Anticancer Drug Rozlytrek Also Works on Korean Cancer Patients: Study

Roche Korea said Monday it has confirmed the safety and efficacy of Rozlytrek (ingredient: entrectinib) for treating Asian cancer patients, including Koreans, regardless of tumor locations.

The pharmaceutical company presented the sub-analysis of Asian patients with cancer in its pivotal studies at the European Society for Medical Oncology (ESMO) Asia Virtual Congress 2020 held on Nov. 20.

Roche Korea re-confirmed the safety and efficacy profile of Rozlytrek (ingredient: entrectinib) for treating Asian patients, including Koreans. (Roche)

Rozlytrek is a tailored anticancer therapy using NTRK (neurotrophic tropomyosin receptor kinase) gene fusion and ROS1, one of the receptor tyrosine kinases, mutation as biomarkers.

According to the study results, the objective response rate (ORR) was 69.2 percent, the median duration of response (DoR) was 10.4 months, and the median progression-free survival (PFS) was 14.9 months in 13 patients with NTRK gene fusion-positive solid tumor who received Rozlytrek. However, Roche Korea could not measure the overall survival rate (OSR).

Roche also confirmed 14.9, 28.3, and 13.6 months of median DoR, OSR, and PFS, respectively, along with 69.8 percent ORR in 73 patients with ROS1-positive non-small cell lung cancer (NSCLC).

The study showed a manageable safety profile similar to the clinical data confirmed in previous trials.

“We have confirmed safety and efficacy profile of Rozlytrek for treating patients with NTRK gene fusion-positive solid tumor and ROS1-positive NSCLC through the sub-study of Asians, including Koreans,” said Professor Ahn Myung-ju of the Department of Hematology and Oncology at Samsung Medical Center.

Roche Korea CEO Nic Horridge added, “Roche launched the fifth new anticancer drug in the world to deliver the value and benefits of tailored treatments based on genomic characteristics to patients and medical staff.”

Rozlytrek won approval from the Ministry of Food and Drug Safety in April and arrived in the local market in October.