Abbisko Therapeutics has entered a strategic collaboration with AstraZeneca to evaluate a combination therapy for non-small cell lung cancer (NSCLC), pairing Abbisko’s investigational oral PD-L1 inhibitor lumipodlin (ABSK043) with osimertinib (Tagrisso).
The companies will jointly conduct a multicenter, open-label Phase I/II clinical trial in patients with EGFR-mutated, PD-L1 positive locally advanced or metastatic NSCLC. The study will assess safety and efficacy of the combination, with Abbisko leading the Phase II portion. China’s National Medical Products Administration cleared the investigational new drug application for the study in May 2026.
Osimertinib, a third-generation EGFR tyrosine kinase inhibitor, is a standard first-line treatment for EGFR-mutated NSCLC. However, patients with high PD-L1 expression have been shown to derive less benefit from EGFR-targeted therapies, highlighting a need for alternative or combination approaches.
Lumipodlin is an orally available small molecule designed to inhibit PD-L1 by promoting its internalization, thereby disrupting PD-1/PD-L1 signaling and restoring T-cell activity. While PD-1 and PD-L1 monoclonal antibodies are widely used, oral small-molecule inhibitors targeting this pathway have not yet been approved.
The combination approach aims to address both oncogenic signaling and immune evasion mechanisms in NSCLC. Lumipodlin is currently being evaluated in an ongoing Phase I study in advanced solid tumors.
The collaboration reflects continued interest in combining targeted therapies with immuno-oncology approaches to improve outcomes in molecularly defined lung cancer populations.
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