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“Xpovio, the only hope for patients with multiple myeloma who have exhausted all treatments”
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“Xpovio, the only hope for patients with multiple myeloma who have exhausted all treatments”
  • Jaehoon SongㆍHyeokgi Lee, Newsmp
  • 승인 2023.02.07 17:21
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Permission to treat 5th or higher… 26% response rate in patients who do not comply with all other medications

[Newsmp] A conference was held to highlight the clinical value of Korea’s first XPO1 inhibitor, Xpovio (ingredient: Selinexor).

Antengene Korea (general manager Kim Min-Young) invited Professor Ajai Chari at Mount Sinai Hospital to hold a media session at GLAD Gangnam COEX Center in Seoul and presented the status of multiple myeloma and phase 2b STORM study, which is the basis for Xpovio’s mechanisms and approval.

▲ Antengene Korea (general manager Kim Min-Young) invited Professor Ajai Chari at Mount Sinai Hospital to hold a media session at GLAD Gangnam COEX Center in Seoul and presented the status of multiple myeloma and phase 2b STORM study, which is the basis for Xpovio’s mechanisms and approval. Antegene Korea General Manager Kim Min-Young.
▲ Antengene Korea (general manager Kim Min-Young) invited Professor Ajai Chari at Mount Sinai Hospital to hold a media session at GLAD Gangnam COEX Center in Seoul and presented the status of multiple myeloma and phase 2b STORM study, which is the basis for Xpovio’s mechanisms and approval. Antegene Korea General Manager Kim Min-Young.

Xpovio’s new mechanism of action which is based on the selective inhibition of the nuclear export protein XPO1 prevents the proliferation of multiple myeloma.

In Korea, Xpovio was approved in July 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody; and as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment, and designated as an orphan drug in October last year (2022).

Xpovio's multiple myeloma-related indications were based on STORM Part 2 clinical trial.

In Part 2 of STORM, treatment efficacy and safety were assessed in patients with multiple myeloma with refractory in bortezomib, carfilzomib, lenalidomide, pomalidomide, daratumumab, glucocorticoid, and alkylating agent, and at least one proteasome inhibitor and one immunomodulatory agent progressed following their most recent therapy.

In other words, they were patients who desperately needed a new treatment because of a recurrence despite using all currently available treatments.

In particular, patients who had received a median of seven previous regimens were cytogenetically high-risk patients, and it was difficult to expect further drug treatment effects.

Nevertheless, Xpovio was worth expecting as it is a novel type of drug that is different from previous treatments.

In STORM Part 2, a total of 122 patients received XPOVIO 80mg orally in combination with dexamethasone 20mg orally.

The findings were encouraging. Despite the fact that all of the patients were refractory to existing treatments in the seven treatment histories, the combined treatment with Xpovio and dexamethasone resulted in a partial response (PR) of 26%, including stringent complete response (sCR) in 2 patients.

Patients with a minimal response or higher were 39%, duration of response (DoR) was 4.4 months, progression-free survival (PFS) was 3.7 months, and median overall survival (OS) was 8.6 months.

Professor Ajai Chari explained that these results are quite encouraging, even though these patients have a long history of treatment and have exhausted almost all available treatments.

The adverse events observed included fatigue, nausea, decreased appetite, low platelet counts, anemia and low white blood cell counts, and low sodium levels.

Thrombocytopenia occurred in 73% of patients, 25% were grade 3 and 33% were grade 4 abnormalities. Grade 3 or higher bleeding occurred in six of the patients who developed thrombocytopenia.

However, most adverse reactions occurred within eight weeks and can be controlled with active management, Professor Ajai Chari said.

It can be managed through interventional treatment that can control each adverse reaction, and in this case, the effect of Xpovio treatment can be further enhanced.

▲ Professor Ajai Chari evaluated the treatment results shown by Xpovio as encouraging in patients who exhausted all available treatment options and said that in actual clinical settings, active interventional treatment for adverse reactions can further enhance the treatment effect.
▲ Professor Ajai Chari evaluated the treatment results shown by Xpovio as encouraging in patients who exhausted all available treatment options and said that in actual clinical settings, active interventional treatment for adverse reactions can further enhance the treatment effect.

In fact, Professor Ajai Chari said that as a result of analyzing the treatment effect of Xpovio in patients subject to Korean approval at Mount Sinai Hospital, the response rate exceeded 50%, and the progression free survival and overall survival doubled.

Furthermore, based on the results of new clinical studies, he explained that in the United States, various combination treatments are administered along with other treatments, and as the mechanism is different, Xpovio as well as other drugs can reduce the amount of dosage while increasing the therapeutic effect and decreasing the burden of adverse events.

Another advantage of Xpovio is that the time to response (TTR) is as fast as about a month. This means that one month is sufficient to evaluate the effect after administration.

Antengene, which currently operates a patient support program in Korea, also applies a different refund rate on a monthly basis.

The company refunds 100% within one month, and 50% after two months.

Currently, there are about 170 multiple myeloma patients who meet the domestic approval criteria, and it is judged that there will be no difficulty in applying for insurance coverage as it can be determined whether or not to continue treatment in one month.

“It is a new company, but as it grows, we are trying to grow in a way that supports Korean patients and Korean researchers,” Kim said. "Currently, Xpovio is working hard to enter the insurance coverage to improve patient access."


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