Novartis Korea (CEO Josh Benugopal) announced that the world’s first CAR-T treatment, Kimria (Tisagen Rexel), was approved in Korea on March 5.
Indications are relapsed refractory ▲Diffuse Large B Cell Lymphoma (DLBCL, Diffuse Large B Cell Lymphoma) and ▲B-cell Acute Lymphoblastic Leukemia (PALL, pediatric Acute Lymphoblastic Leukemia) under 25 years of age).
Kimlia is a method of genetically recombining the T cells collected from the patient so that a chimeric antigen receptor (hereinafter referred to as CAR, Chimeric Antigen Receptor) that recognizes a specific antigen of cancer cells can be expressed on the surface of the patient and then injected into the patient’s body It is a customized anticancer drug.
It is an anticancer drug that has all of the characteristics of cell, gene, and immunotherapy. It leads to complete remission of terminal-stage blood cancer patients who do not have other treatment options with only one treatment, and shows continuous response.
Most of DLBCL and ALL are treated with standard chemotherapy, but a small number of patients do not respond to treatment or experience recurrence.
Among relapsed and refractory patients, the life expectancy is only about 6 months when secondary treatment such as hematopoietic stem cell transplantation fails.
Kimlia is a new anticancer drug that can expect long-term survival as well as return to daily life for patients with relapsed and refractory DLBCL and pALL who no longer have treatment options.
The approval was based on the results of the Phase 2 clinical trials’JULIET’ and’ELIANA’ conducted by Novartis in collaboration with the University of Pennsylvania.
Kimlia’s approved indications are relapsed or refractory DLBCL with a history of treatment with two or more systemic therapies, and relapsed or secondary relapsed or refractory after transplantation in adult patients and children and young adult patients under 25 It’s ALL’s treatment.
In the’JULIET’ study of adult relapsed and refractory DLBCL patients based on authorization, the overall response rate (ORR, Overall Response Rate) at the 3rd month of administration was 53% (NE, 95% CI, 10.02-NE). , Complete remission (CR) was achieved in 39.1% (NE, 95% CI, NE). At 2 years of administration, the progression-free survival (PFS) was 33%.
In addition, as a result of the’ELIANA’ study of children with relapsed and refractory ALL patients, 82% (95% CI, 72%-90%) of patients within 3 months of administration showed complete remission (CR) or incomplete blood. Complete Remission with incomplete blood count recovery (CRi) was achieved, and 98% of patients who reached remission were negative for minimal residual disease (MRD).
At 6 months, the event-free survival (EFS) was 73% (95% CI, 60%-82%).
Clinical efficacy was demonstrated in both clinical studies, and the median duration of response (mDOR) and median overall survival (mOS) were not reached.
According to the management’s explanation, this disproves that the patients who responded continue to have the effect after Kimlia treatment.
At the same time as this approval, Kimlia became the first treatment of the Advanced Regenerative Bio Act (hereinafter referred to as the Cheomba Act), which was implemented since August to strengthen and support the quality and safety management of biopharmaceuticals.
Kimria is customized for one patient through a safe system secured through training and certification of professional personnel and medical institutions in each country of introduction, and a specialized process of manufacturing plants.
Unlike existing pharmaceuticals, it undergoes an advanced one-person customized process, which is a high-tech biopharmaceutical that is manufactured by accommodating the process of ▲cell collection ▲frozen preservation and transport ▲personalized CAR-T cell manufacturing ▲injection back to the patient.
Professor Seongsu Yoon of the Department of Hematology and Oncology at Seoul National University Hospital said, “Kimria is an innovative one-person customized treatment with a new mechanism that has not been in the history of anticancer drugs and a one-shot treatment that ends with one treatment. For patients with relapsed and refractory DLBCL whose life expectancy is only 3 to 6 months, complete remission can be achieved with only one treatment and the survival rate can be increased. It is also of great significance in that it helps patients and other family members return to their daily lives by reducing visits to the hospital.”
“Kimria is a miracle treatment that can bring a new life to young ALL patients who were on the verge of death,” said Professor Yoo Chul-ju of the Department of Pediatric Hematologic Oncology, Yonsei University Severance Hospital. After the treatment, he has maintained a complete remission for 8 years and has been living a normal daily life while attending school. “It is extremely rare for patients with relapsed/refractory ALL in Korea, but these few young patients who occur every year struggle for their lives. “I look forward to seeing similar cases in Korea as the government, pharmaceutical companies, and the medical community work together to create an environment where Kimlia can be treated as quickly as possible.”
Shin Soo-hee, head of the anticancer drug division, Novartis Korea, said, “Novatis Korea is very encouraging that Kimria, an innovative CAR-T treatment, can be used for domestic relapsed and refractory DLBCL and pALL patients as the No. 1 treatment of the Cheomba method with domestic approval.” After introduction, we plan to complete the setting of a treatment center in close cooperation with related institutions such as hospitals to enable CAR-T treatment as quickly as possible.”
In addition, he said, “We will actively cooperate with government agencies and do our best to improve patient accessibility so that patients who are in urgent need of a day with 6 months of life can receive Kimlia treatment.”
Meanwhile, Kimlia has been approved by the US Food and Drug Administration (FDA) for the first time in the world in August 2017, and has been used in 28 countries including Canada, Switzerland, Japan, Australia, and Germany, including Korea.
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