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Neoadjuvant patritumab deruxtecan (HER3-DXd) alone or with letrozole achieved similar pathologic complete response (pCR) rate and overall response rate (ORR) estimates compared with multi-agent chemotherapy in patients with high-risk HR-positive/HER2-negative early breast cancer (eBC), according to results from the SOLTI VALENTINE trial.
Recently, results from the SOLTI-1805 TOT-HER3 trial (NCT04610528) showed that a single dose of the first-in-class antibody-drug conjugate HER3-DXd was associated with an increased CelTIL score and clinical response in patients with HR-positive/HER2-negative eB1,2. These findings prompted the evaluation of HER3-DXd as a potential neoadjuvant therapy in the parallel, randomized, non-comparative, open-label, phase 2 SOLTI VALENTINE trial (NCT0556981). The primary results were presented by Mafalda Oliveira, MD, PhD, University Hospital Vall d’Hebron, in Spain3.
The SOLTI VALENTINE trial included both pre- and post-menopausal women, as well as men with a Ki67 greater than or equal to 20% or high genomic risk. The 122 participants without prior treatment were stratified based on axillary nodal status. The patients were assigned to receive HER3-DXd, as a single agent or combined with letrozole, or chemotherapy. The latter was included as an internal response control. Dr. Oliveira explained that the sample size was selected to ensure a sufficient level of precision in the pCR estimation for each treatment arm.
Dr. Oliveira concluded that treatment with HER3-DXd, alone or combined with letrozole, achieved pCR and ORR rates like multi-agent chemotherapy. HER3-DXd therapy demonstrated biological evidence of antitumor activity and an increased CelTIL score, which correlated with treatment response. Moreover, HER3-DXd was associated with a more favorable safety profile than multi-agent chemotherapy. HER3-DXd has demonstrated effectiveness and holds significant potential as a treatment for patients with high-risk HR-positive/HER2-negative eBC.
Medical writing support was provided by Kulsoom Abdul.
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