Chinese biopharmaceutical company Abbisko Therapeutics Co Ltd (HKEX:02256) announced on Wednesday that it has entered into a strategic collaboration agreement with biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (NYSE:AZN) to jointly advance the clinical development of a novel IO-TKI combination therapy for non-small cell lung cancer (NSCLC).

The multicentre, open-label Phase I/II clinical study will evaluate the safety and efficacy of Abbisko's first-in-class oral small-molecule PD-L1 inhibitor, lumipodlin (ABSK043), in combination with AstraZeneca's third-generation EGFR-TKI, TAGRISSO (osimertinib), for the treatment of patients with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC.

An investigational new drug (IND) application for the combination study was cleared by China's National Medical Products Administration (NMPA) in May 2026. The Phase II study will be led by Abbisko, and both Abbisko and AstraZeneca will share responsibilities for the clinical trial.

Lumipodlin is a potentially first-in-class oral small molecule PD-L1 inhibitor with unique properties beyond its route of administration. Currently, third-generation EGFR-TKIs represented by osimertinib have become the front-line standard of care for EGFR-mutated NSCLC. However, patients with EGFR-mutant and high PD-L1 expression derive less benefit from EGFR-TKIs than those with low or negative PD-L1 expression. There is a long-standing unmet medical need for patients with EGFR mutated, PD-L1 positive NSCLC.