On June 5, 2022 Akeso, Inc. (9926.HK) ( "Akeso" ), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, reported that clinical details in poster presentation featuring phase Ib/II study of its Ivonescimab (PD-1/VEGF BsAbs, AK112) in advanced non-small cell lung cancer (NSCLC) at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, Akeso Biopharma, JUN 5, 2022, View Source [SID1234615589]).

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Summary of the clinical results:

AK112 was safe and well tolerated, with no significant difference between squamous NSCLC (SQ-NSCLC) and non-squamous NSCLC (NSQ-NSCLC) patients. The incidence rate of grade 3-4 TRAE was 13.5%, with no TRAE leading to permanent treatment discontinuation.
Among 54 treatment-naïve patients with PD-L1 positive (PD-L1 TPS≥1%) who had at least one post-treatment tumor assessment, the objective response rate (ORR) was 50.0% and disease control rate (DCR) was 96.3%.
Among 50 treatment-naïve patients receiving AK112 >10 mg/kg Q3W, AK112 presented encouraging anti-tumor efficacy in different PD-L1 expression levels:
In patients with PD-L1 positive patients (TPS ≥ 1%), ORR was 60.0% and DCR was 97.1%.
In patients with TPS 1%-49%, ORR was 50.0% and DCR was 95.5%.
In patients with TPS ≥50%, ORR was 76.9% and DCR was 100.0%.
This is a multicenter, phase Ib/II, open-label study of AK112 monotherapy in advanced NSCLC (NCT04900363). As of 4 March, 2022, 96 patients were enrolled, 90 of whom had at least one post-treatment tumor assessment. The dose-selection part was divided into four different dosing regimens including 10 mg/kg Q3W, 20 mg/kg Q2W, 20 mg/kg Q3W or 30 mg/kg Q3W, with safety and ORR as the primary endpoints.

Akeso is conducting a phase III study of AK112 monotherapy versus Pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression. In addition, a phase III study of AK112 plus chemotherapy versus chemotherapy in EGFR+ advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy (NCT05184712) is ongoing. AK112 has been investigated for different stages of treatment for both NSCLC and small cell lung cancer.

Related Study

KEYNOTE-042 study is a clinical study in patients with PD-L1 positive (TPS ≥ 1%) locally advanced/metastatic non-small-cell lung cancer (NSCLC) without EGFR/ALK alterations. According to this study, ORR was 27.0% in patients with PD-L1 TPS≥1%) and 39.0% in patients with TPS≥50% in the Pembrolizumab group.[1][2]

Reference

[1] Mok TSK, Wu YL, Kudaba I, et al. KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819-1830. doi: 10.1016/S0140-6736(18)32409-7.

[2] Disclaimer: the study mentioned above is for reference only. It doesn’t necessarily represent the latest clinical study ongoing for the same indication, and it is not a head-to-head study derived from AK112 clinical trial.