Delving into the Latest Updates on Famitinib Malate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Famitinib, Famitinib maleate

+ [1]

Target

FGFRs x PDGFR x VEGFR x VEGFR2 x c-Kit

Mechanism

FGFRs antagonists(Fibroblast growth factor receptors antagonists), PDGFR antagonists(Platelet-derived growth factor receptor antagonists), VEGFR antagonists(Vascular endothelial growth factor receptor antagonists)

+ [2]

Therapeutic Areas

NeoplasmsUrogenital DiseasesRespiratory Diseases+ [4]

Active Indication

Uterine Cervical CancerTriple Negative Breast CancerPD-L1 positive Non-Small Cell Lung Cancer+ [17]

Inactive Indication

Advanced breast cancerAdvanced Colorectal AdenocarcinomaAdvanced Lung Non-Small Cell Carcinoma+ [13]

Originator Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Active Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Fudan University

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationBreakthrough Therapy (CN)

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Structure

Molecular FormulaC23H27FN4O2

InChIKeyGKEYKDOLBLYGRB-LGMDPLHJSA-N

CAS Registry1044040-56-3

View All Structures (2)

This study is a prospective, open-label, multi-center, phase II clinical trial designed for HER2-negative breast cancer with pathogenic mutations in the germline gene (gBRCA1/2) that were indicated for neoadjuvant chemotherapy. The characteristics of this study are a precision treatment scheme without chemotherapy, the scheme of HRS-1167 combined with famitinib neoadjuvant therapy for patients with gBRCA mutations is explored, and the efficacy of combined immunotherapy is further explored according to the efficacy of the combination of the two drugs.

Start Date01 Jul 2024

Sponsor / Collaborator

Fudan University

ChiCTR2400085510 / SuspendedPhase 2IIT

Phase ? exploratory clinical study of Camrelizumab combined with Famitinib Malate Capsules and Temozolomide in the treatment of advanced clear cell sarcoma

Start Date21 Jun 2024

Sponsor / Collaborator

Beijing Cancer Hospital

NCT06332950 / Not yet recruitingPhase 1/2IIT

A Randomized, Multi-cohort, Multi-center Phase Ib/II Study of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in Patients With ES-SCLC Pre-treated With Immune Checkpoint Inhibitor(s)

This is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s).

Start Date01 Apr 2024

Sponsor / Collaborator

Shanghai Chest Hospital

100 Clinical Results associated with Famitinib Malate

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100 Translational Medicine associated with Famitinib Malate

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100 Patents (Medical) associated with Famitinib Malate

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37

Literatures (Medical) associated with Famitinib Malate

01 Feb 2024·Journal for ImmunoTherapy of Cancer

First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1%: results from a multicenter, open-label, phase 2 trial

Article

Author: Cheng, Ying ; Liu, Tianshu ; Zhao, Jun ; Luo, Yongzhong ; Han, Bao-Hui ; Gu, Shanzhi ; Yi, Shanyong ; Li, Yalun ; Ren, Shengxiang ; Zhou, Caicun ; Cheng, Yufeng ; Liu, Ying ; Hu, Sheng ; Wang, Shuni ; Liu, Caigang ; Duan, Huijie ; Feng, Jifeng ; Wang, Xicheng ; Gao, Shegan ; Pan, Yueyin ; Fan, Jia ; Yang, Xinfeng

BackgroundThe combination of immune-checkpoint inhibitors and antiangiogenic agents can synergistically modulate the tumor microenvironment and represents a promising treatment option. Here, we evaluated the efficacy and safety of camrelizumab plus famitinib (a receptor tyrosine kinase inhibitor) as a first-line treatment for advanced or metastatic NSCLC patients with a programmed death ligand-1 (PD-L1) tumor proportion score (TPS) of ≥1%, in an open-label, multicenter, phase 2 basket trial.MethodsEligible patients received camrelizumab (200 mg once every 3 weeks via intravenous infusion) plus oral famitinib at an initial dose of 20 mg once daily. The primary endpoint was the objective response rate (ORR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors V.1.1. Key secondary endpoints included disease control rate (DCR), duration of respons, progression-free survival (PFS), overall survival (OS), 12-month OS rate, and safety profile.ResultsOf the enrolled 41 patients, 21 (51.2%) had a PD-L1 TPS of 1–49%. As of the cut-off date on June 22, 2022, the combination regimen of camrelizumab and famitinib achieved an ORR of 53.7% (95% CI 37.4% to 69.3%) and a DCR of 92.7% (95% CI 80.1% to 98.5%). The median PFS was 16.6 months (95% CI 8.3 to not reached), and OS data were not yet mature, with an estimated 12-month OS rate of 76.8% (95% CI 60.0% to 87.3%). The most common treatment-related adverse events of grade 3 or higher included hypertension (22.0%), increased alanine aminotransferase (12.2%), decreased neutrophil count (9.8%), proteinuria (7.3%), decrease platelet count (7.3%), and hypokalemia (7.3%). One (2.4%) patient died from grade 5 hemoptysis, which was considered possibly related to the study treatment by the investigator.ConclusionCamrelizumab plus famitinib demonstrated promising antitumor activity in advanced or metastatic NSCLC patients and had an acceptable safety profile. These findings suggest that this combination regimen could be an alternative therapeutic option and warrant further investigation.Trial registration numberNCT04346381.

01 Feb 2024·The Lancet Oncology

Optimising first-line subtyping-based therapy in triple-negative breast cancer (FUTURE-SUPER): a multi-cohort, randomised, phase 2 trial

Article

Author: Chen, Li ; Hu, Xin ; Xiao, Qin ; Yang, Wen-Tao ; Fan, Lei ; Di, Gen-Hong ; Liu, Guang-Yu ; Cao, A-Yong ; Shao, Zhi-Ming ; Huang, Xiao-Yan ; Shui, Ruo-Hong ; Li, Jun-Jie ; Liu, Xi-Yu ; Sui, Xin-Yi ; Yu, Ke-Da ; Yang, Yun-Song ; Wu, Song-Yang ; Zhang, Wen-Juan ; Wang, Zhong-Hua ; Xu, Ying ; Xiao, Yi ; Wang, Han ; Jiang, Yi-Zhou ; Xia, Yan ; Wu, Jiong ; Jin, Xi ; Liang, Qian-Nan ; Ma, Lin-Xiaoxi

BACKGROUNDTriple-negative breast cancers display heterogeneity in molecular drivers and immune traits. We previously classified triple-negative breast cancers into four subtypes: luminal androgen receptor (LAR), immunomodulatory, basal-like immune-suppressed (BLIS), and mesenchymal-like (MES). Here, we aimed to evaluate the efficacy and safety of subtyping-based therapy in the first-line treatment of triple-negative breast cancer.METHODSFUTURE-SUPER is an ongoing, open-label, randomised, controlled phase 2 trial being conducted at Fudan University Shanghai Cancer Center (FUSCC), Shanghai, China. Eligible participants were females aged 18-70 years, with an Eastern Cooperative Oncology Group performance status of 0-1, and histologically confirmed, untreated metastatic or recurrent triple-negative breast cancer. After categorising participants into five cohorts according to molecular subtype and genomic biomarkers, participants were randomly assigned (1:1) with a block size of 4, stratified by subtype, to receive, in 28-day cycles, nab-paclitaxel (100 mg/m², intravenously on days 1, 8, and 15) alone (control group) or with a subtyping-based regimen (subtyping-based group): pyrotinib (400 mg orally daily) for the LAR-HER2^mut subtype, everolimus (10 mg orally daily) for the LAR-PI3K/AKT^mut and MES-PI3K/AKT^mut subtypes, camrelizumab (200 mg intravenously on days 1 and 15) and famitinib (20 mg orally daily) for the immunomodulatory subtype, and bevacizumab (10 mg/kg intravenously on days 1 and 15) for the BLIS/MES-PI3K/AKT^WT subtype. The primary endpoint was investigator-assessed progression-free survival for the pooled subtyping-based group versus the control group in the intention-to-treat population (all randomly assigned participants). Safety was analysed in all patients with safety records who received at least one dose of study drug. This study is registered with ClinicalTrials.gov (NCT04395989).FINDINGSBetween July 28, 2020, and Oct 16, 2022, 139 female participants were enrolled and randomly assigned to the subtyping-based group (n=69) or control group (n=70). At the data cutoff (May 31, 2023), the median follow-up was 22·5 months (IQR 15·2-29·0). Median progression-free survival was significantly longer in the pooled subtyping-based group (11·3 months [95% CI 8·6-15·2]) than in the control group (5·8 months [4·0-6·7]; hazard ratio 0·44 [95% CI 0·30-0·65]; p<0·0001). The most common grade 3-4 treatment-related adverse events were neutropenia (21 [30%] of 69 in the pooled subtyping-based group vs 16 [23%] of 70 in the control group), anaemia (five [7%] vs none), and increased alanine aminotransferase (four [6%] vs one [1%]). Treatment-related serious adverse events were reported for seven (10%) of 69 patients in the subtyping-based group and none in the control group. No treatment-related deaths were reported in either group.INTERPRETATIONThese findings highlight the potential clinical benefits of using molecular subtype-based treatment optimisation in patients with triple-negative breast cancer, suggesting a path for further clinical investigation. Phase 3 randomised clinical trials assessing the efficacy of subtyping-based regimens are now underway.FUNDINGNational Natural Science Foundation of China, Natural Science Foundation of Shanghai, Shanghai Hospital Development Center, and Jiangsu Hengrui Pharmaceuticals.TRANSLATIONFor the Chinese translation of the abstract see Supplementary Materials section.

15 Dec 2023·Human Vaccines & Immunotherapeutics

Long-lasting complete response to SHR-1701 plus famitinib in refractory advanced gallbladder cancer: A case report

Article

Author: Xie, Jing ; Meng, Zhiqiang ; Yi, Lixia ; Zhu, Xiaoyan

Biliary tract cancer (BTC) is an aggressive malignancy with few options for advanced-stage treatment. The combination of PD-1/PD-L1 inhibitors with famitinib, a receptor tyrosine kinase (RTK) inhibitor, has demonstrated improved clinical outcomes in several clinical trials. We herein reported a case of a gallbladder cancer (GBC) patient with liver metastases, previously resistant to traditional chemotherapy. Remarkably, the patient achieved a complete response (CR) with a long-lasting survival benefit exceeding 3 years. This was achieved using a novel regimen combining SHR-1701, an anti-PD-L1/TGF-βR fusion protein, and famitinib, even though the patient had proficient mismatch repair (pMMR) and tested negative for PD-L1. Adverse events were limited and manageable. This is the first report of such a treatment regimen being applied in a clinical setting, suggesting that the SHR-1701 and famitinib combination may be a promising immunotherapeutic approach for patients with refractory advanced GBC.

100 Deals associated with Famitinib Malate

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Uterine Cervical Cancer	NDA/BLA	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	06 Dec 2023
Advanced Cervical Carcinoma	Phase 3	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	-
Non-squamous non-small cell lung cancer	Phase 3	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	-
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	-
Gastrointestinal Stromal Tumors	Preclinical	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	07 Sep 2020
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Preclinical	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jun 2016
Recurrent Cervical Cancer	Discovery	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	23 Jul 2021
Advanced Colorectal Adenocarcinoma	Discovery	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jan 2015
Colorectal cancer recurrent	Discovery	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jan 2015
Metastatic Colorectal Carcinoma	Discovery	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jan 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04346381 (Pubmed) Manual	Phase 2	Non-Small Cell Lung Cancer First line	41	Camrelizumab+ famitinib	(ngtbhhsyjz) = yenbrlqofn sudvyksdir (riyujtaria, 37.4 - 69.3) View more	Positive	21 Feb 2024
NCT04346381 (Literature) Manual	Phase 2	Non-Small Cell Lung Cancer First line	41	Camrelizumab+famitinib	(cuzlnydvbf) = itdlntwdzk lkelyzmzlf (kwqytvxhgb, 37.4 - 69.3) View more	Positive	21 Feb 2024
CAPSTONE (ESMO_IO2023)	Phase 2	Lung Cancer \| Sarcoma of the Lung First line	15	Camrelizumab plus famitinib	(hfybonpnkh) = gfhcdbvtzv dczehzjuoz (ftblapquws, 21.3 - 73.4) View more	-	07 Dec 2023
NCT05051865 (ASCO2023) Manual	Phase 2	Acral Lentiginous Malignant Melanoma	18	famitinib+Camrelizumab (pts experienced ICI)	(umqfpyppmn) = qqwynzmdmf ypugolaeyp (bkdnmhlmni ) View more	Positive	31 May 2023
ASCO2023	Not Applicable	Adenomatous Polyposis Coli	11	Famitinib 20 mg QD	(qkllgqzvzh) = mrmbtbeznj lrxoegrnov (gfnxcryrge ) View more	Positive	31 May 2023
NCT04346381 (ESMO_ELCC2023) Manual	Phase 2	Non-Small Cell Lung Cancer First line	41	Camrelizumab+Famitinib	(vldjjrldgy) = nqkzqlzexv smgxjmjppk (xhbnfevmcx, 37.4 - 69.3) View more	Positive	31 Mar 2023
NCT03827837 (Pubmed \| Nat Commun)	Phase 2	Metastatic Cervical Squamous Cell Carcinoma	-	Camrelizumab 200mg + Famitinib 20mg	(arsakqrwwe) = znttoqdmqv dfhtqzolqe (kxzjxqpiuw, 22.9 - 57.9)	Positive	08 Dec 2022
NCT04494659 (Pubmed)	Phase 1	-	21	Famitinib 25 mg	(rxvncgspza) = sbqzngzhov hxlqgxiysr (tvcvalwswc )	-	15 Sep 2022
NCT04494659 (Pubmed)	Phase 1	-	21	Rifampin 600 mg	(rxvncgspza) = zupmvzfiwk hxlqgxiysr (tvcvalwswc )	-	15 Sep 2022
NCT04346381 (ASCO2022) Manual	Phase 2	Nasopharyngeal Cancer, Recurrent	15	Camrelizumab 200 mg+Famitinib 20 mg	(yremulqnal) = kaxzbmfvla ossuqiirfa (vatkyfivra, 11.8 - 61.6) View more	Positive	02 Jun 2022
NCT04346381 (ASCO2022) Manual	Phase 2	Metastatic Colorectal Carcinoma	44	overall	(rupmjqjyri) = zbtxkaemou ppihbeveum (yxacbrpztw, 5.2 - 27.4) View more	Positive	02 Jun 2022
NCT04346381 (ASCO2022) Manual	Phase 2	Metastatic Colorectal Carcinoma	44	Camrelizumab 200 mg+famitinib 20 mg (colon cancer)	(ztbvenetlr) = eylqequfit ytbkqdugxi (sypamfshry, 17.7 - 71.1) View more	Positive	02 Jun 2022