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POLARIX® trial

New first-line therapy

assessed for DLBCL1

Watch Expert Perspectives

Specialist views covering a range of POLARIX trial topics

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Dr Hervé Tilly,
University of Rouen, France

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Prof. Christopher Flowers,
MD, Anderson Cancer Center, University of Texas

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Dr Franck Morschhauser,
MD, PhD Professor of Hematology,
University of Lille

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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

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

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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

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

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

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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)
  >60 300 (68.2%) 308 (70.2%)
Gender Female 201 (45.7%) 205 (46.7%)
  Male 239 (54.3%) 234 (53.3%)
ECOG PS 0-1 374 (85.0%) 363 (82.7%)
  2 66 (15.0%) 75 (17.1%)
IPI score 2 167 (38.0%) 167 (38.0%)
  3-5 273 (62.0%) 272 (62.0%)
Ann Arbor Stage I or II 47 (10.7%) 52 (11.8%)
  III or IV 393 (89.3%) 387 (88.2%)
Bulky disease (≥7.5 cm in diameter)
 No 247 (56.1%) 247 (56.3%)
  Yes 193 (43.9%) 192 (43.7%)
Extranodal sites 0-1 227 (51.6%) 226 (51.5%)
  ≥2
 213 (48.4%) 213 (48.5%)
Cell of origin* ABC 102 (30.9%) 119 (35.2%)
  GCB 184 (55.8%) 168 (49.7%)
  Unclassified 44 (13.3.%) 51 (15.1%)
  Unknown 110 101
Double- or triple-hit lymphoma
   26 (7.9%) 19 (5.7%)

No filter results

*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.

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“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 Center

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Efficacy

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

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.