2023-04-19| Trials & Approvals

Roche Could Set New DLBCL Treatment Standard with First-Line Polivy Indication

by Reed Slater
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After gaining accelerated approval to treat diffuse large B-cell lymphoma (DLBCL) in 2019, Roche’s anti-CD79b antibody-drug conjugate, Polivy, received FDA approval to treat the condition alongside other industry standards, Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP). The approval could represent the most significant development in first-line DLBCL treatment in nearly twenty years, potentially overriding the current standard, R-CHOP.

Related Article: Kite’s Yescarta Yields a Success in a Phase 3 Trial for Treating Large B-Cell Lymphoma

Polivy’s Potential Benefit to DLBCL Patients

DLBCL is aggressive, fast-growing, and the most common type of non-Hodgkin lymphoma. More than 30,000 people in the U.S. will likely receive a DLBCL diagnosis in 2023. 

According to Roche, the current treatment standard, Rituxan plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), leaves room for improvements in the DLBCL treatment space. The company claims that up to 40% of patients initially treated with R-CHOP may not respond or relapse after treatment. 

With the lack of improvement in the DLBCL area in mind, Roche worked hard to get Polivy approved on the traditional track to bring the therapy to previously untreated DLBCL patients. In the Phase 3 Polarix trial, Polivy, in combination with R-CHP, reduced the risk of disease progression, relapse, or death by 27% compared to R-CHOP.

Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche, said, “It has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma. Today’s decision from the FDA to approve Polivy in combination with R-CHP in this setting brings a much-needed new treatment option which may improve outcomes and bring other benefits to many patients with this aggressive lymphoma.”

Overcoming the FDA’s Reservations

Despite Polivy’s apparent benefit as a first-line treatment for DLBCL, the FDA had some serious concerns just before approving the drug for its current indication. In March, the regulatory agency released briefing documents outlining some of the worries before a group of experts met to discuss the drug’s future. 

The four main concerns were Polivy’s modest progression-free survival (PFS) benefit, overall survival results, other efficacy endpoints, and the heterogeneity of the trial population. Polivy’s PFS rates, in combination with R-CHP, settled around the same as R-CHOP’s average PFS rates, if not a little bit better, albeit in a much smaller population and shorter timeframe. 

Additionally, the Polarix trial consisted of mostly DLBCL NOS (not otherwise specified) patients, with only a handful with different diagnoses like high-grade B-cell lymphoma. Still, despite the concerns, the FDA Oncologic Drugs Advisory Committee (ODAC) voted 11 to two in favor of Polivy in combination with R-CHP for untreated DLBCL.

Over 70 countries worldwide have approved Polivy in combination with R-CHP for untreated DLBCL, representing a massive shift in the preferred treatment regimen for the cancer type. Roche is also looking to leverage Polivy in other areas, with two other Phase 3 trials underway studying the therapy in combination with other drugs like Lunsumio and MabThera/Rituxan. 

The FDA’s decision to approve Polivy in combination with R-CHP to treat DLBCL as a first-line therapy is a serious notch in the win column for Roche. It is a significant achievement for the company, underscores the massive developments in biotechnology, and provides a ray of hope for the industry’s future and its potential to impact societies around the world positively. 

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