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 "title": "Pola-R-CHP regimen",
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 "excerpt": "Pola-R-CHP is a combination chemotherapy regimen for previously untreated diffuse large B-cell lymphoma in which the vincristine of R-CHOP is replaced by polatuzumab vedotin, approved in the US in 2023.",
 "snippet": "Pola-R-CHP is a combination chemotherapy regimen for previously untreated diffuse large B-cell lymphoma in which the vincristine of R-CHOP is replaced by polatuzumab vedotin, approved in the US in 2023.",
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 "markdown": "# Pola-R-CHP regimen\n\nPola-R-CHP is a combination chemotherapy regimen for previously untreated diffuse large [B-cell lymphoma](https://www.edgepedia.org/b-cell-lymphoma) (DLBCL) in which the vincristine of classic R-CHOP is replaced by polatuzumab vedotin, a CD79b-directed antibody-drug conjugate. The five components are polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone, given over six 21-day cycles followed by two cycles of rituximab alone.<sup>[1](https://doi.org/10.1056/nejmoa2115304)</sup> In the phase 3 POLARIX trial, the regimen improved 2-year progression-free survival over R-CHOP (76.7% vs 70.2%; hazard ratio 0.73) without added toxicity, and on April 19, 2023 the FDA approved polatuzumab vedotin-piiq (Polivy, [Genentech](https://www.edgepedia.org/genentech)) with R-CHP for adults with previously untreated DLBCL, not otherwise specified, or high-grade B-cell lymphoma with an [International Prognostic Index](https://www.edgepedia.org/international-prognostic-index) (IPI) score of 2 or greater.<sup>[1](https://doi.org/10.1056/nejmoa2115304)</sup><sup> • </sup><sup>[2](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq-previously-untreated-diffuse-large-b-cell-lymphoma-not)</sup>\n\n| Key fact | Detail |\n|---|---|\n| Components | Polatuzumab vedotin 1.8 mg/kg, rituximab 375 mg/m², cyclophosphamide 750 mg/m², doxorubicin 50 mg/m² (day 1); prednisone 100 mg days 1–5<sup>[3](https://clinicaltrials.gov/ct2/show/NCT03274492)</sup> |\n| Schedule | Six 21-day cycles, then two cycles of rituximab alone<sup>[1](https://doi.org/10.1056/nejmoa2115304)</sup> |\n| 2-year PFS (POLARIX) | 76.7% vs 70.2% with R-CHOP; HR 0.73 (95% CI 0.57–0.95)<sup>[1](https://doi.org/10.1056/nejmoa2115304)</sup> |\n| 2-year OS | 88.7% vs 88.6%; HR 0.94, not significant<sup>[1](https://doi.org/10.1056/nejmoa2115304)</sup> |\n| US approval | April 19, 2023, IPI score ≥2<sup>[2](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq-previously-untreated-diffuse-large-b-cell-lymphoma-not)</sup> |\n| Added cost | Approximately $18,000 per cycle over R-CHOP in the US<sup>[4](https://www.ovid.com/journals/bjha/fulltext/10.1111/bjh.18934~polarchp-for-frontline-therapy-in-dlbcl-are-we-saving-money)</sup> |\n\n## How it works\n\n[Polatuzumab vedotin](https://www.edgepedia.org/polatuzumab-vedotin) is an antibody-drug conjugate (ADC) composed of an IgG1 monoclonal antibody specific for human CD79b, the anti-mitotic agent monomethyl auristatin E (MMAE), and a protease-cleavable linker, maleimidocaproyl-valine-citrulline-p-aminobenzyloxycarbonyl (mc-vc-PAB).<sup>[5](https://www.gene.com/download/pdf/polivy_prescribing.pdf)</sup> CD79b is a B-cell surface protein expressed in more than 95% of DLBCL.<sup>[6](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761121Orig1s000ClinPharmR.pdf)</sup> After the antibody binds CD79b, the conjugate is internalized, lysosomal proteases cleave the valine-citrulline linker, and MMAE is released intracellularly; MMAE binds microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis.<sup>[7](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20a16ab2-f338-4abb-9dcd-254bd949a2bc)</sup><sup> • </sup><sup>[6](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761121Orig1s000ClinPharmR.pdf)</sup>\n\nVincristine was excluded from the regimen because of the risk of overlapping neurologic toxic effects with MMAE, which is itself associated with peripheral neuropathy.<sup>[1](https://doi.org/10.1056/nejmoa2115304)</sup> Concomitant strong CYP3A inhibitors or inducers can affect exposure to unconjugated MMAE.<sup>[5](https://www.gene.com/download/pdf/polivy_prescribing.pdf)</sup>\n\n## How it is done\n\nOn day 1 of each 21-day cycle, patients receive polatuzumab vedotin 1.8 mg/kg intravenously, rituximab 375 mg/m², cyclophosphamide 750 mg/m², and doxorubicin 50 mg/m², with prednisone 100 mg orally on days 1–5, for six cycles; cycles 7 and 8 are rituximab monotherapy.<sup>[1](https://doi.org/10.1056/nejmoa2115304)</sup><sup> • </sup><sup>[3](https://clinicaltrials.gov/ct2/show/NCT03274492)</sup> The US label specifies antihistamine and antipyretic premedication and G-CSF prophylaxis.<sup>[2](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq-previously-untreated-diffuse-large-b-cell-lymphoma-not)</sup> POLIVY, cyclophosphamide, doxorubicin, and the rituximab product may be given in any order on day 1 after prednisone administration.<sup>[7](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20a16ab2-f338-4abb-9dcd-254bd949a2bc)</sup>\n\nA UK protocol from the SWAG Cancer Alliance adds practical detail: in cycle 1, treatment may be split over two days with rituximab on day 0 and the other drugs on day 1; the first polatuzumab infusion runs over 90 minutes with a 90-minute observation, and subsequent infusions over 30 minutes if no reaction occurs.<sup>[8](https://www.swagcanceralliance.nhs.uk/wp-content/uploads/2023/05/Pola-R-CHP-v1.3.pdf)</sup>\n\n## Origin\n\nPola-R-CHP was demonstrated in the phase 3 POLARIX trial (Study GO39942; NCT03274492), reported by [Hervé Tilly](https://www.edgepedia.org/herve-tilly) and colleagues in the New England Journal of Medicine in 2021 as \"Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma.\"<sup>[1](https://doi.org/10.1056/nejmoa2115304)</sup> The regimen itself built on an earlier phase 1b–2 trial of pola-R-CHP as first-line therapy, in which 89% of patients had an overall response and 77% a complete response; that trial also established the exclusion of vincristine because of overlapping neurologic toxicity.<sup>[1](https://doi.org/10.1056/nejmoa2115304)</sup>\n\n## Variants\n\nThe regimen's composition is fixed in trials and labels, but dosing is modified in some populations. An age-adapted phase 3 trial of pola-R-CHP with dose-attenuated chemotherapy in patients older than 80 is ongoing (NCT04332822).<sup>[1](https://doi.org/10.1056/nejmoa2115304)</sup> A real-world study of 38 DLBCL patients older than 80 used reduced-dose pola-R-CHP, achieving 12-month overall survival of 86.2% and progression-free survival of 78.5%, with 84% complete responses.<sup>[9](https://link.springer.com/article/10.1007/s44313-025-00059-5)</sup> One real-world cohort substituted epirubicin 70 mg/m² for doxorubicin in some patients.<sup>[10](https://link.springer.com/article/10.1007/s00277-025-06526-4)</sup> Polatuzumab vedotin is also approved with bendamustine plus a rituximab product for relapsed or refractory DLBCL after at least two prior therapies, at the same 1.8 mg/kg every-21-day dosing.<sup>[5](https://www.gene.com/download/pdf/polivy_prescribing.pdf)</sup>\n\n## Applications\n\nThe approved frontline indication covers adults with previously untreated DLBCL, NOS, or high-grade B-cell lymphoma with an IPI score of 2 or greater; in POLARIX the main diagnoses were de novo DLBCL, NOS (84%) and [HGBL](https://www.edgepedia.org/high-grade-b-cell-lymphoma) (11%).<sup>[2](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq-previously-untreated-diffuse-large-b-cell-lymphoma-not)</sup> The label's large B-cell lymphoma coverage also extends to EBV-positive DLBCL, NOS, and [T-cell/histiocyte-rich large B-cell lymphoma](https://www.edgepedia.org/t-cell-histiocyte-rich-large-b-cell-lymphoma).<sup>[11](https://www.ncbi.nlm.nih.gov/books/NBK602516/table/tr8269868067031382_ch01_t03/?report=objectonly)</sup> POLARIX excluded patients with lymphoma arising from previously diagnosed indolent lymphoma, primary mediastinal lymphoma, and patients older than 80.<sup>[1](https://doi.org/10.1056/nejmoa2115304)</sup> Real-world experience outside the trial population includes IPI 0–1 and POLARIX-ineligible patients, with a complete response rate after six cycles of 80.6% overall, 91.7% in IPI 0–1 patients, and 73.5% in POLARIX-ineligible patients in a 117-patient cohort.<sup>[10](https://link.springer.com/article/10.1007/s00277-025-06526-4)</sup>\n\nAdoption has been broad. Japan approved polatuzumab vedotin with R-CHP for previously untreated DLBCL in August 2022, ahead of the US decision.<sup>[12](https://pmc.ncbi.nlm.nih.gov/articles/PMC12793779/)</sup> In Europe, the EMA granted a Type II variation marketing authorization for Polivy with rituximab, cyclophosphamide, doxorubicin, and prednisone, with the company restricting the population to IPI 2–5 as in POLARIX.<sup>[13](https://www.nice.org.uk/guidance/TA874/documents/1)</sup> A systematic review and meta-analysis pooled a complete response rate of 78% (95% CI 74–82%), with real-world studies showing higher CR than randomized trials (80% vs 69%), pooled 1-year PFS of 85%, and pooled 1-year OS of 91%.<sup>[14](https://www.nature.com/articles/s41408-026-01552-5)</sup>\n\n## Limitations and alternatives\n\nThe benefit is progression-free survival without a demonstrated overall survival gain. At 2 years, overall survival was 88.7% vs 88.6% (HR 0.94), and the final overall survival analysis at a median follow-up of 3.3 years showed no statistically significant difference (HR 0.94; 95% CI 0.67–1.33).<sup>[1](https://doi.org/10.1056/nejmoa2115304)</sup><sup> • </sup><sup>[7](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20a16ab2-f338-4abb-9dcd-254bd949a2bc)</sup> No improvement was demonstrated in complete response rate at end of therapy (78.0% vs 74.0%), and the application was presented to the FDA's Oncology Drug Advisory Committee because of uncertainty about benefit-risk.<sup>[15](https://pmc.ncbi.nlm.nih.gov/articles/PMC11649458/)</sup><sup> • </sup><sup>[16](https://polivy.global/content/dam/polivy/common/pdf/SmPC_POLIVY-epar-product-information_en.pdf)</sup> FDA analyses showed a heterogeneous effect by IPI: the PFS hazard ratio was 0.99 (95% CI 0.63–1.56) for IPI 2 versus 0.67 (95% CI 0.49–0.91) for IPI 3–5, and PFS benefit appeared concentrated in the activated B-cell-like (ABC) subtype.<sup>[15](https://pmc.ncbi.nlm.nih.gov/articles/PMC11649458/)</sup>\n\nToxicity is broadly comparable to R-CHOP. In POLARIX, peripheral neuropathy of any grade occurred in 52.9% with pola-R-CHP versus 53.9% with R-CHOP, grade 2 or higher in 13.8% versus 16.7%, and dose reductions for neuropathy in 4.4% versus 8.0%; serious adverse reactions occurred in 34%, including febrile neutropenia and pneumonia.<sup>[1](https://doi.org/10.1056/nejmoa2115304)</sup><sup> • </sup><sup>[2](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq-previously-untreated-diffuse-large-b-cell-lymphoma-not)</sup> Real-world rates differ: a Japanese cohort reported peripheral neuropathy in 26% of PV-R-CHP patients (2% grade 3–4) versus 42% with R-CHOP, and grade 1–2 diarrhea in 20% of PV-R-CHP patients.<sup>[12](https://pmc.ncbi.nlm.nih.gov/articles/PMC12793779/)</sup> In the >80-year reduced-dose cohort, febrile neutropenia occurred in 32% and adverse event-related deaths in three patients (8%).<sup>[9](https://link.springer.com/article/10.1007/s44313-025-00059-5)</sup>\n\nCompared with R-CHOP, pola-R-CHP reduced subsequent anti-lymphoma therapy: systemic therapy 20.0% vs 28.2%, stem cell transplant 5.0% vs 8.4%, [CAR T-cell therapy](https://www.edgepedia.org/car-t-cell-therapy) 2.3% vs 4.1%, and bispecific antibodies 1.4% vs 2.1%.<sup>[17](https://ma1.mdedge.com/index.php/content/polarix-extended-results-confirm-standard-care-dlbcl)</sup> Cost is a practical limit: adding polatuzumab increases frontline therapy costs by approximately $18,000 per cycle in the US compared with R-CHOP,<sup>[4](https://www.ovid.com/journals/bjha/fulltext/10.1111/bjh.18934~polarchp-for-frontline-therapy-in-dlbcl-are-we-saving-money)</sup> and NICE documented UK list prices of £2,370 per 30 mg vial and £11,060 per 140 mg vial, with an average course costing £71,718.<sup>[13](https://www.nice.org.uk/guidance/TA874/documents/1)</sup>\n\n## References\n\n1. [Hervé Tilly and colleagues (2021). Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. New England Journal of Medicine.](https://doi.org/10.1056/nejmoa2115304)\n2. [FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq-previously-untreated-diffuse-large-b-cell-lymphoma-not)\n3. [A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With R-CHP Versus R-CHOP in Participants With Diffuse Large B-Cell Lymphoma](https://clinicaltrials.gov/ct2/show/NCT03274492)\n4. [Pola-R-CHP for frontline therapy in DLBCL (British Journal of Haematology commentary)](https://www.ovid.com/journals/bjha/fulltext/10.1111/bjh.18934~polarchp-for-frontline-therapy-in-dlbcl-are-we-saving-money)\n5. [POLIVY full prescribing information (Genentech)](https://www.gene.com/download/pdf/polivy_prescribing.pdf)\n6. [FDA Clinical Pharmacology Review, polatuzumab vedotin (761121Orig1s000)](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761121Orig1s000ClinPharmR.pdf)\n7. [DailyMed - POLIVY- polatuzumab vedotin injection](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20a16ab2-f338-4abb-9dcd-254bd949a2bc)\n8. [SWAG Cancer Alliance Pola-R-CHP Quick Reference Guide](https://www.swagcanceralliance.nhs.uk/wp-content/uploads/2023/05/Pola-R-CHP-v1.3.pdf)\n9. [Real-world effectiveness and safety of pola-R-CHP in patients aged >80 years with DLBCL (Blood Research, 2025)](https://link.springer.com/article/10.1007/s44313-025-00059-5)\n10. [Pola-R-CHP in first-line POLARIX-ineligible and IPI 0–1 DLBCL patients (Annals of Hematology, 2025)](https://link.springer.com/article/10.1007/s00277-025-06526-4)\n11. [NCBI Bookshelf table: Key Characteristics of Polatuzumab Vedotin and R-CHOP](https://www.ncbi.nlm.nih.gov/books/NBK602516/table/tr8269868067031382_ch01_t03/?report=objectonly)\n12. [Real-World Outcomes of Polatuzumab Vedotin Plus R-CHP Versus R-CHOP-Based Regimens in Japanese Patients With Untreated DLBCL](https://pmc.ncbi.nlm.nih.gov/articles/PMC12793779/)\n13. [NICE TA874: Polatuzumab vedotin in combination for treating untreated diffuse large B-cell lymphoma](https://www.nice.org.uk/guidance/TA874/documents/1)\n14. [Pola-R-CHP as frontline therapy for DLBCL: systematic review and meta-analysis of randomized trials and real-world evidence (Blood Cancer Journal)](https://www.nature.com/articles/s41408-026-01552-5)\n15. [FDA Approval Summary: Polatuzumab Vedotin in the First-line Treatment of Select Large B-cell Lymphomas](https://pmc.ncbi.nlm.nih.gov/articles/PMC11649458/)\n16. [Polivy SmPC (EMA product information)](https://polivy.global/content/dam/polivy/common/pdf/SmPC_POLIVY-epar-product-information_en.pdf)\n17. [POLARIX: Extended Results Confirm Standard of Care for DLBCL (MDedge)](https://ma1.mdedge.com/index.php/content/polarix-extended-results-confirm-standard-care-dlbcl)\n\n---\n*Topic: Encyclopedia › Life and health › Human health and medicine › Medicines and therapeutics › Cancer chemotherapy and regimens › Named combination chemotherapy regimens*\n\n*Initially written Sep 29, 2026 · Edited: Oct 15, 2026*\n\n*Copyright 2026 EdgeChat AI, a subsidiary of Biostate AI.*\n\nLicense: Edgepedia Community License 1.0, https://www.edgepedia.org/edgepedia/license\n",
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 "speakable": "Pola-R-CHP is a combination chemotherapy regimen for previously untreated diffuse large B-cell lymphoma in which the vincristine of R-CHOP is replaced by polatuzumab vedotin, approved in the US in 2023."
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