FDA accepts supplemental biologics license application for Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma

F. Hoffmann-La Roche SA

  • Ffirst new treatment regimen in over 20 years to significantly improve outcomes in people with this type of fast-growing lymphoma

  • The app is based on pivotal data from the Phase III POLARIX study showing that Polivy plus R-CHP significantly reduced the risk of disease progression, relapse or death with comparable safety to standard of care, R-CHOP

  • Various combination studies with Polivy and the company’s CD20xCD3 bispecifics in diffuse large B-cell lymphoma are ongoing

Basel, August 16, 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biological License Application (sBLA) of the company for Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL) . The FDA is expected to make a decision on approval by April 2, 2023.

“The results of the POLARIX study suggest that Polivy plus R-CHP could transform the treatment of this aggressive malignancy, and we are working with the FDA to bring this combination to newly diagnosed DLBCL patients as soon as possible,” said Levi Garraway, MD, Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We hope it will become the new standard of care for the first-line treatment of DLBCL, potentially reducing the need for subsequent treatments and limiting patient burden.”

DLBCL is an aggressive blood cancer. Although DLBCL often responds to initial treatment, it is not cured with the current standard of care in four out of 10 people. Most relapses occur within two years of starting treatment and the majority of those that require Later lines of treatment have poor results.

The sBLA is based on results from the pivotal Phase III POLARIX trial, which is the first in two decades to show a clinically meaningful improvement in progression-free survival (PFS) compared to the current standard of care Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP). The risk of disease progression, relapse or death was reduced by 27% with Polivy plus R-CHP compared to R-CHOP after a median follow-up of 28.2 months (relative risk [HR] 0.73; 95% confidence interval [CI]: 0.57–0.95; p

Based on pivotal data from the POLARIX study, the European Commission approved Polivy in combination with R-CHP in May 2022 for the treatment of adult patients with previously untreated DLBCL. Polivy is currently approved as a readily available fixed-duration treatment option for relapsed or refractory (R/R) DLBCL in combination with bendamustine and Mabthera/Rituxan in more than 70 countries worldwide, including in the EU and the United States.

Roche continues to explore areas of unmet need where Polivy has the potential to provide additional benefit, including ongoing studies of combinations of Polivy with the company’s CD20xCD3 T-cell engaging bispecific antibodies, Lunsumio® (mosunetuzumab) and glofitamab, and with Rituxan in combination with gemcitabine and oxaliplatin in the phase III POLARGO study.

About the POLARIX study
POLARIS [NCT03274492] is an international phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of Polivy® (polatuzumab vedotin-piiq) plus Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R -CHP) versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in people with previously untreated diffuse large B-cell lymphoma. Eight hundred and seventy-nine patients were randomized 1:1 to receive either Polivy plus R-CHP plus vincristine placebo for six cycles, followed by rituximab for two cycles; or R-CHOP plus Polivy placebo for six cycles, followed by two cycles of rituximab. The primary endpoint is progression-free survival (PFS) as assessed by the investigator using the Lugano response criteria for malignant lymphoma. POLARIX is conducted in collaboration with the Lymphoma Study Association (LYSA) and the Lymphoma Academic Research Organization (LYSARC). Other clinical researchers around the world also participated in the trial.

About diffuse large B-cell lymphoma (DLBCL)
DLBCL is the most common form of non-Hodgkin’s lymphoma (NHL), accounting for about one in three cases of NHL.[1] DLBCL is an aggressive (fast growing) type of NHL. [1] Although it usually responds to first-line treatment, up to 40% of people will relapse or have refractory disease, at which time lifesaving treatment options are limited and survival is short.[2,3] It is estimated that approximately 150,000 people worldwide are diagnosed with DLBCL each year.[4]

About Polivy® (polatuzumab vedotin-piiq)
Polivy is a first-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B lymphocytes, an immune cell impacted in certain types of non-Hodgkin’s lymphoma (NHL), which makes it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells by delivering an anticancer agent, which is believed to minimize the effects on normal cells. Polivy is developed by Roche using Seagen ADC technology and is currently being studied for the treatment of several types of NHL. Polivy is currently marketed in the EU for the treatment of relapsed or refractory diffuse large B-cell lymphoma.

About Roche in Hematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area is profound. Today, we are investing more than ever in our efforts to bring innovative treatment options to patients across a wide range of blood diseases. Our approved medicines include MabThera/Rituxan® (rituximab), Gazyvaro/Gazyva® (obinutuzumab), Polivy® (polatuzumab vedotin-piiq), Venclexta/Venclyxto® (venetoclax) in collaboration with AbbVie and Hemlibra® (emicizumab). Our pipeline of investigational hematology drugs includes bispecific T-cell engaging antibodies glofitamab and Lunsumio® (mosunetuzumab), targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind to PD-L1 and crovalimab, an anti-C5 antibody designed to optimize complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also offers a unique opportunity to develop combination therapy regimens that aim to further improve the lives of patients.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded drugs, Roche has become the world’s largest biotechnology company and the world leader in in vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics to improve and save the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform the way healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in diagnostics and pharmacy with insights from clinical practice.

In recognition of our efforts to pursue a long-term perspective in everything we do, Roche has been named one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indexes for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare with local partners in all the countries where we work.

Genentech, in the United States, is a full member of the Roche group. Roche is the majority shareholder of Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this press release are protected by law.

References
[1] Cancer.Net. Leukemia – Lymphoma – Non-Hodgkin’s: subtype. [Internet; cited 2022 July]. Available from: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.
[2] Maurer MJ, Ghesquières H, Jais JP, et al. Event-free survival at 24 months is a robust endpoint for disease-related outcomes in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014;32(10):1066-1073.
[3] Sehn LH, Gascoyne RD. Diffuse large B-cell lymphoma: optimization of results in a context of clinical and biological heterogeneity. Blood. 2015;125(1):22-32.
[4] Globocan 2020. Global Fact Sheet. [Internet; cited 2022 July]. Available from: http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
[5] The Lymphoma Study Association (LYSA) and the Lymphoma Academic Research Organization (LYSARC) https://lymphoma-research-experts.org/

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