NORTH CHICAGO, IL, USA I December 6, 2016 I AbbVie (ABBV), a global biopharmaceutical company, today announced positive results from a Phase 2 study (PCYC-1129) evaluating ibrutinib (IMBRUVICA®) in patients with chronic graft-versus-host-disease (cGVHD), a serious and debilitating potential consequence of stem cell or bone marrow transplant,1 who failed prior systemic therapy. The study found ibrutinib demonstrated efficacy, sustained responses and reduced symptom severity, with an overall response rate (ORR) of 67%.2 Final results from this study presented today as a late-breaking oral presentation at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA (abstract #LBA-3). IMBRUVICA, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
At a median follow-up of 14 months in 42 patients, the study found an ORR of 67%. One-third of all responders achieved a complete response (CR). In addition, 71% of patients showed a sustained response of at least 5 months. Similar response rates were seen across all involved organs, and patients with multiple organ involvement generally responded in multiple organs. Over the course of the study, 61% of responders experienced a clinically meaningful improvement in symptoms, as measured by at least a 7-point decrease in Lee Symptom Scale score. In addition, 62% of all patients were able to reduce steroid dose to an acceptable minimal level and five completely discontinued steroids with response. Twelve patients (29%) remain on treatment with ibrutinib.2
“These results are encouraging as they suggest ibrutinib has clinically meaningful potential in patients with steroid-refractory chronic graft-versus-host-disease,” said David Miklos, M.D., Ph.D., Associate Professor of Medicine (Blood and Marrow Transplantation), Stanford University and lead investigator of the study.* “cGVHD patients face a challenging treatment journey with the majority of patients being prescribed steroids, with which long-term use can lead to serious health complications. With no FDA-approved therapies available specifically for cGVHD, new treatment options are critically needed.”
GVHD is a life-threatening condition in which the body is attacked by donor immune cells after a patient undergoes an allogeneic stem cell or bone marrow transplant.1,3 GVHD can be acute or chronic; chronic GVHD (cGVHD) usually starts more than 3 months after a transplant and can last many years.3 Symptoms can include skin problems, hair loss, mouth sores, eye irritation, severe lung injury, or liver dysfunction.3 There are currently no therapies specifically approved for patients with cGVHD who have failed first-line corticosteroid therapy and require additional therapy. Most patients with cGVHD are prescribed high dose glucocorticoids, a systemic steroid that suppresses the immune system and is associated with substantial morbidity and relapse of the underlying disease.3
“Ibrutinib works as a BTK inhibitor, which is showing to have a potential impact beyond blood cancers, including chronic graft-versus-host-disease,” said Lori Styles, M.D., Senior Medical Director and GVHD program clinical lead at Pharmacyclics LLC, an AbbVie company. “We recognize the critical need for new treatments for patients with cGVHD and are encouraged by the results of this well-designed study, giving us confidence to proceed with a Phase 3 trial evaluating the impact of ibrutinib as part of initial therapy for this severe and potentially life-threatening condition. We are committed to exploring the full potential of ibrutinib in a range of health conditions with unmet needs.”
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation and Orphan Drug Designation in June 2016 for ibrutinib as a potential treatment for cGVHD after failure of one or more lines of systemic therapy.
About the Study
PCYC-1129 evaluated the safety and efficacy of ibrutinib in 42 patients (median age 56 years) with cGVHD who failed at least one prior therapy, including corticosteroids. Patients were treated with ibrutinib once daily until cGVHD progression or unacceptable toxicity. The primary endpoint was cGVHD response based on the National Institutes of Health (NIH) consensus response criteria. Secondary endpoints included rate of sustained response, change in Lee cGVHD Symptom Scale, changes in corticosteroid requirement over time, and safety endpoints. Overall, reported adverse events (AEs) were consistent with those treated with ibrutinib for B-cell malignancies and in patients with cGVHD on corticosteroids.2
The most common AEs were fatigue (57%), diarrhea (36%), muscle spasms (29%), nausea (26%), and bruising (24%). Serious AEs (SAEs) occurred in 22 patients (52%), including pneumonia (n=6), septic shock (n=2), and pyrexia (n=2).2
Preliminary results from this trial were previously presented at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation (ESBM) in April 2016 and the 51st American Society of Clinical Oncology (ASCO) Annual Meeting in May 2015.
About IMBRUVICA
IMBRUVICA is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton’s tyrosine kinase (BTK). 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.4,5 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.4
IMBRUVICA is approved to treat patients with CLL/SLL including patients with 17p deletion, patients with MCL who have received at least one prior therapy and patients with WM. 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. 4
IMBRUVICA was one of the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway.
IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry with nearly 30 (n=27) company-sponsored trials underway, 14 of which are Phase 3. In addition, there are more than 40 (n=44) investigator-sponsored trials taking place around the world. To date, more than 65,000 patients around the world have been treated with IMBRUVICA in clinical practice and in clinical trials.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
1 MedlinePlus, U.S. National Library of Medicine. Graft-versus-host-disease. Available from: http://www.nlm.nih.gov/medlineplus/ency/article/001309.htm. Accessed March 2016.
2 Miklos, D, et al. Multicenter Open-Label Phase 2 Study of Ibrutinib in Chronic Graft Versus Host Disease (cGVHD) After Failure of Corticosteroids. ASH 2016 Abstract #LBA-3.
3 The Leukemia and Lymphoma Society. Graft Versus Host Disease. Available from: http://www.lls.org/treatment/types-of-treatment/stem-cell-transplantation/graft-versus-host-disease.
4 IMBRUVICA US Prescribing Information, May 2016.
5 Genetics Home Reference. Isolated growth hormone deficiency. Available from: http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed May 2016.
SOURCE: AbbVie
Post Views: 86
NORTH CHICAGO, IL, USA I December 6, 2016 I AbbVie (ABBV), a global biopharmaceutical company, today announced positive results from a Phase 2 study (PCYC-1129) evaluating ibrutinib (IMBRUVICA®) in patients with chronic graft-versus-host-disease (cGVHD), a serious and debilitating potential consequence of stem cell or bone marrow transplant,1 who failed prior systemic therapy. The study found ibrutinib demonstrated efficacy, sustained responses and reduced symptom severity, with an overall response rate (ORR) of 67%.2 Final results from this study presented today as a late-breaking oral presentation at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA (abstract #LBA-3). IMBRUVICA, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
At a median follow-up of 14 months in 42 patients, the study found an ORR of 67%. One-third of all responders achieved a complete response (CR). In addition, 71% of patients showed a sustained response of at least 5 months. Similar response rates were seen across all involved organs, and patients with multiple organ involvement generally responded in multiple organs. Over the course of the study, 61% of responders experienced a clinically meaningful improvement in symptoms, as measured by at least a 7-point decrease in Lee Symptom Scale score. In addition, 62% of all patients were able to reduce steroid dose to an acceptable minimal level and five completely discontinued steroids with response. Twelve patients (29%) remain on treatment with ibrutinib.2
“These results are encouraging as they suggest ibrutinib has clinically meaningful potential in patients with steroid-refractory chronic graft-versus-host-disease,” said David Miklos, M.D., Ph.D., Associate Professor of Medicine (Blood and Marrow Transplantation), Stanford University and lead investigator of the study.* “cGVHD patients face a challenging treatment journey with the majority of patients being prescribed steroids, with which long-term use can lead to serious health complications. With no FDA-approved therapies available specifically for cGVHD, new treatment options are critically needed.”
GVHD is a life-threatening condition in which the body is attacked by donor immune cells after a patient undergoes an allogeneic stem cell or bone marrow transplant.1,3 GVHD can be acute or chronic; chronic GVHD (cGVHD) usually starts more than 3 months after a transplant and can last many years.3 Symptoms can include skin problems, hair loss, mouth sores, eye irritation, severe lung injury, or liver dysfunction.3 There are currently no therapies specifically approved for patients with cGVHD who have failed first-line corticosteroid therapy and require additional therapy. Most patients with cGVHD are prescribed high dose glucocorticoids, a systemic steroid that suppresses the immune system and is associated with substantial morbidity and relapse of the underlying disease.3
“Ibrutinib works as a BTK inhibitor, which is showing to have a potential impact beyond blood cancers, including chronic graft-versus-host-disease,” said Lori Styles, M.D., Senior Medical Director and GVHD program clinical lead at Pharmacyclics LLC, an AbbVie company. “We recognize the critical need for new treatments for patients with cGVHD and are encouraged by the results of this well-designed study, giving us confidence to proceed with a Phase 3 trial evaluating the impact of ibrutinib as part of initial therapy for this severe and potentially life-threatening condition. We are committed to exploring the full potential of ibrutinib in a range of health conditions with unmet needs.”
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation and Orphan Drug Designation in June 2016 for ibrutinib as a potential treatment for cGVHD after failure of one or more lines of systemic therapy.
About the Study
PCYC-1129 evaluated the safety and efficacy of ibrutinib in 42 patients (median age 56 years) with cGVHD who failed at least one prior therapy, including corticosteroids. Patients were treated with ibrutinib once daily until cGVHD progression or unacceptable toxicity. The primary endpoint was cGVHD response based on the National Institutes of Health (NIH) consensus response criteria. Secondary endpoints included rate of sustained response, change in Lee cGVHD Symptom Scale, changes in corticosteroid requirement over time, and safety endpoints. Overall, reported adverse events (AEs) were consistent with those treated with ibrutinib for B-cell malignancies and in patients with cGVHD on corticosteroids.2
The most common AEs were fatigue (57%), diarrhea (36%), muscle spasms (29%), nausea (26%), and bruising (24%). Serious AEs (SAEs) occurred in 22 patients (52%), including pneumonia (n=6), septic shock (n=2), and pyrexia (n=2).2
Preliminary results from this trial were previously presented at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation (ESBM) in April 2016 and the 51st American Society of Clinical Oncology (ASCO) Annual Meeting in May 2015.
About IMBRUVICA
IMBRUVICA is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton’s tyrosine kinase (BTK). 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.4,5 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.4
IMBRUVICA is approved to treat patients with CLL/SLL including patients with 17p deletion, patients with MCL who have received at least one prior therapy and patients with WM. 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. 4
IMBRUVICA was one of the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway.
IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry with nearly 30 (n=27) company-sponsored trials underway, 14 of which are Phase 3. In addition, there are more than 40 (n=44) investigator-sponsored trials taking place around the world. To date, more than 65,000 patients around the world have been treated with IMBRUVICA in clinical practice and in clinical trials.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
1 MedlinePlus, U.S. National Library of Medicine. Graft-versus-host-disease. Available from: http://www.nlm.nih.gov/medlineplus/ency/article/001309.htm. Accessed March 2016.
2 Miklos, D, et al. Multicenter Open-Label Phase 2 Study of Ibrutinib in Chronic Graft Versus Host Disease (cGVHD) After Failure of Corticosteroids. ASH 2016 Abstract #LBA-3.
3 The Leukemia and Lymphoma Society. Graft Versus Host Disease. Available from: http://www.lls.org/treatment/types-of-treatment/stem-cell-transplantation/graft-versus-host-disease.
4 IMBRUVICA US Prescribing Information, May 2016.
5 Genetics Home Reference. Isolated growth hormone deficiency. Available from: http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed May 2016.
SOURCE: AbbVie
Post Views: 86
