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Redefining outcomes for patients with DLBCL 3

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Prescribing Information
Patient Leaflet
Product Information

Polivy (polatuzumab vedotin) is an antibody-drug conjugate consisting of the mitotic inhibitor monomethyl auristatin E (MMAE) covalently linked to a monoclonal antibody directed against CD79b (recombinant humanized immunoglobulin G1 [IgG1]). 1

 

Therapeutic indications 1

 

  • Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for hematopoietic stem cell transplantation. 

  • Polivy in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
Polivy Mechanism of Action
Key Insights from the POLARIX Study 3

 

POLARIX was a randomised, double-blind, placebo-controlled Phase III study that compared POLIVY-R-CHP to R-CHOP in 1L DLBCL. 

 

Primary Analysis 

POLARIX met its primary endpoint with a statistically significant improvement in PFS in patients with previously untreated DLBCL.

 

POLIVY-R-CHP resulted in a 27% reduction in risk of progression, relapse or death vs R-CHOP:

•  2 year rate: POLIVY-R-CHP: 76.7% (25% CI: 72.7–80.8%); R-CHOP: 70.2% (65.8–74.6%);

•  Stratified* HR: 0.73 (95% CI: 0.57–0.95); log-rank p-value: 0.02.

 

Key secondary endpoints evaluated by hierarchical testing:

•  EFS efficacy: HR: 0.75; p-value: 0.02 (endpoint met, consistent with primary endpoint).

•  PET-CT CR rate at EOT assessed by BICR: POLIVY-R-CHP: 78.0%; R-CHOP: 74.0%; p-value: 0.16  (no statistical difference, DFS & DOR showed remissions were more durable with POLIVY-R-CHP vs R-CHOP).

•  OS: HR: 0.94; p-value: 0.75 (no statistical difference).

 

 

Summary of safety profile

  • No new safety signals were detected and the safety profile was consistent with the known risk of the individual study drugs and was comparable with that of R-CHOP. 3
  • The most frequently-reported (≥ 30%) adverse drug reactions (ADRs) in patients treated with Polivy-R-CHP for previously untreated DLBCL were peripheral neuropathy, nausea, neutropenia, and diarrhoea. 1
  • Serious ADRs were reported in 24.1% of Polivy-R-CHP treated patients. 1
  • The most common serious ADR in ≥ 5% of patients were febrile neutropenia and pneumonia. 1

 

3 & 5 Year Analysis 4,17

 

PFS and OS results were consistent with the primary analysis, and showed that the PFS benefit was sustained with longer follow-up (3-year median follow-up: 39.7 months; 5-year median follow-up: 64.1 months).

 

No new safety signals were detected, and  the safety profile was consistent with the known risk of individual study drugs, and was comparable with that of R-CHOP.

 

*Stratified for IPI score (IPI 2 vs IPI 3–5), bulky disease (present vs absent), and geographical region (Western Europe, United States, Canada and Australia vs Asia vs Rest of World [remaining countries]). All p-values are reported as 2-sided p-values. BICR, blinded independent central review; CI: confidence interval; CR, complete response; CT, computed tomography; DFS, disease free survival; DLBCL, diffuse large B-cell lymphoma; DOR, duration of response; EFS, event free survival; EOT, end of treatment; HR, hazard ratio; IPI, International Prognostic Index; OS, overall survival; PET, positron emission tomography; PFS, progression free survival.

 
Patient Material 

Further information


Medical information/queries:

MedInfo,
ireland.druginfo@roche.com

 

Product materials:

haematologyireland@roche.com

Further Information

 

Medical Information/queries:

MedInfo, ireland.druginfo@roche.com

 

Product materials:

haematologyireland@roche.com

The Drug Surveillance Centre

Roche Products (Ireland) Limited

3030 Lake Drive
Citywest 
D24 KX6Y

Tel: +353 (0)1 469 0700

Email: ireland.drug_surveillance_centre@roche.com

 

Alternatively, suspect adverse reactions should be reported to:
HPRA Pharmacovigilance

Website: www.hpra.ie


Marketing Authorisation Holder: Roche Registration GmbH, EmilBarell-Strasse 1, 79639 Grenzach-Wyhlen, Germany. Polivy® is a registered trademark

References

 

  1. POLIVY Summary of Product Characteristics, available at www.medicines.ie.
  2. HSE – Cancer Drugs Approved for Reimbursement, available at https://www.hse.ie/eng/services/list/5/cancer/profinfo/medonc/cdmp/new.html.
  3. Tilly H, et al. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022; 386:351-63.
  4. Herrera A, et al. Risk Profiling of Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) by Measuring Circulating Tumor DNA (ctDNA): Results from the POLARIX Study. Presented at 64th ASH Annual Meeting December 10–13, 2022.
  5. Aurer I, et al. Gem-(R)CHOP versus (R)CHOP: a randomized phase II study of gemcitabine combined with (R)CHOP in untreated aggressive non-Hodgkin’s lymphoma – EORTC lymphoma group protocol 20021 (EudraCT number 2004-004635-54). Eur J Haematol. 2011; 86:111-6.
  6. Bartlett NL, et al. Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303. J Clin Oncol. 2019; 37:1790-9.
  7. Coiffier B, et al. CHOP CHEMOTHERAPY PLUS RITUXIMAB COMPARED WITH CHOP ALONE IN ELDERLY PATIENTS WITH DIFFUSE LARGE-B-CELL LYMPHOMA. N Engl J Med. 2002; 346:235-42.
  8. Cunningham D, et al. Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles. The Lancet. 2013; 381:1817-26.
  9. Davies A, et al. Gene-expression profiling of bortezomib added to standard chemoimmunotherapy for diffuse large B-cell lymphoma (REMoDL-B): an open-label, randomised, phase 3 trial. Lancet Oncol. 2019; 20:649-62.
  10. Iacoboni G, et al. Methodology of clinical trials evaluating the incorporation of new drugs in the first-line treatment of patients with diffuse large B-cell lymphoma (DLBCL): a critical review. Ann Oncol. 2018; 29:1120-9.
  11. Jaeger U, et al. Rituximab maintenance for patients with aggressive B-cell lymphoma in first remission: results of the randomized NHL13 trial. Haematologica. 2015; 100:955-63.
  12. Seymour JF, et al. R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes. Haematologica. 2014; 99:1343-9.
  13. Vitolo U, et al. Obinutuzumab or Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Previously Untreated Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2017; 35:3529-37.
  14. Vitolo U, et al. ROBUST: First report of phase III randomized study of lenalidomide/R-CHOP (R2-CHOP) vs placebo/R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma. Hematological Oncology. 2019; 37:36-7.
  15. Witzig TE, et al. Adjuvant everolimus in high-risk diffuse large B-cell lymphoma: final results from the PILLAR-2 randomized phase III trial. Ann Oncol. 2018; 29:707-14.
  16. Younes A, et al. Randomized Phase III Trial of Ibrutinib and Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Non–Germinal Center B-Cell Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2019; 37:1285-95.
  17. Morschhauser F et al, J Clin Oncol. 2025 Sep 24;43(35):3698–3705
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