|By PR Newswire||
|December 8, 2012 08:01 AM EST||
ATLANTA, Dec. 8, 2012 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced follow-up results that its investigational oral therapy ibrutinib (PCI-32765), as a single agent, resulted in durable responses for patients over 65 years of age with treatment-naive chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and for those with relapsed/refractory (RR) or high-risk (HR) disease.
In a study of 116 patients, the overall response rate (ORR) was 68 percent in elderly treatment-naive (TN) patients with an estimated 96 percent progression-free survival (PFS) rate at 26 months. In patients with RR CLL/SLL, including those with HR disease, the ORR was 71 percent with an estimated PFS at 26 months of 75 percent.
A second study in 40 patients with HR CLL treated with the combination of ibrutinib and rituximab therapy reported an ORR of 83 percent, with 38 of the 40 patients continuing on therapy without disease progression. Patients with HR disease have inferior responses to standard chemo-immunotherapy and shorter rates of PFS and OS.
These findings, from ongoing Phase 1b/2 and Phase 2 trials, were presented in a press briefing today at the 54th annual meeting of the American Society of Hematology in Atlanta, GA. CLL and SLL are common B-cell non-Hodgkin lymphomas.
In describing the findings of the Phase 1b/2 ibrutinib monotherapy trial, lead investigator John C. Byrd, M.D., said, "We are very encouraged that these results with ibrutinib continue to support the possibility that we can address some of the critical unmet needs in CLL/SLL." Dr. Byrd is the D. Warren Brown Chair of Leukemia Research and Director, Division of Hematology at Ohio State University Comprehensive Cancer Center — Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC — James).
In his presentation, Dr. Byrd noted that current therapies have a number of limitations in terms of how long they can be used in a patient and their tolerability, especially in elderly patients. "Further, virtually all patients relapse, and there are few salvage regimens that produce durable remissions," he pointed out.
The Phase 2 trial, evaluating ibrutinib in combination with rituximab, was led by Jan A. Burger, M.D., Ph.D., associate professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.
"We are very excited by the response rates we saw with ibrutinib-rituximab combination therapy, and believe they emphasize the need for rapid, further development of ibrutinib, especially for patients with high-risk CLL/SLL," said Dr. Burger.
Studies and Findings
Oral presentation 189, The Bruton's Tyrosine Kinase (BTK) inhibitor ibrutinib (PCI-32765) promotes high response rate, durable remissions, and is tolerable in treatment naive (TN) and relapsed or refractory (RR) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients including patients with high-risk (HR) disease: New and updated results of 116 patients in a phase Ib/II study
John C. Byrd, M.D., The Ohio State University, Columbus, OH
This presentation was based on findings from a Phase 1b/2, multi-center trial with 116 patients with TN (n=31), RR (n=61) or HR (n=24) CLL/SLL. Patients were treated with oral ibrutinib monotherapy, either 420 mg or 840 mg daily. Patients with RR disease had received at least two prior therapies; patients with HR disease had relapsed within two years following chemo-immunotherapy. The study objectives were to determine the ORR, PFS, overall safety (OS), safety of the two dosing regimens and pharmacokinetics/pharmacodynamics.
- The overall response rates were:
- 68 percent in TN patients, all of whom were over 65 years old, after a median follow up of 20.3 months
- 71 percent in patients with RR disease, including patients with HR CLL/SLL, after a median follow up of 15.7 months
- The estimated PFS at 26 months is 96 percent for patients over 65 years of age with TN CLL and 75 percent for those with RR/HR disease
- Estimated OS at 26 months is 96 percent in TN patients and 83 percent in patients with RR/HR disease
Responses were independent of high-risk clinical or genetic features, such as a deletion of part of chromosome 17 (del17p).
Most adverse events (AEs) were Grade 1 or 2 in severity, with the most common attributed to ibrutinib being diarrhea, fatigue, nausea and rash. Adverse hematologic events were relatively infrequent. In patients with cytopenia (low blood cell counts) at the beginning of the study, sustained improvements of platelet counts (78 percent) and hemoglobin (82 percent) were seen after treatment. There was no evidence of cumulative toxicity or long-term safety concerns.
Oral presentation 187, The BTK inhibitor ibrutinib (PCI-32765) in combination with rituximab is well tolerated and displays profound activity in high-risk chronic lymphocytic leukemia (CLL) patients
Jan A. Burger, M.D., Ph.D., MD Anderson Cancer Center, Houston, TX
This presentation was based on findings from a Phase 2, single-center trial with 40 patients with HR CLL treated with 420 mg/day ibrutinib in combination with rituximab, a current standard CLL therapy. Patients with HR disease were previously treated and had one of the following characteristics: deletion of a part of chromosome 17 (del17p), which is associated with poorer treatment outcomes; a gene mutation called TP53; del11q, another partial chromosome deletion associated with poorer outcomes; or a short remission duration (less than three years) after first-line chemo-immunotherapy.
The results after a follow-up of three to six months are:
- The ORR was 83 percent
- 38 of 40 patients continue on therapy without disease progression
- 95 percent of all patients and 90 percent of patients with del17p had not progressed
- There was a large and rapid reduction in lymph node and spleen sizes, with 84 percent of patients (26/31) experiencing more than a 50 percent decrease in lymph node size
- Treatment was well tolerated overall, with Grade 3 or Grade 4 toxicities infrequent and transient in nature, including febrile neutropenia (fever with low white blood cell count), anemia, mucositis and pneumonia, in this clinical study
"We believe the updated findings from these two trials further affirm the possibilities of ibrutinib," said Bob Duggan, CEO and Chairman of the Board of Directors of Pharmacyclics. "We look forward to continuing our clinical development program for this therapy, and hope it can help us in achieving Pharmacyclics' mission of improving the quality and duration of life for patients with oncologic diseases."
Ibrutinib was designed to specifically target and selectively inhibit an enzyme called Bruton's tyrosine kinase (BTK). BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel – regulating B-cell apoptosis, cell adhesion, and lymphocyte migration and homing. Data are consistent with a mechanistic model whereby ibrutinib blocks BCR signaling, which drives cells into apoptosis and/or disrupts cell migration and adherence to tumor-protective microenvironments.
The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including CLL/SLL, relapsed/refractory mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma and multiple myeloma. A comprehensive late stage Phase 2 and 3 program is under way.
Conference Call and Webcast Details
Pharmacyclics will be holding a conference call on Wednesday, December 12, 2012 at 8:30 AM ET. To participate in the conference call, please dial 1-877-407-0778 for domestic callers and 1-201-689-8565 for international callers. To access the live audio broadcast or the subsequent archived recording, log on to http://ir.pharmacyclics.com/events.cfm. The archived version of the webcast will be available for 30 days on the Investor Relations section of the company's website at www.pharmacyclics.com.
About the Pharmacyclics and Janssen Collaboration
Pharmacyclics and Janssen Biotech, Inc. entered into a worldwide collaboration on December 8, 2011, to develop and commercialize ibrutinib. Following regulatory approval, Pharmacyclics and Janssen will co-commercialize ibrutinib. Each company will lead development for specific indications as stipulated in a global development plan.
Pharmacyclics® is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our mission and goal is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medial healthcare needs; and to identify promising product candidates based on scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.
Presently, Pharmacyclics has three product candidates in clinical development and several preclinical molecules in lead optimization. We are committed to high standards of ethics, scientific rigor, and operational efficiency as we move each of these programs to viable commercialization.
The Company is headquartered in Sunnyvale, California and is listed on NASDAQ under the symbol PCYC. To learn more about how Pharmacyclics advances science to improve human healthcare visit us at http://www.pharmacyclics.com.
NOTE: This announcement may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements, among others, relating to our future capital requirements and the sufficiency of our current assets to meet these requirements, our future results of operations, our expectations for and timing of ongoing or future clinical trials and regulatory approvals for any of our product candidates, and our plans, objectives, expectations and intentions. Because these statements apply to future events, they are subject to risks and uncertainties. When used in this announcement, the words "anticipate", "believe", "estimate", "expect", "expectation", "should", "would", "project", "plan", "predict", "intend" and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to us and are subject to a number of risks, uncertainties and other factors that could cause our actual results, performance or achievements to differ materially from those projected in, or implied by, these forward-looking statements. Factors that may cause such a difference include, without limitation, our need for substantial additional financing and the availability and terms of any such financing, the safety and/or efficacy results of clinical trials of our product candidates, our failure to obtain regulatory approvals or comply with ongoing governmental regulation, our ability to commercialize, manufacture and achieve market acceptance of any of our product candidates, for which we rely heavily on collaboration with third parties, and our ability to protect and enforce our intellectual property rights and to operate without infringing upon the proprietary rights of third parties. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance or achievements and no assurance can be given that the actual results will be consistent with these forward-looking statements. For more information about the risks and uncertainties that may affect our results, please see the Risk Factors section of our filings with the Securities and Exchange Commission, including our annual report on Form 10-K and quarterly reports on Form 10-Q. We do not intend to update any of the forward-looking statements after the date of this announcement to conform these statements to actual results, to changes in management's expectations or otherwise, except as may be required by law.
Note: Data in this release correspond to ASH Abstracts 189 and 187.
SOURCE Pharmacyclics, Inc.
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data...
Nov. 28, 2015 01:00 PM EST Reads: 469
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
Nov. 28, 2015 12:00 PM EST Reads: 329
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York and Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty ...
Nov. 28, 2015 12:00 PM EST Reads: 547
In his General Session at DevOps Summit, Asaf Yigal, Co-Founder & VP of Product at Logz.io, explored the value of Kibana 4 for log analysis and provided a hands-on tutorial on how to set up Kibana 4 and get the most out of Apache log files. He examined three use cases: IT operations, business intelligence, and security and compliance. Asaf Yigal is co-founder and VP of Product at log analytics software company Logz.io. In the past, he was co-founder of social-trading platform Currensee, which...
Nov. 28, 2015 12:00 PM EST Reads: 227
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, rich desktop and tuned mobile experiences can now be created with a single codebase – without compromising functionality, performance or usability. In his session at DevOps Su...
Nov. 28, 2015 11:45 AM EST Reads: 399
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
Nov. 28, 2015 11:15 AM EST Reads: 411
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Nov. 28, 2015 11:00 AM EST Reads: 510
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Nov. 28, 2015 10:30 AM EST Reads: 308
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Nov. 28, 2015 10:15 AM EST Reads: 242
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ab...
Nov. 28, 2015 10:00 AM EST Reads: 394
We all know that data growth is exploding and storage budgets are shrinking. Instead of showing you charts on about how much data there is, in his General Session at 17th Cloud Expo, Scott Cleland, Senior Director of Product Marketing at HGST, showed how to capture all of your data in one place. After you have your data under control, you can then analyze it in one place, saving time and resources.
Nov. 28, 2015 10:00 AM EST Reads: 186
In recent years, at least 40% of companies using cloud applications have experienced data loss. One of the best prevention against cloud data loss is backing up your cloud data. In his General Session at 17th Cloud Expo, Sam McIntyre, Partner Enablement Specialist at eFolder, presented how organizations can use eFolder Cloudfinder to automate backups of cloud application data. He also demonstrated how easy it is to search and restore cloud application data using Cloudfinder.
Nov. 28, 2015 09:00 AM EST Reads: 177
The Internet of Everything is re-shaping technology trends–moving away from “request/response” architecture to an “always-on” Streaming Web where data is in constant motion and secure, reliable communication is an absolute necessity. As more and more THINGS go online, the challenges that developers will need to address will only increase exponentially. In his session at @ThingsExpo, Todd Greene, Founder & CEO of PubNub, exploreed the current state of IoT connectivity and review key trends and t...
Nov. 28, 2015 08:45 AM EST Reads: 433
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...
Nov. 28, 2015 08:45 AM EST Reads: 331
As organizations shift towards IT-as-a-service models, the need for managing & protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection & E-Discovery of your data - whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise.
Nov. 28, 2015 07:45 AM EST Reads: 208