EGFR T790M inhibitors(Epidermal Growth Factor Receptor T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 20 inhibitors(EGFR exon 20 Mutation inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesNervous System Diseases

Active Indication

EGFR ex20ins mutation in non-small cell lung cancerEGFR exon 19 Deletions Mutant Non-small Cell Lung CancerEGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer+ [16]

Inactive Indication

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Originator Organization

Shanghai Allist Pharmaceuticals Co., Ltd.

Active Organization

Shanghai Allist Pharmaceuticals Co., Ltd.

Arrivent BioPharma, Inc.

Inactive Organization-

License Organization

Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

Shanghai Allist Pharmaceuticals Co., Ltd.

Arrivent BioPharma, Inc.

Drug Highest PhaseApproved

First Approval Date

China (03 Mar 2021),

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

RegulationOrphan Drug (United States), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States)

Structure/Sequence

Molecular FormulaC29H35F3N8O5S

InChIKeyWDPGHXINXNBHAS-UHFFFAOYSA-N

CAS Registry2130958-55-1

118

Clinical Trials associated with Alflutinib Mesylate

NCT07348965

/ Not yet recruitingNot ApplicableIIT

Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis

The goal of this clinical trial is to clarify the efficacy and safety of the high-dose alternate-day furmonertinib in NSCLC with leptomeningeal metastasis. It will also explore the mechanism by which the high-dose alternate-day administration regimen enhances efficacy from a pharmacokinetic perspective, and investigate the impact of co-occurring mutations on the efficacy and prognosis of furmonertinib in the treatment of EGFR-mutant NSCLC with leptomeningeal metastasis. The main questions it aims to answer are:
Does the high-dose alternate-day administration regimen have definite efficacy? Does the high-dose alternate-day administration regimen have favorable safety? Does the high-dose alternate-day administration regimen improve efficacy by increasing the cerebrospinal fluid (CSF) concentration and CSF penetration rate of the drug? Which co-occurring mutations may affect the efficacy and prognosis of patients with EGFR-mutant NSCLC and leptomeningeal metastasis? Participants will enter Cohort A (320mg qod po) or Cohort B (160mg qd po) to receive furmonertinib based on their own willingness and the clinician's decision, until disease, progression or uncontrollable adverse reactions occur. All patients in Cohort A will undergo efficacy and safety evaluation, with some also participating in pharmacokinetic study; patients in Cohort B will only undergo pharmacokinetic study.
Efficacy and safety evaluation will be conducted through imaging examinations, neurological function assessment scales, quality of life self-assessment scales, and adverse event records. Pharmacokinetic study will be carried out by detecting the plasma concentrations and CSF concentrations of furmonertinib and its active metabolites, and calculating the CSF penetration rate for evaluation.

Start Date01 Jan 2026

Sponsor / Collaborator

Guangzhou University of Chinese Medicine

NCT07298148

/ Not yet recruitingPhase 2IIT

A Multicenter, Prospective, Phase II, Single-Arm Study of Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating Stable Disease After 8 Week Induction With Firmonertinib 80 mg

This study evaluates the efficacy and safety of Firmonertinib 160 mg once daily in patients with EGFR-mutant, advanced NSCLC who achieve stable disease after first-line Firmonertinib 80 mg for 8 weeks.

Start Date01 Jan 2026

Sponsor / Collaborator-

ChiCTR2500114582

/ Not yet recruitingPhase 2IIT

A Single-Arm, Multicenter, Phase II Clinical Trial of Firmonertinib in Combination With Definitive Radiotherapy for Patients With Stage III Unresectable Pulmonary Adenocarcinoma Harboring Positive EGFR Uncommon Driver Mutations

Start Date01 Jan 2026

Sponsor / Collaborator

Hunan Cancer Hospital

100 Clinical Results associated with Alflutinib Mesylate

100 Translational Medicine associated with Alflutinib Mesylate

100 Patents (Medical) associated with Alflutinib Mesylate

119

Literatures (Medical) associated with Alflutinib Mesylate

01 Feb 2026·CANCER SCIENCE

Third‐Generation EGFR ‐ TKIs Combined With Chemotherapy in Advanced Non‐Small Cell Lung Cancer: A Real‐World Study

Article

Author: Qi Liang ; Xiao Liang ; Renhua Guo ; Ruohan Huang ; YuQin Jiang ; Chen Zhang ; Jiali Xu ; Wenxin Zhou ; Yuting Zhu ; Jun Li

ABSTRACT:

FLAURA2 has demonstrated that third‐generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR‐TKIs) plus chemotherapy brought a significant survival benefit over EGFR‐TKI monotherapy. This suggests that EGFR‐TKIs combined with chemotherapy may be a viable therapeutic strategy. Our study aimed to evaluate the efficacy, safety, and progression pattern of third‐generation EGFR‐TKIs combined with chemotherapy in advanced EGFR ‐mutant ( EGFR m) non‐small cell lung cancer (NSCLC) in the real world. This study designed as an observational, retrospective, single‐center, real‐world project enrolled 382 NSCLC individuals receiving third‐generation EGFR‐TKIs combined with platinum‐based chemotherapy as first‐line therapy. The primary end point was progression‐free survival (PFS), and secondary end points included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). From July 2016 to May 2024, 382 patients were retrospectively included for the analysis. Of these patients, 120, 165, and 97 patients received osimertinib, aumolertinib, and furmonertinib plus chemotherapy as first‐line therapy, respectively. Overall, the median follow‐up duration was 34.6 months (95% CI: 32.2–35.6), the median PFS was 30.9 months (95% CI: 27.5–39.3), and the median OS was 53.9 months (95% CI: 46.2–NR). Overall, the ORR was 76.4% and the DCR was 98.2%. One hundred thirty‐seven (35.9%) individuals experienced Grade 3 or higher AEs. Different third‐generation EGFR‐TKI groups show no statistically significant difference in PFS (HR = 0.75; 95% CI: 0.51–1.10; p = 0.25) after inverse probability of treatment weighting (IPTW), nor in AEs or severe AEs ( p = 0.852; p = 0.502). First‐line third‐generation EGFR‐TKI combined with pemetrexed‐based chemotherapy demonstrated a favorable ORR and PFS benefit in advanced EGFR m NSCLC.

23 Jan 2026·MEDICINE

Furmonertinib in lung adenocarcinoma with EGFR exon 20 insertion mutation: A case report of positive outcome

Article

Author: You, Chuanyu ; Wang, Qilin ; Gui, Yan ; Chen, Xinyu ; Ye, Juncai ; Xu, Tian ; Yang, Xueping ; Zeng, Beilei

Rationale::

epidermal growth factor receptor (EGFR) mutations play a pivotal role in non-small cell lung cancer (NSCLC), with the EGFR exon 20 insertion (EGFR20ins) mutation being the third most prevalent alteration in the EGFR gene. Patients harboring this mutation typically exhibit a greater tumor burden and poorer overall prognosis. This mutation is strongly associated with resistance to EGFR-TKIs, presenting significant challenges for clinical management. Furmonertinib, an innovative third-generation EGFR-TKI, has been validated in numerous trials for its effectiveness in targeting the EGFR20ins mutation. Against this background, the study aims to explore the clinical application of furmonertinib in patients with advanced EGFR20ins-mutant NSCLC.

Patient concerns::

A patient with advanced EGFR20ins-mutant NSCLC initially presented with a significant tumor burden, resulting in rapid disease progression and a decline in quality of life, which subsequently led to a poor prognosis.

Diagnoses::

Next-generation sequencing of the tumor tissue identified an EGFR20ins mutation (p.p772_H773insPHP) with a mutation prevalence of 83.58%.

Interventions::

The patient received high-dose furmonertinib as first-line treatment. Throughout the treatment, tumor burden, disease stability, progression-free survival (PFS), and adverse effects were closely monitored.

Outcomes::

The patient experienced prolonged advantages from high-dose furmonertinib as initial therapy and attained a PFS of 27 months. The patient demonstrated substantial reduction in tumor burden, attained extended disease stability, and noted enhancements in overall quality of life, accompanied by tolerable adverse effects.

Lessons::

Furmonertinib, as a third-generation EGFR-TKI, demonstrated substantial efficacy in patients with advanced EGFR20ins-mutant NSCLC, significantly extending PFS and improving quality of life. This drug offers a promising new treatment option for patients with resistance to conventional therapies. Further studies will help validate the application of furmonertinib in a broader patient population.

20 Jan 2026·Cancers

Zipalertinib-A Novel Treatment Opportunity for Non-Small Cell Lung Cancers with Exon 20 Insertions and Uncommon EGFR Mutations.

Review

Author: Reinmuth, Niels ; Fenchel, Klaus ; Dempke, Wolfram C M

Non-small cell lung cancer (NSCLC) represents over 80% of all lung cancer cases and still has a huge mortality worldwide. Targeting epidermal growth-factor receptor (EGFR) alterations with overall response rates of more than 80% has provided a paradigm shift in the treatment of NSCLC; however, NSCLC patients harbouring uncommon mutations and exon 20 insertions still have a dismal prognosis underscoring the urgent need to develop novel EGFR tyrosine kinase inhibitors (TKIs) with proven activity against these EGFR alterations. Zipalertinib is a newly developed oral, irreversible compound which is characterized by its unique pyrrolopyrimidine structure which discriminates this novel TKI from others. It is active against the classical mutations (i.e., del19, L858R) and some of the uncommon mutations (e.g., T790M, G719X, S768I, L861Q, but not C797S) and is predominantly active in NSCLC cells harbouring exon20ins. Zipalertinib is currently being extensively evaluated in several clinical NSCLC trials (REZILIENT 1-4) and has shown significant clinical activity in NSCLC patients with uncommon mutations, exon20ins, and in brain metastases (REZILIENT 3 trial). Moreover, zipalertinib in combination with platinum-based chemotherapy followed by zipalertinib monotherapy as first-line therapy is currently being evaluated in the pivotal, ongoing REZILIENT 3 randomized trial. In addition, the efficacy of zipalertinib is also studied in the adjuvant setting (REZILIENT 4 trial, stage IB-IIIA NSCLCs with exon20ins and uncommon mutations). The role and the integration of therapies targeting exon20ins or uncommon mutations into the first- and second-line treatment armamentarium for NSCLC patients is not yet fully established, and the therapeutic impact of monotherapies (e.g., sunvozertinib, firmonertinib) versus combinations with standard platinum-based chemotherapy (e.g., zipalertinib, amivantamab) currently still lacks robust evidence to further change the therapeutic landscape for these patients. Therefore, results from the ongoing trials are eagerly awaited and are expected to shed some light on these open questions.

News (Medical) associated with Alflutinib Mesylate

12 Jan 2026

·www.prnewswire.com

Fast-Tracking the $537B Cancer Cure: How Accelerated Approvals Reshaping Oncology in 2026

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Jan. 12, 2026 /PRNewswire/ -- USANewsGroup.com News Commentary – The oncology landscape is entering a high-velocity regulatory phase as genomics in cancer care expands toward a projected $69.16 billion by 2032[1]. This massive growth is driven by the systematic integration of genotype-directed treatment pathways into standard medical practice. The precision medicine market is now on a trajectory to expand from $138.67 billion in 2026 to over $537.17 billion by 2035[2]. This strategic pivot toward registration-ready precision assets fuels the 2026 investment case for Oncolytics Biotech Inc. (NASDAQ: ONCY), CG Oncology (NASDAQ: CGON), Zentalis Pharmaceuticals (NASDAQ: ZNTL), ArriVent BioPharma (NASDAQ: AVBP), and PDS Biotechnology (NASDAQ: PDSB). The financial momentum behind expedited development pathways is reaching a fever pitch: the orphan drug market is projected to surge from $216.66 billion in 2025 to $687.47 billion by 2035[3]. Current FDA accelerated approval frameworks have already demonstrated meaningful population health gains across 65% of solid tumor indications studied[4]. This validates a new generation of registration-directed study designs that prioritize objective response rates as critical catalysts for major capital allocation in the fight against rare and resistant cancers. Oncolytics Biotech Inc. (NASDAQ: ONCY) is advancing pelareorep, an investigational immunotherapy, toward potential accelerated approval in anal cancer after reporting third-line data that nearly tripled historical response rates in a setting with no FDA-approved treatment options. The company announced updated clinical data from GOBLET Cohort 4 showing pelareorep combined with atezolizumab achieved a 29% objective response rate in patients with third-line metastatic squamous cell anal carcinoma (SCAC). These responses included two complete responses among 14 evaluable patients. Notably, the median duration of response was approximately 17 months (67 weeks). Historical third-line SCAC studies typically show objective response rates of approximately 10% or less, and when responses do occur, duration of response is generally limited. The third-line results build on equally compelling second-line data, where pelareorep achieved a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response reached 15.5 months compared to 9.5 months for standard care, with two durable complete responses. This depth and durability of responses in heavily pretreated patients address a critical unmet need. There are currently no FDA-approved therapies for patients with third-line anal cancer, making pelareorep's activity particularly significant for a patient population with virtually no options outside of chemotherapy. Based on these results and after initial encouraging feedback from the FDA, Oncolytics plans to advance pelareorep into a registration-directed clinical study in second-line and later SCAC. Oncolytics is planning a Type C meeting with the FDA in Q1 2026 to discuss and receive guidance on this development plan. If the objective response rate and duration of response observed in GOBLET Cohort 4 are reproduced in the planned registration study, Oncolytics believes the resulting dataset would be sufficient to support accelerated approval in this indication, consistent with regulatory precedent in rare cancers with no available therapies. "As we continue to analyze the Goblet data, we are finding important trends that are helping to shape our clinical development strategy," said Jared Kelly, Chief Executive Officer of Oncolytics. "When you isolate to anal cancer patients with two prior lines of treatment and see a strong signal like this, it points the arrow in a direct line to a registration study in an indication where there are no FDA-approved therapies. We already had good data here, but looking closer, it becomes clearer that we can make an immediate impact on patients' lives who have no options." The company's broader gastrointestinal oncology strategy received validation through expansion of its Scientific Advisory Board with three globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center. Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease. Leading the charge is CEO Jared Kelly and Chief Business Officer Andrew Aromando, who were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: CG Oncology (NASDAQ: CGON) announced an expedited timeline for the topline data readout now expected in the first half of 2026 for its Phase 3 PIVOT-006 clinical trial comparing adjuvant intravesical cretostimogene grenadenorepvec versus surveillance in patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). PIVOT-006 is the first Phase 3 randomized trial in this patient population, encompassing the broadest range of patient types per AUA/SUO Guidelines, including HG Ta solitary lesions < 3cm, with enrollment completed early across over 90 sites. "We are thrilled to announce that we now expect PIVOT-006 topline Phase 3 data in the first half of 2026, which is nearly one year ahead of schedule thanks to the unprecedented early completion of enrollment," said Arthur Kuan, Chairman and CEO of CG Oncology. "The IR population is estimated to be greater than fifty thousand patients in the US alone, and we look forward to broadening our potential reach to individuals living with IR NMIBC." The expedited timeline represents nearly one year of advancement from the original schedule. Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy studied in more than 400 patients with NMIBC across multiple clinical trials, including the pivotal BOND-003 trial. Zentalis Pharmaceuticals (NASDAQ: ZNTL) provided a corporate update highlighting key milestones and expected momentum in the azenosertib development program for 2026, including completion of enrollment in DENALI Part 2a with dose confirmation expected in the first half of 2026. DENALI Part 2 trial topline readout is expected by year end 2026 with potential to support accelerated approval, while initiation of the ASPENOVA Phase 3 randomized confirmatory trial is planned in the first half of 2026. "2026 represents a pivotal year for Zentalis as we advance azenosertib toward potential approval in Cyclin E1-positive platinum-resistant ovarian cancer and continue to assess its role in additional indications," said Julie Eastland, Chief Executive Officer of Zentalis. "With our strong financial foundation providing an estimated runway into late 2027, we remain focused on executing our strategy to bring this potentially first-in-class, non-chemo, oral therapy to the approximately 50% of PROC patients who are Cyclin E1-positive—a population with significant unmet needs." Strong data across three trials established a solid foundation for the lead indication in Cyclin E1-positive platinum-resistant ovarian cancer. The Company maintained a strong cash position with $280.7 million in cash, cash equivalents and marketable securities as of September 30, 2025. ArriVent BioPharma (NASDAQ: AVBP) announced the first patient has been dosed in the global pivotal Phase 3 ALPACCA study evaluating firmonertinib monotherapy for first-line treatment of EGFR PACC mutant non-small cell lung cancer (NSCLC), with firmonertinib having the potential to redefine first-line treatment in this underserved population as a once daily, oral, brain-penetrant, chemo-free monotherapy. The ALPACCA pivotal trial is designed to support potential accelerated and full regulatory approvals with global ex-China annual incidence of NSCLC patients with EGFR PACC mutations estimated at approximately 42,000 patients. "Initiation of our pivotal Phase 3 ALPACCA trial marks an important milestone in our strategy to expand the global reach of firmonertinib," said Bing Yao, Ph.D., Chairman and Chief Executive Officer of ArriVent. "Patients with EGFR PACC mutant NSCLC currently have limited treatment options and represent a clear unmet medical need. We believe firmonertinib is strongly positioned to bring meaningful innovation to NSCLC patients with PACC mutations and the potential to become a cornerstone therapy across the EGFR mutant spectrum." The randomized Phase 3 study evaluates firmonertinib 240 mg once daily versus the investigator's choice of osimertinib or afatinib in first-line patients with EGFR PACC mutant NSCLC. Firmonertinib was granted FDA Breakthrough Therapy Designation for previously untreated EGFR exon 20 insertion mutations. PDS Biotechnology (NASDAQ: PDSB) announced FDA alignment on the use of progression-free survival as the primary endpoint and submitted an amended protocol for Phase 3 VERSATILE-003 trial following a constructive Type C meeting held with the FDA in December 2025. The submission follows positive final results from the Company's VERSATILE-002 trial, which showed promising median overall survival and durable PFS, with the proposed amendment changing the PFS endpoint to a primary endpoint that can be evaluated earlier with significant statistical power. The amendment retains median overall survival and safety as requirements for full FDA approval and is supported by dialogue with the agency, providing a pathway to potentially accelerate regulatory submission. PDS Biotech specializes in developing novel immunotherapies to transform cancer care, with PDS0101 being developed in combination with checkpoint inhibitors. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES CITED: 1. 2. 3. 4. Logo: 21% more press release views with Request a Demo

Phase 3Breakthrough TherapyClinical ResultImmunotherapyAcquisition

27 Dec 2025

·www.globenewswire.com

ArriVent Announces First Patient Dosed in Global Pivotal Phase 3 ALPACCA Trial Evaluating Firmonertinib for First-Line Treatment of EGFR PACC Mutant Non-Small Cell Lung Cancer

Firmonertinib has the potential to redefine first-line treatment in this underserved population as a once daily, oral, brain-penetrant, chemo-free monotherapy ALPACCA pivotal trial is designed to support potential accelerated and full regulatory approvals Dec. 22, 2025 -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that the first patient has been dosed in the global pivotal Phase 3 ALPACCA study evaluating firmonertinib monotherapy for first-line treatment of EGFR PACC mutant non-small cell lung cancer (NSCLC). Firmonertinib is an oral, once daily, highly brain-penetrant and broadly active mutation-selective EGFR inhibitor. “Initiation of our pivotal Phase 3 ALPACCA trial marks an important milestone in our strategy to expand the global reach of firmonertinib,” said Bing Yao, Ph.D., Chairman and Chief Executive Officer of ArriVent. “Patients with EGFR PACC mutant NSCLC currently have limited treatment options and represent a clear unmet medical need. With a well-characterized safety profile and broad clinical systemic and central nervous system (CNS) activity in patients, we believe firmonertinib is strongly positioned to bring meaningful innovation to NSCLC patients with PACC mutations and the potential to become a cornerstone therapy across the EGFR mutant spectrum.” PACC mutations represent a distinct and underserved population of EGFR mutant NSCLC, with limited approved first-line targeted therapies and historically poor outcomes. The ALPACCA (FURMO-006) randomized, global Phase 3 study is evaluating firmonertinib 240 mg once daily versus investigator’s choice of osimertinib or afatinib in first-line patients with EGFR PACC mutant NSCLC. The primary endpoints are overall response rate (ORR) and progression-free survival (PFS) by blinded independent central review (BICR). The 240 mg dose of firmonertinib was selected for pivotal development based on compelling data showing a 16-month median PFS and a confirmed 68% ORR by BICR in the FURTHER trial. The ALPACCA study is designed to support potential global registration with endpoints for accelerated and full approval pathways. We estimate that the global ex-China annual incidence of NSCLC patients with EGFR PACC mutations to be approximately 42,000 patients and the US annual incidence to be approximately 6,200 patients. ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization. Firmonertinib is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. In March 2021, firmonertinib was approved in China for first-line advanced non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations. Firmonertinib was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. Firmonertinib was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations. Firmonertinib is currently being studied in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase 3 study in first line NSCLC patients with EGFR PACC mutations (ALPACCA). Globally, lung cancer is the leading cause of cancer-related deaths among men and women. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the EGFR is a frequent and early event in the development of NSCLC. EGFR mutations are divided into classical and uncommon. EGFR exon 20 insertion mutations are a group of uncommon EGFR mutations and constitute approximately 9% of all EGFR mutations. PACC mutations are another group of uncommon EGFR mutations and represent approximately 12% of all EGFR mutations. Patients with NSCLC whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy with available therapies and represent an area of unmet medical need. P-loop and αC-helix compressing (PACC) EGFR mutations are a distinct set of approximately 70 mostly missense activating mutations within the kinase domain of EGFR. They are similar to Exon 20 insertion mutations in narrowing the drug binding pocket to affect tyrosine kinase inhibitor activity. PACC mutations are diagnosed through commercially available NGS and most PCR tests. Patients with PACC mutations have limited treatment options, and there is no broadly utilized standard of care treatment for first-line PACC mutant patients. FURVENT is a global, pivotal, 3 arm Phase 3 clinical trial of firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with exon 20 insertion mutations being conducted jointly with our partner Allist. The FURVENT clinical trial is designed to assess the safety and efficacy of firmonertinib administered at either 160 mg or 240 mg, once-daily with each dose being compared to platinum-based chemotherapy with pemetrexed, the current first-line standard of care. The primary endpoint of this study is PFS by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Secondary endpoints in patients with brain metastases at baseline include brain-specific CNS overall response rate (CNS-ORR) and CNS-PFS by modified RECIST (mRECIST). The study enrolled 398 patients globally, including from sites in the United States, Europe and certain Asian countries including Japan and China. An interim analysis for this study has not been performed and there is no plan to perform such analysis given the expected timing of top-line data. The content above comes from the network. if any infringement, please contact us to modify.

Orphan DrugBreakthrough TherapyClinical ResultDrug Approval

16 Dec 2025

·www.prnewswire.com

Immunotherapy Breakthroughs Turn Cold GI Tumors Hot as Market Tops $443B

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Dec. 16, 2025 /PRNewswire/ -- USANewsGroup.com News Commentary – Gastrointestinal cancers that once resisted checkpoint inhibitors are finally responding to novel combination strategies[1], with the FDA fast-tracking multiple targeted therapies designed to transform immunologically cold tumors into treatment-responsive hot targets[2]. This pivotal shift positions Oncolytics Biotech Inc. (NASDAQ: ONCY), AIM ImmunoTech (NYSE-American: AIM), ArriVent BioPharma, Inc. (NASDAQ: AVBP), Merus N.V. (NASDAQ: MRUS), and Halozyme Therapeutics, Inc. (NASDAQ: HALO) as potential leaders in the battle against stolid tumors, including gastrointestinal cancers. The global cancer immunotherapy market is projected to reach $443.17 billion by 2030, growing at 11.90% annually as regulators accelerate approvals for therapies that activate immune responses in historically resistant gastrointestinal malignancies[3]. Institutional capital flows reflect surging confidence in immunotherapy platforms and bispecific antibody combinations, with oncology capturing 53 deals from 115 investors in Q2 2025 alone as the sector races to overcome the immunosuppressive tumor microenvironments that have made first-line GI cancer immunotherapy one of oncology's most challenging frontiers[4]. Oncolytics Biotech Inc. (NASDAQ: ONCY) has announced promising efficacy and translational data supporting pelareorep in KRAS-mutant metastatic colorectal cancer, achieving a 33% objective response rate in second-line patients with microsatellite-stable disease who received pelareorep, Avastin, and FOLFIRI. This represents triple the historical response rate of 6-11% for Avastin plus FOLFIRI in this setting. The data strengthen pelareorep's potential across gastrointestinal tumors, building on recent anal cancer results showing a 30% response rate in second-line squamous cell anal carcinoma, more than double the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response reached 15.5 months compared to 9.5 months for current standard care, with two durable complete responses among responders. Translational analysis revealed that pelareorep treatment led to notable increases in KRAS-mutant-specific T-cell populations, providing mechanistic support for the clinical activity observed in this genetically defined patient population. These findings position pelareorep as a precision immunotherapy capable of providing a meaningful clinical benefit over the current standard of care. "Colorectal cancer is the core of our emerging GI tumor platform strategy for pelareorep, with a projected total addressable market of $20 billion by 2033," said Jared Kelly, CEO of Oncolytics Biotech. "Pelareorep has clearly demonstrated the potential to become a transformational new treatment option in this underserved setting. With translational data supporting its unique activation of KRAS-specific T cells, pelareorep has delivered a 33 percent response rate in KRAS-mutant, MSS colorectal cancer." The company plans to sponsor a controlled study in second-line KRAS-mutant MSS colorectal cancer following consultation with key opinion leaders and regulatory authorities, providing analytical rigor to support potential regulatory submissions. This will enable Oncolytics to have control over the data generated from this study and update relevant stakeholders at their discretion, including investors and potential partners. "These results are extremely encouraging," said Dr. Sanjay Goel, Professor of Medicine at Rutgers Cancer Institute of New Jersey. "Achieving a 33% ORR in KRAS-mutant MSS colorectal cancer is highly unusual in this setting and warrants immediate further study." The company recently established a Gastrointestinal Tumor Scientific Advisory Board to guide registration strategy across pancreatic, colorectal, and anal cancers. Inaugural members include Dr. Goel, Dr. Deva Mahalingam from Northwestern University, and Dr. Dirk Arnold, principal investigator of the GOBLET study. Oncolytics has also secured FDA alignment on its pivotal Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning the company to launch the only immunotherapy registration trial currently planned for this disease. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer. CEO Jared Kelly and Chief Business Officer Andrew Aromando were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson, demonstrating proven ability to advance assets through value-creating transactions. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: AIM ImmunoTech (NYSE-American: AIM) has reported positive clinical progress in its ongoing DURIPANC clinical trial combining Ampligen and AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi for metastatic pancreatic cancer. The company reported Q3 2025 research and development expenses of approximately $607,000, compared to $1.4 million in the prior year period, while maintaining a focused monthly burn rate of approximately $550,000. "The third quarter was marked by solid and positive clinical and operational execution," said Thomas K. Equels, CEO of AIM ImmunoTech. "Our clinical, manufacturing and regulatory teams are heavily focused on moving Ampligen down a pathway toward eventual FDA approval as part of a combination therapy for pancreatic cancer." The company expects to release a year-end update from the DURIPANC trial by the end of the current quarter. AIM ImmunoTech reported cash, cash equivalents and marketable investments of $2.4 million as of September 30, 2025, with a net loss of $3.3 million or $1.57 per share for Q3 2025. ArriVent BioPharma, Inc. (NASDAQ: AVBP) presented final Phase 1b data at the 2025 World Conference on Lung Cancer, demonstrating clinically meaningful outcomes for firmonertinib in EGFR PACC mutant non-small cell lung cancer, advancing two global Phase 3 pivotal studies across uncommon EGFR mutations. The company maintained $305.4 million in cash and investments as of September 30, 2025, supporting operations into mid-2027, while receiving FDA IND clearance for ARR-217, a CDH17-targeted antibody-drug conjugate for gastrointestinal cancers. "Our late-stage firmonertinib program continues to make strong progress across EGFR-mutant NSCLC populations, with two global Phase 3 pivotal studies being conducted in uncommon EGFR mutant non-small cell lung cancer," said Bing Yao, CEO of ArriVent. "Following our strong Phase 1b findings, we are advancing to pivotal development with enrollment of the first patient in our global pivotal Phase 3 trial for PACC mutant NSCLC expected in the fourth quarter of this year. Additionally, we project topline pivotal data from our global Phase 3 trial in exon 20 insertion mutant NSCLC in early 2026, a patient population for which firmonertinib received FDA Breakthrough Therapy Designation." The ALPACCA Phase 3 study expects to enroll its first patient in Q4 2025 for first-line PACC mutant NSCLC, while the FURVENT Phase 3 trial targeting exon 20 insertion mutations projects topline data in early 2026. ArriVent also appointed Brent S. Rice as Chief Commercial Officer to establish commercial leadership ahead of potential regulatory milestones. Merus N.V. (NASDAQ: MRUS) and Halozyme Therapeutics, Inc. (NASDAQ: HALO) entered a global collaboration to develop a subcutaneous formulation of petosemtamab using Halozyme's ENHANZE® drug delivery technology. Petosemtamab, an EGFR x LGR5 bispecific antibody, continues to show encouraging results across numerous solid tumor cancers with the potential to become a first-in-class treatment for head and neck cancer. "We are excited to collaborate with Merus to advance treatment options for patients with r/m HNSCC and other potential indications," said Dr. Helen Torley, CEO of Halozyme. "This collaboration represents a new opportunity for our ENHANZE® technology to improve treatment efficiency and enhance the patient treatment experience." Under the agreement terms, Merus will make an upfront payment to Halozyme plus potential future milestone payments related to commercial and sales attainment. Halozyme will be entitled to up to low-mid single digit royalties on net sales of petosemtamab formulated with the ENHANZE® technology during the royalty term. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES CITED: 1. 2. 3. 4. Logo - 21% more press release views with Request a Demo

Phase 3Phase 1ImmunotherapyClinical ResultBreakthrough Therapy

100 Deals associated with Alflutinib Mesylate

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-	-	L01XE	DB16087

R&D Status

Approved

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Indication	Country/Location	Organization	Date
EGFR ex20ins mutation in non-small cell lung cancer	China	Shanghai Allist Pharmaceuticals Co., Ltd.	02 Feb 2026
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	China	Shanghai Allist Pharmaceuticals Co., Ltd.	28 Jun 2022
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	China	Shanghai Allist Pharmaceuticals Co., Ltd.	28 Jun 2022
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	China	Shanghai Allist Pharmaceuticals Co., Ltd.	03 Mar 2021

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Japan	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Hong Kong	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Singapore	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	South Korea	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Spain	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Taiwan Province	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United Kingdom	Arrivent BioPharma, Inc.	17 Dec 2025
EGFR mutation Solid Tumors	Phase 3	United States	Arrivent BioPharma, Inc.	17 Dec 2025
EGFR mutation Solid Tumors	Phase 3	Japan	Arrivent BioPharma, Inc.	17 Dec 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05364073 (FURMO-002, NEWS) Manual	Phase 1	EGFR-mutated non-small Cell Lung Cancer First line EGFR PACC 突变	-	艾弗沙	xytszwwecx(wjseruptjs) = stdrsytvyf zfsqwcspxn (jymukxktcg ) View more	Positive	26 Dec 2025
ChiCTR2200057048 (ESMO_ASIA2025)	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR 19DEL \| EGFR L858R	20	firmonertinib 160mg	ehmtswaikr(zeadnzskvj) = yfszmshrmy zzwenmzyfe (dxedljebxx, 62.1 - 96.8) View more	Positive	05 Dec 2025
NCT05466149 (FURMO-003, ESMO2025) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma EGFR Exon 20 Insertion	71	Firmonertinib 240 mg QD	vcosokfrjh(tkuugixsrs) = nlblibjdds lkwqoryuir (uhfcsvueqq ) View more	Positive	17 Oct 2025
NCT04858958 (FAVOUR, ESMO2025)	Phase 1	Non-Small Cell Lung Cancer EGFR ex20ins	90	Firmonertinib (detectable EGFR ex20ins at baseline)	kyrcsupfhv(hxvhkngekt) = tnjqlqpxrg nhwbvuegtj (gzkkkkugmo ) View more	Positive	17 Oct 2025
				Firmonertinib (ctDNA negative at baseline)	hvprstoxbx(btzidjjwpi) = pvcbewwznj imbhixtzrh (bokyrkswyo ) View more
NCT05364073 (FURTHER，FURMO-002, WCLC2025)	Phase 1	Advanced Lung Non-Small Cell Carcinoma First line EGFR PACC mutation	45	Alflutinib (240 mg, QD)	tdyyeujbmu(huyxqehsre) = uwbqzgvbbm oyqqobvfky (uupecvigdu, 59.7 - 94.8) View more	Positive	09 Sep 2025
				Alflutinib (160 mg QD)	tdyyeujbmu(huyxqehsre) = yjmtntgwnp oyqqobvfky (uupecvigdu, 30.6 - 73.2) View more
ChiCTR2200060897 (FIRM, WCLC2025)	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line EGFR sensitive mutation (Ex19del, L858R)	33	Alflutinib 160 mg	kfyqwwveso(sapbfxzrru) = ndqffttvus kytfoxwjmy (dtebxgugbe, 17.5 - NR) View more	Positive	09 Sep 2025
				Alflutinib 160 mg (patients with baseline brain metastases)	tzmaagytxs(mrbqydbqxp) = ojzefmmibj jatngeluek (liabsolqom ) View more
NCT05165355 (ATHEM, WCLC2025)	Phase 2	Lung Cancer \| Non-Small Cell Lung Cancer Adjuvant EGFR sensitive mutation (Ex19del, L858R)	79	Alflutinib	zhqplyxkza(bfsmryvjtk) = hzphsszxwr ngvblxfzsn (xajoieubsm )	Positive	07 Sep 2025
NCT05364073 (FURTHER, NEWS) Manual	Phase 1	Non-Small Cell Lung Cancer \| EGFR-mutated non-small Cell Lung Cancer First line EGFR	-	Firmonertinib Firmonertinib 240 mg	qwsnnpjkfr(frcponkmvl) = pbwotwxeki wxjlfztgit (kkkumgvumb ) View more	Positive	23 Jun 2025
				FirmonertinibFirmonertinib 160 mg	qwsnnpjkfr(frcponkmvl) = aaeuzowlau wxjlfztgit (kkkumgvumb )
NCT04895930 (FOCUS-A, ESMO_ELCC2025) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line	40	Firmonertinib 80 mg qd + Anlotinib 10 mg qd	pczkdcrgur(nsvxzktgdv) = wisrmsmtzg dhpyqdissx (vlswlovenf, 73.2 - 95.8) View more	Positive	26 Mar 2025
				Firmonertinib 80 mg qd + AnlotinibAnlotinib 10 mg qd (baseline CNS metastases)	pczkdcrgur(nsvxzktgdv) = extseflxxe dhpyqdissx (vlswlovenf, 61.7 - 98.5) View more
ESMO_ELCC2025	Not Applicable	EGFR-mutated non-small Cell Lung Cancer Adjuvant EGFR mutations	135	Furmonertinib 80 mg	yvusvnqwba(rpoxtjzsdf) = skplxvamqo rlignvltrd (jdnqbxfuji ) View more	Positive	26 Mar 2025

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