New data show that Afinitor (everolimus) tablets significantly shrunk tumors in 33% of patients with relapsed non-Hodgkin’s lymphoma (NHL) and Hodgkin’s disease.
Based on results from this study and other early-stage research, Novartis has initiated a Phase III trial in the most common NHL, diffuse large B-cell lymphoma (DLBCL).
Non-Hodgkin’s lymphoma and Hodgkin’s disease, also known as Hodgkin’s lymphoma, refer to a variety of cancers affecting the immune system, such as DLBCL, mantle cell lymphoma and follicular lymphoma. Up to 60% of patients with aggressive types of NHL, including DLBCL, may be cured with appropriate therapy. However, NHL patients have a high risk of relapse after initial therapy and no treatments are currently available to reduce this risk.
The phase II open-label trial of 145 lymphoma patients was presented at the 14th annual European Hematology Association congress in Berlin, Germany. Results show that 33% of patients with relapsed NHL and Hodgkin’s disease treated with everolimus experienced a 50% or greater reduction in tumor size. This 33% overall response rate (ORR) is defined as complete or partial tumor shrinkage (95% confidence interval: 26-41%). The median time to disease progression for all 145 patients was 4.3 months (95% CI; 3.6-5.9 months) and the median duration of response for the 48 responders was 6.8 months (95% CI; 5.4-11.0 months). Nineteen responders remained progression free at 6 months.
“We continue to see the potential of Afinitor in multiple types of cancer,” said Alessandro Riva, MD, Executive Vice President, Global Head, Novartis Oncology Development.
“These latest data show an antitumor effect in lymphoma that support the rationale for a phase III study of Afinitor to prevent relapse in patients with diffuse large B-cell lymphoma, where there is a significant unmet medical need.”
Novartis has initiated PILLAR-2 (PIvotaL Lymphoma triAls of RAD001), a phase III trial investigating adjuvant treatment with everolimus (RAD001) in poor-risk patients with DLBCL who achieved complete remission with first-line rituximab combined with chemotherapy. This worldwide study will evaluate the potential of everolimus to extend disease-free survival in patients with DLBCL. The longer a patient with DLBCL is in remission the higher their likelihood to remain disease-free. There is no approved therapy for the approximately 50% of patients who will relapse after achieving a complete response on initial treatment, demonstrating an important unmet need.