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POLARIX Trial Design

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POLARIX Trial Design
Patient Characteristics
IPI Assessment

POLARIX trial: Designed to evaluate PFS superiority of POLIVY® + R-CHP over R-CHOP in a head-to-head trial1,15

POLARIX was a double-blind, randomized, multicenter, phase 3 study of 879 patients

Key Exclusion Criteria: Patients with a history of indolent lymphoma, a contraindication to any component of R-CHOP, previous receipt of anthracycline agents, and known CNS involvement

Stratification Factors: IPI score (2 vs 3-5), bulky disease (≥ 7.5 cm vs absence), and geographic region§

Primary Endpoint

Progression-free survival (PFS)II

Key Secondary Endpoints

Modified event-free survival (EFS), complete response (CR) at EOT,# and overall survival (OS)

POLIVY (1.8 mg/kg) or vincristine (1.4 mg/m2), along with rituximab (375 mg/m2), cyclophosphamide (750 mg/m2), and doxorubicin (50 mg/m2) was administered by IV infusion on Day 1 of Cycles 1-6. All patients received 100 mg oral prednisone once daily on Days 1-5 of each of the first 6 cycles. Rituximab monotherapy (375 mg/m2) was administered on Day 1 of Cycles 7 and 8. Each cycle was 21 days.

*Recommended dose of POLIVY is 1.8 mg/kg IV + R-CHP every 21 days for 6 cycles.
†In lieu of vincristine.
‡In lieu of POLIVY.
§W. Europe, US, CAN, and AUS vs Asia vs rest of world.
IIPFS was calculated in a time-to-event analysis, in which investigator-assessed disease progression, disease relapse, or death from any cause were counted as events.
Defined as time from randomization to the earliest occurrence of disease progression, disease relapse, or death, an efficacy finding that led to non-protocol specified lymphoma treatment, or biopsy positive for residual disease.
#Based on PET-CT and determined by BICR.
 

Trial results icon

5-year follow-up data available:
See long-term follow-up data for POLIVY + R-CHP vs R-CHOP

See PFS Results

POLARIX patient characteristics: POLIVY + R-CHP was studied in a range of patients with previously untreated LBCL1,15

Patient characteristics were well-balanced across POLARIX treatment arms

DLBCL, NOS (including GCB and ABC) represented ~85% of LBCL cases in POLARIX, similar to real-world estimates1,15,16

Patients with an IPI score of 2 made up 38% of the trial; IPI scores of 3-5 made up 62%15

    POLIVY + R-CHP
(n=440)		 R-CHOP
(n=439)
IPI score, n (%)** 2 167 (38.0) 167 (38.0)
3-5 273 (62.0) 272 (62.0)
Histologic diagnosis, n (%) DLBCL NOS (including GCB and ABC) 373 (84.8) 367 (83.6)
HGBL (including NOS and DHL/THL) 43 (9.8) 50 (11.4)
Other large B-cell lymphomas†† 24 (5.5) 22 (5.0)
Age >60 years, n (%) 300 (68.2) 308 (70.2)
Median (range) 65.0 (19-80) 66.0 (19-80)
Sex, n (%) Male 239 (54.3) 234 (53.3)
Female 201 (45.7) 205 (46.7)
Geographic region, n (%)** W. Europe, US, CAN, AUS 302 (68.6) 301 (68.6)
Asia 81 (18.4) 79 (18.0)
Rest of world 57 (13.0) 59 (13.4)
ECOG PS, n (%)‡‡ 0-1 374 (85.0) 363 (82.7)
2 66 (15.0) 75 (17.1)
Bulky disease, n (%)**,§§   193 (43.9) 192 (43.7)
Ann Arbor stage, n (%)‖‖ I-II 47 (10.7) 52 (11.8)
III-IV 393 (89.3) 387 (88.2)

**This variable was a stratification factor.
††Other large B-cell lymphomas by local diagnosis included EBV+ DLBCL, NOS, and T-cell/histiocyte-rich large B-cell lymphoma.
‡‡Patients had a baseline ECOG PS score of 0-2 (on a 5-point scale, with higher numbers indicating greater disability). ECOG PS was not reported for 1 patient in the R-CHOP group.
§§Bulky disease was defined as the presence of ≥ 1 lesions that were ≥ 7.5 cm in greatest dimension.
‖‖Stages range from I to IV. Higher stages indicate more extensive disease.

IPI assessment in DLBCL12,20-22

  • IPI is the primary clinical tool for risk assessment in patients with 1L DLBCL
  • IPI identifies 4 independent risk groups of patients using a combination of 5 clinical variables
IPI Risk Factor
Ann Arbor stage III or IV
Age > 60 years
Serum LDH > 1 x ULN
ECOG performance status ≥ 2
Extranodal involvement ≥ 2¶¶

¶¶Per Cheson, et al. 2014, extranodal involvement may include sites that have focal uptake by PET-CT, such as: spleen, liver, bone, thyroid, cutaneous, GI, bone, kidneys, pleural or pericardial effusions, ascites.

IPI Risk Group Number of IPI Risk Factors
Low 0 or 1
Low-Intermediate 2
High-Intermediate 3
High 4 or 5

NCCN

CATEGORY 1
TREATMENT OPTION

The National Comprehensive Cancer Network® (NCCN®) recommends polatuzumab vedotin-piiq (POLIVY) + R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone) as an NCCN Category 1 treatment option across all stages of DLBCL for certain## patients.2

  • Polatuzumab vedotin-piiq (POLIVY) + R-CHP is the only Category 1 recommended treatment option across all stages of previously untreated DLBCL for certain## patients2

NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

POLIVY + R-CHP is approved for 1L DLBCL, NOS or HGBL and IPI ≥2.1
 

##Category 1 treatment option for patients with previously untreated stage I-II (without extensive mesenteric disease) diffuse large B-cell lymphoma and smIPI score >1; Category 1 preferred treatment option for patients with previously untreated stage II (with extensive mesenteric disease) or stage III-IV diffuse large B-cell lymphoma and IPI score ≥2.

ABC = activated B cell; AUS = Australia; BICR = blinded independent central review; CAN = Canada; CNS = central nervous system; DHL = double-hit lymphoma; DLBCL = diffuse large B-cell lymphoma; EBV = Epstein-Barr virus; ECOG PS = Eastern Cooperative Oncology Group performance status; EOT = end of treatment; GCB = germinal center B cell; GI = gastrointestinal; HGBL = high-grade B-cell lymphoma; IPI = International Prognostic Index; IV = intravenous; LBCL = large B-cell lymphoma; LDH = lactate dehydrogenase; NCCN = National Comprehensive Cancer Network® (NCCN®); NOS = not otherwise specified; PET-CT = positron emission tomography and computed tomography; PFS = progression-free survival; R-CHOP = rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHP = rituximab, cyclophosphamide, doxorubicin, and prednisone; smIPI = stage-modified International Prognostic Index; THL = triple-hit lymphoma; ULN = upper limit of normal; US = United States; W. Europe = Western Europe.

NEXT: POLARIX Trial Results PFS
Safety icon

Compare safety results:
See how safety for POLIVY + R-CHP compares to R-CHOP

See Safety Data
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.

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