Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, announced that it has entered into a strategic collaboration agreement with AstraZeneca (LSE/STO/NYSE: AZN) to jointly advance the clinical development of a novel IO-TKI combination therapy for non-small cell lung cancer (NSCLC).

As a multicenter, open-label Phase I/II clinical study, the combination 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. On May 20, 2026, the investigational new drug (IND) application for the combination study was cleared by the National Medical Products Administration (NMPA). This 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^[1],^[2]. There is a long-standing unmet medical need for patients with EGFR mutated, PD-L1 positive NSCLC.