SABCS 2022 | A correlative analysis of CORALLEEN: preoperative ribociclib +letrozole vs chemo in HR+/HER2- BC
Tomás Pascual, MD, Hospital Clinic Barcelona, Barcelona, Spain, shares the results of a corerlative analysis of the Phase II CORALLEEN (NCT03248427) trial exploring cycle Inhibition and immune microenvironment in HR-positive/HER2-negative breast cancer during and fter preoperative ribociclib and letrozole vesus chemotherapy. Patients were randomized to receive standard neoadjuvant anthrocycline and taxane-based chemotherapy versus letrozole plus ribociclib. The primary endpoint was the rate of PAM50 Risk of Relapse (ROR)-low score at surgery in each arm. The rate of risk of ROR-low was the same for chemotherapy and letrozole plus ribociclib, as well as overall-response rate (ORR), pathologic complete response (pCR), amongst other patients outcomes. This suggests that chemotherapy could be spared in some patients and replaced with letrozole plus ribociclib or other endocrine therapy. Additionally, samples were prospectively collected at baseline, day 15, and surgery and sTILs score, ki67 IHC and gene expression analysis were determined and gene expression profiling by mRNA sequencing (RNAseq) was evaluated. A higher decrease in proliferation of the tumor following CDK4/6 inhibitor was observed with letrozole plus ribociclib versus chemotherapy, as well as a higher rate of senescence. Additionally, immune infiltration was observed to be higher in tumors with a high response to chemotherapy and in tumors with a poor response to letrozole plus ribociclib. The prognostic value of immune and anti-proliferative effects of letrozole plus ribociclib in residual tumors is currently being evaluated in the prospective Phase II RIBOLARIS (NCT05296746) clinical trial. This interview took place at the San Antonio Breast Cancer Symposium (SABCS) 2022 in San Antonio, TX.
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