Roche Korea said Lunsumio (ingredient: mosunetuzumab), a CD20/CD3 bispecific antibody, has received approval from the Ministry of Food and Drug Safety to treat adult patients with recurrent or refractory follicular lymphoma (FL) who have undergone two or more systemic therapies.
Lunsumio is the first medicine that received approval after going through the regulator’s "Global Innovative Products on Fast Track (GIFT)" program.
The drug is the first-in-class CD20/CD3 T-cell engaging bispecific antibody for recurrent or refractory follicular lymphoma. It is designed to bind simultaneously to CD3, a protein on the surface of T cells, and CD20, a protein on the surface of malignant B cells, directing T cells to target B cells. Notably, the treatment can be administered on an outpatient basis without needing hospitalization. The treatment period is fixed at eight cycles, with the possibility to extend up to 17 cycles if complete remission is not achieved.
The government’s GIFT program facilitates the rapid commercialization of medicines intended to treat life-threatening serious diseases or rare diseases, especially those without existing treatments.
Lunsumio was designated as the first candidate of the GIFT program in November 2022, as a medication without existing treatment options.
FL is a type of non-Hodgkin lymphoma (NHL) that arises when cells in the lymph tissue turn malignant. Because the symptoms are mild and progress slowly, about 80 percent of cases are diagnosed in stage 3 or 4, after the disease has advanced, and the prognosis becomes worse with each recurrence.
While the median progression-free survival (mPFS) is 10.6 years for patients after first-line treatment, it drastically reduces to two years for patients after third-line treatment.
The MFDS approved the treatment based on the single-group, multicenter, central cohort expansion phase 2 study GO29781, which involved 90 adult patients with recurrent or refractory follicular lymphoma who had undergone at least two systemic therapies in 49 centers across seven countries, including Korea.
After eight cycles of Lunsumio treatment, with each cycle being 21 days, the primary endpoint of complete remission rate (CR) at the 18-month point reached 60 percent, and the secondary endpoint of overall response rate (ORR) reached 80 percent,
The median time to initial response after Lunsumio treatment was 1.4 months, and the median time to reach the first complete remission was three months, indicating a rapid response.
Also, despite 52.5 percent of all patients being those known to have a relatively poor prognosis because they relapsed within 24 months, 70 percent of the patients who achieved complete remission maintained the response for at least 18 months after treatment completion.
The duration of response also reached about two years, with a median progression-free survival of 17.9 months.
The most common treatment-related adverse reaction was cytokine release syndrome (CRS), which mostly presented at a mild level of grade 1-2 and lasted about three days during the initial cycle, resolving in all patients during the study period.
Other reported side effects included fatigue (36 percent), rash (34 percent), fever (24 percent), and headache (21 percent).
"FL is considered a benign lymphoma with a life expectancy reaching up to 20 years, but as the disease becomes more aggressive and the prognosis worsens with each recurrence, an effective treatment capable of providing a cure was urgently needed for patients who have experienced more than two relapses," said Professor Kim Won-seok of the Department of Hematology-Oncology at Samsung Medical Center.
Ted Lee, Roche Korea Medical Partnership Cluster Lead, said, "We are very pleased to provide an innovative new drug that can offer the dream of a cure to domestic follicular lymphoma patients who have failed several rounds of existing treatments with Lunsumio, the first CD20/CD3 bispecific antibody in the series."