Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, autoimmune, metabolic, ophthalmology and other major diseases, and Laekna Therapeutics, a clinical-stage biotechnology company dedicated to bringing ground-breaking therapies to cancer and liver fibrosis patients worldwide, jointly announced that the first patient has been dosed in a Phase 1/2 clinical trial (clinicaltrials.gov, NCT05383482) of a three-drug combination therapy (afuresertib + sintilimab + chemotherapy) in patients with specific solid tumors who were resistant to anti-PD-1/PD-L1 therapy at the West China Second Hospital of Sichuan University. This marks a key milestone on the first anniversary of the clinical research partnership established between Innovent and Laekna in July 2021.
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The study is a multi-center, single-arm, open-label, dose-escalation Phase 1/2 clinical study, assessing recommended Phase 2 dose (RP2D), safety, tolerability and anti-tumor activity of afuresertib in combination with sintilimab and chemotherapy (nab-paclitaxel or docetaxel) in patients with solid tumors who were resistant to prior anti-PD-1/PD-L1 therapy. The principal investigator of the study is Professor Lin Shen, Director of the Department of Gastrointestinal Oncology of Beijing Cancer Hospital. The primary endpoints of the Phase 1 dose escalation study are maximum tolerated dose (MTD) and RP2D, and the primary endpoint of the Phase 2 study is overall response rate (ORR). The study is planned to be extended as a multi-regional clinical trial at the pivotal stage.
The clinical trial assesses five types of solid tumors, including non-small cell lung cancer (NSCLC), gastric cancer/gastroesophageal junction cancer (GC/GEJC), esophageal cancer (EsC), cervical cancer (CC) and endometrial cancer (EC). The study focuses on the AKT inhibitor, a potential new therapy for drug resistant-cancer, to address the unmet medical needs in cancer immunotherapy resistance and bring hope to solid tumor patients who have received prior anti-PD-1/PD-L1 treatments.
The combination therapy consists of Laekna’s afuresertib (LAE002), a highly selective ATP competitive AKT inhibitor in pivotal clinical trials with favorable clinical efficacy and safety profile, and Innovent’s PD-1 inhibitor sintilimab (TYVYT®), which has been approved for six indications in China with the first four included in the National Reimbursement Drug List (NRDL).