Recently, the United States Food and Drug Administration announced the accelerated approval of the antibody-conjugate drug (ADC) Polivy (polatuzumab vedotin-piiq) for the treatment of refractory adult patients with diffuse large B-cell lymphoma in combination with bendamustine and rituximab. FDA points out that this is also the first chemoimmunotherapy for the disease.
Diffuse large B-cell lymphoma abbreviated as DLBCL, is the most common non-Hodgkin’s lymphoma. It is estimated that the number of new DLBCL cases in the United States exceeds 18000 each year. Although the condition of many patients can be effectively controlled after initial treatment, 30% to 40% of patients will eventually have a recurrence.
Polivy, which was accelerated recently, is an antibody-drug conjugate (ADC) that targets a specific CD79b protein on the surface of B cells at one end and chemotherapeutic drugs at the other end. According to the assumption, when it binds specifically and enters the B cell, it will release the chemotherapeutic drugs and kill the cells, thus controlling the cancer condition.
In a phase 1b/2 clinical trial, the efficacy of Polivy was verified. The trial evaluated 80 patients with recurrent or refractory DLBCL who were randomly divided into two groups: one group received standard bendamustine and rituximab, and the other group received additional Polivy. The results showed that in the standard treatment group, the complete remission rate was 18%. In the Polivy treatment group, the number reached 40%, more than doubled! In addition, 64% of patients who achieved partial or complete remission in the Polivy treatment group had remission lasting more than half a year and nearly half in more than a year (48%).
Based on these excellent results, the FDA of the United States accelerated the approval of Polivy in combination with standard therapy for the treatment of these refractory lymphoma patients. Previously, it was awarded breakthrough therapy recognition, priority review, and orphan drug qualification by the FDA in the United States.
“Antibody-drug conjugates are a new type of cancer targeted therapy. Unlike traditional chemotherapy, it can target specific cells,” said Dr. Richard Pazdur of the FDA Drug Evaluation and Research Center. “The Polivy approved today brings new treatments to patients who have received multiple rounds of treatment but have not worked.”
“Although there has been significant progress in the treatment of DLBCL when the disease has developed drug resistance or recurrence after multiple rounds of treatment, the treatment options for patients are very limited,” commented Dr. Sandra Horning, Chief Medical Officer and head of Global Product Development at Genentech. “Today’s approval of Polivy combination therapy will lead to new treatments for the immediate benefit of those who need it.”