ArriVent BioPharma (AVBP) Study Update summary

Study background and objectives

• Focus on firmonertinib, an EGFR inhibitor, for NSCLC patients with PACC mutations, addressing a population with poor outcomes on current therapies.

• FURTHER Phase 1b global study evaluated firmonertinib monotherapy in locally advanced/metastatic NSCLC with EGFR PACC mutations, enrolling 60 patients across 10 countries.

• EGFR PACC mutations represent 12% of all EGFR mutations and are linked to lower life expectancy and unmet medical need.

• High incidence of brain metastases observed, typical for EGFR mutant NSCLC.

• Primary endpoint was overall response rate (ORR) by blinded independent central review (BICR); secondary endpoints included duration of response and CNS activity.

Key study results

• Confirmed ORR for 1L PACC patients was 68.2% at 240 mg and 43.5% at 160 mg (BICR), with most responses at first tumor assessment and disease control rates up to 100%.

• Median progression-free survival (mPFS) was 16.0 months at 240 mg and 11.1 months at 160 mg, exceeding historical benchmarks.

• CNS activity demonstrated with 53% CNS ORR and 41% complete CNS responses in evaluable patients.

• Median duration of response was 14.6 months at the 240 mg dose.

• Safety profile remained manageable and consistent with EGFR-TKI class, with no grade 4-5 treatment-related adverse events or new safety signals.

Next steps and development plans

• Advancing firmonertinib into a global pivotal Phase 3 registration study (ALPACCA) as an oral, chemo-free monotherapy for 1L EGFR PACC mutant NSCLC, with first patient enrollment expected in the second half of 2025.

• ALPACCA will randomize 480 patients to firmonertinib 240 mg or investigator's choice of osimertinib/afatinib, with primary endpoints of ORR and PFS and potential for accelerated and full approval.

• Topline pivotal Phase 3 data in 1L EGFR Exon 20 insertion mutant NSCLC expected in 2025.

• Firmonertinib is also being studied in other global trials for various EGFR mutations, including exon 20 insertions.

• Firmonertinib has received FDA Breakthrough Therapy and Orphan Drug designations for related indications.