ArriVent reports strong Phase 1b results for firmonertinib in EGFR PACC‑mutant lung cancer
ArriVent BioPharma announced Phase 1b data for its oral EGFR inhibitor firmonertinib in treatment‑naïve patients with EGFR PACC‑mutant non‑small cell lung cancer. The drug achieved a 43% confirmed overall response rate (ORR) at 160 mg and a 68% ORR at 240 mg, with median progression‑free survival of 11.1 and 16.0 months respectively. Intracranial activity was observed in 47% of patients with brain metastases and 80% of evaluable patients cleared ctDNA by cycle 3. The company is enrolling a global Phase 3 ALPACCA trial comparing firmonertinib with osimertinib or afatinib.
Why it matters
The company says the data suggest firmonertinib could change the treatment paradigm for this underserved patient group, which may increase the drug’s commercial potential and affect AVBP’s valuation.
Key facts
- 1Confirmed overall response rate was 43% at a 160 mg dose and 68% at a 240 mg dose. stocktitan.net
- 2Median progression‑free survival was 11.1 months for the 160 mg dose and 16.0 months for the 240 mg dose. stocktitan.net
- 3Intracranial confirmed ORR was 47% (8 of 17 patients) with 41% complete responses among those with baseline brain metastases. stocktitan.net
- 480% of evaluable patients achieved complete molecular response (ctDNA clearance) by cycle 3. stocktitan.net
- 5Safety profile was consistent with prior studies of firmonertinib. stocktitan.net
- 6ArriVent is enrolling a global Phase 3 ALPACCA trial comparing firmonertinib with investigator’s choice of osimertinib or afatinib. stocktitan.net
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.