Patritumab Deruxtecan Phase 2 trial unveils encouraging outcomes in metastatic NSCLC

The HERTHENA-Lung01 Phase 2 trial, presented at the 2023 World Conference on Lung Cancer by Daiichi Sankyo, demonstrated that Patritumab Deruxtecan has potential for treating EGFR-mutated metastatic non-small cell lung cancer (NSCLC). The drug revealed a confirmed objective response rate (ORR) of 29.8% in 225 patients, with a median progression-free survival of 5.5 months and median overall survival of 11.9 months as of May 18, 2023.

The Unmet Need for Advanced NSCLC Therapies

With limited efficacy in currently available therapies after patients undergo EGFR TKI and platinum-based chemotherapy, there’s a growing need for new treatments for NSCLC, which accounts for approximately 85% of all lung cancers.

Efficacy and Anti-Tumor Activity

The drug, engineered using Daiichi Sankyo’s proprietary DXd ADC technology, showed efficacy outcomes consistent across subgroups. Anti-tumor activity was observed across diverse mechanisms of EGFR TKI resistance. “The results from HERTHENA-Lung01 provide compelling evidence of efficacy of Patritumab Deruxtecan in heavily pretreated patients with advanced EGFR-mutated NSCLC,” said Helena Yu, MD, Associate Attending Physician, Memorial Sloan Kettering Cancer Center.

The Clinical Details

Further details reveal a median duration of response (DOR) of 6.4 months and a disease control rate (DCR) of 73.8%. In a subset of 30 patients with brain metastases, an intracranial ORR of 33.3% was observed. “Disease progression is inevitable in patients with previously treated and relapsed metastatic EGFR-mutated NSCLC, reinforcing the need for new and innovative treatments,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.

Safety Profile and Future Steps

Safety profiles were consistent with previous trials. Patritumab Deruxtecan was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in December 2021, setting the stage for ongoing discussions with health authorities for its potential as a new standard of care in treating EGFR-mutated NSCLC.