Polivy makes 3rd bid for reimbursement…DREC review imminent

Failed 2 previous reimbursement attempts, including its use as third-line therapy.

Roche submits additional follow-up analysis from the POLARIX study.

Attention is focused on whether Polivy, the first new first-line treatment for diffuse large B-cell lymphoma (DLBCL) in 20 years, will succeed on its third attempt to obtain reimbursement listing in Korea.

According to industry sources, Roche Korea's Polivy (polatuzumab vedotin), a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), is expected to be submitted to the Health Insurance Review and Assessement Service's Drug Reimbursement Evaluation Committee next month (April).

It remains to be seen whether progress can be made approximately 8 months after passing the Cancer Disease Deliberation Committee last July.

Originally, Polivy sought reimbursement in 2021 for its first approved indication as a third-line therapy, in combination with the BR regimen (bendamustine + rituximab), but the application failed to pass CDDC review at that time.

Later, in the first half of 2023, Roche submitted a reimbursement application for first-line therapy using Polivy in combination with R-CHOP therapy (rituximab, cyclophosphamide, doxorubicin, and prednisone). However, this application also failed to pass the Cancer Disease Deliberation Committee in February 2024.

Expectations are high for Polivy's latest reimbursement attempt. Roche has submitted additional follow-up analysis results with a 60.9-month follow-up period from the POLARIX study, which evaluated the effectiveness of Polivy in combination with Pola-R-CHP as a first-line treatment for DLBCL.

The study, presented at the American Society of Hematology (ASH 2024) annual meeting, has been regarded as the first clinical trial in 20 years to expand the standard first-line treatment for DLBCL. Key results show patients receiving Polivy combination therapy demonstrated a clear improvement in overall survival (OS) compared with those treated with the existing standard therapy, R-CHOP.

The lymphoma-related mortality rate was 9.0% in the Polivy combination therapy group and 11.4% in the R-CHOP control group. At approximately 5 years after treatment initiation, the mortality risk in the Polivy combination therapy group decreased by 15%, an improvement over the previous 3-year follow-up result (6% risk reduction).

In addition, patients receiving the Polivy combination therapy (38.7%) required follow-up treatments (radiation therapy, systemic chemotherapy, or CAR-T cell therapy) about 25% less frequently than those in the R-CHOP control group (61.7%).

Meanwhile, diffuse large B-cell lymphoma (DLBCL) is an aggressive type of blood cancer and the most common form of non-Hodgkin lymphoma. In South Korea, the number of new patients diagnosed with DLBCL is estimated to reach 5,000 each year.

Accounting for the highest proportion of non-Hodgkin lymphomas, diffuse large B-cell lymphoma is an aggressive lymphoma requiring immediate treatment due to its rapid progression. Although more than half of patients respond well to treatment and achieve remission, 30–40% of patients either fail to respond to the standard therapy R-CHOP or experience relapse after first-line treatment.

Despite the fact that most patients experience relapse within two years and that survival is only about six months upon relapse, making it a highly lethal disease, relapsed/refractory diffuse large B-cell lymphoma remains an area with limited effective treatment options.