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Leclza’s partner ‘Rybrevant’ lands in Big 5 hospitals
by Eo, Yun-Ho Feb 17, 2023 05:50am
The anticancer drug Rybrevant which targets a small number of lung cancer patients has landed at general hospitals in Korea. According to industry sources, Janssen Korea’s Rybrevant (amivantamab), which is used to treat EGFR exon 20 insertion non-small-cell lung cancer (NSCLC) that is insensitive to currently available EGFR tyrosine kinase inhibitors (TKIs), has passed the drug committees of 18 medical institutions in Korea including tertiary hospitals such as the Samsung Medical Center, Seoul National University Hospital, Seoul St.Mary’s Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital, as well as other institutions nationwide, such as Gangnam Severance Hospital, National Cancer Center, Konyang University Hospital, Kyungpook National University Hospital, Ajou University Hospital, Incehon St.Mary’s Hospital, Jeonbuk National University Hospital, Chungnam National University Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital. The drug has landed relatively quickly for prescriptions after being approved in Korea in February last year. However, Rybrevant is currently a non-reimbursed drug. Janssen applied for reimbursement but was unable to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. The company is known to be preparing to reapply for reimbursement. EGFR exon 20 insertion mutations in NSCLC are so rare that it is found in only 2% of all NSCLC patients harboring EGFR mutations in Korea. With no suitable treatment available for the specific condition, even the NCCN guidelines have only been recommending platinum-based chemotherapy for the patients. And even this is subject to expenditure cuts. Although lung cancer in itself is not a rare disease, NSCLC with EGFR exon 20 insertions can be classified as a rare condition. Unlike other common EGFR mutations, NSCLC patients with EGFR exon 20 insertion mutations have a 75% higher risk of death, a 5-year survival rate of 8%, and a life expectancy of less than 2 years. Rybrevant, which is well known for its combined use with ‘lasertinib (Leclaza),’ was the first targeted therapy approved in Korea for the treatment of NSCLC with EGFR exon 20 insertion mutations in February this year. The approval for the drug was based on the results from the CHRYSALIS study, where the drug demonstrated an overall response rate (ORR) of 40%, a 4% complete response (CR), and 36% partial response (PR) rate. The U.S. Food and Drug Administration (FDA) granted accelerated approval for the drug based on Phase I trial results in recognition of its value as a treatment for a rare type of cancer. Following the approval in the U.S., the drug also was designated for expedited review and approved in Korea. However, the issue lies in whether its value will be accepted during the reimbursement review. As the drug was approved based on data from a single-arm clinical trial that was conducted without a control group, Rybrevant needs to take the pharmacoeconomic evaluation exemption track for reimbursement. Therefore, the key issue lies in whether Rybrevant’s value as a treatment for a rare cancer, not just lung cancer, will be acknowledged during the reimbursement review. Byoung-Chul Cho, Chief of the Lung Cancer Center at Yonsei Cancer Center, said “EGFR exon 20 insertion presents in various subtypes, and the sub-analysis of the CHRYSALIS study showed that Rybrevant showed an even response rate across several subtypes. In addition to its target inhibition effect, Rybrevant shows more promise due to its immune cell-directing activity.”