Daiichi Sankyo and MSD (Merck & Co) have reported that the Phase III HERTHENA-Lung02 clinical trial of patritumab deruxtecan, an HER3-directed DXd antibody-drug conjugate (ADC) in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), met the primary endpoint of progression-free survival (PFS).
The international, multicentre, open-label trial assessed patritumab deruxtecan’s efficacy and safety at a dose of 5.6mg/kg every three weeks against four cycles of pemetrexed and platinum chemotherapy.
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Individuals with metastatic or locally advanced NSCLC harbouring an EGFR-activating mutation, who had previously failed third-generation EGFR tyrosine kinase inhibitor treatment, were part of the trial.
According to the findings, the trial successfully met its primary endpoint, demonstrating a statistically significant improvement in PFS for subjects treated with patritumab deruxtecan versus those receiving platinum plus pemetrexed chemotherapy, followed by pemetrexed maintenance.
Secondary endpoints of the study include overall survival (OS), objective response rate, duration of response, and safety, among others.
While OS data were not mature at the time of the assessment, the trial will continue to evaluate this secondary endpoint.
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By GlobalDataPatritumab deruxtecan’s safety profile in the trial was in line with previous lung cancer studies, without any new safety signals identified.
Most interstitial lung disease (ILD) events were observed to be low grade, with two grade 5 ILD events reported in the trial.
Discovered by Daiichi Sankyo, patritumab deruxtecan is jointly developed by Daiichi Sankyo and MSD.
Daiichi Sankyo research and development global head Ken Takeshita said: “These results from HERTHENA-Lung02 demonstrate the potential of patritumab 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 the next steps.”
Last month, Daiichi Sankyo and MSD announced the dosing of the first participant in the Phase III IDeate-Lung02 trial of ifinatamab deruxtecan (I-DXd) in people with relapsed small cell lung cancer (SCLC).
