The U.S. Food and Drug Administration (FDA) has granted first Breakthrough Therapy Designation in bladder cancer for MPDL3280A
BASEL, Switzerland I May 31, 2014 I Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from a Phase I open-label study that showed the investigational cancer immunotherapy MPDL3280A (anti-PDL1) shrank tumours (overall response rate) in 43 percent (13/30) of people previously treated for metastatic urothelial bladder cancer (UBC) whose tumours were characterised as PD-L1 (Programed Death Ligand-1) positive by a test being developed by Roche.1 Adverse events (AEs) were consistent with what has been previously reported for MPDL3280A. There were no severe (Grade 4-5) treatment related AEs.
The FDA has granted MPDL3280A Breakthrough Therapy Designation. This designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible.
“Bladder cancer is the ninth most common cancer worldwide, for which there have been no new treatment advances in nearly 30 years, so we are pleased the FDA has granted breakthrough designation for MPDL3280A in metastatic bladder cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are evaluating MPDL3280A in a broad range of tumours, and have begun pivotal studies that include a companion diagnostic test in lung and bladder cancers.”
Full results of the study will be presented today at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) by Thomas Powles, M.D., clinical professor of Genitourinary Oncology, Barts Cancer Institute at the Queen Mary University of London, UK (Abstract #5011, Saturday, May 31, 3:36–3:48 P.M. Central Time).1
About the Phase I MPDL3280A Study
The Phase I study is a single-arm, multi-center, open-label trial with a cohort of 68 people with previously treated, metastatic bladder cancer.
The study included 30 patients who were identified as PD-L1 positive (immunohistochemistry [IHC] 2/3) using an investigational PD-L1 diagnostic test being developed by Roche.
After six weeks of follow-up, the objective response rate (ORR) as measured by RECIST criteria was 43 percent (13/30), and after 12 weeks, ORR was 52 percent (13/25) in people with PD-L1-positive tumours.
A complete response (no radiographic evidence of tumour) was observed in 7 percent of PD-L1-positive patients (2/30).
The ORR was 11 percent (4/35) in people whose tumours were identified as PD-L1-negative (IHC 0/1) by our investigational test.
People in the study experienced a median time to response of 42 days.
Treatment-related Grade 3 AEs occurred in 4 percent (3/68) of people in the study and included weakness (asthenia; 2 percent), low platelet count (thrombocytopenia; 2 percent) and low phosphate levels (blood phosphorus decrease; 2 percent).
The most common AEs observed to date occurring in more than 5 percent of patients were decreased appetite (12 percent), fatigue (12 percent), nausea (12 percent), fever (pyrexia; 9 percent) and weakness (asthenia; 7 percent).
About MPDL3280A (anti-PDL1)
MPDL3280A (also known as anti-PDL1) is an investigational monoclonal antibody designed to interfere with a protein called PD-L1. MPDL3280A is designed to target PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. By inhibiting PD-L1, MPDL3280A may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells.
About Metastatic Urothelial Bladder Cancer
Metastatic urothelial bladder cancer is associated with a poor prognosis and limited treatment options. Bladder cancer is the ninth most common cancer worldwide, with 430,000 new cases diagnosed in 2012 and it results in approximately 145,000 deaths globally each year.2, 3 Men are three times more likely to suffer from bladder cancer compared with women and it is also three times more common in developed countries than in less developed countries.2, 3
About Roche in Cancer Immunotherapy
For more than 30 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer. Our personalised cancer immunotherapy research and development programme comprises more than 20 investigational candidates, which include the evaluation of biomarkers to determine which people may be appropriate candidates for our medicines.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
1. Powles T, et al. Inhibition of PD-L1 by MPDL3280A leads to clinical activity in pts with metastatic urothelial bladder cancer (UBC). Abstract number: #5011. Saturday, May 31, 3:36–3:48 P.M. Central Time.
2. World Cancer Research Fund International. Available at: www.wcrf.org/cancer_statistics/data_specific_cancers/bladder_cancer_statistics.php Accessed May, 2014.
3 Ploeg M et al., The present and future burden of urinary bladder cancer in the world; World Journal of Urology 2009; 27(3):289-293.Available from: http://www.ipsen.com/en/pathology/ipsen-in-urology-oncology/bladder-cancer/Accessed May, 2014.
SOURCE: Roche
Post Views: 333
The U.S. Food and Drug Administration (FDA) has granted first Breakthrough Therapy Designation in bladder cancer for MPDL3280A
BASEL, Switzerland I May 31, 2014 I Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from a Phase I open-label study that showed the investigational cancer immunotherapy MPDL3280A (anti-PDL1) shrank tumours (overall response rate) in 43 percent (13/30) of people previously treated for metastatic urothelial bladder cancer (UBC) whose tumours were characterised as PD-L1 (Programed Death Ligand-1) positive by a test being developed by Roche.1 Adverse events (AEs) were consistent with what has been previously reported for MPDL3280A. There were no severe (Grade 4-5) treatment related AEs.
The FDA has granted MPDL3280A Breakthrough Therapy Designation. This designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible.
“Bladder cancer is the ninth most common cancer worldwide, for which there have been no new treatment advances in nearly 30 years, so we are pleased the FDA has granted breakthrough designation for MPDL3280A in metastatic bladder cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are evaluating MPDL3280A in a broad range of tumours, and have begun pivotal studies that include a companion diagnostic test in lung and bladder cancers.”
Full results of the study will be presented today at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) by Thomas Powles, M.D., clinical professor of Genitourinary Oncology, Barts Cancer Institute at the Queen Mary University of London, UK (Abstract #5011, Saturday, May 31, 3:36–3:48 P.M. Central Time).1
About the Phase I MPDL3280A Study
The Phase I study is a single-arm, multi-center, open-label trial with a cohort of 68 people with previously treated, metastatic bladder cancer.
The study included 30 patients who were identified as PD-L1 positive (immunohistochemistry [IHC] 2/3) using an investigational PD-L1 diagnostic test being developed by Roche.
After six weeks of follow-up, the objective response rate (ORR) as measured by RECIST criteria was 43 percent (13/30), and after 12 weeks, ORR was 52 percent (13/25) in people with PD-L1-positive tumours.
A complete response (no radiographic evidence of tumour) was observed in 7 percent of PD-L1-positive patients (2/30).
The ORR was 11 percent (4/35) in people whose tumours were identified as PD-L1-negative (IHC 0/1) by our investigational test.
People in the study experienced a median time to response of 42 days.
Treatment-related Grade 3 AEs occurred in 4 percent (3/68) of people in the study and included weakness (asthenia; 2 percent), low platelet count (thrombocytopenia; 2 percent) and low phosphate levels (blood phosphorus decrease; 2 percent).
The most common AEs observed to date occurring in more than 5 percent of patients were decreased appetite (12 percent), fatigue (12 percent), nausea (12 percent), fever (pyrexia; 9 percent) and weakness (asthenia; 7 percent).
About MPDL3280A (anti-PDL1)
MPDL3280A (also known as anti-PDL1) is an investigational monoclonal antibody designed to interfere with a protein called PD-L1. MPDL3280A is designed to target PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. By inhibiting PD-L1, MPDL3280A may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells.
About Metastatic Urothelial Bladder Cancer
Metastatic urothelial bladder cancer is associated with a poor prognosis and limited treatment options. Bladder cancer is the ninth most common cancer worldwide, with 430,000 new cases diagnosed in 2012 and it results in approximately 145,000 deaths globally each year.2, 3 Men are three times more likely to suffer from bladder cancer compared with women and it is also three times more common in developed countries than in less developed countries.2, 3
About Roche in Cancer Immunotherapy
For more than 30 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer. Our personalised cancer immunotherapy research and development programme comprises more than 20 investigational candidates, which include the evaluation of biomarkers to determine which people may be appropriate candidates for our medicines.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
1. Powles T, et al. Inhibition of PD-L1 by MPDL3280A leads to clinical activity in pts with metastatic urothelial bladder cancer (UBC). Abstract number: #5011. Saturday, May 31, 3:36–3:48 P.M. Central Time.
2. World Cancer Research Fund International. Available at: www.wcrf.org/cancer_statistics/data_specific_cancers/bladder_cancer_statistics.php Accessed May, 2014.
3 Ploeg M et al., The present and future burden of urinary bladder cancer in the world; World Journal of Urology 2009; 27(3):289-293.Available from: http://www.ipsen.com/en/pathology/ipsen-in-urology-oncology/bladder-cancer/Accessed May, 2014.
SOURCE: Roche
Post Views: 333
