The Addario Lung Cancer Medical Institute and Biocept Inc. announced a clinical collaboration and initiation of the landmark ALCMI-009 liquid biopsy clinical trial, which was developed and will be conducted by ALCMI and its consortium of leading U.S. and international oncology centers.
EpiThany, Merck KGaA, Pfizer to evaluate combination of avelumab and EP-101 STEMVAC in breast cancer
EpiThany today announced that they have entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer to evaluate avelumab*, a human anti-PD-L1 antibody, and EP-101 STEMVAC, a multi-antigen, polyepitope vaccine, in a phase II trial in women with breast cancer.
Array BioPharma Inc. announced it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the United States and Canada) to investigate the safety and efficacy of Array's MEK inhibitor, binimetinib, with Merck's anti-PD-1 therapy, Keytruda (pembrolizumab), in metastatic colorectal cancer patients with microsatellite stable tumors.
OncoSec Medical Inc. has entered a clinical trial collaboration and supply agreement with Merck to evaluate the combination of OncoSec's ImmuoPulse IL-12 with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in a phase II clinical trial, referred to as PISCES.
Regeneron Pharmaceuticals Inc. and SillaJen Inc. announced a clinical and supply agreement for a phase Ib dose-escalation study in renal cell carcinoma.
Regeneron Pharmaceuticals Inc. and Inovio Pharmaceuticals Inc. announced a clinical study agreement for a Phase Ib/IIa immuno-oncology trial.
FDA granted accelerated approval to durvalumab (trade name Imfinzi) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Palmetto GBA, a Medicare administrative contractor that assesses molecular diagnostic technologies, has issued a draft local coverage determination for the Oncotype DXGenomic Prostate Score issued a draft LCD that recommends Medicare coverage for use of the test in qualified patients with favorable intermediate-risk prostate cancer.
The European Commission approved Opdivo (nivolumab) as monotherapy for the treatment of squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy.
FDA granted accelerated approval to Genentech's Tecentriq (atezolizumab) for the initial treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy.
