Express precise treatment of non-small cell lung cancer, FDA granted EGFR inhibitor breakthrough therapy designation

▎Editor of WuXi AppTec's content team On January 4, 2022, Cullinan Oncology announced that the US FDA has granted the epidermal growth factor receptor (EGFR) inhibitor CLN-081 breakthrough therapy designation for the treatment of previous systemic drugs.
Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received platinum chemotherapy and carry EGFR exon 20 insertion mutations
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 NSCLC is the most common type of lung cancer.
According to statistics from the World Health Organization, it accounts for approximately 85% of newly diagnosed lung cancer cases worldwide each year
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Metastatic NSCLC patients with positive EGFR exon 20 insertion account for about 1-2% of NSCLC patients, and the disease is more common in Asian populations
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Such patients have a worse prognosis than those with other EGFR mutations
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CLN-081 is an irreversible oral next-generation small molecule EGFR inhibitor that can selectively target cells carrying EGFR exon 20 insertion mutations without affecting cells expressing wild-type EGFR
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For treated NSCLC patients with EGFR exon 20 mutations, Cullinan is evaluating the efficacy and safety of different doses of CLN-081 in a phase 1/2a clinical trial
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Image source: Cullinan Oncology's official website Cullinan CEO Mr.
Nadim Ahmed said: "We are very pleased that the US FDA has granted CLN-081 breakthrough therapy designation
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This designation emphasizes the urgent need to bring innovative targeted therapies to this patient population.
And further support the differentiated clinical features of CLN-081
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The data obtained from the Phase 1/2a trial that we are conducting in more patients shows that in patients who have received a large number of pre-treatments, the drug has a high response rate and a long-lasting effect, which significantly improves the progression-free survival of patients
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In addition, we are also encouraged by the good safety characteristics observed so far
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We look forward to ongoing regulatory discussions with the FDA
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"Reference: [1] FDA Grants Breakthrough Therapy Designation for Cullinan Oncology's CLN-081 in Patients with Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer.
Retrieved January 4, 2022, from https://investors.
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