Novartis Korea, the world’s first CAR-T treatment2, is a customized anti-cancer drug for recurrent and refractory diffuse large B-cell lymphoma (DLBCL) and B-cell acute lymphocytic leukemia (pALL) under 25 years of age. On the 5th, it was revealed that the ingredient name Tisagen Lexucel)’ received domestic approval.
Kimlia’s licensed indications are relapsed or refractory DLBCL with a history of treatment with two or more systemic therapies, and relapsed or second or more relapsed or refractory after transplantation in adult patients and children and young adult patients under 25 years of age. It can be used as ALL treatment.
Kimlia is an anticancer drug that is genetically recombined so that a chimeric antigen receptor (CAR) that recognizes a specific antigen of cancer cells can be expressed on the surface of T cells collected from a patient and then injected into the patient’s body. It is an anticancer drug that possesses all the characteristics of cell, gene, and immunotherapy, and it leads to complete remission in terminal-stage blood cancer patients who do not have other treatment options with only one treatment, and shows a 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.
In the JULIET study of adult relapsed and refractory DLBCL patients, the overall response rate (ORR) at 3 months of administration was 53% (NE, 95% CI, 10.02-NE), and 39.1% (NE, 95% CI, NE) to complete remission (CR). At 2 years of administration, the progression-free survival rate (PFS) was 33%.
In addition, according to the ELIANA study of children with relapsed and refractory ALL, 82% (95% CI, 72%-90%) of patients within 3 months of administration showed complete remission or complete remission (CRi) with incomplete blood level recovery. ), and 98% of the patients who reached remission were negative for microscopic residual disease (MRD). At 6 months, the event-free survival rate (EFS) was 73% (95% CI, 60%-82%).
Both clinical studies demonstrated clinical efficacy, and the median duration of response (mDOR) and median overall survival (mOS) were not reached. This disproves that the patients who responded continued to be effective after Kimlia treatment.
At the same time as this approval, Kimlia became the first treatment of the Advanced Regenerative Bio Act, which was implemented in 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 who are only 6 months old, a single treatment can reach complete remission and increase the survival rate. “Kimria not only improves the survival period, but also reduces patient visits to the hospital with one treatment. It is also of great significance in that it helps patients and other family members return to their daily lives.”
“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 at Severance Hospital. He has maintained a state of complete remission for 8 years and has been leading a normal daily life while attending school. “It is extremely rare for patients with relapsed and refractory ALL in Korea, but this small number of young patients who occur every year are as fast as they struggle for their lives. “We 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,” he said.
He added, “We will actively cooperate with government agencies and do our best to improve patient access quickly so that patients who are in urgent need of a day with a lifespan of 6 months 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.