Given the licensing and insurance system in Korea, the Xalkori-Alecensa sequential treatment strategy may be most effective in treating patients with anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC), a Japanese expert said.
|Professor Takashi Seto of Kyushu National Cancer Center in Japan explains the benefits of the Xalkori-Alecensa sequential treatment during a recent interview with Korea Biomedical Review at the Lotte Hotel World in Seoul.|
Professor Takashi Seto of Japan's Kyushu National Cancer Center (KNCC) made this and other points during a recent interview with Korea Biomedical Review, highlighting the usefulness of a sequential treatment strategy for Xalkori.
Professor Seto has been leading the phase 3 clinical trials for ALK tyrosine kinase inhibitors (TKI), including Xalkori and Alecensa, as the director of the department of clinical oncology at KNCC. He recently visited Korea to speak in the lung cancer session at the Korean Academy of Tuberculosis and Respiratory Diseases (KATRD) International Conference 2019.
During the conference, Professor Seto made a presentation on “What is the optimal long-term treatment strategy for treating ALK-positive NSCLC patients?”
The Japanese experts elaborated on the benefits of the Xalkori-Alecensa sequential treatment strategy identified through the results of a large-scale real-world study conducted in Japan.
“Although Alecensa demonstrated longer progression-free survival (PFS) as first-line treatment compared to Xalkori, no long-term basis for actual treatment response or overall survival (OS) had been established,” Seto said. “Therefore, there have been many discussions about what kind of treatment method is more beneficial for the improvement of long-term survival in ALK-positive NSCLC patients in Japan.”
However, there were a few studies in which, although limited, sequential treatment strategies using Xalkori as a first-line treatment can provide long-term survival benefits, he explained. Professor Seto gave the retrospective study comparing the Xalkori-Alecensa sequential treatment group with Xalkori-only and Alecensa-only groups in Mie Prefecture, Japan, as an example.
“The trial results showed that the Xalkori-Alecensa sequential group showed better survival data than the other monotherapy groups,” Seto said. “Based on such accumulated data, we were able to conduct the recent large-scale real-world research.”
The real-world study, unveiled during the conference, analyzed the data from 535 patients who used Xalkori as a first-line treatment and 305 patients who used Alecensa as a first-line treatment in ALK-positive non-small cell lung cancer. Afterward, the researchers compared the time to treatment failure (TTF) of the Xalkori-Alecensa sequential treatment group with the TFF of the Alecensa monotherapy group.
The study could be conducted thanks to the rapid accumulation of clinical data in Japan as the country had approved Alecensa as a first-line treatment earlier than other countries. The study analyzed data for patients treated with either Xalkori or Alecensa at 61 institutions in Japan from May 2012 to December 2016.
As a result, the TTF of the Xalkori-Alecensa sequential group was 34.4 months, which was statistically significantly longer than the Alecensa group's 27.2 months. However, Xalkori-Alecensa sequential group and Alecensa group showed no significant difference in OS
“Although OS benefits were not demonstrated in the Xalkori-Alecensa sequential group, the study confirmed that the TTF was longer,” Professor Seto said. “The significance of this data is that the duration of treatment was significantly longer when Xalkori was used first than when Alecensa was used first.”
According to Professor Seto, Japan currently has no restrictions on approval or insurance benefits for sequential treatment. This means that if there is justifiable data, the treatment sequence can be set differently according to the expert’s judgment.
By comparison, although Xalkori, Alecensa, and Zykadia have received approval as a first-line treatment for ALK-positive NSCLC in Korea, the nation only allows chemotherapy as a second-line treatment if the first-line treatment fails.
“Therefore, considering the situation in Korea where there is a limit on insurance coverage in sequential treatment, administering Xalkori first and then Alecensa afterward would be the best strategy for treating patients with ALK-positive NSCLC in Korea,” Professor Seto said.
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