The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Roche’s Polivy (polatuzumab vedotin) in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL).
Polivy plus R-CHP is the first treatment regimen to significantly improve outcomes in this disease in more than 20 years. A final decision regarding the approval of this Polivy combination is expected from the European Commission in the near future, Roche said in its press release.
DLBCL is the most common form of non-Hodgkin lymphoma and it is estimated 40,000 people in Europe are diagnosed with the disease each year. Approximately four out of ten patients will relapse after first line treatment and the majority of patients who require subsequent lines of therapy have poor outcomes.
“A significant proportion of people newly diagnosed with diffuse large B-cell lymphoma, an aggressive form of blood cancer, do not respond adequately to existing therapies,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Therefore, more treatment options are needed that could increase a person’s chance of cure, and we look forward to bringing this new Polivy combination to people with DLBCL as soon as possible.”
The company explained that the CHMP opinion was based on efficacy and safety data from the phase III POLARIX study (GO39942), comparing Polivy in combination with chemotherapy regimen R-CHP versus the standard of care MabThera plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in treatment of first-line DLBCL. The study showed significantly higher progression-free survival (PFS) versus R-CHOP after a median follow-up of 28.2 months (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57–0.95; P<0.02). PFS is a clinically meaningful disease-related outcome for people with previously untreated DLBCL and represents a goal of first-line therapy: decreasing the risk of disease worsening. The safety profile was comparable for Polivy plus R-CHP versus R-CHOP, including rates of grade 3-4 adverse events (AEs; 57.7% versus 57.5%), serious AEs (34.0% versus 30.6%), grade 5 AEs (3.0% versus 2.3%), and AEs leading to dose reduction (9.2% versus 13.0%), respectively. Results were presented for the first time in December 2021 at the 63rd American Society of Hematology Annual Meeting & Exposition and simultaneously published in the New England Journal of Medicine.
Once approved, Polivy’s conditional marketing authorisation in the EU in combination with bendamustine plus MabThera, for the treatment of adult patients with relapsed or refractory DLBCL who are not candidates for a haematopoietic stem cell transplant will be converted to a full approval.