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- Evaluating the Optimal TKI for Patients With ALK Positive Advanced Non-Small-Cell Lung Cancer (aNSCLC) in the First Line (1L) Setting: An Updated Systematic Literature Review (SLR) and Network Meta-Analysis (NMA) () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_1757;
With the unprecedented CROWN 5Y data (Solomon et al., JCO 2024), the relative effect of 1L lorlatinib is significantly improved vs. other TKIs. Totality of evidence across available NMAs consistently support lorlatinib as preferred 1L treatment of choice for ALK+ aNSCLC patients.
- Anluoqing (envonalkib) / Sino Biopharm, Shouyao Holdings
Economic Evaluation of Envonalkib, Iruplinalkib, and Critizonib in the Treatment of Anaplastic Lymphoma Kinase-Positive Advanced Non-Small-Cell Lung Cancer in China () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_1415;
P3
Totality of evidence across available NMAs consistently support lorlatinib as preferred 1L treatment of choice for ALK+ aNSCLC patients. Envonalkib is the more economical compared with iruplinalkib and critizonib at the set price(1161.78 dollar), and iruplinalkib are cost-saving and utility-increasing compared to critizonib, which can help healthcare system in making optimal policies and help clinicians in the medication of patients.
- || Anluoqing (envonalkib) / Sino Biopharm, Shouyao Holdings
PK/PD data, Journal: Pharmacokinetics, mass balance, and metabolism of [14C]envonalkib (TQ-B3139), a novel ALK tyrosine kinase inhibitor, in healthy Chinese subjects. (Pubmed Central) - Oct 12, 2024
Envonalkib is the more economical compared with iruplinalkib and critizonib at the set price(1161.78 dollar), and iruplinalkib are cost-saving and utility-increasing compared to critizonib, which can help healthcare system in making optimal policies and help clinicians in the medication of patients. Envonalkib was extensively metabolized prior to excretion and eliminated primarily as metabolites via feces.
- || Retrospective data, Review, Journal, Metastases: Efficacy of ALK inhibitors in Asian patients with ALK inhibitor-na (Pubmed Central) - Sep 12, 2024
Eight studies, involving 1,477 Asian patients and seven treatments (crizotinib, alectinib, brigatinib, ensartinib, envonalkib, iruplinalkib, and lorlatinib), were included in the NMA. Next-generation ALK inhibitors had better efficacy than crizotinib in the treatment of Asian patients with ALK inhibitor-na
- Xalkori (crizotinib) / Pfizer, envonalkib (TQ-B3139) / Sino Biopharm
Envonalkib vs crizotinib in treatment-naïve advanced ALK-positive NSCLC: A randomized, multicenter, phase III trial (Hall 406) - Oct 1, 2022 - Abstract #ESMOAsia2022ESMO_Asia_288;
P3
Conclusions Compared with Cri, Env significantly prolonged PFS in advanced ALK-positive NSCLC pts who had not received a prior ALK inhibitor, and showed greater advantages in controlling BMs. The safety profiles following Env treatment were manageable.
- || TQ-B3139 / Sino Biopharm
P1 data, Clinical Trial,Phase I, Journal: First-in-human phase I study of TQ-B3139 (CT-711) in advanced non-small cell lung cancer patients with ALK and ROS1 rearrangements. (Pubmed Central) - Sep 2, 2022
P1
The safety profiles following Env treatment were manageable. TQ-B3139 was well-tolerated and exhibited promising anti-tumor activities in patients with ALK and ROS1 positive advanced NSCLC.
- || Anluoqing (envonalkib) / Sino Biopharm, Shouyao Holdings
Enrollment open, Trial primary completion date: Effect of High-fat Meal on the Pharmacokinetics of TQ-B3139 Capsules (clinicaltrials.gov) - Apr 1, 2021
P1, N=12, Recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
TQ-B3139 was well-tolerated and exhibited promising anti-tumor activities in patients with ALK and ROS1 positive advanced NSCLC. Not yet recruiting --> Recruiting | Trial primary completion date: Mar 2021 --> Mar 2022
- || Anluoqing (envonalkib) / Sino Biopharm, Shouyao Holdings
New P1 trial: Effect of High-fat Meal on the Pharmacokinetics of TQ-B3139 Capsules (clinicaltrials.gov) - Dec 19, 2020
P1, N=12, Not yet recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- ||| Anluoqing (envonalkib) / Sino Biopharm, Shouyao Holdings
Enrollment open, Metastases: A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - Sep 10, 2020
P2, N=71, Recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Not yet recruiting --> Recruiting | Trial primary completion date: Mar 2021 --> Mar 2022 Not yet recruiting --> Recruiting
- |||| Anluoqing (envonalkib) / Sino Biopharm, Shouyao Holdings
New P2 trial, Metastases: A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - May 22, 2020
P2, N=71, Not yet recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- ensartinib (X-396) / Xcovery, Xalkori (crizotinib) / Pfizer
[VIRTUAL] A phase I, dose-escalation and expansion study of TQ-B3139, a novel ALK TKI, in Chinese ALK or ROS1 positive advanced non-small cell lung cancer (NSCLC). (Poster Board 351) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2438;
P1
RP2D was established at 600mg bid. A randomized phase III trial of TQ-B3139 versus Crizotinib in advanced ALK-TKI naïve NSCLC patients is underway.
- ||| Anluoqing (envonalkib) / Sino Biopharm, Shouyao Holdings
Enrollment open: Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib (clinicaltrials.gov) - Nov 15, 2019
P2, N=135, Recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A randomized phase III trial of TQ-B3139 versus Crizotinib in advanced ALK-TKI naïve NSCLC patients is underway. Not yet recruiting --> Recruiting
- |||||| Anluoqing (envonalkib) / Sino Biopharm, Shouyao Holdings
Enrollment open: Study of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - Oct 31, 2019
P3, N=260, Recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Anluoqing (envonalkib) / Sino Biopharm, Shouyao Holdings
New P2 trial: Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib (clinicaltrials.gov) - Aug 13, 2019
P2, N=135, Not yet recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- |||||||||| Anluoqing (envonalkib) / Sino Biopharm, Shouyao Holdings
New P3 trial: Study of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - Jul 4, 2019
P3, N=260, Not yet recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Anluoqing (envonalkib) / Sino Biopharm, Shouyao Holdings
Enrollment open, Trial initiation date, Metastases: A Phase I Study of TQ-B3139 on Tolerance and Pharmacokinetics (clinicaltrials.gov) - Sep 18, 2017
P1, N=20, Recruiting, Sponsor: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Mar 2017 --> Jul 2017
- | Anluoqing (envonalkib) / Sino Biopharm, Shouyao Holdings
New P1 trial, Metastases: A Phase I Study of TQ-B3139 on Tolerance and Pharmacokinetics (clinicaltrials.gov) - Apr 4, 2017
P1, N=20, Not yet recruiting, Sponsor: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd