Three negative breast cancer (TNBC) immunotherapy! Keytruda + chemotherapy in the first-line treatment of phase III clinical reached the main end point, extending the progression free survival period!

February 13, 2020 / BIOON / -- Merck & Co recently announced that the evaluation of keytruda (Coretta, common name: pembrolizumab, pabolizumab) combined with chemotherapy in the first-line treatment of tumor expression PD-L1 (with positive score [CPS] ≥ 10) triple negative breast cancer Keynote-355 (nct02819518), a phase III clinical study in patients with TNBC, achieved progression free survival (PFS), one of the dual primary endpoints According to a mid-term analysis conducted by the independent data monitoring committee (DMC), among mtnbc patients with tumor expression of PD-L1 (CPS ≥ 10), compared with chemotherapy (NAB paclitaxel, paclitaxel or gemcitabine / carboplatin), keytruda combined with first-line chemotherapy significantly improved PFS, with statistical and clinical significance According to DMC's recommendations, the study will continue without any changes to assess the overall survival (OS) of another dual primary endpoint In this study, keytruda's security is consistent with that previously reported, and no new security signal is found "Triple negative breast cancer is an aggressive malignancy," said Dr Roger M Perlmutter, President of the MSD research laboratory Keytruda combined with chemotherapy, as the first-line treatment for metastatic diseases and as a new adjuvant treatment in the keynote-522 study, have shown positive results, which is very encouraging We look forward to sharing these findings with the medical community at the upcoming scientific conference and discussing them with the FDA and other regulators " Keytruda's breast cancer clinical development project includes several internal and external collaborative studies In the TNBC field, in addition to keynote-355, there are two other ongoing registration support studies keynote-242 and keynote-522 In October 2019, MSD published data from the key neoadjuvant / adjuvant phase III keynote-522 study (nct03036488) to evaluate keytruda in the treatment of early TNBC patients It is worth mentioning that this study is the first randomized study to evaluate a new adjuvant / adjuvant therapy of anti PD-1 for TNBC This is a randomized, double-blind phase III study, which is investigating keytruda combined chemotherapy, placebo combined chemotherapy as neoadjuvant therapy, followed by keytruda, placebo as adjuvant therapy for TNBC patients The results of mid-term analysis showed that in neoadjuvant therapy, keytruda + chemotherapy (n = 401) showed a statistically significant increase in pathological complete remission (PCR) compared with chemotherapy (n = 201), regardless of the expression of PD-L1 in early TNBC patients (PCR: 64.8% vs 51.2%, P = 0.00055) In another primary end point, event free survival (EFS), a median follow-up of 15.5 months, keytruda showed a favorable trend in EFS, reducing the risk of progression and recurrence of neoadjuvant disease by 37% (HR = 0.63 [95% CI: 0.43-0.93]) compared with chemotherapy placebo In this study, the safety of keytruda and chemotherapy was consistent with previous studies It is worth mentioning that keytruda is the first anti PD-1 therapy to show statistically significant improvement in PCR as a new adjuvant therapy for TNBC (regardless of PD-L1 status) Breast cancer is the most common type of cancer among women, with more than 2 million confirmed cases every year around the world TNBC accounts for about 15-20% of all breast cancers Compared with other types of breast cancer, TNBC is more common in women under 50 years old TNBC refers to breast cancer with negative expression of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2) It is an invasive breast cancer with rapid progress, poor prognosis, high recurrence rate and 5-year survival rate of less than 15% TNBC has no effect on hormone therapy and HER2 targeted therapy (such as Herceptin) Metastatic TNBC is one of the most aggressive and refractory breast cancer It is worth mentioning that in March 2019, the US FDA accelerated the approval of Roche's anti-PD-L1 therapy tecentriq (tersanqi, general name: atezolizumab, atraxane) combined with chemotherapy (Abraxane) for the first-line treatment of PD-L1 positive non resectable locally advanced or metastatic TNBC patients This approval makes tecentriq + Abraxane combination the first cancer immunotherapy for PD-L1 positive metastatic TNBC In phase III clinical study impression130, tecentriq + Abraxane significantly reduced the risk of disease progression or death in PD-L1 positive patients by 40% compared with placebo + Abraxane (median PFS: 7.4 months vs 4.8 months, HR = 0.60, 95% CI: 0.48-0.77, P < 0.0001) New data released at the ASCO meeting in 2019 showed that tecentriq + Abraxane regimen improved the overall survival (OS) of patients with PD-L1 positive by 7 months compared with placebo + Abraxane regimen (median OS: 25.0 vs 18.0 months, HR = 0.71, 95% CI: 0.54-0.93) Original source: Merck's keytruda ® (pembrolizumab) in combination with chemotherapy met primary endpoint of progression free survival (PFS) as first line treatment for metastatic triple negative burst cancer (mtnbc)