Daiichi Sankyo has reported data from the HERTHENA-Lung01 Phase II trial of patritumab deruxtecan (HER3-DXd) for the treatment of EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

The international, two-arm, open-label, multicentre study enrolled patients from Oceania, Asia, North America, and Europe.

It assessed the efficacy and safety of patritumab deruxtecan in NSCLC patients following disease progression with an EGFR TKI and platinum-based chemotherapy.

Objective response rate (ORR), as assessed by blinded independent central review was the primary endpoint of the study.

Secondary endpoints included duration of response (DOR), progression-free survival, disease control rate (DCR), time to response, as well as investigator-assessed ORR, overall survival, tolerability, and safety.

Out of the total patients, 225 participants who received patritumab deruxtecan 5.6 mg/kg showed an ORR of 29.8%.

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One complete response (CR), 66 partial responses (PR) and 99 stable disease (SD) cases were also observed.

A DCR of 73.8% and a median DOR of 6.4 months were also demonstrated during the study.

Efficacy outcomes were found to be consistent in a subset of 209 patients who previously received treatment with third-generation EGFR TKI and platinum-based chemotherapy.

An intracranial ORR of 33.3% was demonstrated in a subset of 30 subjects with brain metastases at baseline and no prior radiotherapy treatment.

In these patients, one intracranial PR, nine intracranial CRs, and 13 cases of SD were observed.

Daiichi Sankyo Research and Development global head Ken Takeshita said: “The results from HERTHENA-Lung01, coupled with early trial results, show that patritumab deruxtecan demonstrates clinically meaningful and durable responses, illustrating the potential of this HER3 directed antibody drug conjugate to become a new standard of care for this patient population with high unmet medical need.

“These data will support our ongoing discussions with health authorities including our planned submission in the US.”