Anluoqing (envonalkib) / Sino Biopharm, Shouyao Holdings - LARVOL DELTA

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) (ISPOR-EU 2024) - "Besides alectinib and brigatinib, this analysis also included ensartinib, envonalkib and iruplinalkib. 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."

Metastases • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Economic Evaluation of Envonalkib, Iruplinalkib, and Critizonib in the Treatment of Anaplastic Lymphoma Kinase-Positive Advanced Non-Small-Cell Lung Cancer in China (ISPOR-EU 2024) - P3 | "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."

HEOR • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Efficacy of ALK inhibitors in Asian patients with ALK inhibitor-naïve advanced ALK-positive non-small cell lung cancer: a systematic review and network meta-analysis. (PubMed, Transl Lung Cancer Res) - "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-naïve advanced ALK-positive NSCLC. Iruplinalkib may have more favorable PFS benefit than other ALK inhibitors for Asians."

Journal • Metastases • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

VOLUNTARY ANNOUNCEMENT APPROVAL FOR MARKETING OF CATEGORY 1 INNOVATIVE DRUG ENVONALKIB CITRATE CAPSULES “ENVONALKIB (TQ-B3139)” (Sino Biopharm Press Release) - "The board of directors (the 'Board') of Sino Biopharmaceutical Limited...announces that the category 1 innovative drug Envonalkib Citrate Capsules 'Envonalkib (TQ-B3139)' (trade name: Anluoqing self-developed by the Group has obtained approval for marketing from the National Medical Products Administration of China for the treatment of anaplastic lymphoma kinase (ALK)-positive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not been treated with ALK inhibitors. The approval of Envonalkib, a novel ALK inhibitor independently developed by the Group, for the indication of first-line treatment of ALK-positive NSCLC is based on the results of a multi-center, randomised, controlled phase III clinical study of Envonalkib versus Crizotinib for the first-line treatment of ALK-positive advanced NSCLC (NCT04009317)."

China approval • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pharmacokinetics, mass balance, and metabolism of [14C]envonalkib (TQ-B3139), a novel ALK tyrosine kinase inhibitor, in healthy Chinese subjects. (PubMed, Cancer Chemother Pharmacol) - "Envonalkib was extensively metabolized prior to excretion and eliminated primarily as metabolites via feces."

Journal • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Identifying optimal ALK inhibitors in first- and second-line treatment of patients with advanced ALK-positive non-small-cell lung cancer: a systematic review and network meta-analysis. (PubMed, BMC Cancer) - "Considering both efficacy and safety, alectinib appears to be the preferable treatment in first-line and second-line, particularly for Asian patients."

Journal • Metastases • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Envonalkib versus crizotinib for treatment-naive ALK-positive non-small cell lung cancer: a randomized, multicenter, open-label, phase III trial. (PubMed, Signal Transduct Target Ther) - P3 | "Grade ≥3 treatment-related adverse events were observed in 55.73% and 42.86% of participants in the envonalkib and crizotinib groups, respectively. Envonalkib significantly improved PFS and delayed brain metastasis progression in advanced ALK-positive NSCLC."

Journal • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Envonalkib vs crizotinib in treatment-naïve advanced ALK-positive NSCLC: A randomized, multicenter, phase III trial (ESMO Asia 2022) - 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."

Clinical • P3 data • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1 • TP53

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, Eur J Cancer) - P1 | "TQ-B3139 was well-tolerated and exhibited promising anti-tumor activities in patients with ALK and ROS1 positive advanced NSCLC."

Journal • P1 data • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1 • TP53

[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). (ASCO 2020) - P1 | "Sixteen patients had prior ALK inhibitor therapy (11 Crizotinib, 5 Ensartinib), and 23 (36.5%) with baseline brain metastasis. TQ-B3139 was well tolerated in Chinese NSCLC patients with high antitumor activity. 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."

Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • ALK • ROS1

Effect of High-fat Meal on the Pharmacokinetics of TQ-B3139 Capsules (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Clinical • New P1 trial • Oncology • Solid Tumor • ALK • MET • ROS1

Effect of High-fat Meal on the Pharmacokinetics of TQ-B3139 Capsules (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • ALK • MET • ROS1

A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2; N=71; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2; N=71; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Clinical • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib (clinicaltrials.gov) - P2; N=135; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • 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) - P3; N=260; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • 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) - P2; N=135; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P2 trial