‘Access to bispecific antibody Columvi should be improved’

“Based on the clinical value it demonstrated”

Dr. Chris Fox, Professor of Haematology at the University of Nottingham, U.K.

Achieved 40% complete response in clinical trials...effective even in relapsed patients

Aims to receive reimbursement in Korea...secured "18-month follow-up data.”

Dr.

 

Chris Fox, Professor of Haematology at the University of Nottingham, U.K.

“Diffuse large B-cell lymphoma (DLBCL) is a disease in which one in four patients experience relapse even after treatment.

 

The bispecific antibody Columvi has demonstrated efficacy in relapsed patients at up to 18 months of follow-up.

 

The clinical performance of Columvi is not just an incremental improvement over existing therapies, but a paradigm shift in the DLBCL treatment environment.” At a recent meeting with Dailypharm, Dr.

 

Chris Fox, Professor of Haematology at the University of Nottingham, U.K., recently described so about Columbo, a bispecific antibody approved for diffuse large B-cell lymphoma in Korea.

 

DLBCL is a disease in which the body's protective “B cells” grow or multiply uncontrollably and is the most common form of non-Hodgkin's lymphoma that accounts for about 40% of all non-Hodgkin's lymphomas.

 

The disease is characterized by aggressive, rapidly progressive staging.

 

The number of DLBCL patients in Korea was 14,183 as of last year, a 36% increase from the 10,428 in 2018.

 

Up to 15% of DLBCL patients fail first-line standard therapy, and 25% of patients experience relapse within 18 months despite achieving a complete response (CR).

 

Patients with relapsed or refractory DLBCL show a characteristically rapidly worsening prognosis as the number of treatment cycles increases.

 

Columvi, the first bispecific antibody targeting CD20XCD3 enters the market...offers the advantage of a fixed dosing period The good news is that a variety of new drugs have emerged for this disease.

 

Roche's Polivy, a representative DLBCL drug, is said to be effective in about two-thirds of patients when used as a first-line treatment.

 

However, this means that about one-third of patients who do not respond to first-line treatment remain in need of further options.

 

Bispecific antibodies and chimeric antigen receptor T-cell (CAR-T) therapy, such as Columvi, are used in such cases of relapse.

 

Columvi, the first bispecific antibody to target CD20xCD3 in DLBCL, was launched without reimbursement in Korea in May and is now on the formulary of more than 10 general hospitals.

 

The drug has a 2:1 structure that binds to two CD20 regions on the surface of malignant B cells and one CD3 region on immune T cells, resulting in a stronger binding.

 

Bispecific antibodies have two targets, each targeting a different cell: one that draws immune T cells closer to malignant B cells and the other that activates the T cells to kill the malignant B cells.

 

Based on this mechanism of action, bispecific antibodies have been shown to be effective in patients who are resistant to conventional antibody therapies or chemotherapy.

 

“Bispecific antibodies and CAR-T therapies have been explored as treatment options for DLBCL, but without head-to-head trials, it is difficult to say which is better.

 

The choice of treatment should be based on the individual patient's state of disease progression.

 

However, one of the side effects of CAR-T in elderly patients, immune effector cell-associated neurotoxicity syndrome (ICANS), is considered when selecting a treatment,” said Dr.

 

Fox.

 

He added, “Columvi has a fixed dosing period.

 

It is designed to be administered for up to 12 cycles (8.3 months), so there is a clear end date for the treatment.

 

It also has the advantage of being an off-the-shelf treatment that can be administered to patients immediately.” Columvi achieves 39% CR rate - still effective after 18 months...“justifies the need for its reimbursement” Columvi demonstrated efficacy in the multicenter, open-label Phase I/II NP30179 trial in patients with relapsed or refractory DLBCL after two or more prior systemic therapies.

 

Trial results showed that Columvi achieved a complete response (CR) of 40% and an overall response rate (ORR) of 52%.

 

Among patients who achieved CR, the median duration of response was 26.9 months, with 67% of patients maintaining CR at 18 months.

 

The study also included about one-third of patients who had received prior CAR-T therapy.

 

“Columvi demonstrated a 40% CR rate in the trial, even in patients who are difficult to treat,” said Dr.

 

Fox.

 

This data alone confirms the efficacy of Columvi, as such data cannot be expected with existing standard treatment options, and Columvi is showing similar results in the real world to the clinical trial,” said Dr.

 

Fox.

 

“In DLBCL, relapse typically occurs within 12 to 18 months, and staging progresses rapidly in relapsed patients.

 

We already have data on Columvi’s use in these patients up to 18 months of follow-up.

 

So we can be confident about Columvi’s efficacy data and maintenance of its effect.” However, Columvi’s reimbursement was rejected in July by the Cancer Disease Review Committee, the first gateway to reimbursement in Korea, due to the lack of long-term data.

 

Roche Korea is aiming to reapply for Columvi’s CDDC review later this year.

 

“Patient access to Columvi has been secured in the UK with reimbursement approval,” said Dr.

 

Fox.

 

“This is because the health authorities have recognized Columvi as an effective treatment in DLBCL.” “Columvi is not just an improvement over existing therapies, but a paradigm-shifting treatment for DLBCL.

 

I want to emphasize that this is a treatment that could have an impact on prolonging the survival of patients with relapsed or refractory DLBCL.”