Pfizer has announced positive phase 3 data for its antibody-drug conjugate, Adcetris (brentuximab vedotin), in combination with lenalidomide and rituximab for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Currently the most common form of lymphoma, DLBCL is a fast-growing, aggressive blood cancer that affects more than 25,000 people in the US every year.
Approximately 40% of patients living with DLBCL do not respond to initial treatment or develop relapsed disease after first-line treatment.
Involving 230 patients recruited across North America, Europe and Asia-Pacific, the ongoing, randomised, double-blind phase 3 ECHELON-3 study is evaluating the Adcetris combination versus lenalidomide and rituximab plus placebo in adult patients with relapsed or refractory DLBCL.
Results from the trial showed that the Adcetris combination demonstrated a statistically significant and clinically meaningful improvement in overall survival in comparison to lenalidomide and rituximab plus placebo.
In addition, the study met its key secondary endpoints, including progressive free survival and overall response rate, and the safety and tolerability of Adcetris were consistent with previous results for patients with relapsed or refractory DLBCL in clinical trials.
The company intends to share data from the ECHELON-3 trial with the US Food and Drug Administration to potentially support regulatory filings in the US.
Roger Dansey, chief development officer, oncology, Pfizer, commented: “This is the third phase 3 study in a type of lymphoma to demonstrate an overall survival benefit for an Adcetris combination.
“Based on the strong results from ECHELON-3,… Adcetris could address an area of high unmet need in patients with relapsed or refractory DLBCL, irrespective of CD30 expression.”
Currently, Adcetris is already a standard of care for patients living with certain lymphomas. It is approved for seven indications in the US, including relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma.
Since receiving its first US approval in 2011, more than 55,000 patients have received treatment with Adcetris and more than 140,000 patients have been treated with Adcetris worldwide.
Most recently, Pfizer’s once-daily S1P receptor modulator Velsipity (etrasimod) received approval by the Medicines and Healthcare products Regulatory Agency to treat moderate-to-severely active ulcerative colitis.