SHANGHAI, China, July 1, 2026
Abbisko Therapeutics and AstraZeneca have entered into a strategic collaboration to advance the clinical development of a first-in-class oral PD-L1 inhibitor in combination with the blockbuster EGFR tyrosine kinase inhibitor (EGFR-TKI) TAGRISSO® (osimertinib) for the treatment of EGFR-mutated, PD-L1-positive non-small cell lung cancer (NSCLC). The collaboration will jointly evaluate lumipodlin (ABSK043), Abbisko’s innovative oral small-molecule PD-L1 inhibitor, alongside AstraZeneca’s established targeted therapy in a multicenter, open-label Phase I/II clinical trial. The study follows National Medical Products Administration (NMPA) clearance of the investigational new drug (IND) application on May 20, 2026, enabling the partners to investigate a novel immunotherapy-targeted therapy combination designed to address a significant unmet medical need in patients who experience limited benefit from existing EGFR-targeted treatments alone. The partnership represents an important milestone in the development of next-generation immuno-oncology therapies, combining targeted precision medicine with innovative immune checkpoint inhibition to improve outcomes for patients with advanced lung cancer.
Phase I/II Trial Explores First-in-Class Oral PD-L1 Inhibitor
The collaborative Phase I/II clinical study will evaluate the safety, tolerability, and preliminary efficacy of lumipodlin (ABSK043) in combination with TAGRISSO® (osimertinib) in patients diagnosed with locally advanced or metastatic EGFR-mutated, PD-L1-positive NSCLC. Abbisko Therapeutics will lead the multicenter clinical trial while both companies share responsibility for study execution and development activities. Lumipodlin is a highly selective oral small-molecule PD-L1 inhibitor designed to block the interaction between PD-1 and PD-L1, restoring T-cell activation and enhancing anti-tumor immune responses.
Unlike currently approved PD-1/PD-L1 monoclonal antibodies, lumipodlin offers the potential advantage of oral administration, providing greater treatment convenience while maintaining robust immunotherapeutic activity. Preclinical studies have demonstrated anti-tumor efficacy comparable to approved PD-L1 antibodies, supporting its continued clinical evaluation across multiple solid tumor indications.
Novel Combination Addresses Unmet Need in EGFR-Mutated NSCLC
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TAGRISSO® (osimertinib) remains the global standard first-line therapy for patients with EGFR-mutated non-small cell lung cancer, having demonstrated significant improvements in survival and disease control. However, clinical studies have shown that patients with high PD-L1 expression frequently derive less benefit from EGFR-TKI therapy than patients with low or negative PD-L1 levels, leaving an important gap in treatment options.
The combination of lumipodlin and TAGRISSO® seeks to overcome this limitation by simultaneously targeting oncogenic EGFR signaling while reactivating anti-tumor immune responses through PD-L1 inhibition. Researchers believe this dual mechanism may improve treatment efficacy in a patient population with historically limited therapeutic benefit, potentially establishing a new precision medicine strategy for EGFR-mutated lung cancer. If successful, the combination could represent one of the first oral immunotherapy-targeted therapy regimens developed specifically for this challenging subgroup of NSCLC patients.
Strategic Alliance Expands Precision Oncology Innovation
The collaboration strengthens Abbisko Therapeutics’ growing portfolio of precision oncology and immuno-oncology programs, while reinforcing AstraZeneca’s leadership in lung cancer research and targeted therapies. Abbisko continues advancing an expanding pipeline of innovative small-molecule therapeutics focused on addressing significant unmet medical needs in oncology through targeted and immune-based approaches. Meanwhile, TAGRISSO® has already treated more than one million patients worldwide, serving as one of the most successful targeted therapies for EGFR-mutated NSCLC.
By combining Abbisko’s innovative oral PD-L1 inhibitor with AstraZeneca’s extensive expertise in global oncology drug development, the partnership aims to accelerate the development of differentiated treatment strategies capable of improving outcomes for patients with advanced lung cancer. The collaboration also reflects the growing trend toward combination precision therapies that integrate immunotherapy and targeted medicine to overcome resistance mechanisms and deliver more personalized cancer care.
Source: Abbisko Therapeutics, AstraZeneca press release
