Article

Additional Results From POLARIX Study Show Improved PFS With No Reduction in HRQOL

Author(s):

New data from the POLARIX STUDY show that substituting polatuzumab vedotin for 1 part of a classic first-line chemotherapy combination to manage diffuse large B-cell lymphoma improved progression-free survival without compromising health-related quality-of-life.

New data from the POLARIX STUDY (NCT03274492) show that substituting polatuzumab vedotin (Polivy) for 1 part of a classic first-line chemotherapy combination to manage diffuse large B-cell lymphoma (DLBCL) improved progression-free survival (PFS) without compromising health-related quality-of-life (HRQOL).1

“These data may represent a benchmark for patient-reported HRQOL in frontline DLBCL in the modern era,” the investigators reported.

The results, presented during the 64th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, Louisiana, showed that physical functioning and fatigue scores were similar at baseline and improved during and after treatment for patients in both arms of the POLARIX study. The main results, presented in 2021 at the 63rd ASH Meeting and Exposition in Atlanta, Georgia, showed that combining polatuzumab with rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) improved PFS by 27% compared with the standard of care, R-CHOP, which consists of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.2

Jeff P. Sharman, MD, was an author on the original POLARIX study and is the senior author on the HRQOL analysis presented at ASH 2022. Sharman is director of research at the Willamette Valley Cancer Institute and Research Center in Eugene, Oregon, and the medical director of hematology research for The US Oncology Network. The US Oncology Network is a Strategic Alliance Partner of The American Journal of Managed Care®.

In the POLARIX study, 879 patients were randomly assigned 1:1 to receive either Pola-R-CHP (n = 440) or R-CHOP (n = 439). Lymphoma symptom scores were measured using the Functional Assessment Cancer Therapy-Lymphoma subscale. Physical functioning, fatigue, constipation, diarrhea, nausea, and vomiting were measured with the European Organisation for Research and Treatment of Cancer Quality of Life Cancer Patients questionnaire.

Patients who had not experienced progression were given questionnaires during treatment on the first day of cycles 1, 2, 3, and 5 and at the end of treatment. Patients also received questionnaires biannually for 2 years after treatment ended and then once a year for 3 years. Data from patients who experienced clinically meaningful improvements or worsening or no change from baseline in functioning, fatigue, or lymphoma symptom scores were reported based on validated thresholds.

More than 80% of patients responded to questionnaires throughout the study. At baseline, scores for lymphoma symptoms, physical functioning, and fatigue were similar in both treatment arms, and reported levels of constipation, diarrhea, nausea, and vomiting were similarly low. According to the abstract, both Pola-R-CHP and R-CHOP brought rapid improvement in lymphoma symptoms in most respondents beginning with the first cycle; 82.3% and 81.3% of patients experienced clinically meaningful improvement, respectively. Investigators reported this was “sustained with improvement plateauing by the first assessment after [end of treatment].” Results showed improvements in physical functioning (42.4% of patients in the Pola-R-CHP group vs 39.6% of patients in the R-CHOP group) and fatigue (74.8% of patients vs 68.2% of patients, respectively).

Between cycle 2 and the end of treatment, diarrhea was more frequently reported in the Pola-R-CHP group (17%-34%) than the R-CHOP group (18%-24%), and constipation was more frequently reported with the R-CHOP group (21%-42%) than the Pola-R-CHP group (23%-35%). For both groups, diarrhea and constipation symptoms returned to baseline levels by the end of treatment.

Nausea and vomiting were reported less frequently in both arms and returned to baseline levels at end of treatment in both arms. For the Pola-R-CHP group, 12% to 33% of patients reported nausea vs 11% to 30% of patients in the R-CHOP group. Additionally, 3% to 11% of patients in the Pola-R-CHP group reported vomiting vs 4% to 10% of patients in the R-CHOP group.

Genentech, the manufacturer of polatuzumab, said in a statement that other data presented at the 64th ASH Annual Meeting & Exposition in New Orleans showed that the Pola-R-CHP combination had the potential to reduce the number of patients in second-line treatment by 27% compared with R-CHOP.3,4 A biologics license application has been accepted by the FDA, with a decision expected by April 2, 2023.4

Long-term PFS data show that after a median follow-up of 3 years, Pola-R-CHP continues to offer a statistically significant reduction in the risk of worsening disease or death compared with R-CHOP (HR, 0.76; 95% CI, 0.60-97). Overall survival data remained immature and similar between the 2 arms after 39.7 months (HR, 0.94; 95% CI, 0.67-1.33; P = .73).3

References
1. Friedberg JW, Thompson CA, Trněný M, et al. Health-related quality of life (HRQoL) in patients with diffuse large B-cell lymphoma (DLBCL) treated with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin and prednisone (Pola-R-CHP) versus rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in the phase III POLARIX study. Abstract presented at: 64th American Society of Hematology Annual Meeting & Exposition; December 10-13, 2022; New Orleans, LA. Abstract 2949. https://ash.confex. com/ash/2022/webprogram/Paper157761.html

2. Tilly H, Morschhauser F, Sehn LH, et al. Polatuzumab vedotin in previously untreated diffuse large B-cell lymphoma. N Engl J Med. 2022;386(4):351-363. doi:10.1056/NEJMoa2115304

3. Genentech presents new and updated data for Polivy in previously untreated diffuse large B-cell lymphoma at ASH 2022. News release. Genentech. December 11, 2022. https://www.gene.com/ media/press-releases/14976/2022-12-11/genentech-presents-new-and-updated-data-

4. Boissard F,TillyH,LenzG,etal. Epidemiological impact of polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin and prednisone (Pola-R-CHP) use in previously untreated diffuse large B-cell lymphoma (DLBCL) in terms of second line (2L) treatment: an ad hoc analysis from the POLARIX study. Abstract presented at: 64th American Society of Hematology Annual Meeting & Exposition; December 10-13, 2022; New Orleans, LA. Abstract 2958. https://ash.confex.com/ash/2022/webprogram/Paper157904.html

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