2014年5月8日讯 /生物谷BIOON/ --默沙东（Merck & Co）5月7日宣布，FDA已接受审查MK-3475的生物制品许可申请（BLA），该药是一种实验性抗PD-1抗体，用于既往接受ipilimumab疗法的不可切除性或转移性黑色素瘤患者的治疗。FDA已授予MK-3475 BLA优先审查资格并已指定处方药用户收费法（PDUFA）目标日期为2014年10月28日，并将通过FDA的加速审批程序审查。此前，FDA已授予MK-3475治疗晚期黑色素瘤的突破性疗法认定。如果获批，MK-3475有望成为新一类免疫检查点调节剂中的首个抗PD-1抗体。
英文原文：Merck Announces FDA Acceptance for Review of MK-3475 Biologics License Application for Advanced Melanoma
Priority Review Designation for MK-3475 BLA for Proposed Indication of Unresectable or Metastatic Melanoma in Patients Who Have Been Previously Treated with Ipilimumab
Advancing New Phase 3 Studies with MK-3475 in Adjuvant Melanoma, Previously-Untreated Non-Small Cell Lung Cancer, Advanced Head & Neck and Bladder Cancers
Data from Studies in Three Different Cancer Types to be presented at 2014 ASCO Annual Meeting
Initiating Phase 1 Study with Investigational Anti-GITR Antibody (MK-4166)
BOSTON--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MK-3475, Merck’s investigational anti-PD-1 antibody, for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab. The FDA granted Priority Review designation with a PDUFA date of October 28, 2014, and the MK-3475 BLA will be reviewed under the FDA’s Accelerated Approval program. The FDA previously granted MK-3475 Breakthrough Therapy designation for advanced melanoma, the most dangerous type of skin cancer. If approved by the FDA, MK-3475 has the potential to be the first anti-PD-1 antibody in a new class of immune checkpoint modulators.
Merck also announced it plans to file a Marketing Authorization Application for MK-3475 in Europe for advanced melanoma by the end of 2014.
“Patients with advanced melanoma have few therapeutic options and often fail to respond to all available treatments,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We are hopeful that the FDA, through their priority review of our application, will agree to make MK-3475 available to patients with advanced melanoma who have no other therapeutic options.”
MK-3475 Development Ongoing in 30 Tumors, as Monotherapy and in Combination
Today, Merck highlighted progress on the advancement of the MK-3475 development program – currently ongoing in 30 tumor types as monotherapy and in combination. It is anticipated that by the end of 2014, the MK-3475 development program will grow to more than 24 clinical trials across 30 different tumor types, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide, including four new Phase 3 studies. Ongoing and planned late-stage monotherapy and combination studies include:
Seven Phase 3 registrational trials spanning advanced melanoma (adjuvant, ipilimumab-naïve, and ipilimumab-refractory), advanced non-small cell lung cancer (NSCLC) (previously-treated and previously-untreated), advanced head & neck cancer and advanced bladder cancer; and,
Ten combination studies, including advanced melanoma, advanced NSCLC, advanced renal cell carcinoma, HER2+ breast cancer and other solid tumors.
Merck also said today that based on encouraging preclinical data, it plans to initiate a Phase 1 dose-ranging study with its investigational anti-GITR agonistic antibody, MK-4166, in patients with advanced malignances. GITR (glucocorticoid-induced TNFR receptor) is an activating immune checkpoint receptor, which is believed to stimulate immune activity against cancer cells. This will be the second investigational immune checkpoint antibody within Merck’s immuno-oncology discovery program to enter clinical development.
Dr. Perlmutter added, “Our priority is advancing breakthrough immunomodulatory molecules that reveal the ability of the immune system to eliminate cancer cells. While MK-3475 provides a firm foundation for Merck’s research and development strategy in oncology, we are also advancing a broad pipeline of immune checkpoint agonists and antagonists.”
MK-3475 Presentations at 2014 ASCO Annual Meeting
At the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting, Merck will have more than 15 company-sponsored abstracts on MK-3475, including six oral presentations. Clinical data will be presented from studies in advanced melanoma, advanced NSCLC, as well as advanced head & neck cancer, which is the first time data for MK-3475 will be presented in this cancer type.