Roche’s Lunsumio and Columvi win approval in Korea

Offering hope for new lymphoma treatment options

Roche held a media session celebrating bispecific antibodies Lunsumio and Columvi on the 3rd.

Lunsumio and Columvi became available as the third-line treatment options… Response rates were confirmed in the clinical trials

Kim Seok Jin, professor of the Department of Hematology and Oncology at Samsung Medical Center.

 

Roche's Lunsumio and Columvi are the first bispecific antibodies for lymphoma treatment, showing effectiveness as a third-line treatment for patients with lymphoma.

 

These two drugs are highly regarded for their clinical advantages, as they have additional specific antigen-binding sites compared to monoclonal antibodies.

 

Roche Korea held a media session on the 3rd, celebrating the Korean approval of CD20/CD3 bispecific antibodies Lunsumio (mosunetuzumab-axgb) and Columvi (glofitamab).

 

Lunsumio is a CD20/CD3 T-cell engaging bispecific antibody that was initially indicated to treat relapsed or refractory diffuse large B cell lymphoma (DLBCL).

 

Lunsumio received approval from the Ministry of Food and Drug Safety (MFDS) as the first medicine to be listed as ‘Global Innovative products on Fast Track (GIFT)’ in October last year.

 

As a result, Lunsumio may be prescribed for the treatment of adult patients with relapsed or refractory DLBCL after at least two or more earlier systemic therapy.

 

Relapsed or refractory DLBCL, a type of non-Hodgkin lymphoma caused by malignant transformation of cells of lymphatic tissues, is associated with poor prognosis with recurrence.

 

As a result, there is a critical need for effective treatment options for relapsed patients.

 

Results from the Phase 2 GO29781 trials have demonstrated the effectiveness of Lunsumio in adult patients with relapsed or refractory DLBCL after at least two lines of previous systemic therapy.

 

Lunsumio has shown effectiveness with a primary endpoint of complete response (CR) rate of 60%, as assessed by the independent review committee.

 

The objective response rate (ORR) was 80%, and the estimated median duration of response rate (DOR) was 22.8 months.

 

In terms of safety measures, the most frequently reported adverse reaction associated with Lunsumio was cytokine-releasing syndrome, and the most frequent severe adverse reaction observed was a reduction in neutrophil counts.

 

Nine patients discontinued the treatment due to side effects of the medicine.

 

"Third-line treatment options for DLBCL are limited, with chemotherapy such as Mabthera being the primary option.

 

Chemotherapy yields a treatment effect of only 15%," Kim Seok Jin, professor of the Department of Hematology and Oncology at Samsung Medical Center, stated.

 

"Lunsumio has shown promising effectiveness in clinical trials and may become a valuable third-line treatment option." Columvi, confirmed effectiveness in DLBCL third-line treatments Columvi was approved in Korea on the 7th of last month as a treatment for patients with relapsed or refractory DLBCL after two or more lines of previous systemic therapy.

 

DLBCL is a disease in which B cells, a lymphocyte responsible for protecting the body, either grow or replicate uncontrollably.

 

DLBCL can have a poor prognosis after multiple treatment regimens because of the fast progression of the disease.

 

However, the third-line treatment options are currently limiting for the patients who failed first- and second-line treatment regimens.

 

Columvi has demonstrated effectiveness in the Phase1/Phase2 NP30179 clinical trials enrolling 155 patients with relapsed or refractory DLBCL after two or more lines of previous systemic therapy.

 

The clinical outcome has shown that Columvi recorded CR of 40% and ORR of 81%.

 

The effect was consistent in the sub-group analysis.

 

The most frequently reported side effect was cytokine releasing syndrome.

 

Columvi is anticipated to be a valuable third-line treatment options for patients with DLBCL, alongside Kymriah, a Chimeric Antigen Receptor (CAR)-T Cell therapy.

 

“CAR-T treatment and bispecific antibody may complement each other.

 

Patients can start with Kymriah, a CAR-T therapy, in third-line treatment, or they can begin with Columnvi,” the professor Kim stated.

 

“I believe the treatment choice may vary depending on individual patient’s characteristics and the progression of the disease.”