A PHASE 3 STUDY COMPARING POLATUZUMAB VEDOTIN PLUS R-CHP VERSUS R-CHOP IN PATIENTS WITH DLBCL (POLARIX)
Author(s): ,
Hervé Tilly
Affiliations:
Centre Henri Becquerel,ROUEN CEDEX,France
,
Christopher Flowers
Affiliations:
Winship Cancer Institute of Emory University,Atlanta,United States
,
Jonathan W. Friedberg
Affiliations:
University of Rochester Medical Center,Rochester,United States
,
Charles Herbaux
Affiliations:
University of Lille,CHU Lille,Lille Cedex,France
,
Franck Morschhauser
Affiliations:
University of Lille,CHU Lille,Lille Cedex,France
,
Laurie H. Sehn
Affiliations:
BC Cancer Agency,Vancouver,Canada
,
Jeff Sharman
Affiliations:
US Oncology and Willamette Valley Cancer Institute,Springfield,United States
,
Marek Trněný
Affiliations:
Charles University,Prague,Czech Republic
,
Lijia Wang
Affiliations:
Genentech, Inc.,South San Francisco,United States
,
Calvin Lee
Affiliations:
Genentech, Inc.,South San Francisco,United States
Gilles Salles
Affiliations:
Hospices Civils de Lyon,Université Lyon-1,Lyon,France
EHA Learning Center. TILLY H. Jun 14, 2018; 216635
Hervé TILLY
Hervé TILLY

Access to EHA Members only content is an EHA membership benefit. Click here to join EHA or renew your membership here.


Abstract
Discussion Forum (0)
Rate & Comment (0)

Abstract: PB1770

Type: Publication Only

Background
R-CHOP remains the standard of care in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). However, patients with high-risk disease have poorer outcomes with R-CHOP. Polatuzumab vedotin (pola) is an antibody-drug conjugate targeting CD79b; it delivers the antimitotic agent MMAE and is being evaluated as a replacement strategy for vincristine within the R-CHOP regimen. In a phase Ib/II study in higher risk DLBCL patients, pola + R-CHP produced promising efficacy across different subtypes of DLBCL and a safety profile similar to that observed in the R-CHOP arm of the GOYA study (Tilly H, et al. Hematol Oncol 2017; Vitolo U, et al. J Clin Oncol 2017).

Aims

To evaluate the efficacy and safety of pola plus R-CHP compared with R-CHOP in patients with previously untreated DLBCL to see whether pola can improve outcomes in patients with low to high-risk disease.

 

Methods

This is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study in patients with previously untreated DLBCL. Patients (planned N = 875) aged 18-80 years with CD20-positive DLBCL (including DLBCL not otherwise specified [NOS], germinal center B-cell like [GCB], and activated B-cell like [ABC] subtypes), ECOG performance status 0–2, and IPI score 2–5, will be randomized 1:1 to one of two treatment groups, stratified by IPI score (2 versus 3–5), bulky disease and geographical region (Figure). Arm A will receive pola 1.8 mg/kg on Day 1 plus R-CHP (standard dosing schedule) plus vincristine placebo for 6 cycles; Arm B will receive R-CHOP (standard dosing schedule) with pola placebo for 6 cycles. In both arms, R will be administered as monotherapy in cycles 7 and 8.

The primary endpoint is progression-free survival (PFS), as assessed by the investigator, using the Lugano classification (Cheson B, et al. J Clin Oncol 2014). Secondary endpoints include PET-CT complete response rate at end of treatment assessed by an independent review committee, event-free survival due to efficacy reason, 2-year PFS rate, and overall survival.

PET-CT and CT scans will be obtained at screening, after 4 cycles (planned interim assessment), and 6–8 weeks after end of study treatment. Patient follow-up will continue for 5 years after end of treatment.

 

Results

Enrolment began November 2017.  

 

Conclusion
This phase 3 study, POLARIX, will evaluate clinical outcomes with pola plus R-CHP compared with R-CHOP in patients with previously untreated DLBCL. Clinical trial information: the study is funded by F. Hoffmann-La Roche Ltd; NCT03274492.

Session topic: 21. Aggressive Non-Hodgkin lymphoma - Clinical

Keyword(s): Diffuse large B cell lymphoma, Immunoconjugate, Phase III

Code of conduct/disclaimer available in General Terms & Conditions
Anonymous User Privacy Preferences

Strictly Necessary Cookies (Always Active)

MULTILEARNING platforms and tools hereinafter referred as “MLG SOFTWARE” are provided to you as pure educational platforms/services requiring cookies to operate. In the case of the MLG SOFTWARE, cookies are essential for the Platform to function properly for the provision of education. If these cookies are disabled, a large subset of the functionality provided by the Platform will either be unavailable or cease to work as expected. The MLG SOFTWARE do not capture non-essential activities such as menu items and listings you click on or pages viewed.


Performance Cookies

Performance cookies are used to analyse how visitors use a website in order to provide a better user experience.



Google Analytics is used for user behavior tracking/reporting. Google Analytics works in parallel and independently from MLG’s features. Google Analytics relies on cookies and these cookies can be used by Google to track users across different platforms/services.


Save Settings