The HERTHENA-Lung01 Phase 2 Trial demonstrated significant, lasting effects of Patritumab Deruxtecan in non-small cell lung cancer patients

Findings from the HERTHENA-Lung01 phase 2 investigation reveal that, following their disease advancement with an EGFR TKI and platinum-infused chemotherapy, patritumab deruxtecan (HER3-DXd) offered notable and long-lasting effects on patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer. The research was delivered as an oral presentation at the 2023 Global Lung Cancer Conference.

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Patritumab deruxtecan represents a meticulously formulated prospective first-in-class in the HER3 directed antibody drug conjugate group, developed utilizing Daiichi Sankyo’s unique DXd ADC technology. 

Non-small cell lung cancer represents nearly 85% of all lung cancer incidences worldwide. At the time of diagnosis, 55% of these cases have already metastasized distantly. Among all cases, EGFR-activating mutations are identified in 14% to 38% of all NSCLC tumors. After the disease evolves post-treatment with an EGFR TKI and platinum-based chemotherapy, the available treatment options offer minimal efficacy, underlining the necessity to explore novel methodologies for better patient outcomes.

The consistent efficacy outcomes, including a sub-group of 209 patients who had previously gone under third-generation EGFR TKI and platinum-based chemotherapy treatments were observed. Anti-tumor activities with patritumab deruxtecan were also noted across varied mechanisms of EGFR TKI resistance and throughout a spectrum of pretreatment tumor HER3 membrane expression levels.

"The results obtained from HERTHENA-Lung01 furnished considerable support to the effectiveness of patritumab deruxtecan in patients with advanced EGFR-mutated non-small cell lung cancer," stated Helena Yu, MD, an Associate Attending Physician at Memorial Sloan Kettering Cancer Center.

"Disease progress is a certainty in patients who have been previously treated and recurred metastatic EGFR-mutated non-small cell lung cancer, thereby strengthening the demands for novel and innovative treatment methodologies encompassing diverse mechanisms of resistance," remarked Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "These results will serve as a pillar to our ongoing discussions with health authority bodies including our future submission plans in the U.S."

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According to the data provided by the Synapse Database, As of September 14, 2023, there are 2 investigational drugs for the HER3 and TOP1 target, including 16 applicable indications,8 R&D institutions involved, with related clinical trials reaching 30，and as many as 153 patents.

Patritumab deruxtecan is currently being evaluated as both a monotherapy and in combination with other therapies in a global development program. Patritumab deruxtecan was granted Breakthrough Therapy Designationby the U.S. FDA in December 2021 for the treatment of patients with EGFR-mutated locally advanced or metastatic NSCLC with disease progression on or after treatment with a third-generation TKI and platinum-based therapies.