Tumor immunotherapy! Lilly's $1.6 billion acquisition of the IL-10 project pegilodecakin first-line treatment of pancreatic cancer phase III clinical failure!

October 17, 2019 / Biovalley BIOON / - Eli Lilly, an American pharmaceutical giant, recently published the top line results of the phase III seqoia study, which was carried out in patients with metastatic pancreatic cancer during or after the first-line treatment with gemcitabine, and evaluated the efficacy and safety of pegilodecakin combined with FOLFOX (folic acid + 5-FU + oxaliplatin) The results showed that the study did not reach the primary end point of overall survival (OS) Compared with FOLFOX group, the most common level 3 / 4 adverse events in pegilodecakin + FOLFOX group were neutropenia, thrombocytopenia, fatigue and anemia Detailed results of efficacy and safety will be published at future medical conferences Metastatic pancreatic cancer is one of the most deadly major cancers, with only 3% of patients in the United States surviving five years after diagnosis Pancreatic cancer is the third leading cause of cancer deaths in the United States and is expected to be the second leading cause of cancer-related deaths in the next decade Globally, pancreatic cancer is the seventh leading cause of cancer-related death Pegilodecakin is an immunotherapy, which can stimulate the body's natural defense against cancer, and expand anti-cancer T cells, which can penetrate and destroy cancer cells The drug was acquired by Lilly after its US $1.6 billion acquisition of ARMA Biosciences in May 2018, largely based on pegilodecakin's potential in pancreatic cancer Pegilodecakin is a PEGylated recombinant human cytokine IL-10 (enhanced IL-10), which can effectively stimulate CD8 + T cells in tumor environment, promote the survival, expansion and lethality of CD8 + T immune cells, and inhibit the inflammatory response in other parts of the body In the Ivy study involving 14 different solid tumors, pegilodecakin showed the ability to activate CD8 + T cells in blood and tumor, whether it was single drug or combined with chemotherapy or PD-1 It shows response including partial remission or safety remission, among which excellent clinical data have been obtained in the treatment of solid tumors such as pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) and melanoma Based on Ivy research results, armo launched seqoia research in March 2017 Ivy results are also the basis of two ongoing phase II clinical studies, cypress 1 and cypress 2, which were launched by armo in March 2018 Pegilodecakin combined with immunosuppressive checkpoint inhibitors is being evaluated for the treatment of non-small cell lung cancer (NSCLC) The results are expected to be obtained in early 2020, and the data will give some hints for pegilodecakin's future research in the field of NSCLC For the next step of clinical development of pegilodecakin, Lilly is focusing on the evaluation of biomarkers and research in NSCLC and other tumor types (including RCC), among which pegilodecakin has shown potential activity Original source: 1 Lily announcements phase 3 study in patients with metastatic pancreatic cancer did not meet primary endpoint of overall survival 2 PEGylated IL-10 (pegilodeckin) industries systematic immune activation, CD8 + T cell involvement and polyclonal T cell expansion in cancer patients