Abbisko and AstraZeneca to trial oral PD-L1 drug with Tagrisso

Abbisko Therapeutics and AstraZeneca (NYSE: AZN) have entered into a collaboration agreement to jointly conduct a clinical trial combining Abbisko's oral PD-L1 inhibitor, lumipodlin (ABSK043), with AstraZeneca's Tagrisso (osimertinib) for the treatment of non-small cell lung cancer (NSCLC), according to a press release.

The multicenter, open-label Phase I/II study will evaluate the safety and efficacy of the combination in patients with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC. Abbisko will lead the Phase II portion of the study, with both companies sharing clinical trial responsibilities.

China's National Medical Products Administration (NMPA) cleared the investigational new drug application for the combination study on May 20, 2026.

Lumipodlin is described by Abbisko as an orally bioavailable small molecule that selectively binds to the PD-L1 receptor. While multiple PD-1/PD-L1 monoclonal antibodies have received regulatory approval globally, no orally bioavailable PD-1/PD-L1 small molecule drugs are currently approved. Lumipodlin is already being evaluated in an ongoing Phase I trial for advanced solid tumors in Australia and China.

Tagrisso is a third-generation EGFR inhibitor that has been used to treat more than one million patients across its approved indications worldwide. The combination therapy referenced in the agreement has not been approved in China.

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