Mainz, November 28th 2018: BioNTech Diagnostics GmbH announced new results from a clinical performance evaluation study of the CE-marked IVD MammaTyper® which were presented at the European Society for Medical Oncology (ESMO) in Munich in October.1,2
For this prospectively planned study samples from the TECHNO and PREPARE trial cohorts were used to validate a pre-defined score and cut-off integrating highly standardized mRNA measurements of ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (Ki-67) by MammaTyper®. The score allows the prediction of pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) based on the pre-treatment biopsy. The cut-off accurately separates patients with a good response rate from patients with a low probability of pCR for which a different treatment than NACT or additional post-neoadjuvant treatment may be considered.
Additionally it was demonstrated that standardized measurement of ERBB2, ESR1, PGR and MKI67 mRNA is comparable to the determination of the markers on IHC level and is strongly associated with response to NACT as well as long-term outcome.
Within the group of HER2-positive patients from the TECHNO trial ERBB2 mRNA predicted pCR in the subgroup of ESR1 positive samples and may carry additional information that may help to better predict response based on the pre-treatment biopsy
“Achieving a pCR after NACT in breast cancer (BC) is strongly associated with long-term disease-free survival. Although the prognostic impact of pCR on different BC subtypes may vary, achieving pCR remains an important factor in clinical decision-making”, said Prof. Dr. med. Sibylle Loibl, CEO of GBG Forschungs GmbH and chair of the German Breast Group. “Reliable procedures for predicting pCR before treatment are limited as current predictors of pCR like imaging, clinical and histopathological parameters may need improvement before implementation in clinical routine”.
These studies demonstrated that the MammaTyper® test, with its accurate and reproducible assessments of ERBB2, ESR1, PGR and MKI67 mRNA levels from pre-treatment biopsy, could be used as a valid predictor of the likelihood of complete pathologic remission after neoadjuvant chemotherapy treatment. A standardized predictive model has been used successfully in combination with other clinic-pathological factors facilitating the identification of patients who most likely will not respond to neo-adjuvant chemotherapy and therefore helps clinicians in deciding on the therapeutic approach.
1. Fasching et al; Evaluation of the MammaTyper® as a molecular predictor for pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) and outcome in patients with different breast cancer (BC) subtypes. ESMO 2018 Congress, October 19-23 2018, Munich, Germany | 227 P.
2. Fasching et al.; Validation of the MammaTyper® pathological complete response (pCR)-score as a predictor for response after neoadjuvant chemotherapy (NACT) in patients with early breast cancer (BC). ESMO 2018 Congress, October 19-23 2018, Munich, Germany | 168 P