Abstract 8MO
Background
TQ-B3101 is a novel small molecule receptor tyrosine kinase inhibitor, which targets to ALK, ROS1 and MET. Preclinical studies showed that it had a good tumor inhibition activity and duration. This study aims to evaluate the efficacy and safety of TQ-B3101 monotherapy in the first-line treatment in patients with ROS1-positive non-small cell lung cancer (NSCLC).
Methods
This is a multicenter, single arm phase II trial (NCT03972189). ROS1 positive locally advanced or metastatic NSCLC patients with ROS1-TKI treatment naïve were enrolled. TQ-B3101 was orally administered at dose of 300 mg BID in a 28-day cycle, until disease progression or intolerable toxicity. The primary endpoint was independent review committee (IRC) assessed objective response rate (ORR). The secondary endpoints included IRC assessed disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), intracranial ORR/DoR, intracranial time to progress and safety.
Results
As of October 15, 2021, 111 patients had received TQ-B3101 therapy (median age 52 yrs, 61.3% female, 71.2% ECOG PS 1, 92.8% stage IV, 29.7% with brain metastasis), with a median follow up of 12.1 months. 1 patient achieved complete response and 86 patients achieved partial response with ORR assessed by IRC of 78.4% (95% CI, 69.6%-85.6%) and DCR of 87.4% (95% CI, 79.7% - 92.9%). The median PFS assessed by IRC was 15.6 months (95% CI, 10.2 - 27.0) and median DoR was 20.3 (95% CI, 11.0 - 26.1). Median OS has not been reached and the 12- and 24-month OS rate were 98.1% and 88.1% respectively. Treatment related adverse events (TRAEs) occurred in 99.1% of patients (≥G3 TRAEs occurred in 45.1%). Treatment-related SAEs occurred in 3.6% of patients, and only 2 (1.8%) patients had treatment discontinuation due to TRAEs. Most common TRAEs were AST increased (73.9%), ALT increased (72.1%), emesis (63.1%), neutrophils count decrease (56.8%), leukocyte count decrease (52.3%), sinus bradycardia (52.3%), and diarrhea (43.2%).
Conclusions
For the first-line treatment of ROS1-positive locally advanced or metastatic NSCLC patients, TQ-B3101 showed the promising efficacy with a manageable safety profile, offering a new first-line therapeutic strategy.
Clinical trial identification
NCT03972189.
Legal entity responsible for the study
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Funding
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
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