Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Firmonertinib · 2 trials · 8 indications
PFS is defined as the time from randomization to the first occurrence of disease progression as determined by BICR using RECIST v1.1, or death from any cause, whichever occurs first.
Confirmed ORR is defined as the percentage of participants with a confirmed CR or PR based on BICR assessment relative to the total number of participants.
DFS as assessed by the investigator in Stage II- IIIB. DFS defined as the time from the date of randomization to the first observation of disease recurrence (by pathological diagnosis or imaging) or death caused by any reason, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Firmonertinib 240 mg | EXPERIMENTAL | - |
| EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choice | ACTIVE_COMPARATOR | - |
| Firmonertinib | EXPERIMENTAL | Firmonertinib: 240 mg, QD, orally |
| Placebo | PLACEBO_COMPARATOR | Placebo: 240 mg, QD, orally |
| Name | Type | Description |
|---|---|---|
| Firmonertinib | DRUG | 240 mg oral, daily firmonertinib tablet |
| EGFR-TKI inhibitor based on investigator's choice | DRUG | osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet |
| Placebo | DRUG | Placebo: 240 mg, QD, orally |
Key Eligibility Criteria: * Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy. * Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissu...
Firmonertinib is an investigational small molecule being studied for the treatment of non-small-cell lung cancer (NSCLC). It is being evaluated in Phase 3 clinical trials for adjuvant treatment of stage IB-IIIB NSCLC with uncommon EGFR mutations following complete surgical resection, and as first-line treatment for locally advanced or metastatic NSCLC with EGFR P-loop and alpha C-helix compressing (PACC) uncommon mutations.
Firmonertinib targets the epidermal growth factor receptor (EGFR), acting as an inhibitor. It is being studied in patients with NSCLC who harbor uncommon EGFR mutations, including P-loop and alpha C-helix compressing (PACC) mutations, which are distinct from the more common EGFR mutations like exon 19 deletions and L858R.
Firmonertinib is being developed by ArriVent BioPharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AVBP. The company is advancing the drug through Phase 3 clinical trials for the treatment of non-small-cell lung cancer.
Firmonertinib is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has received Breakthrough Therapy and Orphan Drug designations from the FDA, reflecting its potential in treating NSCLC with uncommon EGFR mutations.
Firmonertinib is being studied in two Phase 3 trials. NCT07010419 (FIRMOST) evaluates the drug versus placebo as adjuvant treatment in stage IB-IIIB NSCLC with uncommon EGFR mutations after surgery. NCT07185997 compares Firmonertinib to investigator's choice of EGFR inhibitor as first-line treatment in advanced or metastatic NSCLC with EGFR PACC mutations.
Firmonertinib is a distinct EGFR inhibitor being developed by ArriVent BioPharma. It is designed to target uncommon EGFR mutations, including PACC mutations, which may not respond well to earlier-generation EGFR inhibitors. Its unique profile is being tested in head-to-head trials against other EGFR inhibitors in the first-line setting.