Immunotherapy for metastatic Merkel cell carcinoma! Merck / Pfizer released bavencio's three-year data, with long-lasting efficacy and good safety!

October 23, 2019 / BIOON / -- Merck KGaA and Pfizer, partners, recently published the three-year results of the key phase II javelin Merkel 200 trial Part A, which involved the long-term total survival (OS) and long-term response of bavencio (avelumab) immunotherapy with PD-L1 in patients with previously treated MMCC Exploratory analysis showed that the overall survival rate (OS) was 32%, median duration of remission (DOR) was 40.5 months, and objective remission rate (ORR) was 33.0% at the three-year time point The orr data was consistent with that at the one-year time point The data was released at the first International Conference on cell cancer held in Tampa, Florida Javelin Merkel 200 is an international, multicenter, open label, single group phase II trial Part a included 88 patients with stage IV MCMC who had previously received chemotherapy to control distant metastasis but had progressed during or after chemotherapy In the study, patients received bavencio (10mg / kg, intravenously once every two weeks) until the disease progressed or the toxicity was unacceptable The primary end point of part a was the best overall response rate (BOR), and the secondary end points included duration of response (DOR), progression free survival (PFS), overall survival (OS), safety and tolerability The analysis published at the meeting showed that the minimum follow-up period was 36 months, the median follow-up period was 40.8 months (range: 36.4-49.7), the orr was 33.0% (95% CI: 23.3%, 43.8%), and the median dor was 40.5 months (95% CI: 18.0, NE) Of the 11.4% (10 / 88) patients with complete remission (CR), half (n = 5) had sustained remission by the end of the data The 2-year and 3-year PFS rates were 26% (95% CI: 17%, 36%) and 21% (95% CI: 12%, 32%) respectively The median OS was 12.6 months (95% CI: 7.5, 17.1), and the 2-year and 3-year OS rates were 36% (95% CI: 26%, 46%) and 32% (95% CI: 23%, 42%) respectively The comparative analysis of OS and historical comparison data is not part of this analysis There was no unexpected adverse event (AE) or delayed infusion related reaction after long-term treatment The incidence of treatment-related adverse events at any level was 77.3% (≥ Level 3 events occurred in 11.4% of patients); 21.6% of patients had any level of immune-related adverse events (≥ Level 3 events occurred in 4.5% of patients) Sandra p.d'angelo, MD, chief investigator of Javelin Merkel 200 trial and oncologist of memorial Sloan Kettering cancer center, said: "historically, chemotherapy is the only way to treat advanced Merkel cell carcinoma, and the response lasts less than a year In the javelin Merkel 200 trial, as many as a third of the patients treated with bavencio were still alive for three years The three-year follow-up of bavencio's clinical efficacy and long-term survival results highlights the therapeutic benefits of the drug in patients with metastatic Merkel cell carcinoma " Based on the data of Javelin Merkel 200 study, bavencio was approved by FDA in March 2017 to treat metastatic Merkel cell carcinoma (MCMC) Bavencio is a PD-L1 tumor immunotherapy, which is the first immunotherapy to treat MCMC in the world MCC is a rare invasive skin cancer with poor clinical prognosis The mortality of metastatic MCC is higher than that of melanoma The 1-year survival rate is less than 50%, and the 5-year survival rate is less than 20% Therefore, the approval of bavencio to market marks a major milestone in the clinical treatment of MCMC Original source: exploration analysis reports efficiency and safety of bakencio ® (avelumab) over three years in previously treated metastatic Merkel cell carcinoma