ArriVent Reports Positive Phase 1b Data for Firmonertinib in EGFR Mutant Lung Cancer at 2024 World Conference

ArriVent BioPharma, Inc., a company focused on biopharmaceutical developments, has announced promising interim results from its global Phase 1b FURTHER trial for firmonertinib, a first-line treatment for non-small cell lung cancer (NSCLC) with EGFR PACC mutations. The encouraging findings were shared during a Presidential Symposium Presentation at the IASCLC 2024 World Conference on Lung Cancer in San Diego, California. 

Firmonertinib has demonstrated significant systemic and central nervous system (CNS) anti-tumor activity in patients with EGFR PACC mutant NSCLC. The interim data revealed an 81.8% overall response rate (ORR) by blinded independent central review (BICR) at the 240 mg dose, and a 63.6% confirmed ORR by BICR. CNS metastases showed a 46.2% confirmed ORR. Additionally, 90.9% of patients with confirmed responses remained in the study, with no median duration of response reached at the time of analysis.

The trial results highlight firmonertinib’s potential as an effective, chemotherapy-free oral therapy for patients with these uncommon mutations. Bing Yao, CEO of ArriVent, emphasized the trial's significance, noting the well-tolerated safety profile and the durability of responses, reinforcing the drug’s therapeutic promise. 

Dr. Xiuning Le from MD Anderson Cancer Center, the lead investigator, pointed out the clinical challenge posed by uncommon EGFR mutations, including PACC and Exon 20 insertions, due to the need for more potent and better-tolerated inhibitors. The positive interim data indicate that firmonertinib could be a promising new therapy for patients with CNS involvement as well.

The presentation underscored the challenges current treatments face with uncommon EGFR mutations, which comprise 12% and 9% of NSCLC cases respectively. Firmonertinib is a highly brain-penetrant EGFR inhibitor with broad activity, and these interim results signify its potential in addressing these challenges. The data cut-off as of June 20, 2024, showed notable response rates at different dosages: 81.8% at 240 mg and 47.8% at 160 mg ORR by BICR, with confirmed ORRs of 63.6% and 34.8% respectively. The trial also noted that the median duration of response remains undetermined, with a significant majority of patients continuing their participation.

The safety profile of firmonertinib is consistent with previous data, with common side effects including diarrhea, rash, dry skin, stomatitis, and elevated hepatic enzymes. Importantly, there were no treatment discontinuations due to these adverse events.

Firmonertinib's development is part of ArriVent’s broader strategy to address unmet medical needs in cancer treatment. As an oral EGFR inhibitor, firmonertinib is already approved in China for specific EGFR mutations and has received Breakthrough Therapy Designation from the U.S. FDA for NSCLC with exon 20 insertion mutations. It also holds Orphan Drug Designation for treating non-small cell lung cancer with EGFR or HER2 mutations.

Currently, firmonertinib is under investigation in a global Phase 3 trial and a Phase 1b study targeting EGFR PACC mutations. Further studies include a clinical combination trial for advanced NSCLC with classical EGFR mutations, in collaboration with Beijing InnoCare Pharma Tech Co., Ltd.

Lung cancer remains the leading cause of cancer-related deaths globally, with NSCLC accounting for 85% of cases. EGFR mutations, both classical and uncommon, play a significant role in NSCLC development. Uncommon EGFR mutations such as PACC and exon 20 insertions, which represent a smaller percentage of cases, have a poorer prognosis with existing treatments, highlighting the urgent need for new therapeutic options like firmonertinib.

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