Reveal Genomics highlights results for breast cancer predictive test in phase II clinical trial

Breast Mammo Social

Precision oncology firm Reveal Genomics on Thursday announced that its HER2Dx genomic test for HER2+ breast cancer has been validated in the PHERGain phase II clinical trial.

The PHERGain trial was led by Medsir, a Barcelona, Spain-based firm that manages clinical trials. Reveal Genomics and Medsir entered a strategic partnership in 2022.

Detailed results of the PHERGain trial will be submitted for publication and presented at a future medical congress. The initial findings from the study were published in the Lancet Oncology in 2021.

HER2Dx is a standardized 27-gene expression predictive assay for patients with early-stage HER2+ breast cancer. Along with giving a predictive score for a patient’s likely response to anti-HER2-based treatment before surgery, the test also scores risk of relapse and recurrence in patients with newly diagnosed HER2+ breast cancer.

The phase II clinical trial randomized 356 patients with newly diagnosed HER2+ breast cancer to neoadjuvant systemic therapy with six cycles of multiagent chemotherapy, trastuzumab, and pertuzumab or two cycles of chemotherapy-free dual HER2 blockade with trastuzumab and pertuzumab. When used in baseline pre-treatment tumor biopsies, the HER2Dx score for pathological complete response (pCR) was found to be significantly associated with pCR, regardless of the treatment regime, 18F-FDG-PET metabolic response, or hormone receptor status.

Moreover, in the study, HER2Dx identified 85% of patients with an invasive disease event as high-risk; 98% of patients scored as low-risk by HER2Dx were disease-free at last follow-up.

"The results of HER2Dx in PHERGain are remarkable and support the strong predictive and prognostic value of the test in patients with early-stage HER2+ breast cancer," Dr. Antonio Llombart, principal investigator of the PHERGain trial, co-founder of Medsir, and head of the medical oncology department at Hospital Arnau de Vilanova in Valencia, Spain, said in a statement. "The test will help to select which patients might be treated with trastuzumab and pertuzumab without chemotherapy, a treatment strategy with better quality of life than multiagent chemotherapy."

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