“Imbruvica works better than any other existing chemotherapy in relapsed and refractory mantle cell lymphoma (MCL). Many other targeted therapies have brought a change in the treatment paradigm, but Imbruvica is the only reimbursable drug among MCL treatments in Korea. The increased survival rate of local patients with MCL is attributed to Imbruvica.”

Cho Seok-goo, a professor at Hematology Department at Seoul St. Mary’s Hospital, speaks during a recent interview with Korea Biomedical Review.

Professor Cho Seok-goo of the Hematology Department at Seoul St. Mary’s Hospital made the assessment of how Imbruvia (ingredient: ibrutinib) had been fairing in relapsed and refractory MCL treatment since it began to benefit insurance coverage three years ago. MCL is categorized as a rare and intractable disease.

“There are 8.7 MCL patients per 100,000 people in Korea. As of 2018, 568 patients received treatment because of MCL. Annually, about 107 patients are newly diagnosed with MCL,” Cho said in a recent interview with Korea Biomedical Review.

According to Cho, the average age of local MCL patients is between 60 and 65, and most of them experience a relapse within three to five years of treatment. “Only 64 percent of patients who had a relapse or did not respond to the existing treatment have a two-year overall survival, 39 percent of them have a two-year disease-free survival, and 20 percent, a five-year overall survival. Prognosis of the diseases is quite poor,” he said.

Physicians usually use R-CHOP therapy (rituximab/cyclophosphamide/doxorubicin/vincristine/prednisolone) as the standard treatment for relapsed and refractory MCL. Recently, however, treatment options have widened with the arrival of effective therapies such as ibrutinib, bendamustine, and rituximab.

Imbruvica obtained regulatory approval in August 2014 for the treatment of MCL patients who had received at least one prior therapy. In June 2016, the drug became reimbursable.

Cho recently disclosed the results of a follow-up on Imbruvica’s therapeutic effect for three and a half years in relapsed and refractory MCL patients in Korea.

“I grouped patients who participated in Imbruvica’s phase-2 and 3 trials and had a long-term follow-up. The results showed that Imbruvica had not only short-term efficacy but long-term safety. It also raised progression-free survival, proving clinical utility,” he said. “As a researcher, I also participated in Imbruvica’s multinational phase-3 trial, RAY. However, I found that the patients who received the drug at my hospital showed better disease-free survival.”

He emphasized that Imbruvica worked better in patients who were not overexposed to anticancer drugs, as the previous phase-3 trial showed.

For such reason, Imbruvica is being recognized as the standard therapy for relapsed MCL patients, Cho said. “Researchers are also testing Imbruvica with other targeted therapy from the diagnosis stage as maintenance therapy,” he added.

According to Cho, Imbruvica’s other strength is that it is easy to control side effects thanks to its weak toxicity. Imbruvica’s side effects disappear within one year of the administration and rarely appear afterward, which makes it possible for long-term medication, he said.

“Various therapies are being mentioned at academic conferences, but Imbruvica is the only reimbursable drug for relapsed and refractory MCL patients in Korea. Thus, the improved survival rate of the patients is much attributed to Imbruvica,” Cho said.

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