During the upcoming annual meeting of the American Society of Clinical Oncology(ASCO), to be held May 30 – June 3, 2014, in Chicago, Il, results from the Phase III Resonate? trial with Ibrutinib (PCI-32765, Imbruvica?; Pharmacyclics), will be featured in ten abstracts, including both company-sponsored research studies and investigator-sponsored studies. Ibrutinib is indicated for the treatment of patients with mantle cell lymphoma or chronic lymphocytic leukemia who have received at least one prior therapy. 
Ibrutinib is a first in class, oral therapy that inhibits a protein called Bruton’s tyrosine kinase or BTK). BTK is a key signaling molecule of the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells. The drug blocks signals that tell malignant B cells to multiply and spread uncontrollably.
Phase II Trial
The resonate trial is a randomized, multicenter, open-label Phase III study of single agent ibrutinib versus single agent ofatumumab in patients with relapsed or refactory CLL or relapsed or refractory SLL with measurable nodal disease and who were not eligible for treatment with purine analog-based therapy. The study enrolled 391 patients who had received at least one prior therapy. Patients were randomized to receive 420 mg of ibrutinib orally once daily or intravenous doses of ofatumumab over the course of 24 weeks until disease progression or unacceptable toxicity.
Patients randomized to the ofatumumab arm who experienced disease progression were evaluable for consideration of subsequent IMBRUVICA therapy.
….these presentations … showcase ibrutinib’s long-term efficacy and safety profile as a single agent, even in high-risk patients, as well as high response rates with long-term durability … combination with an antibody targeting CD20…
Breakthrough Therapy Designation
The drug is one of the first medicines to file for FDA approval via the new Breakthrough Therapy Designation pathway, enabling Pharmacyclics to rapidly bring this medicine to patients in need.
To date, 11 Phase III trials have been initiated with ibrutinib.
Presentations at ASCO
Preliminary data gleaned from the abstracts to be presented at ASCO shows a long term 3 year follow up with single agent ibrutinib in which the drug achieved durable responses in patients with treatment naive (TN) or relapsed/refractory (R/R) CLL/SLL including those with deletion 17p, as independently confirmed.
The ASCO presentations also include longer term follow up of ibrutinib’s use in combination with an antibody targeting CD20, ofatumumab. This study shows how the combination is well tolerated and highly active (83% ORR) in patients with previously treated R/R CLL/SLL in all dosing sequences investigated.
“These presentations at ASCO showcase ibrutinib’s long-term efficacy and safety profile as a single agent, even in high-risk patients, as well as high response rates with long-term durability when ibrutinib is administered in combination with an antibody targeting CD20,” noted Bob Duggan, CEO and Chairman of the Board, Pharmacyclics.
For more information:
Full prescribing information [Package Insert]
Copyright ? 2014 InPress Media Group/Sunvalley Communication. All rights reserved. Republication or redistribution of InPress Media Group/Sunvalley Communication content, including by framing or similar means, is expressly prohibited without the prior written consent ofInPress Media Group/Sunvalley Communication. InPress Media Group/Sunvalley Communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Onco’Zine and Oncozine are registered trademarks and trademarks of Sunvalley Communication around the world.
