Skin Squamous Cell Carcinoma (cSCC) immunotherapy! Mercado anti-PD-1 therapy Keytruda (Corrida) new indications approved by the U.S. FDA!

, June 25, 2020 /PRNewswireBiovalleyBIOON/-- Merck and Corecently announced that the U.SFood and Drug Administration (
FDA) has approved the anti-PD-1 therapy Keytruda (Corrida, generic name: pemlibabsub, Pabolizumab) as a monotherapy for the treatment of recurrent or recurrent skin cancer patients who cannot be cured by surgery or radiationapproval marks Keytruda's first indication of cSCCThe approval is based on data from the PHASE II KEYNOTE-629 (NCT03284424) trialThis is a multi-center, multi-queue, non-random, open trial, a total of 105 cases of cSCC patients, of which 87% received one or more treatments, 74% of patients previously received radiation therapy, 45% of patients only local recurrent cSCC, 24% of patients only metastatic cSCC, 31% of patients have local recurrence and metastatic cSCCIn the study, patients infusion of 200 mg of Keytruda intravenously every 3 weeks until the disease progresses, is not acceptable toxicity, or is treated for up to 24 monthsIn this trial, the patient was exposed to Keytruda for a median duration of 5.8 months (1 day to 16.1 months)data show that Keytruda showed meaningful efficacy and long-lasting remission, with an objective mitigation rate (ORR) of 34% (95% CI:25-44), a full mitigation rate (CR) of 4%, and a partial mitigation rate (PR) of 31%In patients with remission, 69% of patients with remission lasted 6 months or moreAfter 9.5 months of median follow-up, the median mitigation duration (DOR) still did not reach (2.7-13.1 months)In terms of safety,adverse reactions in cSCC patients similar to Keytruda single drug treatments melanoma or non-small cell lung cancer patients, with higher incidence of laboratory abnormalities (3-4 levels) including lymphocyte reduction "Skin squamous cell carcinoma (cSCC) is the second most common form of skin cancer," said Dr Jonathan Cheng, vice president of clinical research at the 's Mersadon Research Laboratory IN THE KEYNOTE-629 TRIAL, KEYTRUDA THERAPY WAS CLINICALLY SIGNIFICANT AND LONG-LASTING Today's approval is good news for cSCC patients and further demonstrates our commitment to bringing new treatments for patients with advanced refractive cancer "
Keytruda is a PD-(L) 1 tumor immunotherapy that helps detect and fight tumor cells by improving the body's immune system." Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, activating T lymphocytes that may affect tumor cells and healthy cells So far, 11 PD-(L) 1 oncology immunotherapy have been approved worldwide, of which Keytruda is the leader in the field, with more than 20 therapeutic indications approved and global sales reaching $11.1 billion in 2019, up 58% from the previous year in China, Keytruda recently received approval from the National Drug Administration (NMPA) for a new indication for the treatment of esophageal squamous cell carcinoma (ESCC) With this new approval, Keytruda is now approved in China for five types of cancer, including first-line treatment (single drug therapy and combined chemotherapy) for patients with advanced non-small cell lung cancer (NSCLC) and second-line treatment as advanced melanoma Specifically: (1) treatment for non-removable or metastatic melanoma with first-line treatment, (2) combined permeitus and platinum chemotherapy for first-line treatment of metastatic non-scaly NSCLC, negative for EGFR/ALK gene mutation, and (3) application to NMPA-approved testing as PD-L1 positive expression (TPS 1%) FR/ALK gene mutation negative local late or metastatic NSCLC first-line single drug treatment; (4) combined carpurandand and yew alcohol is suitable for metastatic scaly NSCLC first-line treatment; (5) as a monodrug therapy for the treatment of previous systemic therapy, tumor expression OfD-L1 (CPS 10) local late-stage or metastatic ESCC patients Mercado has the largest clinical development of immunothologists in the industry, with more than 1,200 clinical trials
investigating Keytruda's role in a variety of types of tumor and therapeutic context The Keytruda Clinical Project aims to understand the drug's role in cancer and factors that may predict patients' benefits from Keytruda treatment, including exploring several different biomarker (BioValleyBioon.com) original origin: FDA
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ofe Merck's keytruDa ® (pembrolizumab) for treatment of patients with Recurrent or Metastatic Cutan Squamous Cell Carcinoma (cSCC) that is not butable by Cury
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