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Arrivent’s Furmonertinib Receives FDA Breakthrough Therapy Designation


Furmonertinib is in development for the treatment of advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations.

Non Small Cell Lung Cancer (NSCLC) in the lung tissue – closeup view 3d illustration. Image Credit: Adobe Stock Images/LASZLO

Image Credit: Adobe Stock Images/LASZLO

ArriVent Biopharma, Inc. announced that the FDA has granted breakthrough therapy designation to furmonertinib for the treatment of patients with previously untreated, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.1

Furmonertinib is an oral, brain penetrant, EGFR tyrosine kinase inhibitor developed for broad activity and selectivity across EGFR mutations. The treatment has previously shown positive tolerability when studied at doses up to 240 mg once a day. Furmonertinib has also shown promising efficacy across treatment-naïve and previously treated patients with NSCLC with EGFR Exon20ins.2

“Breakthrough therapy designation is an important step forward in our development of furmonertinib and highlights its exciting potential as a first-line therapy for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations,” said Bing Yao, chairman, co-founder, CEO, ArriVent, in a company press release.1

Lung cancer is the second most common form of the disease in both men and women in the United States. The American Cancer Society’s estimates that approximately 238,340 new cases of lung cancer—117,550 in men and 120,790 in women—will be diagnosed in the United States inn 2023, with approximately 127,070 deaths—67,160 in men and 59,910 in women.3

Approximately 80% to 85% of lung cancers are NSCLC, with the main subtypes being adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. These forms of NSCLC begin from different types of lung cells that are identified as NSCLC because the treatment and prognoses are typically similar.3

According to ArriVent Biopharma, the breakthrough therapy designation was given based on results from the FAVOUR trial (NCT04858958), a phase 1b, randomized, open-label, multi-center clinical trial evaluating the efficacy and safety of furmonertinib in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. The FDA grants breakthough designation to advance the development and review of drugs intended to treat a serious or life-threatening condition for which preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapies.

In terms of safety, furmonertinib was found to be well tolerated at both the 240 mg and 160 mg dose levels, with low rates of dose reduction and treatment discontinuation associated with treatment-related adverse events (TRAEs). TRAEs of any grade were observed in 97% of treatment-naïve patients in the FAVOUR trial, 100% in the previously treated 240 mg cohort, and 89% in the previously treated 160 mg cohort. Grade 3 or higher TRAEs were observed in 13%, 29%, and 18% of patients across cohorts, respectively, with no deaths reported due to TRAEs.

Across patient cohorts, the most common TRAEs of any grade were diarrhea, anemia, aspartate elevated aminotransferase, and elevated alanine aminotransferase.

“This FDA designation underscores the encouraging clinical activity we have seen with furmonertinib in the FAVOUR study and reflects the critical need for effective and tolerable therapeutic options for these patients,” said Stuart Lutzker, co-founder, president of R&D, Arrivent, in the release.1 “We look forward to continuing our work with the agency as we progress our furmonertinib clinical development program in NSCLC, including our ongoing pivotal, global phase 3 Furvent trial evaluating furmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion mutations.”

Currently, Arrivent is enrolling patients for the global phase 3 Furvent study.


1. ArriVent Receives FDA Breakthrough Therapy Designation for Furmonertinib for First-Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. Arrivent. October 30, 2023. Accessed November 1, 2023. https://arrivent.com/arrivent-receives-fda-breakthrough-therapy-designation-for-furmonertinib-for-first-line-treatment-of-advanced-or-metastatic-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations/

2. American Cancer Society. Lung Cancer Key Statistics. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed November 1, 2023.

3. Study of FURMONERTINIB in patients with NSCLC having exon 20 insertion mutation (FAVOUR). ClinicalTrials.gov. Updated January 18, 2023. Accessed November 1, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT04858958

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