Abbisko Therapeutics and AstraZeneca will evaluate lumipodlin, an oral PD‑L1 inhibitor, plus Tagrisso in EGFR‑mutated, PD‑L1‑positive NSCLC. The NMPA‑cleared Phase I/II trial aims to address poor outcomes in this subgroup.
Written By: Shaik Yasmeen, PharmD
Reviewed By: Pharmacally Editorial Team
Abbisko Therapeutics has partnered with AstraZeneca to jointly develop a first-in-class immuno-oncology and targeted therapy combination for patients with EGFR-mutated, PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). The collaboration will evaluate lumipodlin (ABSK043), an investigational oral small-molecule PD-L1 inhibitor, in combination with Tagrisso (osimertinib), AstraZeneca’s third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI).
The multicenter, open-label Phase I/II clinical trial received clearance from China’s National Medical Products Administration (NMPA) on May 20, 2026, allowing clinical evaluation of the novel combination. Abbisko will sponsor and lead the Phase II study, while both companies will jointly support clinical development.
The collaboration targets an important unmet need in patients whose tumors harbor EGFR mutations alongside high PD-L1 expression, a subgroup that has historically shown poorer responses to EGFR-TKI therapy than patients with low or negative PD-L1 expression.
Oral PD-L1 Inhibition May Expand Immunotherapy Options
Lumipodlin (ABSK043) is an orally bioavailable, highly selective small-molecule inhibitor of programmed death-ligand 1 (PD-L1) developed by Abbisko Therapeutics. Unlike currently approved PD-1 or PD-L1 monoclonal antibodies, lumipodlin is administered orally and works by binding directly to PD-L1, triggering its internalization from the tumor cell surface. This blocks PD-1/PD-L1 signaling and restores T-cell activation against cancer cells.
Preclinical studies have shown antitumor activity comparable to approved PD-L1 antibodies. If successful, lumipodlin could become the first approved oral small-molecule therapy targeting the PD-1/PD-L1 immune checkpoint pathway.
The drug is currently under evaluation in an ongoing Phase I study involving patients with advanced solid tumors in Australia and China.
Combination Strategy Targets a Persistent Treatment Gap
Osimertinib has become the global standard first-line treatment for EGFR-mutated NSCLC, offering durable disease control and proven activity against central nervous system metastases. More than one million patients worldwide have received Tagrisso across its approved indications.
Despite these advances, evidence suggests that patients with high PD-L1 expression derive less benefit from EGFR-TKI therapy, highlighting the need for combination approaches capable of overcoming resistance while maintaining targeted inhibition of EGFR signaling.
The new study will assess the safety, tolerability, and preliminary efficacy of combining lumipodlin with osimertinib in patients with locally advanced or metastatic disease. Although detailed study endpoints have not yet been disclosed, the Phase I/II design is expected to establish an appropriate dose while evaluating early antitumor activity and clinical benefit.
Collaboration Strengthens Development of Next-Generation Immuno-Oncology
The agreement brings together Abbisko’s emerging oral immunotherapy platform and AstraZeneca’s established expertise in EGFR-targeted treatment. The partnership also reflects growing interest in combining immune checkpoint inhibition with targeted therapies for molecularly defined lung cancers that remain difficult to treat despite advances in precision oncology.
If the combination demonstrates favorable safety and meaningful clinical activity, the program could advance into later-stage development and offer a new therapeutic strategy for patients with EGFR-mutated, PD-L1-positive NSCLC, an area where effective treatment options remain limited.
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About the Writer
Shaik Yasmeen (LinkedIn) is a Pharm.D graduate with interests in clinical pharmacy, pharmacovigilance, and medical writing. She has gained experience through hospital clinical postings, patient case reviews, case presentations, and literature evaluation. Passionate about evidence-based healthcare, she is committed to creating accurate and engaging medical content while continuously expanding her professional knowledge.