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BeBetter Med’s Pan-mutant EGFR Inhibitor BEBT-109 Phase III Clinical Trial Application is Approved by CDE
2023-10-16       Source:BeBetter Med

  Recently, the pan-mutant EGFR inhibitor BEBT-109, developed by BeBetter Med Inc., has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration in China to conduct a confirmatory Phase III clinical trial for the second-line treatment for patients with non-small cell lung cancer (NSCLC) who have an EGFR exon 20 insertion mutation.


  According to analysis by Frost & Sullivan, the number of new cases of NSCLC in China has increased from 714,000 in 2017 to 811,000 in 2021, with a compound annual growth rate of 3.2%, and is expected to reach 1,057,000 by 2030. Common driver genes in NSCLC include mutations in EGFR, KRAS, c-MET, HER2, as well as rearrangements in ALK/ROS1 and RET. Among these EGFR has the highest mutation rate. In China, the proportion of NSCLC patients with EGFR mutations has reached 40%, which is higher than that observed in Western countries and regions. The EGFR exon 20 insertion mutation is found in approximately 10% of these EGFR-mutated NSCLC patients. The number of new cases of EGFR exon 20 insertion mutation NSCLC in China was 31,000 in 2021, and is expected to rise to 36,000 by 2025.


  Patients with NSCLC harboring EGFR exon 20 insertion mutation usually have a poor prognosis and the current standard first-line treatment involves platinum-based chemotherapy. This year, two targeted drugs, mobocertinib and suvatinib were launched in China following conditional approval based on results of single-arm phase II clinical trials. According to recent news from Takeda Pharmaceutical Company, they plan to voluntarily withdraw the marketing approval in the United States for mobocertinib for the treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion after platinum-based chemotherapy, due to the failure of a confirmatory Phase III clinical trial. BeBetter Med is planning a confirmatory Phase III clinical trial for BEBT-109 as a second-line treatment for NSCLC with EGFR exon 20 insertion mutation.


  About BEBT-109:

  BEBT-109 is a highly potent pan-mutant EGFR inhibitor developed by BeBetter Med., distinct from osimertinib, the world’s first marked third-generation EGFR inhibitor, and mobocertinib, the world’s first marked EGFR exon 20 insertion mutant inhibitor. Addressing the limitations of Osimertinib and Mobocertinib, BEBT-109 and its metabolites have extremely activity against wild-type EGFR, resulting in high safety.


  In dose-escalation trials for advanced NSCLC with EGFR T790M mutation, no adverse events of grade 3 or above occurred with BEBT-109, and its oral absorption is higher than the same dosage of osimertinib. Efficacy results show that the objective response rates (ORR) reached 66.7% to 100% and disease control rate (DCR) was 100% for the 80 mg/day, 120 mg/day, and 180 mg/day dosage groups. According to the date of September 6, 2023, in a phase Ib/II clinical trial for advanced NSCLC patients with EGFR exon 20 insertion mutation who had previously received at least one platinum-based systemic chemotherapy, the ORR for 40 subjects who had undergone at least one tumor evaluation after receiving BEBT-109 treatment was 37.5%, with a median progression-free survival (mPFS) of 9.4 months, and overall survival (OS) data is yet immature. BEBT-109 has demonstrated good safety and tolerability. The related study results will be published in academic journals and presented at academic conferences subsequently.


  About BeBetter Med:

  BeBetter Med Inc. is a biopharmaceutical company focused on the research and development of breakthrough medications in vital therapeutic fields such as oncology, autoimmune diseases, and metabolic disorders. Established in 2012 in Guangzhou by Professor Changgeng Qian alongside a cadre of global returnees, BeBetter Med utilizes its proprietary technology platform to formulate groundbreaking pharmaceutical solutions that balance clinical effectiveness with practical utility. Adhering to the ethos of "Committed to Innovation, Striving for Excellence," the company is unwavering in its commitment to independent research and development of globally patented, safe, and effective medications.

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