Great New | Allist Annouces that FDA Grants Breakthrough Therapy Designation to Furmonertinib in First-Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

October 30th, 2023 Shanghai Allist Pharmaceuticals Co., Ltd. (hereby referred as Allist) announced that our oversea partner ArriVent Biopharma, Inc., (hereby referred as ArriVent) today has been granted Breakthrough Therapy designation for furmonertinib in 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 by the U.S. Food and Drug Administration (FDA).


FDAs Breakthrough Therapy designation is designed to expedite development and review of drugs intended to treat a serious or life-threatening condition for which preliminary clinical evidence indicates the drug may a demonstrate substantial improvement over available therapies.  The Breakthrough Therapy designation was granted based on interim results from FAVOUR trial (NCT04858958 / CTR20201697), 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. Interim results from FAVOUR demonstrated furmonertinib has promising efficacy as a single agent, but also has a well-tolerated safety profile in the first-line and previously treated patients. Under 240 mg dose QD, 1st line NSCLC patients with EGFR exon 20 insertion mutations had confirmed overall response rate (cORR) around 78.6% and median duration of response (mDoR) around 15.2 months The pivotal registrational Phase III FURVENT trial (NCT05607550 / CTR20201697) of furmonertinib for the treatment of first-line NSCLC with EGFR exon 20 insertion mutations is currently enrolling patients globally.


Furmonertinib is a self-developed third generation of EGFR TKI with novel structure by Allist. It has received approvals in both EGFR classical mutations and T790 mutations at China, and both were included in China National Drug Reimbursement List (NRDL). In addition, clinical studies have shown that furmonertinib has excellent efficacy and safety in both NSCLC  patients with EGFR exon 20 insertion mutations and other EGFR uncommon mutations. Because of the potentials in furmonertinib, Allist has entered into an oversea license agreement with ArriVent in 2021. Both parties agreed to collaborate in clinical development worldwide. The BTD FDA granted to furmonertinib fully confirmed that the efficacy of furmonertinib from previous clinical study in NSCLC with EGFR exon 20 insertion mutations is better that that in current standard of care. The BTD will not only fasten the communication and review process with FDA, but also will grant prior approval opportunities. In addition, this BTD granted by FDA is also a positive result from the collaboration between Allist and ArriVent. It showed both the expertise and advantages in resource from both parties, and further established more collaborations in future. Currently, the enrollment of FURVENT is successfully on-going, including China, America, Japan, Korea, England, Fance, and etc. I am looking forward to the global approval of furmonertinib, eventually benefiting patients around the globe,said Jie Hu, Vice Chairman of Allist.


Breakthrough Therapy designation is an important step forward in our development with Allist in 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 Dr. Bing Yao, Chairman, Co-founder and Chief Executive Officer of ArriVent.


Dr. Stuart Lutzker, co-founder and President of R&D added; 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. We and Allist look forward to continuing our work with FDA as we progress our furmonertinib clinical development program in NSCLC, including our ongoing pivotal, global Phase III FURVENT trial.


About EGFR mutant NSCLC

Globally, lung cancer is the leading cause of cancer-related deaths among men and women. Non-small cell lung cancer (NSCLC) is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the epidermal growth factor receptor (EGFR) is a common and early event in the development of NSCLC.EGFR mutations occur in approximately 24% of NSCLC cases in the Amercias and up to 50% in Asian populations. The most common EGFR mutations are exon 19 deletions and a point mutation in exon 21 (L858R), which together are termed classical EGFR mutations and account for approximately 70% of all EGFR mutations. The remaining EGFR mutations are termed uncommon EGFR mutations of which exon 20 insertion mutations constitute approximately 9% of all EGFR mutations. Patients with NSCLC whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy.


About Breakthrough therapy designation by US Food and Drug Administration (FDA)

Breakthrough Therapy designation, started at July, 2012 by FDA, is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). A drug that receives Breakthrough Therapy designation is eligible for the following, including all fast track designation features, intensive guidance on an efficient drug development program, and oarganizational counselnvolving senior managers from FDA.


About Furmonertinib

Furmonertinib is a self-developed 3rd generation of EGFR TKI with independent IP from China. It is approved for the treatment in adult patients with locally advanced or metastatic NSCLC who have progressed or have prior treatment with EGFR tyrosine kinase inhibitors TKIs) and who have tested positive in EGFR T790M mutations. It is further approved for 1st line treatment on June, 2022 by CDE; it is used for the 1st line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) mutations. Besides the approvals in indications, Allist has entered a license agreement with ArriVent on 2021. Both parties reached a comprehensive collaboration on the development and commercialization of furmonertinib in oversea markets.


About Allist

Shanghai Allist Pharmaceuticals Co., Ltd, founded in March, 2004, is an innovative pharmaceutical company with a fully integrated system for research and development, manufacturing, and commercialization of novel oncology drugs with a purpose to meet with medical needs across the globe. In accordance with its development concept Advancing Long Life with Innovation of Science and Technology, Allist is dedicated to self-develop First-in-class and Best-in-class drug candidates. After 18 years of endeavor, Allist has successfully developed and received approvals of two innovative drugs by its own. Allist has comprehensive ability to continue invent novel anti-tumor drugs, which not only have confirmed efficacy and potentially is best in class, but also has independent IP rights. On December 2nd, 2020, Shanghai Allist Pharmaceuticals Co., Ltd. was officially listed in in Science and Technology Innovation Board of the Shanghai Stock Exchange (stock number: 688578).


About ArriVent

ArriVent is dedicated to accelerating the global development of innovative biopharmaceutical products. With a deep and global network, ArriVent seeks to access unique and best-in-class drug candidates at various development stages, including those coming from China and other emerging biotech hubs. Through strategic collaborations with innovative biopharma companies, ArriVent aims to globalize medicines for patients with unmet medical need in a broad range of diseases, with an initial focus in oncology. For additional information, visit