X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    NHS Acquires Potentially Lifesaving Breast Cancer Medication

    Transfusion of The First Patients Lab-Grown Blood Cells

    Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    $2 Million Gene Therapy Might Become The Standard In The US

    $2 Million Gene Therapy Might Become The Standard In The US

    Cancer Medicine Prices Jump 53% In Five Years In The U.S

    Food And Drug Administration User Fee Has Been Reauthorized

    Cancer Clinical Trials Get A Brand New Platform In Melbourne

    Report Indicates UK £62bn Behind In Global R&D Investment

    Report Indicates UK £62bn Behind In Global R&D Investment

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    NHS Acquires Potentially Lifesaving Breast Cancer Medication

    Transfusion of The First Patients Lab-Grown Blood Cells

    Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    $2 Million Gene Therapy Might Become The Standard In The US

    $2 Million Gene Therapy Might Become The Standard In The US

    Cancer Medicine Prices Jump 53% In Five Years In The U.S

    Food And Drug Administration User Fee Has Been Reauthorized

    Cancer Clinical Trials Get A Brand New Platform In Melbourne

    Report Indicates UK £62bn Behind In Global R&D Investment

    Report Indicates UK £62bn Behind In Global R&D Investment

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

Exelixis’ Phase III prostate cancer trial of cabozantinib fails to meet primary endpoint

Yuvraj_pawp by Yuvraj_pawp
2nd September 2014
in Clinical Trials

US-based biopharmaceutical firm Exelixis has reported disappointing top-line results from the final analysis of COMET-1, the Phase III trial of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC).

The trial evaluated cabozantinib in mCRPC patients whose disease progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide.

The company said that the trial failed to meet its primary endpoint of showing a statistically significant increase in overall survival (OS) for patients treated with cabozantinib as compared to prednisone.

The median OS for the cabozantinib arm of the Phase III trial was 11 months versus 9.8 months for the prednisone arm.
Exelixis president and chief executive officer Michael Morrissey said: “We are very disappointed that COMET-1 did not meet its primary endpoint of extending overall survival in men with mCRPC.

“We are grateful to the patients, physicians, nurses, caregivers, and other study team members who participated in the trial.

“We remain focused on the development programme for cabozantinib beyond mCRPC, including the ongoing METEOR and CELESTIAL phase 3 pivotal trials, from which we expect top-line data in 2015 and 2017, respectively.”

Results from the COMET-1 are the subject of ongoing analyses and the company intends to submit additional data, including secondary and exploratory endpoints, for presentation at a future medical meeting.

“We are very disappointed that COMET-1 did not meet its primary endpoint of extending overall survival in men with mCRPC.”

In addition to OS, the exploratory endpoint of progression-free survival (PFS) as evaluated by the investigators is the only time-to-event-based endpoint for which data are available.

Based on the outcome of the COMET-1 trial, the company now intends to start a significant workforce reduction that will help in focusing on its financial resources on the late-stage clinical trials of cabozantinib in metastatic renal cell carcinoma (the METEOR trial) and advanced hepatocellular carcinoma (the CELESTIAL trial).

As a result of the outcome of trial, the company has deprioritised the clinical development of cabozantinib in mCRPC.

Patient enrolment has been stopped in COMET-2, a second major trial in mCRPC and evaluates pain palliation.

The company said that based on the outcome of COMET-2 trial, it will carry out discussions with regulatory authorities about the potential regulatory path, if any, of cabozantinib in mCRPC.

Other company-sponsored mCRPC trials, including a randomised Phase II trial of cabozantinib in combination with abiraterone, will also be stopped.

Tags: America
Previous Post

Senesco completes patient enrolment in Phase Ib/IIa SNS01-T trial

Next Post

Gilenya® data at ACTRIMS-ECTRIMS to show Novartis is redefining MS treatment goals for patients

Related Posts

Clinical Trials

Transfusion of The First Patients Lab-Grown Blood Cells

9th November 2022
Clinical Trials

Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

8th November 2022
First Virtual Drug Study Tests 2 Likely Alzheimer Therapies
Clinical Trials

First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

7th November 2022
Clinical Trials

Cancer Clinical Trials Get A Brand New Platform In Melbourne

3rd November 2022
Clinical Trials

UK Clinical Trials Have Plummeted In The Past Five Years

22nd October 2022
Clinical Trials

Pistoia Alliance To Study Clinical Trial Ecology Effect

14th October 2022
Next Post

Gilenya® data at ACTRIMS-ECTRIMS to show Novartis is redefining MS treatment goals for patients

Latest News

FDA Approvals

NHS Acquires Potentially Lifesaving Breast Cancer Medication

9th November 2022
Clinical Trials

Transfusion of The First Patients Lab-Grown Blood Cells

9th November 2022
Clinical Trials

Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

8th November 2022
India Seeks Better Pharma Market Access In The UK: Official
Facilities & Operation

India Seeks Better Pharma Market Access In The UK: Official

8th November 2022
First Virtual Drug Study Tests 2 Likely Alzheimer Therapies
Clinical Trials

First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

7th November 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