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

IBRUTINIB (IMBRUVICA®) COMBINATION DATA SHOW PROMISE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

Yuvraj_pawp by Yuvraj_pawp
21st December 2015
in Clinical Trials

AbbVie , a global biopharmaceutical company, announced preliminary data from the ongoing Phase 1/2b PCYC-1119 trial suggesting that the combination of ibrutinib (IMBRUVICA®) plus carfilzomib with or without dexamethasone was well tolerated in relapsed or refractory patients with multiple myeloma (MM), with an initial objective response rate (ORR) of 62%. These data will be presented today in an oral presentation at the 57th Annual American Society of Hematology (ASH) Meeting and Exposition in Orlando, FL at 5:30 p.m. ET. IMBRUVICA is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company, and Janssen Biotech, Inc.

 

MM is a blood cancer that most commonly arises from B cells, a type of white blood cell (lymphocyte) that originates in the bone marrow. This year, approximately 26,850 people will be diagnosed with the disease and about 11,240 will die.1

 

“Multiple myeloma can be a very difficult form of cancer to treat and many patients eventually relapse or become resistant to treatment with standard therapies,” said Ajai Chari, M.D., Associate Professor of Medicine and Director of Clinical Research in the Multiple Myeloma Program at the Icahn School of Medicine at Mount Sinai, New York, NY, and lead study investigator.* “These initial data are encouraging as they suggest the combination of ibrutinib plus carfilzomib and dexamethasone has promising clinical potential, particularly in the primarily refractory patient population who participated in this study.”

 

Thirty-nine patients were evaluable for efficacy and demonstrated a 62% ORR during early follow-up, with a clinical benefit rate (CBR) of 72%. Overall, the combination was well tolerated, with no dose- limiting toxicities observed during the dose escalation phase.

 

“As we continue to investigate the use of ibrutinib across a number of hematologic malignancies, multiple myeloma remains an area of great clinical need,” said Thorsten Graef, M.D., Ph.D., Head of Hematology & Global Medical Safety at Pharmacyclics. “Many of these patients eventually relapse when treated with other traditional therapies, so new options are greatly needed. We are hopeful ibrutinib may help answer the call for new alternatives and look forward to continuing to follow its promising progress for the treatment of this disease.”

 

The ongoing, multicenter, dose-escalation Phase 1/2b study evaluated the safety and efficacy of ibrutinib in combination with carfilzomib with or without dexamethasone in 40 relapsed or refractory MM patients. Patients received the combination across multiple dose levels during the Phase 1 portion, with no dose-limiting toxicities observed. Cohorts 2b (n=14; ibrutinib 560mg once daily plus carfilzomib and dexamethasone) and 3b (n=18; ibrutinib 840mg once daily plus carfilzomib and dexamethasone) was determined to be the recommended Phase 2 dose to further assess the safety and efficacy of the combination. In cohort 3b, the ORR was 65% and the CBR was 76%, including three very good partial responses and one stringent complete response.

 

The most common all grade non-hematologic adverse events (AEs in ≥20% of patients) across all cohorts in this study were diarrhea, constipation, fatigue, cough and nausea. Grade 3 or greater hematologic AEs (≥10% of patients) included hypertension, anemia, pneumonia, thrombocytopenia, diarrhea and fatigue. In addition, 12 patients discontinued treatment due to progressive disease, eight discontinued due to an AE and nine discontinued due to investigator or patient decision.

 

About IMBRUVICA
IMBRUVICA is currently approved for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, CLL patients who have del 17p and patients with Waldenström’s macroglobulinemia.2 IMBRUVICA is also approved for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for the MCL indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.2

 

IMBRUVICA is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton’s tyrosine kinase (BTK).2 IMBRUVICA was one of the first medicines to receive a U.S. FDA approval after being granted a Breakthrough Therapy Designation, and IMBRUVICA is one of the few therapies to receive three separate designations.

 

BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells.2,3 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.2

 

IMBRUVICA is being studied alone and in combination with other treatments in several blood cancers. More than 6,100 patients have been treated in clinical trials of IMBRUVICA conducted in 35 countries by more than 800 investigators. Currently, 16 Phase 3 trials have been initiated with IMBRUVICA and 67 trials are registered on www.clinicaltrials.gov.

 

To learn more about the medical terminology used in this news release, please visit http://stedmansonline.com/.

 

INDICATIONS IMBRUVICA is indicated to treat people with:

  • Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy
  • Chronic lymphocytic leukemia (CLL) with 17p deletion Waldenström’s macroglobulinemia
  • Mantle cell lymphoma (MCL) who have received at least one prior therapy – accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
  • Patients taking IMBRUVICA for CLL or WM should take 420 mg taken orally once daily (or three 140 mg capsules once daily).
  • Patients taking IMBRUVICA for MCL should take 560 mg taken orally once daily (or four 140 mg capsules once daily).
  • Capsules should be swallowed whole with a glass of water. Do not open, break or chew the capsules.

Previous Post

IMBRUVICA® (IBRUTINIB) PHASE 3 RAY DATA SHOW SIGNIFICANT REDUCTIONS IN DISEASE PROGRESSION VERSUS TEMSIROLIMUS IN RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA PATIENTS

Next Post

CABBVIE ANNOUNCES NEW ENGLAND JOURNAL OF MEDICINE ONLINE PUBLICATION OF VENETOCLAX PHASE 1 DATA IN RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA

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

CABBVIE ANNOUNCES NEW ENGLAND JOURNAL OF MEDICINE ONLINE PUBLICATION OF VENETOCLAX PHASE 1 DATA IN RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA

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