
Patritumab Deruxtecan Application Withdrawn Following Disappointing Phase 3 Results for Advanced Lung Cancer
2025-05-29
Author: Ting
Patritumab Deruxtecan BLA Takes a Surprising Turn
In a shocking move, Daiichi Sankyo and Merck have voluntarily pulled their Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd), a treatment aimed at patients with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC). This decision comes after the unsettling topline overall survival (OS) results from the HERTHENA-Lung02 Phase 3 trial, which failed to demonstrate statistical significance.
While the companies had hoped for accelerated approval based on previous promising data, discussions with the U.S. Food and Drug Administration (FDA) led to this unexpected withdrawal. Importantly, this decision was not influenced by a prior Complete Response Letter received in June 2024 regarding third-party manufacturing issues.
Trial Results and Future Directions
Data from the HERTHENA-Lung02 trial—including previously reported encouraging findings around progression-free survival (PFS)—is set to be unveiled at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2025. This global Phase 3 study evaluated patritumab deruxtecan against traditional chemotherapy regimens in patients whose condition progressed after third-generation EGFR TKI treatments.
Dr. Ken Takeshita, global head of R&D at Daiichi Sankyo, expressed disappointment over the survival results but emphasized the company's commitment to biomarker analyses. The aim is to finely identify patients who may still benefit from this targeted therapy as the company continues its ambitious development program across various cancer types.
The Battle Against Lung Cancer Continues
With lung cancer tragically remaining a leading cause of cancer deaths globally, the challenges of treating EGFR-mutated NSCLC are glaring. Dr. Eliav Barr from Merck emphasized the difficulties faced in late-stage treatment and extended gratitude to study participants and their families.
Notably, results from HERTHENA-Lung02 suggested a safety profile consistent with earlier trials, with no novel safety concerns emerging.
What Lies Ahead for Patritumab Deruxtecan?
Patritumab deruxtecan, a sophisticated HER3-directed antibody-drug conjugate, was designed to address the unmet needs in treating this challenging cancer subtype. With multiple clinical trials ongoing, Daiichi Sankyo and Merck firmly believe in the potential of this drug despite the setbacks.
As new findings are expected to emerge, the future of patritumab deruxtecan in the oncology landscape may still hold promise. The extensive global clinical development program aims not only to navigate the challenges of lung cancer treatment but also to explore combinations and other innovative approaches to enhance patient outcomes.
Understanding EGFR-Mutated NSCLC
Lung cancer remains alarmingly prevalent, with nearly 2.5 million cases diagnosed worldwide in 2022. EGFR mutations are found in a significant percentage of NSCLC cases, particularly in specific demographics, underscoring the pressing need for effective treatments.
As experts continue their quest for effective therapies, patients with EGFR-mutated NSCLC await hopeful advancements that could transform their treatment landscape.