FGFRs antagonists(Fibroblast growth factor receptors antagonists), PDGFR antagonists(Platelet-derived growth factor receptor antagonists), Tyrosine kinase inhibitors

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseRespiratory Diseases+ [8]

Active Indication

Endometrial CarcinomaExtensive stage Small Cell Lung CancerDifferentiated Thyroid Gland Carcinoma+ [57]

Inactive Indication

Acral Lentiginous Malignant Melanomaadenocarcinoma of biliary tractAdvanced Bile Duct Carcinoma+ [31]

Originator Organization

Advenchen Laboratories LLC

Active Organization

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Advenchen Laboratories LLC

Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.

Inactive Organization

Peking University People's Hospital

Drug Highest PhaseApproved

First Approval Date

China (08 May 2018),

Non-Small Cell Lung Cancer

RegulationOrphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Special Review Project (China)

Structure/Sequence

Molecular FormulaC23H23ClFN3O3

InChIKeyGTAUHBAHFJIAQT-UHFFFAOYSA-N

CAS Registry1360460-82-7

649

Clinical Trials associated with Anlotinib Dihydrochloride

NCT06874933

/ Not yet recruitingPhase 2IIT

A Prospective, Single-Arm Clinical Study on the Treatment of HR+/HER2- Breast Cancer With Neoadjuvant Chemotherapy Combined With Anlotinib and Benmelstobart Monoclonal Antibody

Our center plans to conduct a prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Anlotinib and Benmelstobart in the treatment of HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy de-escalation for patients with HR+/HER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer.

Start Date01 Apr 2025

Sponsor / Collaborator

The First Affiliated Hospital, Zhejiang University Sch of Med

NCT06851169

/ Not yet recruitingPhase 2IIT

A Two-cohort, Exploratory Clinical Study of Perioperative Benmelstobart Alone or Combined with Anlotinib in Patients with Resectable PD-L1≥50% Non-small Cell Lung Cancer

A total of 58 patients were enrolled in this exploratory study and randomly assigned to cohort 1 and cohort 2, with 29 patients in each group. Cohort 1: Neoadjuvant therapy (benmelstobart combined with anlotinib, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 12 mg, po, qd, was taken orally for 2 consecutive weeks and stopped for 1 week. Anlotinib was stopped 1 week before surgery. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 12 mg, po, qd, was taken orally for 2 weeks and stopped for 1 week. Cohort 2: Neoadjuvant therapy (benmelstobart only, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Adjuvant therapy (benmelstobart, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1.

Start Date01 Apr 2025

Sponsor / Collaborator

Tangdu Hospital

NCT06848439

/ Not yet recruitingPhase 2IIT

A Phase II Study of Benmelstobart Combined with Anlotinib and Chemotherapy As Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients with Locally Advanced Oral Cancer

Exploring the Safety and Efficacy of Benmelstobart Combined with Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients with Locally Advanced Oral Cancer
This is a single-center, Phase II study targeting patients with stage III-IVb locally advanced oral squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy consists of Benmelstobart combined with Anlotinib and chemotherapy for 3 cycles (21 days per cycle). Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading:
Group A (Pathological Complete Response, pCR): Postoperative radiotherapy (RT) alone: 45Gy/5 weeks.
Group B (Major Pathological Response, MPR): Postoperative radiotherapy (RT) alone: 50-55Gy/5 weeks.
Group C (Partial Pathological Response/No Pathological Response):
Low-to-intermediate risk patients (no extracapsular nodal extension and negative margins): RT: 60Gy/6 weeks.
High-risk patients (extracapsular nodal extension and/or positive margins): Concurrent chemoradiotherapy (CCRT): 60-66Gy/6-6.6 weeks + Cisplatin: 60mg/m² every 3 weeks, 2-3 cycles.
Additionally, all patients will receive adjuvant Benmelstobart 3-4 weeks after surgery, followed by Benmelstobart maintenance therapy (total treatment duration of 1 year).

Start Date15 Mar 2025

Sponsor / Collaborator

Jiangsu Cancer Hospital

100 Clinical Results associated with Anlotinib Dihydrochloride

100 Translational Medicine associated with Anlotinib Dihydrochloride

100 Patents (Medical) associated with Anlotinib Dihydrochloride

1,248

Literatures (Medical) associated with Anlotinib Dihydrochloride

31 Dec 2025·ANNALS OF MEDICINE

The efficacy and safety of anlotinib plus PD-1 inhibitor in locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients who progressed on prior immune checkpoint inhibitors (ICIs): a retrospective real-world study (NCT 04984096)

Article

Author: Zhang, Ming ; Yu, Wen ; Ma, Xiumei ; Liu, Jun ; Zhu, Xueru ; Li, Zhigang ; Fu, Xiaolong ; Zhao, Lei ; Cheng, Yan ; Li, Hongxuan ; Feng, Wen ; Wu, Jianguo

BACKGROUND:

Several studies have shown that combining immune checkpoint inhibitors (ICIs) with antiangiogenic tyrosine kinase inhibitors is effective for solid tumors, including esophageal squamous cell carcinoma (ESCC). However, most of these studies were focused on immunotherapy-naive patients. This retrospective real-world study offers insights into the efficacy and safety of combining anlotinib with ICIs in locally advanced/metastatic ESCC patients who progressed on prior ICI.

METHODS:

We retrospectively analyzed the efficacy and safety of anlotinib plus PD-1 inhibitor in locally advanced/metastatic ESCC patients who had progressed on PD-1 inhibitor. Efficacy was assessed according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The primary endpoints were the objective response rate (ORR) and disease control rate (DCR), while secondary endpoints were safety, overall survival (OS) and progression-free survival (PFS). Baseline characteristics and adverse events (AEs) were documented throughout the study.

RESULTS:

Between July 2020 and March 2022, 29 eligible patients were included in the final analysis, with 23 (79.3%) having previously undergone resection for ESCC. Of these 29 patients, 8 (27.6%) received first-line systemic therapy, 20 (69.0%) received second-line therapy, and 1 patient (3%) received third-line therapy. At the data cutoff, the ORR was 31.0%, and the DCR was 86.2%, with 9 patients achieving partial response (PR), 16 patients with stable disease (SD) and 4 patients with disease progression (PD). The median PFS was 5.33 months (95% CI: 4.28-6.38), and the median OS was 10.37 months (95% CI: 6.26-14.46). All patients experienced treatment-related adverse events (TRAEs), with anemia and lymphopenia being the most common. Only 2 patients (6.9%) experiencing grade 3-4 lymphopenia. All AEs were managed with symptomatic treatment and no treatment-related deaths occurred.

CONCLUSION:

The combination of anlotinib and a PD-1 inhibitor demonstrated promising antitumor efficacy and manageable toxicity in patients with locally advanced/metastatic ESCC who progressed on prior ICI. This regimen represents a feasible and well-tolerated treatment option for this patient population.

TRIAL REGISTRATION NUMBER:

NCT04984096.

01 Aug 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Development and validation of a UPLC-MS/MS method for almonertinib with its active metabolite HAS-719 and anlotinib in human plasma

Article

Author: Huang, Chenrong ; Qin, Yi ; Miao, Liyan ; Guan, Xiaojun ; Zhang, Zijie ; Zhang, Shichao

Almonertinib and anlotinib are tyrosine kinase inhibitors used to treat malignant tumors, with their combination currently applied to non-small cell lung cancer (NSCLC) patients. This study aimed to develop a simple and rapid UPLC-MS/MS method for simultaneously detecting almonertinib, its active metabolite HAS-719, and anlotinib in human plasma. The analytes were separated on a Waters HSST3-C18 column following protein precipitation with acetonitrile. Mass detection was performed on a Waters TQS triple quadrupole mass spectrometer under positive electrospray ionization mode. The MRM ions were m/z 526.5→71.96 for almonertinib, m/z 512.4 → 455.41 for HAS-719, m/z 408.16→ 339.03 for anlotinib and m/z 518.5→372.26 for d6-HAS-000719 (internal standard). Method validation followed FDA guidelines and Chinese Pharmacopoeia regulations, demonstrating acceptable accuracy, precision, matrix effects, recovery, and stability. The method showed excellent linearity over 0.5-500 ng/mL for all three analytes, with correlation coefficients (r²)≥ 0.99. The validated UPLC-MS/MS method successfully monitored almonertinib and anlotinib concentrations in clinical, particularly for NSCLC patients.

01 May 2025·Journal of Proteomics

Proteomic insights into the molecular mechanism of anlotinib inhibition in TP53-mutated non-small cell lung cancer

Article

Author: Zhang, Teng ; Xia, Quan ; Jiang, Jie-Mei ; Zhang, Li ; Tan, Ting-Fei ; Hou, Kai-Feng ; Shi, Han-Bing ; Cheng, Zi-Wei

OBJECTIVE:

Tumor protein 53 (TP53) is the commonly mutated gene in non-small cell lung cancer (NSCLC) that is associated with poor prognosis, and anlotinib exerts inhibitory effects on TP53-mutated NSCLC. The aim of this study was to investigate the inhibitory effect of anlotinib on TP53-mutated NSCLC and its possible mechanism.

METHODS:

The growth ability of TP53-mutated NSCLC cells were tested by Cell counting kit-8 assay. Proteins in TP53-mutated NSCLC cells treated with anlotinib were analyzed using label-free liquid chromatography-mass spectrometry. Differentially represented proteins were analyzed by KEGG, GO, and PPIs. TP53 pathway related proteins were verified using western blotting.

RESULTS:

The cell viability was significantly reduced in TP53-mutated NSCLC cell as opposed to TP53 wild cell by anlotinib treatment. 126 differentially represented proteins (37 upregulated and 89 downregulated) were found between the anlotinib and control groups in TP53-mutated NSCLC cell. Bioinformatics analyses revealed that the differentially represented proteins were primarily involved in catalytic activity, cellular processes, and metabolite interconversion. PANTHER Classification System found that anlotinib mainly impacted the p53 signaling pathway, De novo purine biosynthesis and Integrin signaling. KEGG enrichment and PPI networks of the differentially represented proteins revealed cyclin-dependent kinase 1 (CDK1) and mitogen-activated protein kinase kinase 3 (MAP2K3) as the core protein, which are related to the p53 signaling pathway. Western blotting also revealed that anlotinib significantly suppressed the expression of CDK1 and MAP2K3 in TP53-mutated NSCLC cells, that indicated the possible mechanism may involve the MAP2K3/p53/CDK1 pathway.

CONCLUSIONS:

Our findings showed that anlotinib selectively inhibited the growth of TP53-mutated NSCLC cells and downregulated the expression levels of CDK1 and MAP2K3. The MAP2K3/p53/CDK1 pathway may be the molecular mechanism underlying anlotinib's efficacy in TP53-mutated NSCLC.

STATEMENT OF SIGNIFICANCE:

Tumor protein 53 (TP53) is the commonly mutated gene in non-small cell lung cancer (NSCLC) that is associated with poor prognosis, and anlotinib exerts inhibitory effects on TP53-mutated NSCLC. However, the action mechanism of anlotinib in the treatment of TP53-mutated NSCLC remains unclear. In this study, we used label-free quantitative proteomics to reveal the molecular mechanism of anlotinib inhibition in TP53-mutated NSCLC. We found that anlotinib significantly inhibited the growth of TP53-mutated NSCLC cells and downregulated the expression levels of CDK1 and MAP2K3. The MAP2K3/p53/CDK1 pathway may be the molecular mechanism underlying anlotinib's efficacy in TP53-mutated NSCLC. Our study promotes the use of anti-angiogenic drugs in TP53-mutated NSCLC. It provides new ideas for the treatment of TP53-mutated NSCLC.

News (Medical) associated with Anlotinib Dihydrochloride

20 Mar 2025

·www.prnewswire.com

Dizal's Golidocitinib in Combination with Anti-PD-1 Shows Promise in IO Resistant Non-Small Cell Lung Cancer

Golidocitinib is a JAK1 only inhibitor approved for the treatment of relapsed or refractory PTCL The combination of golidocitinib and PD-1 antibody showed synergistic anti-tumor effects in anti-PD-1-resistant NSCLC SHANGHAI, March 20, 2025 /PRNewswire/ -- Dizal (SSE: 688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, today announced new findings on golidocitinib, a first-in-class Janus kinase 1 (JAK1) only inhibitor, in combination with PD-1 antibodies for patients who have progressed on anti-PD-1 therapy. The details of the trial design and clinical results will be presented at the 2025 European Lung Cancer Congress (ELCC 2025) in Paris, March 26-29. Recent studies showed that the dysregulated activation of the JAK/STAT pathway, which leads to the prolonged release of IFN-γ, is a significant contributor to the resistance to immune checkpoint inhibitors in cancer immunotherapy. Preclinical and clinical studies have demonstrated that the combination of JAK inhibitors with PD-1 immunotherapy can reverse or delay onset of immunotherapy resistance by modulating the JAK/STAT pathway in Hodgkin's lymphoma and NSCLC. Golidocitinib has shown excellent clinical benefits by effectively inhibiting the JAK/STAT pathway, leading to its approval for the treatment of relapsed/refractory peripheral T-cell lymphoma (r/r PTCL) in China. Preclinical studies also show that the combination of Golidocitinib and PD-1 antibody has synergistic potentials for anti-tumor effects. Building on these findings, an exploratory phase Ib clinical study combining golidocitinib with PD-1 antibodies was designed to explore the synergistic effects of this combined regimen in NSCLC patients who have failed from anti-PD-1 containing regimens. This study will enroll 30 locally advanced or metastatic NSCLC patients who have previously received anti-PD-1 monotherapy or anti-PD-1 therapy with platinum-containing chemotherapy regimens. "Immunotherapy alone or with chemotherapy is commonly used as front line treatment for NSCLC patients without driver mutations. Unfortunately, resistance is inevitable and once the disease progresses, the prognosis is poor and treatment option is limited." said Xiaolin Zhang, PhD, CEO of Dizal. "The findings we are presenting at ELCC 2025 highlight the potential for Golidocitinib-based combination regimen to delay or overcome the resistance. The preliminary results are very promising and justify further clinical validation." In addition to the golidocitinib-based combination therapy, positive results from a Phase II study of sunvozertinib in combination with Anlotinib will also be presented. Sunvozertinib combined with anlotinib was well tolerated and demonstrated encouraging antitumor activity in NSCLC patients with EGFR mutations who had failed prior EGFR-TKI therapies. As of December 25, 2024, the objective response rate (ORR) and the disease control rate (DCR) were 33.3% and 100%, respectively, in this heavily pre-treated patient population. Enrollment is ongoing and detailed results will be updated at the congress. Dizal presentation details during ELCC 2025 About golidocitinib (DZD4205) Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, mDoR reached 20.7 months. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) was published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) was published in The Lancet Oncology (Impact Factor: 54.4). About sunvozertinib (DZD9008) Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable. Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins. Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine. About Dizal Dizal is a biopharmaceutical company, dedicated to the discovery, development, and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two approved drugs and multiple assets in global pivotal studies. To learn more about Dizal, please visit , or follow us on Linkedin or Twitter. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions. Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect. Contacts Investor Relations: [email protected] Business Development: [email protected] Media Contact: [email protected] SOURCE Dizal Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyPhase 1Fast TrackDrug Approval

17 Mar 2025

·www.prnewswire.com

Akeso's Penpulimab Receives NMPA Approval for First-Line Treatment of Nasopharyngeal Cancer

HONG KONG, March 16, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) announced that its innovative, self-developed anti-PD-1 monoclonal antibody, penpulimab, has been officially approved by the National Medical Products Administration (NMPA) for the first-line treatment of recurrent or metastatic nasopharyngeal cancer (NPC) in combination with chemotherapy. Previously, penpulimab was approved for use as a third-line treatment for advanced NPC. With this new approval, penpulimab now provides comprehensive treatment coverage across all stages of NPC, offering patients a continuous immunotherapy option from first-line to third-line therapy. This marks the fourth approved indication for penpulimab. In addition to the two NPC indications, penpulimab is also approved for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) when combined with chemotherapy, as well as for monotherapy in patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have previously received at least two lines of systemic chemotherapy. Furthermore, a supplemental New Drug Application (sNDA) for penpulimab in combination with anlotinib for first-line treatment of advanced hepatocellular carcinoma (HCC) is currently under review. Professor Hu Chaosu, one of the principal investigators of penpulimab at Fudan University Shanghai Cancer Center, said: "In China, there remains a significant unmet clinical need for NPC. As the only IgG1 subtype anti-PD-1 monoclonal antibody globally, penpulimab has demonstrated robust efficacy in clinical studies, enhancing the effectiveness of immunotherapy for NPC. The approval for first-line treatment marks a major milestone, as it provides a comprehensive treatment regimen for clinicians and patients, benefiting a large population of NPC patients in China, from first-line to third-line therapy." Professor Chen Xiaozhong, one of the principal investigators of penpulimab at Zhejiang Cancer Hospital, said: "Nasopharyngeal cancer (NPC) is a highly prevalent malignancy in certain regions, and patients with recurrent or metastatic NPC typically face a poor prognosis. Penpulimab has demonstrated a significantly high response rate and prolonged survival benefits in both first-line treatment of NPC and in patients with metastatic NPC who have failed multiple lines of prior therapy. Additionally, it has shown a favorable safety profile, with a low incidence of immune-related adverse events. " Dr. Xia Yu, Founder, Chairwoman, CEO, and President of Akeso, said: "We want to extend our sincere gratitude to all the researchers, clinical trial participants, and NPC patients who have contributed to this milestone. With its differentiated design, penpulimab has gained widespread recognition among clinicians and patients for its efficacy and safety in treating diseases like non-small cell lung cancer (NSCLC), Hodgkin lymphoma, and nasopharyngeal cancer. The approval for first-line treatment of advanced NPC will allow more patients in China to benefit from this new PD-1 monoclonal antibody, further improving survival outcomes." "As key drugs like cadonilimab, ivonescimab, and penpulimab receive approval for a wide range of indications, Akeso's commitment to innovation and excellence in drug development—from discovery to clinical application—is clearly demonstrated. These advancements are not only improving patient outcomes but also reaffirming our dedication to transforming global healthcare. Moving forward, Akeso will continue to pioneer breakthrough therapies with the potential to set new standards of care, driving positive change in treatment paradigms and improving the lives of patients worldwide." SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapy

04 Dec 2024

·www.prnewswire.com

Akeso's Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) Combination Therapy for PD-(L)1 Resistant NSCLC Showcased in Oral Presentation at 2024 Asian Conference on Lung Cancer

HONG KONG, Dec. 4, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced the results from a prospective, open-label, single-arm, multi-center phase Ib/II clinical study (AK104-IIT-018) of cadonilimab (PD-1/CTLA-4 bispecific antibody) in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who had progressed after prior PD-(L)1 inhibitor treatment, were presented at the 2024 Asian Conference on Lung Cancer (ACLC). Professor Han Baohui from Shanghai Chest Hospital presented the initial positive results of the cadonilimab combination therapy for immune-resistant NSCLC at the conference. The treatment demonstrated a 6-month progression-free survival (PFS) rate of 56.9%, a median PFS of 6.5 months, a disease control rate (DCR) of 94.0%, and a median duration of response (DoR) of 5.0 months. Nearly all patients showed long-lasting tumor control, highlighting cadonilimab as a promising and effective second-line treatment for advanced immune-resistant NSCLC. The AK104-IIT-018 study is a prospective, open-label, single-arm, multicenter Phase Ib/II clinical trial (NCT05816499) conducted across four centers in China. The study was initated in February 2023, and this report presented the preliminary data analysis. The study enrolled patients with unresectable, incurable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC), who tested negative for driver mutations and had previously received PD-1/L1 inhibitors along with platinum-based doublet chemotherapy (either in combination or sequentially, regardless of sequence), with disease progression. Patients were treated with a combination regimen of cadonilimab (10 mg/kg every 3 weeks), anlotinib, and docetaxel (60 mg/m²). The primary endpoint of the study is the 6-month progression-free survival (PFS) rate. As of May 31, 2024, 46 patients had been enrolled in the study. Among these, 41.3% had non-squamous NSCLC and 58.7% had squamous NSCLC. Regarding PD-L1 expression, 10.9% of patients had levels <1%, 28.3% between 1-49%, and 15.2% had PD-L1 expression≥50%. Reflective of the real-world NSCLC patient population, 10.9% of patients had brain metastasis, 6.5% of the patients had liver metastasis, and 23.9% of the patients had bone metastasis. Progression-Free Survival (PFS): As of May 31, 2024, the maturity of PFS was 30.4%, with a 6-month PFS rate of 56.9% (compared to 30% for docetaxel monotherapy). The median PFS was 6.5 months (versus 4 months for docetaxel monotherapy). Tumor Response: Out of 33 patients, 10 achieved partial response (PR), and 21 had stable disease (SD). The overall objective response rate (ORR) was 30.3%, which is significantly higher than the 14% ORR observed in previous studies of docetaxel alone. Among the 10 patients with partial response, the median duration of response (DoR) was 5.0 months. Disease Control Rate (DCR): The DCR reached 94.0%, with nearly all patients experiencing effective tumor control. Safety: The combination of cadonilimab, anlotinib, and docetaxel for treating advanced, driver gene-negative, immune-resistant NSCLC was well-tolerated. The adverse events were manageable and controllable, and the safety profile was favorable. For patients with advanced, driver gene-negative NSCLC who progress after first-line immunotherapy combined with chemotherapy, treatment options are limited. The standard treatment recommended by the NCCN guidelines is single-agent chemotherapy, but its efficacy is limited, with an objective response rate (ORR) of 14%–17%, a 6-month progression-free survival (PFS) rate of approximately 30%, PFS of 4.0–5.4 months, and overall survival (OS) of 10.5–12 months. The cadonilimab regimen holds potential as a new treatment option for immune-resistant NSCLC. Cadonilimab is a bispecific antibody that targets both PD-1 and CTLA-4, and is independently developed by Akeso. It is a humanized immunoglobulin G1 (IgG1) bispecific antibody (BsAb). Cadonilimab promotes "immune normalization" in the tumor microenvironment through multiple mechanisms. Its unique tetravalent symmetric structure design and Fc modifications enable enhanced accumulation in tumor tissues. As a result of this study, cadonilimab demonstrated the potential to improve the efficacy of tumor immunotherapy while reducing adverse reactions. Akeso has conducted several clinical trials to evaluate cadonilimab in the treatment of immune-resistant or poorly responsive tumors. These include the registrational phase III trial (AK109-301) of cadonilimab combined with its VEGFR-2 monoclonal antibody for advanced gastric cancer progressing after PD-1/L1 inhibitors plus chemotherapy, and the phase III trial (AK104-307) comparing cadonilimab plus chemotherapy to tislelizumab plus chemotherapy as first-line treatment for PD-L1-negative NSCLC. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin, and X (formerly Twitter). SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Immunotherapy

100 Deals associated with Anlotinib Dihydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	DB11885

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Endometrial Carcinoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	22 Nov 2024
Extensive stage Small Cell Lung Cancer	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 May 2024
Differentiated Thyroid Gland Carcinoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 Apr 2022
Thyroid Cancer, Medullary	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	30 Jan 2021
Small Cell Lung Cancer	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Sep 2019
Soft Tissue Sarcoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Jul 2019
Non-Small Cell Lung Cancer	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 May 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hepatocellular Carcinoma	NDA/BLA	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	21 Nov 2024
Metastatic Renal Cell Carcinoma	NDA/BLA	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Aug 2024
Unresectable Renal Cell Carcinoma	NDA/BLA	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Aug 2024
Primary peritoneal carcinoma	Phase 3	United States	Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	United States	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	China	Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	Italy	Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	Italy	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	Spain	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	06 Apr 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_ELCC2025	Not Applicable	Non-Small Cell Lung Cancer	539	Anlotinib alone	unvjxudekd(dwgwiitbdm) = 10.2% osnweditdd (ysqknnmoqc ) View more	Positive	26 Mar 2025
				Combined therapy
ESMO_ELCC2025	Not Applicable	Non-squamous non-small cell lung cancer	746	Anlotinib monotherapy with prior bevacizumab	whjfhsdplg(xotnhvcufj) = jmpurdzaed uqxufpamfo (oxeqjfnfqx )	Positive	26 Mar 2025
				Anlotinib monotherapy without prior bevacizumab	whjfhsdplg(xotnhvcufj) = fgwbdexplm uqxufpamfo (oxeqjfnfqx )
ESMO_SRC2025	Not Applicable	Locally Advanced Soft Tissue Sarcoma Maintenance VEGFR 1-3	295	Anlotinib	gsbbjxlkdp(rxlgqthjff) = bdrgllzgqm tylgvzcdzl (fbedlnorlm, 3.70 - 4.47) View more	Positive	20 Mar 2025
				Anlotinib plus chemotherapy	gsbbjxlkdp(rxlgqthjff) = xbknnkfowg tylgvzcdzl (fbedlnorlm, 4.10 - 5.53)
NCT05252078 (ALTER-E005, ASCO_GI2025) Manual	Phase 2	Esophageal Squamous Cell Carcinoma Adjuvant	30	Anlotinib + Benmelstobart	uexxwvckez(djhnvzbckq) = not reached vvjyqkhyeb (jzwfmylrcp ) View more	Positive	23 Jan 2025
NCT02332499 (ASCO_GI2025) Manual	Phase 3	Colorectal Cancer Last line	73	Anlotinib	ocmzhlwvpe(iyhelbzpna) = jotiaxcugn eetnelvwgp (zrfirnzaln, 3.4 - 4.6) View more	Positive	23 Jan 2025
ASCO_GI2025	Not Applicable	Esophageal Squamous Cell Carcinoma	128	Anlotinib + Radiotherapy	zdgijbvosk(thgkolhwdc) = ycjfjcovee jugriqfxxv (pmwzedwbjx, 72.5 - 96.7) View more	Positive	23 Jan 2025
ChiCTR2400089133 (ASCO_GI2025)	Phase 2	Advanced Esophageal Squamous Cell Carcinoma First line	30	Anlotinib + Penpulimab + Nab-paclitaxel	obayynpgww(ptivnqlagu) = hjbokisfto gfdreztudq (nurotsigkt, 7.57 - 14.11) View more	Positive	23 Jan 2025
NCT04213118 (ALTER-H004, ASCO_GI2025)	Phase 2	Hepatocellular Carcinoma Adjuvant	30	Anlotinib + TACE	oukvpoudlr(nmqhkuxcpe) = dryiesybwe omwijdxrct (ghmiupqbzm, 50.2 - 85.6) View more	Positive	23 Jan 2025
NCT04007835 (CTONG-1803/ALTER-L001, Pubmed) Manual	Phase 2	EGFR positive non-small cell lung cancer EGFR Mutation	120	Anlotinib 12 mg/day + EGFR-TKIs	vjecfzyhvr(ywhcfrnhuc) = luxbwemuip rtieuyrcvc (bbvzobybvr, 6.8 - 11.7) View more	Positive	05 Jan 2025
				Anlotinib 12 mg/day + EGFR-TKIs (first-line 1st /2nd generation EGFR-TKIs)	vjecfzyhvr(ywhcfrnhuc) = dnlfyldlqb rtieuyrcvc (bbvzobybvr, 6.7 - 12.6)
NCT04325763 (TQB2450-Ⅲ-05, NEWS) Manual	Phase 3	Non-Small Cell Lung Cancer Consolidation	-	贝莫苏拜单抗	xvztmhmgmt(eeomnbeska) = vzfkrzzoeg rhkvicrbou (oeudqgpgeo )	Positive	19 Dec 2024
				贝莫苏拜单抗 + 安罗替尼	-

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