An advisory committee for the European Medicines Agency has recommended the conditional approval of Roche‘s Polivy (polatuzumab vedotin) in combination with MabThera (rituximab) and bendamustine (a chemotherapy) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for a hematopoietic stem cell transplant.
The European Commission will now review the recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) before making a final decision.
“People with relapsed or refractory diffuse large B-cell lymphoma have limited treatment options — especially those who are not candidates for haematopoietic stem cell transplant,” Levi Garraway, Roche’s chief medical officer and head of global product development, said in a press release. “We are pleased the CHMP has recognised the potential of Polivy to provide a much needed new treatment option for patients with this aggressive disease.”
Polivy is an antibody-drug conjugate that targets the CD79b protein — a cell surface molecule found in most types of B-cell non-Hodgkin’s lymphoma. The binding of Polivy to CD79b is intended to kill these B-cells with a targeted approach to minimize the effects on healthy cells while boosting tumor cell death.
CHMP’s opinion is based on results from a global, open-label Phase 1b/2 clinical trial (NCT02257567), which assessed the safety, tolerability, and activity of Polivy in combination with rituximab (sold as Rituxan in the U.S.) and bendamustine (known as the BR combo) or Gazyva (obinutuzumab) in people with relapsed or refractory follicular or diffuse large B-cell lymphoma who were not eligible for a hematopoietic stem cell transplant.
In the Phase 2 part of the trial, in which 80 DLBCL patients were included, participants were randomized to receive Polivy in addition to BR, or BR alone for six 21-day cycles.
The primary outcome was complete response at the end of treatment (or the disappearance of all signs of cancer). Secondary outcomes included overall response rate (complete response and partial response, or significant reduction in the extent of cancer in the body). Exploratory outcomes included duration of response, progression-free survival, event-free survival, and overall survival.
Of the patients receiving Polivy in combination with BR, 40% showed a complete response at the end of treatment, compared with 17.5% of those who received the standard BR therapy alone.
Furthermore, the overall survival of patients who received Polivy plus BR was more than double that of patients who received BR alone (12.4 months vs. 4.7 months, respectively).
The most common side effects in patients receiving Polivy and BR were anemia, fatigue, diarrhea, nausea, low blood platelet count, low numbers of neutrophils (a type of white blood cell), and increased body temperature.
In June, the U.S. Food and Drug Administration granted accelerated approval to Polivy in combination with Rituxan and bendamustine for the treatment of relapsed or refractory DLBCL patients who had received at least two prior therapies.
Polivy was also designated a breakthrough therapy by the FDA and given PRIME, or priority medicines, designation by the European Medicines Agency in 2017 as a potential treatment of patients with relapsed or refractory DLBCL.