Kangfang Bio-PD-1/VEGF dual antibody initiates phase 3 clinical treatment of non-small cell lung cancer

ArticleMedicine Guanlan

According to the Chinese drug clinical trial registration and information disclosure platform, Kangfang Bio has initiated a phase 3 clinical study of AK112 or placebo combined with chemotherapy for non-small cell lung cancer (NSCLC) patients who have failed EGFR-TKI treatment

According to the press release issued by Kangfang Biologics earlier, AK112 is designed based on the company's unique TETRABODY technology, which can block the binding of PD-1 to PD-L1 and PD-L2, and at the same time block the binding of VEGF to VEGF receptors

Previously, AK112 has shown good safety and tolerability in early clinical studies on various types of lung cancer including NSCLC and small cell lung cancer (SCLC), and has shown good anti-tumor effects

The data showed that a total of 26 patients with newly-treated NSCLC completed at least one post-baseline tumor assessment, of which 18 were non-squamous cell carcinomas, 8 were squamous cell carcinomas; 12 had negative PD-L1 expression, 11 had positive PD-L1 expression, and 3 were unknown

This time, Kangfang Biology initiated a randomized, double-blind, multi-center phase 3 clinical study, that is, AK112 combined with pemetrexed and carboplatin compared with placebo combined with pemetrexed and carboplatin for the treatment of EGFR-TKI Patients with locally advanced or metastatic non-squamous non-small cell lung cancer with failed EGFR mutations

Kangfang Biotech once stated in a press release that AK112 is the world's leading drug in the phase 3 clinical research phase.

In addition to the Phase 3 clinical trial launched this time, the company will also launch the late stage clinical trial: AK112 first-line treatment of PD-L1-positive NSCLC with negative driver gene Phase 3 clinical studies, and AK112 first-line treatment of extensive-stage SCLC phase 3 Clinical research

Reference materials:

[1] China Drug Clinical Trial Registration and Information Disclosure Platform.

[3] The Phase II clinical study of PD-1/VEGF double antibody (AK112) single-agent or combined chemotherapy neoadjuvant/adjuvant therapy can cut non-small cell lung cancer was approved.