On July 1, 2026 Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) reported that it has entered into a strategic collaboration agreement with AstraZeneca (LSE/STO/NYSE: AZN) to jointly advance the clinical development of a novel IO-TKI combination therapy for non-small cell lung cancer (NSCLC). As a multicenter, open-label Phase I/II clinical study, the combination will evaluate the safety and efficacy of Abbisko’s first-in-class oral small-molecule PD-L1 inhibitor, lumipodlin (ABSK043), in combination with AstraZeneca’s third-generation EGFR-TKI, TAGRISSO (osimertinib), for the treatment of patients with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC. On May 20, 2026, the investigational new drug (IND) application for the combination study was cleared by the National Medical Products Administration (NMPA). This Phase II study will be led by Abbisko, and both Abbisko and AstraZeneca will share responsibilities for the clinical trial.
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Lumipodlin is a potentially first-in-class oral small molecule PD-L1 inhibitor with unique properties beyond its route of administration. Currently, third-generation EGFR-TKIs represented by osimertinib have become the front-line standard of care for EGFR-mutated NSCLC. However, patients with EGFR-mutant and high PD-L1 expression derive less benefit from EGFR-TKIs than those with low or negative PD-L1 expression[1],[2]. There is a long-standing unmet medical need for patients with EGFR mutated, PD-L1 positive NSCLC.
References
[1] Brown H, Vansteenkiste J, Nakagawa K, et al. Programmed cell death ligand 1 expression in untreated EGFR mutated advanced NSCLC and response to osimertinib versus comparator in FLAURA. J Thorac Oncol. 2020;15(1):138–143.
[2] Niu J, Jing X, Xu Q, et al. Strong PD-L1 affect clinical outcomes in advanced NSCLC treated with third-generation EGFR-TKIs. Future Oncol. 2024;20(32):2481-2490.
About Lumipodlin (ABSK043)
Lumipodlin is a novel, orally bioavailable, highly selective small molecule PD-L1 inhibitor independently developed and wholly owned by Abbisko Therapeutics. Tumor cells can exploit immune checkpoints such as PD-1 and its ligand PD-L1 to evade immune detection and clearance, thereby suppressing or limiting T-cell responses. Lumipodlin selectively binds to the PD-L1 receptor and induces its internalization from the cell surface, effectively inhibiting the PD-1/PD-L1 interaction and alleviating PD-L1-mediated suppression of T-cell activation. In preclinical models, lumipodlin has demonstrated anti-tumor efficacy comparable to approved PD-L1 antibodies. While several PD-1/PD-L1 monoclonal antibodies have been approved worldwide, there are currently no approved orally bioavailable PD-1/PD-L1 small molecule drugs. Lumipodlin is currently being explored in an ongoing Phase I clinical trial for advanced solid tumors in Australia and China.
About Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in EGFRm NSCLC, including against central nervous system metastases. Tagrisso (40mg and 80mg QD oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.
(Press release, Abbisko Therapeutics, JUL 1, 2026, View Source [SID1234669039])