AZ, Abbisko Shake on Oral PD-L1, EGFR Drug Combo in NSCLC

AstraZeneca (AZ) and Chinese partner Abbisko Therapeutics have entered into a clinical collaboration to evaluate the latter's lumipodlin, an oral small-molecule PD-L1 inhibitor, in combination with Tagrisso (osimertinib) for first-line treatment of PD-L1-positive, EGFR-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC). The Phase I/II study will assess safety, tolerability and preliminary efficacy of the all-oral targeted-immunotherapy regimen – an approach historically hampered by interstitial lung disease and toxicity risks when using intravenous PD-1/PD-L1 antibodies with EGFR-TKIs.

Lumipodlin is a first-in-class oral PD-L1 inhibitor designed to offer a shorter half-life and improved safety profile compared to monoclonal antibodies (mAbs), potentially circumventing the safety barriers that stalled prior EGFR-TKI plus immuno-oncology combinations such as the TATTON study.

Positive Phase I/II data from a similar combination (ABSK043 + furmonertinib) showed no dose-limiting toxicities or interstitial lung disease, supporting the rationale for this evaluation.

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