Patritumab Deruxtecan Proves More Effective In Progression-Free Survival (PFS) For Patients With EGFR-Mutated Non-Small Cell Lung Cancer Over Chemotherapy In Latest Trial

The HERTHENA-Lung02 Phase 3 study explored the effects of patritumab deruxtecan in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) who had previously undergone EGFR tyrosine kinase inhibitor (TKI) therapy. The trial successfully met its primary goal by showing a notable improvement in progression-free survival (PFS) compared to the conventional platinum and pemetrexed chemotherapy regimen. The data on overall survival (OS) were not yet mature, so the study will continue to monitor OS as a secondary outcome.

Patritumab deruxtecan is an innovative HER3-targeted antibody-drug conjugate (ADC) developed by Daiichi Sankyo and Merck. This potential first-in-class treatment aims to address a significant need in lung cancer care. Non-small cell lung cancer (NSCLC) represents about 85% of lung cancer cases globally, with up to 70% diagnosed at an advanced stage. 

EGFR mutations are found in 14% to 38% of these tumors. Many patients with metastatic EGFR-mutated NSCLC, who initially respond to EGFR tyrosine kinase inhibitors (TKIs), eventually face disease progression. This situation underscores the urgent need for new and effective treatments in the second-line setting.

Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo commented, “These results from HERTHENA-Lung02 demonstrate the potential of Parilumab Deruxtecan to become an important treatment option for certain patients with EGFR-mutated non-small cell lung cancer with prior tyrosine kinase inhibitor treatment. We plan to share these findings with regulatory authorities to discuss next steps.” 

Marjorie Green, MD, Senior Vice President and Head of Oncology, Global Clinical Development, Merck, said in a statement, “We are encouraged by these results demonstrating a statistically significant progression-free survival improvement compared to platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who received prior tyrosine kinase inhibitor treatment. Together with Daiichi Sankyo, we are committed to helping patients with previously treated EGFR-mutated non-small cell lung cancer, where there is a high unmet need.”

In the HERTHENA-Lung02 trial, patritumab deruxtecan exhibited a safety profile similar to what has been seen in earlier lung cancer studies, with no new safety concerns emerging. Most cases of interstitial lung disease (ILD) were mild (grades 1 and 2), though there were two reported instances of severe grade 5 ILD.