Christopher R. Flowers, MD, MS
Investigators are studying the value of polatuzumab vedotin (RG7596) in patients with intermediate- or high-risk diffuse large B-cell lymphoma (DLBCL). Polatuzumab vedotin is a CD79b-specific antibody conjugated to a microtubule disrupting agent, monomethyl auristatin E (MMAE), with a stable linker. The novel antibody–drug conjugate is being combined with R-CHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) as a first-line treatment in the phase III, randomized, multicenter POLARIX clinical trial (NCT03274492) (Figure).
Figure. Polatuzumab Vedotin in DLBCL (Click to enlarge image)
This combination is being compared with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), which is the current first-line standard of care for patients with DLBCL. Although many patients with DLBCL treated with R-CHOP are cured, “following standard R-CHOP, 30% to 40% of patients with DLBCL relapse, [and] patients who experience early relapse have a poor prognosis. The trial aims to address these problems by evaluating a new approach for firstline treatment of DLBCL that may improve upon [outcomes with] R-CHOP,” said Christopher R. Flowers, MD, MS, professor of hematology and medical oncology at Emory University School of Medicine in Atlanta, Georgia. He also is director of the Emory Lymphoma Program and scientific director of Winship Research Informatics Shared Resource at Emory University’s Winship Cancer Institute. Flowers is the principal investigator for POLARIX at Emory and a member of the trial’s international steering committee.
The study will enroll patients with any subtype of CD20-positive DLBCL with an ECOG performance status of 0 to 2, a cardiac ejection fraction of at least 50%, and intermediate- to high-risk disease (International Prognostic Index [IPI]score, 2-5). Patients with an IPI score of 2 to 5 havea a greater risk of relapse and worse survival with standard R-CHOP than the general group of patients with DLBCL. Participants cannot have had prior treatment for DLBCL. The investigators will assess the safety and efficacy of polatuzumab vedotin using investigator-assessed progression-free survival as the primary endpoint. They also will evaluate potential biomarkers to predict improved outcomes and as a means for devising new therapeutic approaches in the future, according to Flowers.
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