Zipalertinib Demonstrates Clinically Meaningful Intracranial Antitumor Activity in Patients with NSCLC with EGFR Exon 20 Insertion or Uncommon EGFR Mutations and Active CNS Metastases
Cullinan Therapeutics and Taiho Oncology announced Phase 2 REZILIENT2 Cohort C results for zipalertinib in NSCLC patients with EGFR exon 20 insertion or uncommon EGFR mutations and active CNS metastases. Among 43 evaluable patients, zipalertinib achieved a 30.2% intracranial objective response rate, a 72.1% intracranial disease control rate, and a median intracranial duration of response of 9.7 months, with the drug well tolerated at 100 mg twice daily. This is the first prospective study of intracranial activity for an EGFR TKI in this population; data will be presented at the ESMO Congress 2026 on October 26 in Madrid.
Key figures
- Drug Name
- zipalertinib (CLN-081/TAS6417)
- Phase Of Trial
- Phase 2b (REZILIENT2, Cohort C)
- Intracranial dcr
- 72.1%
- Intracranial orr
- 30.2%
- Enrolled patients
- 59
- Evaluable patients
- 43
- Grade 3plus trae rate
- 20.9%
- Iorr no prior egfr tki
- 37.5%
- Median intracranial dor months
- 9.7
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