Delving into the Latest Updates on Ficonalkib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

ALK

Mechanism

ALK inhibitors(Anaplastic lymphoma kinase inhibitors)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

ALK positive Non-Small Cell Lung CancerAdvanced Lung Non-Small Cell CarcinomaLTK-positive Solid Tumors

Inactive Indication-

Originator Organization

Shouyao Holdings (Beijing) Co. Ltd.

Active Organization

Shouyao Holdings (Beijing) Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC29H39N7O3S

InChIKeyLDTJJGGYLQQRSP-UHFFFAOYSA-N

CAS Registry2233574-95-1

Primary objective: To evaluate the efficacy of CT-3505 capsules compared with crizotinib capsules in patients with ALK-positive NSCLC who are undergoing treatment for the first time. Secondary objective: To evaluate the safety of CT-3505 capsules in patients with ALK-positive NSCLC who are undergoing treatment for the first time.

Start Date22 Mar 2024

Sponsor / Collaborator

Shouyao Holdings (Beijing) Co. Ltd.

100 Clinical Results associated with Ficonalkib

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100 Translational Medicine associated with Ficonalkib

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100 Patents (Medical) associated with Ficonalkib

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3

Literatures (Medical) associated with Ficonalkib

01 Oct 2024·Journal of Thoracic Oncology

A Response to the Letter to the Editor: Response to Ficonalkib’s Promise and the Path Forward: A Comment on Advanced ALK-Positive NSCLC Treatment

Letter

Author: Shi, Yuankai

A review The study titled "Ficonalkib (SY-3505) in Advanced ALK-Pos. NSCLC: A Multicenter, Open-Label, Single-Arm, Phase 1/2 Study" evaluated the safety, tolerability, pharmacokinetics, and feasibility of ficonalkib in advanced ALK-pos. NSCLC.The study is currently conducting a pivotal phase 2 study in a larger population and a large-sample, randomized-controlled phase 3 study comparing ficonalkib with crizotinib in patients naive to ALK tyrosine kinase inhibitor with advanced ALK-pos. NSCLC.The clin. benefit of ficonalkib in patients with brain metastases was evident, with a confirmed objective response rate of 43.5% in 46 patients.

01 Oct 2024·Journal of Thoracic Oncology

Ficonalkib’s Promise and the Path Forward: A Comment on Advanced ALK-Positive NSCLC Treatment

Letter

Author: Chen, Hong-Lin ; Ge, Meng-Wei

01 Jun 2024·Journal of Thoracic Oncology

Ficonalkib (SY-3505) in Advanced ALK-Positive NSCLC: A Multicenter, Open-Label, Single-Arm, Phase 1/2 Study

Article

Author: Gong, Caifeng ; Mei, Qi ; Dong, Xiaorong ; Jiang, Liyan ; Wang, Pingli ; Wang, Ke ; Li, Xingya ; Li, Yongsheng ; Sun, Yinghui ; Hu, Xingsheng ; Liu, Baogang ; Meng, Xiangjiao ; Yang, Runxiang ; Wang, Huijuan ; Luo, Yongzhong ; Zhang, Shucai ; Shi, Yuankai ; Yang, Limin

INTRODUCTIONTreatment options for second-generation (2^nd-gen) ALK tyrosine kinase inhibitor (TKI)-resistant patients are limited. We evaluated the safety, pharmacokinetics, and efficacy of ficonalkib (SY-3505), a third-generation (3^rd-gen) ALK TKI, in patients with advanced ALK-positive non-small cell lung cancer.METHODSThis first-in-human, phase 1/2 study (Chinese Clinical Trial Registry identifier: ChiCTR1900025619; ClinicalTrials.gov identifier: NCT05257512) had two parts. Phase 1 included a dose-escalation phase (25-800 mg quaque die [QD]) and a dose-expansion phase (500 mg QD or 600 mg QD). Phase 2 enrolled patients treated at recommended phase 2 dose. Primary end points were safety in phase 1 and objective response rate (ORR) in phase 2.RESULTSBetween April 21, 2020, and August 31, 2023, a total of 127 patients with advanced ALK-positive non-small cell lung cancer were enrolled, with 62 in phase 1. Ficonalkib was well absorbed and tolerated, with one dose-limited toxicity event occurring at 800 mg QD. Treatment-related adverse events occurred in 85.5% of patients, with 19.4% experienced greater than or equal to grade 3 events. The ORR was 38.3% (23 of 60, 95% confidence interval [CI]: 26.1%-51.8%) in phase 1, and 600 mg QD was established as recommended phase 2 dose. In phase 2, a total of 65 patients received ficonalkib at 600 mg QD. In total, 88 patients received ficonalkib at 600 mg QD in phase 1/2, and all had received prior 2^nd-gen ALK TKI treatment. Furthermore, 90.9% of the patients experienced treatment-related adverse events and 14.8% experienced greater than or equal to grade 3 events. The ORR in efficacy-assessable patients who received ficonalkib at 600 mg QD was 47.5% (38 of 80, 95% CI: 36.2%-59.0%), with an intracranial ORR of 37.5% (12 of 32, 95% CI: 21.1%-56.3%) in these patients with measurable brain lesions at baseline.CONCLUSIONSFiconalkib (SY-3505) was well tolerated, with favorable safety profiles and promising efficacy in patients resistant to prior 2^nd-gen ALK TKI.

100 Deals associated with Ficonalkib

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
ALK positive Non-Small Cell Lung Cancer	Phase 3	CN	Shouyao Holdings (Beijing) Co. Ltd.	22 Mar 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 2	CN	Shouyao Holdings (Beijing) Co. Ltd.	30 Jun 2023
LTK-positive Solid Tumors	Phase 1	CN	Shouyao Holdings (Beijing) Co. Ltd.	30 Aug 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05257512 \| ChiCTR1900025619 (Pubmed) Manual	Phase 1/2	ALK positive Non-Small Cell Lung Cancer	127	Ficonalkib (SY-3505) 500 mg QD	(pfocplpxwe) = ohqkvlveya erceegtgfr (jiydiicflq, 26.1 - 51.8)	Positive	01 Jan 2024
				Ficonalkib (SY-3505) 600 mg QD	(pfocplpxwe) = dafdbamcmy erceegtgfr (jiydiicflq, 36.2 - 59.0)
NCT05257512 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	ALK positive Non-Small Cell Lung Cancer ALK Expression	82	CT-3505	(wlgsbhoowd) = boyolqntvh bjtqrcpcyx (icypajicgh, 24.0 - 45.5) View more	Positive	31 May 2023
				CT-3505 (patients received SY-3505 at 600mg once daily)	(wlgsbhoowd) = tqqosecwns bjtqrcpcyx (icypajicgh, 24.5 - 53.6) View more