X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Catalent acquires cell and gene therapy-focused MaSTherCell for $315m

    Cytiva and NecstGen form strategic collaboration to accelerate development of cell and gene therapies

    Astrazeneca Says Covid-19 Long-Acting Antibody Combination AZD7442 Rapidly Advances Into Phase III Clinical Trials

    Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma's VP3 Nasal Spray System

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma’s VP3 Nasal Spray System

    Cryoport and Cell Matters Enter into Strategic Partnership

    Cryoport and Cell Matters Enter into Strategic Partnership

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19

    Gilead Sciences Announces FDA Approval of Veklury for Treatment of Non-Hospitalized Patients at High Risk for COVID-19

    Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations

    Australia Therapeutic Goods Administration Grants Provisional Registration for Novavax COVID-19 Vaccine

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Catalent acquires cell and gene therapy-focused MaSTherCell for $315m

    Cytiva and NecstGen form strategic collaboration to accelerate development of cell and gene therapies

    Astrazeneca Says Covid-19 Long-Acting Antibody Combination AZD7442 Rapidly Advances Into Phase III Clinical Trials

    Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma's VP3 Nasal Spray System

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma’s VP3 Nasal Spray System

    Cryoport and Cell Matters Enter into Strategic Partnership

    Cryoport and Cell Matters Enter into Strategic Partnership

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19

    Gilead Sciences Announces FDA Approval of Veklury for Treatment of Non-Hospitalized Patients at High Risk for COVID-19

    Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations

    Australia Therapeutic Goods Administration Grants Provisional Registration for Novavax COVID-19 Vaccine

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Americas

Syndax and Merck Announce First Patients Dosed in Phase 1b/2 Clinical Trial of Entinostat and KEYTRUDA®

Yuvraj_pawp by Yuvraj_pawp
19th November 2015
in Americas, Clinical Trials

Clinical trial to assess safety and efficacy of immuno-oncology combination in patients with advanced NSCLC or melanoma

 

Syndax Pharmaceuticals, Inc. and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the dosing of the first patients in the Phase 1b/2 clinical trial of Syndax’s entinostat in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with non-small cell lung cancer (NSCLC) or melanoma. The clinical trial, designated ENCORE 601 by Syndax and KEYNOTE 142 by Merck, is evaluating the safety, tolerability and efficacy of entinostat, an oral, small molecule that targets immune regulatory cells, combined with KEYTRUDA, an anti-programmed cell death protein 1 (anti-PD-1) antibody.

 

“This is an important clinical milestone for Syndax and our collaboration with Merck that was achieved on schedule with our joint development plan,” said Michael L. Meyers, M.D., Ph.D., Syndax’s Chief Development Officer. “As entinostat has been shown in preclinical models to reduce the number and inhibit the function of host immune suppressor cells, we believe that entinostat combined with KEYTRUDA could result in an improved response rate for the combination compared to either agent alone. The initiation of this trial advances our immuno-oncology program developing entinostat as a
potential combination therapy in multiple cancer indications with an initial focus on tumors that have shown sensitivity to immunotherapy.”

“Our collaboration with Syndax exemplifies our interest in exploring innovative therapeutic combinations with KEYTRUDA,” said Eric Rubin, M.D., vice president and therapeutic area head, early-stage oncology development, Merck Research Laboratories. “We are pleased with the rapid initiation and progress being made by Syndax towards gaining a better understanding of the potential of KEYTRUDA and entinostat in these difficult-to-treat patient populations.”

The ENCORE 601/KEYNOTE 142 trial is designed as a Phase 1b/2 open label clinical trial with dose escalation for entinostat, in which the Phase 1b portion will evaluate the safety and tolerability of the combination of entinostat and KEYTRUDA in patients with NSCLC, and the Phase 2 portion will assess the safety and preliminary efficacy of the combination in separate cohorts in patients with NSCLC or melanoma. The trial will be conducted in the United States and is expected to enroll up to 178 patients.

About KEYTRUDA® (pembrolizumab)

KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Pneumonitis occurred in 12 (2.9%) of 411 patients, including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA.

Monitor patients for signs and symptoms of pneumonitis.

Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 pneumonitis.

Colitis (including microscopic colitis) occurred in 4 (1%) of 411 patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%) patients, respectively, receiving KEYTRUDA. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients, including a Grade 4 case in 1 (0.2%) patient, receiving KEYTRUDA. Monitor patients for changes in liver function.

Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hypophysitis occurred in 2 (0.5%) of 411 patients, including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving KEYTRUDA.

Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids for Grade 2 or greater hypophysitis. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3; and permanently discontinue KEYTRUDA for Grade 4 hypophysitis.

Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients, including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer corticosteroids for Grade 3 or greater hyperthyroidism.

Withhold KEYTRUDA for Grade 3; permanently discontinue KEYTRUDA for Grade 4 hyperthyroidism. Isolated hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.

Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred in patients receiving KEYTRUDA. Monitor patients for hyperglycemia and other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA in cases of severe hyperglycemia until metabolic control is achieved.

Nephritis occurred in 3 (0.7%) patients, consisting of one case of Grade 2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis with renal failure (0.5%), one Grade 3 and one Grade 4.

Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

Other clinically important immune-mediated adverse reactions can occur. The following clinically significant immune-mediated adverse reactions occurred in patients treated with KEYTRUDA: exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, partial seizures arising in a patient with inflammatory foci in brain parenchyma, severe dermatitis including bullous pemphigoid, myasthenic syndrome, optic neuritis, and rhabdomyolysis.

For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement of the adverse reaction to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Restart KEYTRUDA if the adverse reaction remains at Grade 1 or less. Permanently discontinue KEYTRUDA for any severe or Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

Infusion-related reactions, including severe and life-threatening reactions, have occurred in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For severe or life-threatening reactions, stop infusion and permanently discontinue KEYTRUDA.

Based on its mechanism of action, KEYTRUDA may cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

KEYTRUDA was discontinued for adverse reactions in 9% of 411 patients. Adverse reactions, reported in at least two patients, that led to discontinuation of KEYTRUDA were: pneumonitis, renal failure, and pain. Serious adverse reactions occurred in 36% of patients. The most frequent serious adverse reactions, reported in 2% or more of patients, were renal failure, dyspnea, pneumonia, and cellulitis.

The most common adverse reactions (reported in at least 20% of patients) were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).

The recommended dose of KEYTRUDA is 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity. No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA. It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA. Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.

Tags: America
Previous Post

Merck and DNAtrix Announce Phase 2 Immuno-Oncology Collaboration in Patients with Aggressive Form of Brain Cancer

Next Post

Merck and Samsung Bioepis Announce Approval of BRENZYS™ (Etanercept), a Biosimilar of Enbrel, in Korea

Related Posts

Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials
Clinical Trials

Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

7th February 2022
Astrazeneca Says Covid-19 Long-Acting Antibody Combination AZD7442 Rapidly Advances Into Phase III Clinical Trials
Clinical Trials

Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

7th February 2022
Qatar approves emergency use of Modernas COVID-19 vaccine
Clinical Trials

Moderna Starts Variant Specific Vaccine Trials After Pfizer

28th January 2022
Autism clinical trials now open on the TrialWire Platform
Clinical Trials

Autism clinical trials now open on the TrialWire Platform

10th January 2022
Takeda
Clinical Trials

Valneva Announces Positive Lot-to-Lot Consistency Trial Results for its Single-Shot Chikungunya Vaccine Candidate

4th January 2022
Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials
Clinical Trials

CASI Pharmaceuticals And Bioinvent Announce CTA Approval For Clinical Study Of BI-1206 In NHL In China

14th December 2021
Next Post

Merck and Samsung Bioepis Announce Approval of BRENZYS™ (Etanercept), a Biosimilar of Enbrel, in Korea

Latest News

Envirotainer introduces the RAP for the future - part of the Releye series
Packaging & Logistic

Envirotainer introduces the RAP for the future – part of the Releye series

14th February 2022
United Cargo Meets Growing Demand for Pharmaceuticals with New TempControl Containers
Packaging & Logistic

Opticooler receives technical approval by Japanese major airlines

14th February 2022
Aptar Pharma Launches HeroTracker Sense, Novel Connected Smart Device for Respiratory Disease
Press Statements

Aptar Pharma Launches HeroTracker Sense, Novel Connected Smart Device for Respiratory Disease

14th February 2022
Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S.
News

Indian Scientists Claim To Design Vaccine For All Variants

9th February 2022
Drones for Delivery To Carry Pharmaceutical Weight Forward
News

Drones for Delivery To Carry Pharmaceutical Weight Forward

9th February 2022
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In