Abbisko to pair oral PD-L1 inhibitor with AstraZeneca's Tagrisso in combination trial for NSCLC

Shanghai-based Abbisko Therapeutics (HKEX: 02256.HK) has [entered a clinical collaboration](https://www.prnewswire.com/news-releases/abbisko-therapeutics-and-astrazeneca-enter-a-strategic-collaboration-to-conduct-the-clinical-trial-of-lumipodlin-absk043-a-first-in-class-oral-pd-l1-inhibitor-in-combination-with-tagrisso-for-nsclc-302816115.html) with AstraZeneca (NYSE: AZN) to evaluate [lumipodlin](https://app.allsci.com/drugs/ASC-DR-0000000031174-1.0-1772718717)[ (ABSK043)](https://app.allsci.com/drugs/ASC-DR-0000000031174-1.0-1772718717), a small-molecule PD-L1 inhibitor, in combination with osimertinib (Tagrisso) in EGFR-mutated, PD-L1 positive non-small cell lung cancer. The deal gives AstraZeneca a clinical partner for a novel immunotherapy modality with no approved precedent, while positioning Abbisko as the most clinically advanced oral PD-L1 program globally backed by a major pharma combination partner. No financial terms were disclosed. The arrangement is a co-development collaboration rather than a licensing transaction: AstraZeneca contributes osimertinib as the combination backbone, Abbisko leads the Phase II study, and both parties share clinical trial responsibilities. Abbisko retains full ownership of lumipodlin. China's National Medical Products Administration cleared the IND for the combination on May 20, 2026. ### Deal context Lumipodlin is described by Abbisko as a selective small-molecule PD-L1 inhibitor that binds the PD-L1 receptor and induces its internalization from the cell surface, thereby blocking the PD-1/PD-L1 interaction and relieving T-cell suppression. In preclinical models, Abbisko reports anti-tumor activity comparable to approved PD-L1 antibodies, though no clinical efficacy data have been published. The molecule entered [Phase I testing](https://clinicaltrials.gov/search?term=ABSK043) in advanced solid tumors in Australia and China, and has reached Phase II stage across various indications. The biological rationale for the combination targets a specific unmet need: published clinical data indicate that EGFR-mutant patients with high PD-L1 expression derive less benefit from osimertinib monotherapy than those with low or negative PD-L1 expression. Prior attempts to combine osimertinib with anti-PD-1/PD-L1 antibodies, including pembrolizumab in the TATTON trial, were associated with excess pulmonary toxicity — a safety concern that an oral small molecule with a different pharmacokinetic profile may potentially circumvent, though this hypothesis has not been tested clinically. Abbisko has a history of pursuing immuno-oncology combination strategies; the company previously [reported](https://app.allsci.com/news/ASC-NR-0000000130510-1.0-1769544334) a 50% objective response rate for its FGFR4 inhibitor irpagratinib combined with atezolizumab in advanced hepatocellular carcinoma, and [presented updated data](https://app.allsci.com/news/ASC-NR-0000000153542-1.0-1769549884) from that combination at the 2025 ESMO GI Congress. The oral PD-L1 inhibitor class remains unvalidated clinically. No such agent has received regulatory approval globally, and the leading Western program, Incyte's [INCB086550, saw its Phase II study terminated ](https://app.allsci.com/clinical-trial/ASC-CT-0000001305019-1.0-1782753497)in early 2025, raising questions about the modality's viability as a monotherapy. Abbisko's lumipodlin is now the most advanced oral PD-L1 program with a named major pharma combination partner, which provides a credibility signal but does not resolve the underlying clinical differentiation question. *** This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: [https://allsci.com/news/](https://allsci.com/news/) --- Spot something wrong? [Report an issue with this article](https://newsgen-prod.reframedata.com/feedback/pd-l1-inhibitor-nsclc-abbiskos-first-in-class)