The European Commission has conditionally approved Roche’s Polivy (polatuzumab vedotin), in combination with rituximab and bendamustine, to treat people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for a hematopoietic (blood) stem cell transplant (HSCT).
Conditional approval is granted to therapies with the potential to fulfill an unmet medical need in serious or life-threatening diseases, where the benefit of immediate availability outweighs potential risks associated with less comprehensive clinical data than normally required.
“With this approval, people in the EU with relapsed or refractory diffuse large B-cell lymphoma will have the opportunity to benefit from this new Polivy combination,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said in a press release.
“For patients battling this aggressive disease, the prognosis is poor, and few treatments are available. We are proud to bring this first-in-class treatment option to those who need it most,” he added.
The decision was supported by a recent recommendation for conditional approval given by the Committee for Medicinal Products for Human Use, an arm of the European Medicines Agency (EMA) that evaluates medicines being considered for commercial use in the EU.
It also follows the similar accelerated approval given to this Polivy combination by the U.S. Food and Drug Administration in June 2019. The FDA’s decision supported its use in relapsed or refractory DLBCL patients who failed to respond to at least two prior therapies.
Polivy is an antibody-drug conjugate that targets CD79b — a protein found on the surface of most immune B-cells involved in certain types of non-Hodgkin’s lymphoma. After binding to CD79b, Polivy releases a toxic substance into cells, killing them.
This targeted approach is intended to minimize damage to healthy cells while boosting tumor cell death.
The conditional approval was based on data from a global, open-label Phase 1b/2 clinical trial (NCT02257567) showing that adding Polivy to standard chemoimmunotherapy with bendamustine plus rituximab (BR combo) was superior to the BR combo alone in DLBCL patients.
The study evaluated the safety and effectiveness of Polivy in combination with the BR combo, or with bendamustine and Gazyva (obinutuzumab), in pre-treated patients with DLBCL or follicular lymphoma who were not eligible for a HSCT.
In the Phase 2 part of this trial, which included 80 DLBCL patients, participants were randomly assigned to either Polivy plus the BR combo or the BR combo alone for six, 21-day cycles.
This part’s main goal was to assess the percentage of patients achieving a complete response (tumor eradication) at the end of treatment. Secondary goals included overall response rate — the proportion of complete and partial responses, or a significant reduction in cancer extension or tumor size — duration of responses, and several measures of survival.
Results from these DLBCL patients showed that 40% of those treated with Polivy plus BR combo achieved a complete response, compared with 17.5% on the BR combo alone.
Compared with standard therapy, the Polivy triple combination also more than doubled the duration of patients’ responses (10.3 months vs. 4.1 months) and extended their lives by more than two-fold (12.4 months vs. 4.7 months).
The most common adverse events reported by people using Polivy were anemia, low blood platelet count, low numbers of neutrophils (a type of white blood cell), fatigue, diarrhea, nausea, and fever.
Polivy was previously given a priority medicines, or PRIME, designation from the EMA, and a breakthrough therapy designation from the FDA as a potential treatment for relapsed or refractory DLBCL. It was also designated an orphan drug by both regulatory agencies for the same patient group.
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