural abnormalities, at exposures below those occurring clinically at the recommended dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with POLIVY and for 3 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with POLIVY and for 5 months after the last dose.

The Most Common Adverse Reactions

The most common adverse reactions (≥20%), excluding laboratory abnormalities, in patients with previously untreated DLBCL treated with POLIVY in combination with R-CHP are peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis. The most common Grade 3 to 4 laboratory abnormalities (≥10%) are lymphopenia, neutropenia, hyperuricemia, and anemia.

The most common adverse reactions (≥20%) in patients with relapsed or refractory DLBCL treated with POLIVY in combination with BR are neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia.

Lactation

Advise women not to breastfeed during treatment with POLIVY and for 2 months after the last dose.

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.

    • POLIVY Prescribing Information. South San Francisco, CA: Genentech, Inc.; April 2023.

      POLIVY Prescribing Information. South San Francisco, CA: Genentech, Inc.; April 2023.

    • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.4.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed June 8, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.

      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.4.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed June 8, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.

    • Sehn LH, Herrera AF, Flowers CR, et al. Polatuzumab vedotin in relapsed or refractory diffuse large B-cell lymphoma. J Clin Oncol. 2020;38(2):155-165.

      Sehn LH, Herrera AF, Flowers CR, et al. Polatuzumab vedotin in relapsed or refractory diffuse large B-cell lymphoma. J Clin Oncol. 2020;38(2):155-165.

    • Data on File. South San Francisco, CA: Genentech, Inc. 2018.

      Data on File. South San Francisco, CA: Genentech, Inc. 2018.

    • D’Arena G, Musto P, Cascavilla N, Dell’Olio M, Di Renzo N, Carotenuto M. Quantitative flow cytometry for the differential diagnosis of leukemic B-cell chronic lymphoproliferative disorders. Am J Hematol. 2000;64(4):275-281.

      D’Arena G, Musto P, Cascavilla N, Dell’Olio M, Di Renzo N, Carotenuto M. Quantitative flow cytometry for the differential diagnosis of leukemic B-cell chronic lymphoproliferative disorders. Am J Hematol. 2000;64(4):275-281.

    • Dornan D, Bennett F, Chen Y, et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood. 2009;114(13):2721-2729.

      Dornan D, Bennett F, Chen Y, et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood. 2009;114(13):2721-2729.

    • Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16): 1800-1808.

      Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16): 1800-1808.

    • Morrison VA, Shou Y, Bell JA, et al. Evaluation of treatment patterns and survival among patients with diffuse large B-cell lymphoma in the USA. Future Oncol. 2019;15(9):1021 -1034.

      Morrison VA, Shou Y, Bell JA, et al. Evaluation of treatment patterns and survival among patients with diffuse large B-cell lymphoma in the USA. Future Oncol. 2019;15(9):1021 -1034.

    • National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) V4. 2009. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed June 20, 2023.

      National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) V4. 2009. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed June 20, 2023.

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