Daiichi Sankyo announced that the first patient has been dosed in the global HERTHENA-Lung02 phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan (HER3-DXd) versus platinum-based chemotherapy in patients with EGFRmutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with disease progression following treatment with one or more EGFR tyrosine kinase inhibitors (TKIs) including a thirdgeneration EGFR TKI.

Patritumab deruxtecan is a specifically designed potential first-in-class HER3 directed antibody drug conjugate (ADC) discovered and being developed by Daiichi Sankyo.

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide. Approximately 80% to 85% of lung cancer is classified as NSCLC with EGFR mutations occurring in up to 30% of tumors. While the efficacy and safety of targeted therapy with EGFR TKIs is well-established for the treatment of advanced EGFR-mutated NSCLC, the development of a broad range of resistance mechanisms is likely to lead to disease progression. After failure of one or more EGFR TKIs, platinumbased chemotherapy and subsequent salvage therapies have limited efficacy.

“We are encouraged by the early results seen with patritumab deruxtecan and have initiated HERTHENALung02 to further evaluate whether this HER3 directed antibody drug conjugate will be more effective than standard chemotherapy in treating patients with previously treated EGFR-mutated metastatic non-small cell lung cancer,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Clinical Development, Oncology R&D, Daiichi Sankyo.

“Initiating this phase 3 trial emphasizes our ongoing commitment to accelerate development of patritumab deruxtecan to potentially improve the standard of care for patients with this specific subtype of lung cancer.”