CLN-081 from Cullinan Oncology shows promising results in NSCLC patients with EGFR Exon 20 Insertion Mutations.
CLN-081 is an irreversible, orally given EGFR inhibitor that targets cells with exon 20 insertion mutation of the epidermal growth factor (EGFR) while protecting cells that express wild-type EGFR.
The US Food and Drug Administration (FDA) granted CLN-081 Breakthrough Therapy Designation in January 2022 for the treatment of patients with locally advanced or metastatic NSCLC who have EGFR exon 20 insertion mutation and have had platinum-based systemic chemotherapy before.
The results of the company's ongoing Phase I/IIa open-label, multi-center research (NCT04036682) were presented. 73 individuals had been treated by the cutoff date of May 2022, with dosages ranging from 30 to 150 mg twice daily (BID).
In this subgroup, the median progression-free survival (PFS) was 12 months. CLN-081 had a partial response that was confirmed (PR)
• Among the 39 patients who got the medicine at a dose of 100 mg twice daily, the findings demonstrated a confirmed PR rate of 41% (n= 16), with a median DOR of more than 21 months.
In this category, the median PFS was ten months
• Furthermore, patients who received CLN-081 at a twice-daily dose of 65 mg or less had a confirmed PR rate of 35%, with a median DOR of more than 19 months and a median PFS of 8 months.
• In the 11 patients who received CLN-081 at a twice-daily dose of 150 mg, the confirmed PR rate was 36.4 percent, the median DOR was 7 months, and the median PFS was 8 months.
For long-term treatment, CLN-081 appears to have a favorable safety profile.
Conclusion
Ex20ins mutations are one of the most common subtypes of EGFR Inhibitors mutations, accounting for about 10% of EGFR-NSCLC cases. NSCLC with an EGFR ins20 mutation has proven difficult to treat in the past. Previously, there had been little progress in the EGFR ins20 NSCLC arena, but with the approval of amivantamab-vmjw (Rybrevant, Janssen Biotech), the story has changed.
Many problems remain, such as understanding the biology of individual EGFR ins20 variants and the causes of resistance to the many therapies now being researched. The complexity of clinical decisionmaking over choosing the proper therapy at theright time for these patients will continue to climb as several novel targeted therapies for this patient population are developed.
CLN081 is a novel EGFR tyrosine kinase inhibitor that has been classified as a Breakthrough Therapy by the FDA for the treatment of EGFR ins20 NSCLC patients. According to recent data, this medication has the potential to modify the standard of therapy for EGFR ins20 NSCLC.
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