POLARIX® trial

New first-line therapy

assessed for DLBCL1

Watch experts perspectives

Specialist views covering a range of POLARIX trial topics

Dr Hervé Tilly

University of Rouen, France

Prof. Christopher Flowers

MD, Anderson Cancer Center, University of Texas

Dr Franck Morschhauser

MD, PhD Professor of Hematology,
University of Lille

Dr Laurie H. Sehn

MD, MPH Clinical Assistant
Professor with the BC Cancer Agency and University
of British Columbia

What is the significance of the POLARIX trial?

The POLARIX trial is the first Phase III study with a meaningful improvement over R-CHOP in previously untreated DLBCL in 20 years.1-3

Efficacy

Benefit superior to 20-year standard of care1,3

Since the addition of rituximab to the CHOP regimen over 20 years ago, numerous randomised trials have attempted to advance first-line treatment options for patients with DLBCL.1-3 Efforts to improve treatment have been largely unsuccessful and R-CHOP has remained the standard of care.1-13

4/10

patients relapse after first-line treatment with R-CHOP, the majority of whom face poor outcomes1

The POLARIX trial showed a progression-free survival benefit with POLIVY-R-CHP compared to the R-CHOP regimen at 2 years and beyond.1,14

Among patients with previously untreated intermediate-risk or high-risk DLBCL, the risk of disease progression, relapse, or death was significantly lower in those who received POLIVY-R-CHP compared to R-CHOP.1

POLARIX® trial design

International, randomised, double-blind, placebo-controlled, phase III trial1

The POLARIX study compared R-CHOP to a modified drug combination (POLIVY-R-CHP) that omits vincristine and includes polatuzumab vedotin, a CD79b-targeting antibody drug conjugate.1

The trial enrolled 879 patients in 23 countries. Half of the participants were randomly assigned to receive  POLIVY-R-CHP and half were randomly assigned to receive R-CHOP.1

Broad patient population

The patient population studied in the POLARIX trial encompasses a broad population of patients with 1L DLBCL.1

Patients were included from a diverse geographic background and a broad age range. IPI scores ranged between 2 and 5 and ECOG
performance status between 0 to 2.1

The population studied in the POLARIX trial is representative of the typical DLBCL patient population1,15

Selected demographics and baseline characteristics1

  

POLIVY-R-CHP

(N=440)

R-CHOP

(N=439)

Age (years)Median (range)65 (19-80)66 (19-80)
 >60300 (68.2%)308 (70.2%)
GenderFemale201 (45.7%)205 (46.7%)
 Male239 (54.3%)234 (53.3%)
ECOG PS0-1374 (85.0%)363 (82.7%)
 266 (15.0%)75 (17.1%)
IPI score2167 (38.0%)167 (38.0%)
 3-5273 (62.0%)272 (62.0%)
Ann Arbor StageI or II47 (10.7%)52 (11.8%)
 III or IV393 (89.3%)387 (88.2%)
Bulky disease (≥7.5 cm in diameter)No247 (56.1%)247 (56.3%)
 Yes193 (43.9%)192 (43.7%)
Extranodal sites0-1227 (51.6%)226 (51.5%)
 ≥2213 (48.4%)213 (48.5%)
Cell of origin*ABC102 (30.9%)119 (35.2%)
 GCB184 (55.8%)168 (49.7%)
 Unclassified44 (13.3.%)51 (15.1%)
 Unknown110101
Double- or triple-hit lymphoma 26 (7.9%)19 (5.7%)

*Centrally performed tests: cell-of-origin was performed by NanoString Lymph 2Cx, MYC and BCL2 immunohistochemistry were performed for DEL; MYC and BCL2, and/or BCL6 rearrangements were performed for double- and triple-hit lymphoma; percentages are calculated from the evaluable population. Baseline tumour tissue samples were not received from 63 patients in the ITT population, the remainder of unknown results represent test failures; together, these account for the difference between ITT and biomarker-evaluable population.

“POLIVY-R-CHP in general benefits all patients who enrolled in the trial, so I think that’s the major population where we should think about the use of this regimen.”

– Prof. Christopher Flowers

University of Texas MD Anderson Cancer Cente

Efficacy

Are you interested to see the latest efficacy data from the POLARIX trial?

read more

1L=first line; ABC=activated B-cell-like subtype; BICR=blinded independent central review; CR=complete response; DLBCL=diffuse large B-cell lymphoma; ECOG PS=Eastern Cooperative Oncology Group Performance Status; EOT=end of treatment; GBC=Germinal-centre B-cell-like subtype; IPI=International Prognostic Index; INV=investigator; N=population size; PET=positron emission tomography; PFS=progression free survival; POLIVY-R-CHP=polatuzumab vedotin + rituximab, cyclophosphamide, doxorubicin, prednisone; Q21D=every 21 days; R-CHOP=rituximab + cyclophosphamide, doxorubicin, vincristine, prednisone; OS=overall survival; R=randomisation.

 

References:

  1. Tilly H, et al. N Engl J Med. 2022;386:351-63.
  2. Coiffier B, et al. N Engl J Med. 2002;346:235-42.
  3. Younes A, et al. J Clin Oncol. 2019;37:1285-95.
  4. Aurer I, et al. Eur J Haematol. 2011;86:111-6.
  5. Bartlett NL, et al. J Clin Oncol. 2019;37:1790-9.
  6. Cunningham D, et al. Lancet. 2013;381:1817-26.
  7. Davies A, et al. Lancet Oncol. 2019;20:649-62.
  8. Iacoboni G, et al. Ann Oncol. 2018;29:1120-9.
  9. Jaeger U, et al. Haematologica. 2015;100:955-63.
  10. Seymour JF, et al. Haematologica. 2014;99:1343-9.
  11. Vitolo U, et al. J Clin Oncol. 2017;35:3529-37.
  12. Vitolo U, et al. Hematological Oncology. 2019;37:36-7.
  13. Witzig TE, et al. Ann Oncol. 2018;29:707-14.
  14. Herrera A, et al. Poster presented at: 2022 ASH; December 2022; New Orleans, LA.
  15. Sehn LH, Salles G. N Engl J Med. 2021;384:842-58.