Triple-negative breast cancer (TNBC) heavyweight! Mersadon Keytruda plus chemotherapy first-line treatment PD-L1 high expression patients significantly extended progressionless survival!

2020 May 14 News /BioValleyBIOON / - Merck Sharp & Dohme (Merck & Co) recently announced the anti-PD-1 therapy Keytruda (can Rui up, common name: KEYNOTE-355 study pembrolizumab, Pabo Li natalizumab) a treatment of triple negative breast cancer(TNBC) III of (NCT02819518) positive resultsThis was a randomized, double-blind trial to evaluate the Keytruda + chemotherapy and placebo plus chemotherapy in first-line treatment for efficacy and safety in patients with TNBCThe trial, chemotherapy is one of three scenarios: nab- paclitaxel, paclitaxel, gemcitabine / carboplatindata shows PD-L1 expression, and the combined positive rates (CPS) in patients ≥10tumor in comparison with placebo plus chemotherapy, Keytruda + chemotherapy to achieve progression-free survival statistically significant and clinically meaningful significantly longer (median PFS: 9.7 months vs5.6 months), the risk of disease progression or death was significantly reduced 35% (HR = 0.65; 95% CI: 0.49-0.86; p = 0.0012)Expression of a tumor in aPD-L1 and the combined score positive patients (CPS) ≥1, in comparison with placebo plus chemotherapy, Keytruda + chemotherapy improved progression-free survival (median PFS: 7.6 months vs5.6 months), disease progression or death risk reduction 26% (HR = 0.74; 95% CI: 0.61-0.90; p = 0.0014), but these results are not statistically significantAs mentioned earlier, the recommendation of the Independent Data Monitoring Committee (DMC), and the study will continue, without any change, in order to assess another dual primary endpoint overall survival (OS)Merck Research Laboratories chief medical officer, DrRoyBaynes director, Senior Vice President, Global Clinical Development, said: "progression-free survival results observed in KEYNOTE-355 has the potential first-line treatment for some metastatic triple-negative breast cancer patients to bring change in the true senseMerck is committed to evaluate innovative treatments to Keytruda basis, across multiple environments and stages of breast cancer treatmentwe KEYNOTE-355 and neoadjuvant / adjuvant KEYNOTE-522 phase III Dui encouraged by the positive results of the study, these studies demonstrate the potential Keytruda combination chemotherapy in triple negative breast cancerDr "
Quironsalud healthcare IOB cancer Institute breast cancer project leader JavierCortes representation : "breast cancer is a highly aggressive disease, patients with new treatment options exist result .KEYNOTE-355 study showed that significant medical needs, if approved, Keytruda in combination with chemotherapy in patients with TNBC will provide a specific the new first-line treatment of choice "a number of internal and external collaborative research Keytruda breast cancer clinical development program included TNBC field in addition KEYNOTE-355, further comprising two additional studies support the ongoing registration KEYNOTE-242 and KEYNOTE-522 to October, Merck announced a critical assessment Keytruda neoadjuvant therapy in patients with early-522 KEYNOTE TNBC Assisted Phase III / (NCT03036488) data It is worth mentioning that the study is the first randomized study evaluated for one PD-1 therapy for TNBC neoadjuvant / adjuvant therapy of anti This was a randomized, double-blind phase III study, is investigating Keytruda in combination with chemotherapy, placebo plus chemotherapy as neoadjuvant therapy followed by Keytruda placebo as an adjunctive therapy for the treatment of patients with TNBC interim analysis showed that: in the adjuvant treatment of, TNBC early treatment of patients, regardless of the state of PD-L1 expression, as compared with (n = 201) chemotherapy, Keytruda + chemotherapy (n = 401) in pathologic complete remission (pCR) showed a statistically significant aspects significant increase (pCR: 64.8% vs51.2%, p = 0.00055) In another primary endpoint event-free survival (EFS) terms, with a median follow-up of 15.5 months with chemotherapy - compared to placebo scheme, Keytruda program showed favorable trends in terms of EFS, the recurrence of disease progression and new auxiliary aid of reduced risk of 37% (HR = 0.63 [95% CI: 0.43-0.93]) In this study, the same research Keytruda and safety of chemotherapy and prior worth mentioning is that based on the research data, Keytruda first TNBC as a neoadjuvant therapy (PD-L1 regardless of the state) in terms of pCR showed statistically significant improvement in the anti-PD-1 treatment breast cancer in women is the most common type of cancer, more than 2 million cases diagnosed worldwide each year TNBC accounts for about 15-20% of all breast cancers proportion compared with other types of breast cancer, TNBC is more common in women 50 years of age TNBC especially estrogen receptor (the ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2) were negative in all three breast cancer, this is an invasive breast cancer, rapid progress, the prognosis is poor, high recurrence rate, 5-year survival rate of less than 15% TNBC hormone therapy and HER2-targeted therapies (such as Herceptin) are invalid, clinical treatment options are very limited, mainly rely on chemotherapy Is the most aggressive metastatic TNBC, one of the most difficult to treat breast cancer 2019 March US FDA accelerated approval of Roche's anti-PD-L1 therapy Tecentriq (especially good odd, common name: atezolizumab, Art trastuzumab) in combination with chemotherapy (Abraxane) line treatment of PD-L1-positive unresectable locally advanced or metastatic TNBC patient The approval of the Tecentriq + Abraxane combination therapy became PD-L1-positive metastatic TNBC's first cancer immunotherapy program April this year, the FDA accelerated approval Immunomedics Company antibody drug conjugates (ADC) Trodelvy (sacituzumabgovitecan-hziy), for previously received at least two treatment of metastatic disease with metastatic triple negative breast cancer (mTNBC) in adult patients It is worth mentioning that, Trodelvy is the first FDA-approved pharmaceutical ADC specialized treatment of relapsed or refractory mTNBC, is a FDA approved a first anti-Trop-2ADC drugs (Biovalley Bioon.com) ORIGINAL: Merck'sKEYTRUDA® (pembrolizumab) PlusChemotherapyDemonstratedStatisticallySignificantImprovementinProgression-FreeSurvivalVersusChemotherapyinCertainPatientswithMetastaticTriple-NegativeBreastCancer