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HERTHENA-Lung02 Phase 3 Trial of Patritumab Deruxtecan Initiated in Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer

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Daiichi Sankyo (TSE: 4568) announced today 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 EGFR-mutated 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 third-generation 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.1 Approximately 80% to 85% of lung cancer is classified as NSCLC with EGFR mutations occurring in up to 30% of tumors.2,3 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.4,5,6 After failure of one or more EGFR TKIs, platinum-based chemotherapy and subsequent salvage therapies have limited efficacy.7

“We are encouraged by the early results seen with patritumab deruxtecan and have initiated HERTHENA-Lung02 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.”

About HERTHENA-Lung02

HERTHENA-Lung02 is a global, multicenter, open-label, phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan (5.6 mg/kg) versus platinum-based chemotherapy (pemetrexed in combination with cisplatin or carboplatin) in patients with locally advanced or metastatic non-squamous NSCLC with an EGFR-activating mutation (exon 19 deletion or exon 21 L858R mutation) previously treated with an EGFR TKI with disease progression on or after treatment with a third-generation TKI. Patients will be randomized 1:1 to receive patritumab deruxtecan or platinum-based chemotherapy.

The primary endpoint of HERTHENA-Lung02 is progression-free survival (PFS) as assessed by blinded independent central review (BICR). Secondary endpoints include overall survival, investigator-assessed PFS as well as BICR and investigator-assessed objective response rate, clinical benefit rate, disease control rate, duration of response, time to response and safety. HERTHENA-Lung02 will enroll approximately 560 patients at multiple sites across Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

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