[약업신문]Takeda oral myeloma treatment Ninra, insurance benefits from March

As a second-line treatment option for multiple myeloma, oral three-drug therapy is expected to be in full swing.

As insurance coverage for the multiple myeloma treatment’Ninraro®’ (ingredient name ixazomib citrate) begins in March, oral three-drug therapy is expected to become a full-fledged second-line treatment option for multiple myeloma in Korea.

Takeda Pharmaceutical Korea (CEO Hee-Seok Moon) held an online press conference on the 26th to commemorate the application of insurance benefits for the oral multiple myeloma treatment’Ninraro®’ (ingredient name ixazomib citrate).

NINRARO® is the first oral proteasome inhibitor (PI) for the treatment of multiple myeloma, and is used as a combination therapy with lenalidomide and dexamethasone among patients with multiple myeloma who have failed the previous treatment since March 1. If so, insurance benefits are applied.

At the conference on this day, Professor Deok-Hyun Yoon of the Department of Oncology at Asan Medical Center, Seoul, served as the first speaker and gave a lecture on the theme of’The Latest Knowledge of Relapse and Refractory Multiple Myeloma Treatment.

Professor Deokhyun Yoon▲ Professor Deokhyun Yoon

Professor Yoon Deok-Hyun said, “The number of patients with multiple myeloma with many elderly patients and frequent recurrence will gradually increase as the population ages, and the socio-economic burden will increase.” “In the treatment of relapsed and refractory multiple myeloma patients, the disease progresses for a long time. “A treatment strategy that keeps you from avoiding it is important, and one of the factors to consider for this is patient compliance.”

Prof. Yoon said, “The combination therapy of three drugs through ixazomib is a treatment option that lowers the patient’s treatment burden for outpatient and administration time and enhances the convenience of taking medication. It was previously stated in the National Cancer Network (NCCN) guidelines (ver4. 2021). “Category 1, preferred for patients with multiple myeloma who have received more than one treatment.”

NINRARO® has confirmed its efficacy and safety profile in the’TOURMALINE-MM1′ study conducted in 722 adult patients with relapsed or refractory multiple myeloma. As a result of the study, NINRARO® extended the median progression-free survival time (mPFS) by about 6 months compared to the placebo group when coadministered with’lenalidomide + dexamethasone’ (median PFS: 20.6 months in the NINRARO® group vs. 14.7 months in the placebo group). Months, HR=0.74, p=0.01)

Professor Ki-Hyun Kim of the Department of Hematology and Oncology at Samsung Medical Center, who was in charge of the second presentation, explained’the clinical value of NINRARO® confirmed through the results of major clinical trials and retrospective Real-World Evidence’.

Professor Kihyun Kim▲ Professor Kihyun Kim

Professor Kihyun Kim said, “Since there are many patients with comorbid diseases in the elderly, multiple myeloma is often different from the results of clinical trials conducted in a controlled environment and treatment results in an actual treatment environment, so the results of retrospective real world observations are important. I said.

Professor Kim said, “Ninraro® combination therapy (IRd) not only extended the progression-free survival (PFS) by about 40% compared to the placebo group in a clinical study in patients with relapsed or refractory multiple myeloma, but also A directed real-world observational study also showed significantly longer TTNT than the carfilzomib (KRd) and bortezomib (VRd)-treated groups in the second and third-line chemotherapy, confirming that it is an effective treatment option at the early stage of chemotherapy. I said.

He added, “I am looking forward to seeing a consistent effect and safety profile in real world data in Korea if the use of NINRARO® increases according to the benefits of salary.”

NINRARO® combination therapy (IRd) is a retrospective real-world observational study conducted in a real medical setting in the U.S. in a longer TTNT (TTNT: time to next therapy) compared to the carfilzomib 3-drug and bortezomib 3-dose combination therapy group. , The proxy scale for PFS in real world analysis) was confirmed. (Median TTNT when administered with NINRARO®, carfilzomib, and bortezomib in the 2nd and 3rd treatment, respectively: 16.8 months in the Ninraro® group vs. 9.5 months in the carfilzomib (KRd) group, 14.6 months in the bortezomib (VRd) group )

Hee-Seok Moon, CEO of Takeda Pharmaceutical Korea, said, “I am pleased to add a major treatment option that can dramatically change the treatment pattern of patients with relapsed and refractory multiple myeloma in Korea through the application of NINRARO® insurance benefits.” “As a combination of oral three-drug therapy with improved medication convenience has become possible, I hope that patients can continue their daily life with steady and active treatment during the treatment period.”

Meanwhile, NINRARO®, approved in Korea in 2017, can be taken orally once a week, three times a month after visiting a hospital about once a month (28 days per cycle).

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