“Incyte Corporation (Nasdaq:INCY) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the decision to advance the clinical development program investigating the combination of epacadostat, Incyte’s investigational oral selective IDO1 inhibitor, with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy.
“With the expansion of the clinical development program, the companies plan to initiate pivotal studies of epacadostat in combination with KEYTRUDA in four additional tumors: non-small cell lung cancer, renal cell carcinoma, bladder cancer and squamous cell carcinoma of the head and neck. Presentations of data from the ongoing studies of epacadostat in combination with KEYTRUDA, which support this decision, are expected at upcoming medical meetings.”
“Incyte Corporation (INCY) today announced that the first patient has been treated in the ECHO-301 study—a Phase 3 trial evaluating epacadostat, Incyte’s investigational, highly potent and selective oral IDO1 inhibitor, in combination with Keytruda®(pembrolizumab), Merck’s anti-PD-1 therapy, as first-line treatment for patients with advanced or metastatic melanoma. Incyte expects initial data from the ECHO-301 study to be available in 2018…
“ ‘We are very pleased to treat the first patient in the ECHO-301 study and advance the Phase 3 program evaluating epacadostat in combination with pembrolizumab,’ said Steven Stein, M.D. Incyte’s Chief Medical Officer. ‘This trial—the first to test this combination in a pivotal study—is part of the larger ECHO program evaluating epacadostat, including combination studies with anti-PD-1 and PD-L1 therapies across multiple tumor types.’ “
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“In a study reported in the Journal of Clinical Oncology, Denkert et al found that increased tumor-infiltrating lymphocytes and the presence of lymphocyte-predominant breast cancer were associated with increased rates of pathologic complete response in patients receiving neoadjuvant anthracycline-taxane treatment with or without carboplatin. Higher rates were observed with carboplatin, with treatment interactions being significant among all patients and among those with HER2-positive disease but not among those with triple-negative disease. mRNA profiles for immune-related genes also distinguished pathologic complete response rates.
“The study involved 580 tumors from patients in the GeparSixto trial, which assessed the effects on pathologic complete response rates of adding carboplatin to neoadjuvant anthracycline plus taxane treatment. The current analysis assessed the effects on pathologic complete response of tumor-infiltrating lymphocyte levels, the presence of lymphocyte–predominant disease, and levels of immune-activating (CXCL9, CCL5, CD8A, CD80, CXCL13, IGKC, CD21) and immunosuppressive genes (IDO1, PD-1, PD-L1, CTLA4, FOXP3).”
Many kinds of tumors make an immune system-suppressing protein that is linked to more extensive disease and reduced survival. Now, a completed phase I trial suggests that an experimental drug that inhibits this protein could help people with a range of cancers that have not responded to other treatments. The protein is called oral indoleamine dioxygenase-1 (IDO1) and the drug that inhibits it is called INCB024360. The trial showed that this drug kept tumors from growing in 30% of the 52 people treated, half of whom had colorectal cancer, which has generally resisted immunotherapy. Moreover, this new drug had manageable side effects. These findings were presented at the 2013 meeting of the American Society of Clinical Oncology. Now, a phase I/II trial is underway to test treating melanoma with INCB024360, both alone and in combination with ipilimumab, another immunotherapy.