Regenerative / Sanofi PD-1 inhibitor phase 2 clinical results are positive
December 14, 2017 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Regeneron Pharmaceuticals and Sanofi today announced a positive top-line results from a phase 2 clinical trial using cemiplimab for critical clinical trials in 82 patients with advanced squamous cell carcinoma (CSCC) .
CSCC is the second most deadly skin cancer after melanoma. Early detection of CSCC has a good prognosis, but it will become very refractory if progressing to the advanced stage. Patients who progress to advanced stages experience disfigurement due to multiple surgical removals of CSCC tumors located in the head, neck, and other areas.
Cemiplimab is a human-derived antibody targeting PD-1 (programmed cell death protein 1), developed jointly by Regeneron and Sanofi under a global cooperation agreement. Regeneron uses the company's proprietary VelocImmune technology to invent and produce optimized fully human antibodies. Currently Cemitlimab is in the clinical development stage.
EMPOWER-CSCC 1 is a single-group, open-label, phase 2 clinical trial in which patient recruitment has been completed. Patients with metastatic CSCC receive a 3 mg/kg dose of cemiplimab every two weeks. The remaining two study groups of patients with metastatic CSCC continued to receive a 350 mg flat dose of cemiplimab every three weeks, and patients with locally advanced and unresectable CSCC received a 3 mg/kg dose of cemiplimab every two weeks.
Previous data from cemiplimab showed that the patient's overall response rate (ORR) was 46.3% after independent review. The median duration of remission (DOR) has not been reached (32 of 38 patients are ongoing). All patients were followed for a minimum of 6 months at the time of analysis. The safety data in the study were consistent with the approved anti-PD-1 drugs. The efficacy data for this time included the results of 82 patients from EMPOWER-CSCC1. About two-thirds of these patients develop disease after receiving previous systemic chemotherapy or radiation therapy. The latest results from the EMPOWER-CSCC Phase 1 and Phase 1 clinical trials will be made public at the 2018 Medical Congress.
â–² Dr. Israel Lowy, Vice President of Global Clinical Development and Director of Translational Science and Clinical Oncology, Regeneron (Source: LinkedIn)
"For CSCC patients who cannot undergo surgery or radiation therapy, there is currently no FDA-approved treatment, and late CSCC causes 3,900 to 8,800 deaths per year in the United States." Israel Lowy, vice president of global clinical development and director of translational science and clinical oncology, Regeneron “This is the largest prospective study ever, and we are pleased that many patients are able to achieve deep and lasting remission through cemiplimab alone, and the high rate of sustained response observed in the study is particularly noteworthy because the study Not related to the patient's biomarker status."
â–² Dr. Elias Zerhouni, President of Sanofi Global R&D (Source: Sanofi Official Website)
“EMPOWER-CSCC 1 started in 2016 and quickly recruited patients, highlighting the serious unmet needs of the late CSCC.†Dr. Elias Zerhouni, President of Sanofi Global R&D, said: “We look forward to working with regulators around the world as soon as possible. These advanced CSCC patients provide important treatments, and we will continue to rapidly advance a wide range of development projects to evaluate cemiplimab as a monotherapy and combination therapy for a variety of solid tumors and hematological tumors."
These key data will form the basis for a rolling biologics licensing application (BLA) filed with the FDA, which has been launched and is expected to be completed in the first quarter of 2018. Documents submitted to the European Medicines Agency (EMA) are also expected to be completed in the first quarter of 2018. These data confirm the results of the active phase 1 clinical trial expansion cohort reported at the 2017 American Society of Clinical Oncology (ASCO) annual meeting. Cemiplimab has received a FDA-approved breakthrough therapy award this year.
We look forward to hearing more positive news from this clinical trial at next year's medical conference, and hope that the review process of this new drug will proceed smoothly and bring new treatment options for cancer patients at an early date.
Reference materials:
[1] Besties Regeneron, Sanofi Show Off Phase II Skin Cancer Data
[2] Regeneron and Sanofi Announce Positive Topline Pivotal Results for PD-1 Antibody Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma
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