Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Furmonertinib 160mg, furmonertinib , daily
Furmonertinib · 4 trials · 8 indications
Percentage of patients with a confirmed CR or PR relative to the total number of patients.
Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable Response Evaluation Criteria in Solid Tumors (RECIST) assessment.
| Arm | Type | Description |
|---|---|---|
| Furmonertinib 240mg QD | EXPERIMENTAL | Treating patients of locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy. |
| Group A: Furmonertinib 80mg QD | EXPERIMENTAL | Furmonertinib (AST2818) 80mg QD. All patients enrolled into this group will receive furmonertinib 80mg daily. |
| Group B1: Furmonertinib 80mg QD | EXPERIMENTAL | Furmonertinib (AST2818) 80mg QD. All patients enrolled into this group will receive furmonertinib 80mg daily. |
| Group B2: Furmonertinib plus chemotherapy | EXPERIMENTAL | Furmonertinib 80 mg QD and platinum-based chemotherapy All patients enrolled into this group will receive furmonertinib 80 mg daily, in combination with Pemetrexed (500 mg/m2) plus carboplatin (AUC 5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed maintenance (500 mg/m2) every 3 weeks. |
| Group B3: Furmonertinib plus chemotherapy and bevacizumab | EXPERIMENTAL | Furmonertinib 80 mg QD plus platinum-based chemotherapy and bevacizumab All patients enrolled into this group will receive furmonertinib 80 mg daily, in combination with Pemetrexed (500 mg/m2) plus carboplatin (AUC 5) plus bevacizumab (7.5mg/kg) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed (500 mg/m2) with bevacizumab (7.5mg/kg) maintenance every 3 weeks. |
| treated subjects will receive Furmonertinib 160mg/day, | EXPERIMENTAL | treated subjects will receive Furmonertinib 160mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability. |
| treated subjects will receive Furmonertinib 240mg/day, | EXPERIMENTAL | treated subjects will receive Furmonertinib 160mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability. |
| treatment-naïve subjects will receive Furmonertinib 240mg/day | EXPERIMENTAL | Treatment naïve patients with EGFR exon 20 insertion mutation positive NSCLC |
| Stage 1 Dose Escalation and Backfill | EXPERIMENTAL | Experimental: Previously treated patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations |
| Stage 2 Expansion Cohort 1 | EXPERIMENTAL | Previously Treated NSCLC Patients with EGFR Exon 20 Insertion Mutations |
| Stage 2 Expansion Cohort 2 | EXPERIMENTAL | Previously treated NSCLC Patients with HER2 Exon 20 Insertion Mutations |
| Stage 2 Expansion Cohort 3 | EXPERIMENTAL | Previously treated NSCLC Patients with EGFR Activating Mutations, who are not eligible for Cohorts 1 and 4 |
| Stage 2 Expansion Cohort 4 | EXPERIMENTAL | Untreated or Previously treated EGFR TKI Naïve NSCLC Patients with EGFR Uncommon Mutations, excluding EGFR exon 20 insertion mutations |
| Name | Type | Description |
|---|---|---|
| Furmonertinib | DRUG | 240mg QD on a continuous dosing schedule. |
| Furmonertinib/Pemetrexed/Carboplatin | DRUG | Furmonertinib 80mg daily + Pemetrexed (500 mg/m2) plus carboplatin (AUC 5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed maintenance (500 mg/m2) every 3 weeks. |
| Furmonertinib/Pemetrexed/Carboplatin/Bevacizumab | DRUG | Furmonertinib 80mg daily + Pemetrexed (500 mg/m2) plus carboplatin (AUC 5) plus bevacizumab (7.5mg/kg) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed (500 mg/m2) with bevacizumab (7.5mg/kg) maintenance every 3 weeks. |
| Furmonertinib 160mg | DRUG | randomized to 160mg QD |
| Furmonertinib 240mg | DRUG | randomized to 240mg QD |
Inclusion Criteria: * Age ≥ 18 years at time of signing Informed Consent Form * Histologically or cytologically documented, locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy * Documented validated results from local or central testing (as designated by the Sponso...
Furmonertinib is an investigational small molecule being developed for non-small cell lung cancer (NSCLC), including metastatic and advanced forms of the disease. It is studied in patients with EGFR mutations, such as exon 20 insertions and uncommon mutations, and is currently in clinical trials.
Furmonertinib targets the epidermal growth factor receptor (EGFR), an inhibitor of this receptor. It is being studied in non-small cell lung cancer patients with activating EGFR mutations, including exon 20 insertions and uncommon mutations like G719X and S768I.
Furmonertinib is being developed by ArriVent BioPharma, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol AVBP. The company is conducting clinical trials to evaluate the drug in patients with non-small cell lung cancer.
Furmonertinib is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing trials include a Phase 2 study in NSCLC with EGFR exon 20 insertions, and a Phase 3 study comparing it to chemotherapy.
Furmonertinib is being studied in several clinical trials, including NCT05466149 (Phase 2 in NSCLC with EGFR exon 20 insertion), NCT05607550 (Phase 3 FURVENT trial comparing to chemotherapy), NCT04858958 (Phase 1 in NSCLC with exon 20 insertion), and NCT05364073 (Phase 1 in advanced NSCLC with EGFR or HER2 mutations).
Yes, Furmonertinib is the same drug as furmonertinib 160mg and furmonertinib 240 mg oral daily. These names refer to the same investigational medication, which is being studied in various dosages for the treatment of non-small cell lung cancer.