lanisidenib (TQB3454) / Sino Biopharm - LARVOL DELTA

Clinical Trial Evaluating the Efficacy and Safety of TQB3454 Tablets in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=127 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P2 trial • Oncology • Solid Tumor

Acceptance of new drug application for TQB3454 tablet “IDH1 inhibitor” (HKEXnews) - "This new drug application is based on a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study (TQB3454-III-01), designed to evaluate the efficacy and safety of TQB3454 in patients with advanced BTC harboring IDH1 mutations who have previously failed treatment with gemcitabine and fluoropyrimidine-based regimens."

China filing • Biliary Tract Cancer

TQB3454 Tablets "IDH1 Inhibitor" Included in Priority Review and Approval Procedure (iis.aastocks.com) - "SBP GROUP...announced that TQB3454 tablets, an 'IDH1 inhibitor' independently developed by its subsidiary Chia Tai Tianqing Pharmaceutical as a Category 1 innovative drug in China, have been included in the Priority Review and Approval Procedure by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China. The drug is intended for the treatment of patients with locally advanced, recurrent and/or metastatic biliary tract cancer (BTC) with IDH1 mutations who have failed prior treatment with gemcitabine- and fluorouracil-based regimens."

China filing • Priority review • Biliary Tract Cancer

Positive Results on Phase III Clinical Study of TQB3454 ’IDH1 Inhibitor’ for Biliary Tract Cancer (HKEXnews) - "As determined by the Independent Data Monitoring Committee (IDMC), the pre-specified primary endpoints of both progression-free survival (PFS) and overall survival (OS) have been reached. The Group has communicated with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) in respect of the marketing application for this indication and obtained written approval from the CDE, with the marketing application to be submitted shortly....Results from the interim analysis showed that, compared to the control group, TQB3454 significantly reduced the risk of disease progression or death in patients with advanced biliary tract cancer, while significantly prolonging PFS and OS....The Group plans to present detailed data from the study at an authoritative international academic conference this year."

China filing • P3 data • Biliary Tract Cancer

TQB3454-III-01: A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma. (clinicaltrials.gov) - P3 | N=165 | Active, not recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Oncology • Solid Tumor

A Phase II Study of IDH1 Inhibitor Combined With Serplulimab and Docetaxel in Previously Treated Advanced NSCLC (ChiCTR2400086196) (IASLC-WCLC 2025) - P2 | "Second-line therapeutic options remain limited: docetaxel demonstrates modest efficacy (objective response rate [ORR] 6-11%; median overall survival [mOS] 5-10 months), while PD-1 inhibitors (e.g., tislelizumab) show improved survival outcomes (ORR 21.9% vs. 7.0%; mOS 17.2 vs. 11.9 months compared to docetaxel)...This IDH1-mediated immunosuppressive niche may contribute to immunotherapy resistance, suggesting that IDH1 inhibition could restore immune sensitivity.TQB3454, a novel IDH1 inhibitor, exhibits superior preclinical safety and efficacy compared to AG-120 (ivosidenib)...Secondary: DCR, DOR, PFS, OS.Target accrual: 39 patients. MiniMax two-stage design (α=0.05, power=80%) with H0: ORR=7% (historical docetaxel) vs. H1: ORR=20%.Statistical Design: Survival endpoints analyzed by Kaplan-Meier method."

IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • CXCL12 • IDH1 • TGFB1

TQB3454 in mutant IDH1 advanced cholangiocarcinoma (CCA): Results of a phase I dose escalation and expansion study cohort (ESMO-GI 2024) - P1 | "These results suggest that TQB3454 has a manageable toxicity profile and notable clinical benefit in CCA pts with mutant IDH1. A phase III clinical trial aimed to further evaluate the efficacy and safety of TQB3454 for CCA with IDH1 mutations is currently underway."

IO biomarker • Metastases • P1 data • Anemia • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Hematological Disorders • Oncology • Renal Disease • Solid Tumor • IDH1

A Study of TQB3454 Tablets in Patients With Blood Tumors (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Clinical Trial of TQB3454 Tablets in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Trial completion date • Trial initiation date • Trial primary completion date • Biliary Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

A Clinical Trial of TQB3454 Tablets in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1 trial • Biliary Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma. (clinicaltrials.gov) - P3 | N=165 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Metastases • New P3 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets (clinicaltrials.gov) - P1; N=96; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Trial primary completion date: Aug 2021 ➔ Dec 2022

Clinical • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets (clinicaltrials.gov) - P1; N=96; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets (clinicaltrials.gov) - P1; N=96; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Clinical • New P1 trial • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor