BLINCYTO® Added to Multiphase Consolidation Chemotherapy Reduced Risk of Death by 58% Showing Superior Overall Survival Versus Chemotherapy Alone
First and Only Bispecific T-cell Engager (BiTE®) Therapy for Consolidation Treatment Regardless of Measurable Residual Disease (MRD) Status
THOUSAND OAKS, CA, USA I June 14, 2024 I Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved BLINCYTO® (blinatumomab) for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status.
“B-ALL is an aggressive blood cancer with enduring high unmet need. BLINCYTO has helped thousands of patients with B-ALL over the last 10 years. Today’s approval in the frontline consolidation phase, regardless of MRD status, allows us to reach more patients than ever with this transformative, first-in-class Bispecific T-cell Engager (BiTE®) therapy,” said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen.
The approval marks the third indication for BLINCYTO and is based primarily on the Phase 3 E1910 clinical trial led by ECOG-ACRIN Cancer Research Group that studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment, which aims to deepen remission to achieve durable responses. Study results demonstrated that BLINCYTO added to multiphase consolidation chemotherapy showed superior overall survival (OS) versus chemotherapy alone. The 3-year OS was 84.8% in the BLINCYTO plus chemotherapy arm (n=112) and 69% in the chemotherapy arm (n=112), with the hazard ratio for OS of 0.42. With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the BLINCYTO plus chemotherapy arm and 62.5% in the chemotherapy arm.
“In the E1910 study, blinatumomab reduced risk of death and showed a remarkable improvement in overall survival,” said Selina M. Luger, M.D., professor of hematology-oncology at the University of Pennsylvania’s Perelman School of Medicine and Abramson Cancer Center, chair of the ECOG-ACRIN Leukemia Committee and an investigator on the study. “This approval redefines the standard of care for patients with B-ALL and provides them with a more effective treatment option than standard chemotherapy alone.”
“The risk of B-ALL recurrence after the initial phase of treatment is relatively high, making this approval for patients noteworthy,” said E. Anders Kolb, M.D., president and chief executive officer of The Leukemia & Lymphoma Society. “B-ALL is the most common type of ALL and having another effective option available earlier in a patient’s treatment journey is critical for clinicians who are working to give these patients more time with their loved ones.”
The E1910 study was designed and conducted independently from industry. ECOG-ACRIN sponsored the trial with public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Other NCI-funded network groups took part in the study. In addition, Amgen provided BLINCYTO and support through an NCI Cooperative Research and Development Agreement.
About Acute Lymphoblastic Leukemia (ALL)
ALL, also known as acute lymphoblastic leukemia, is a fast-growing type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. ALL is a rare disease, with 6,540 new cases diagnosed in the U.S. in 2023 affecting both children and adults.1 B-ALL begins in immature cells that would normally develop into B-cell lymphocytes, which are white blood cells that grow in bone marrow.2,3 B-ALL is the most common type of ALL, constituting approximately 75% of cases in adults.4
About BLINCYTO® (blinatumomab)
BLINCYTO is the first globally approved BiTE® immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE® molecules fight cancer by helping the body’s immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE® immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers.
BLINCYTO was granted breakthrough therapy and Priority Review designations by the U.S. FDA and is approved in the U.S. for the treatment of:
- Adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-ALL during the consolidation phase of multiphase therapy.
- CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1% in adults and pediatric patients one month or older.
- Relapsed or refractory CD19-positive B-ALL in adults and pediatric patients one month or older.
In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of:
- Adults with Philadelphia chromosome-negative CD19-positive relapsed or refractory B-ALL. Patients with Philadelphia chromosome-positive B-ALL should have failed treatment with at least two tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.
- Adults with Philadelphia chromosome-negative CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1%.
- Pediatric patients aged 1 year or older with Philadelphia chromosome-negative CD19-positive B-ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
- Pediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome-negative CD19-positive B-ALL as part of the consolidation therapy.
INDICATIONS
BLINCYTO® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with:
- Philadelphia chromosome-negative disease in the consolidation phase of multiphase chemotherapy.
- Minimal residual disease (MRD) greater than or equal to 0.1% in first or second complete remission.
- Relapsed or refractory disease.
Please see BLINCYTO® full Prescribing Information, including BOXED WARNINGS.
About BiTE® Technology
Bispecific T-cell Engager (BiTE®) technology is a targeted immuno-oncology platform that is designed to engage patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE® immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE® platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing multiple BiTE® molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE® technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE® technology, visit https://www.amgenoncology.com/bite-platform.html.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world’s toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
- National Cancer Institute. Available at: https://seer.cancer.gov/statfacts/html/alyl.html. Accessed on February 8, 2024.
- Terwilliger T, et al. Blood Cancer J. doi:10.1038/bcj.2017.53.
- Cancer.org. Available at: https://www.cancer.org/cancer/types/acute-lymphocytic-leukemia/about/what-is-all.html Accessed on February 8, 2024.
- Leukemia & Lymphoma Society. Available at: https://www.lls.org/research/acute-lymphoblastic-leukemia-all#:~:text=B%2DALL%20is%20more%20common,about%2075%20percent%20of%20cases. Accessed on February 8, 2024.
SOURCE: Amgen
Post Views: 1,825
BLINCYTO® Added to Multiphase Consolidation Chemotherapy Reduced Risk of Death by 58% Showing Superior Overall Survival Versus Chemotherapy Alone
First and Only Bispecific T-cell Engager (BiTE®) Therapy for Consolidation Treatment Regardless of Measurable Residual Disease (MRD) Status
THOUSAND OAKS, CA, USA I June 14, 2024 I Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved BLINCYTO® (blinatumomab) for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status.
“B-ALL is an aggressive blood cancer with enduring high unmet need. BLINCYTO has helped thousands of patients with B-ALL over the last 10 years. Today’s approval in the frontline consolidation phase, regardless of MRD status, allows us to reach more patients than ever with this transformative, first-in-class Bispecific T-cell Engager (BiTE®) therapy,” said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen.
The approval marks the third indication for BLINCYTO and is based primarily on the Phase 3 E1910 clinical trial led by ECOG-ACRIN Cancer Research Group that studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment, which aims to deepen remission to achieve durable responses. Study results demonstrated that BLINCYTO added to multiphase consolidation chemotherapy showed superior overall survival (OS) versus chemotherapy alone. The 3-year OS was 84.8% in the BLINCYTO plus chemotherapy arm (n=112) and 69% in the chemotherapy arm (n=112), with the hazard ratio for OS of 0.42. With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the BLINCYTO plus chemotherapy arm and 62.5% in the chemotherapy arm.
“In the E1910 study, blinatumomab reduced risk of death and showed a remarkable improvement in overall survival,” said Selina M. Luger, M.D., professor of hematology-oncology at the University of Pennsylvania’s Perelman School of Medicine and Abramson Cancer Center, chair of the ECOG-ACRIN Leukemia Committee and an investigator on the study. “This approval redefines the standard of care for patients with B-ALL and provides them with a more effective treatment option than standard chemotherapy alone.”
“The risk of B-ALL recurrence after the initial phase of treatment is relatively high, making this approval for patients noteworthy,” said E. Anders Kolb, M.D., president and chief executive officer of The Leukemia & Lymphoma Society. “B-ALL is the most common type of ALL and having another effective option available earlier in a patient’s treatment journey is critical for clinicians who are working to give these patients more time with their loved ones.”
The E1910 study was designed and conducted independently from industry. ECOG-ACRIN sponsored the trial with public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Other NCI-funded network groups took part in the study. In addition, Amgen provided BLINCYTO and support through an NCI Cooperative Research and Development Agreement.
About Acute Lymphoblastic Leukemia (ALL)
ALL, also known as acute lymphoblastic leukemia, is a fast-growing type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. ALL is a rare disease, with 6,540 new cases diagnosed in the U.S. in 2023 affecting both children and adults.1 B-ALL begins in immature cells that would normally develop into B-cell lymphocytes, which are white blood cells that grow in bone marrow.2,3 B-ALL is the most common type of ALL, constituting approximately 75% of cases in adults.4
About BLINCYTO® (blinatumomab)
BLINCYTO is the first globally approved BiTE® immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE® molecules fight cancer by helping the body’s immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE® immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers.
BLINCYTO was granted breakthrough therapy and Priority Review designations by the U.S. FDA and is approved in the U.S. for the treatment of:
- Adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-ALL during the consolidation phase of multiphase therapy.
- CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1% in adults and pediatric patients one month or older.
- Relapsed or refractory CD19-positive B-ALL in adults and pediatric patients one month or older.
In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of:
- Adults with Philadelphia chromosome-negative CD19-positive relapsed or refractory B-ALL. Patients with Philadelphia chromosome-positive B-ALL should have failed treatment with at least two tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.
- Adults with Philadelphia chromosome-negative CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1%.
- Pediatric patients aged 1 year or older with Philadelphia chromosome-negative CD19-positive B-ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
- Pediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome-negative CD19-positive B-ALL as part of the consolidation therapy.
INDICATIONS
BLINCYTO® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with:
- Philadelphia chromosome-negative disease in the consolidation phase of multiphase chemotherapy.
- Minimal residual disease (MRD) greater than or equal to 0.1% in first or second complete remission.
- Relapsed or refractory disease.
Please see BLINCYTO® full Prescribing Information, including BOXED WARNINGS.
About BiTE® Technology
Bispecific T-cell Engager (BiTE®) technology is a targeted immuno-oncology platform that is designed to engage patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE® immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE® platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing multiple BiTE® molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE® technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE® technology, visit https://www.amgenoncology.com/bite-platform.html.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world’s toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
- National Cancer Institute. Available at: https://seer.cancer.gov/statfacts/html/alyl.html. Accessed on February 8, 2024.
- Terwilliger T, et al. Blood Cancer J. doi:10.1038/bcj.2017.53.
- Cancer.org. Available at: https://www.cancer.org/cancer/types/acute-lymphocytic-leukemia/about/what-is-all.html Accessed on February 8, 2024.
- Leukemia & Lymphoma Society. Available at: https://www.lls.org/research/acute-lymphoblastic-leukemia-all#:~:text=B%2DALL%20is%20more%20common,about%2075%20percent%20of%20cases. Accessed on February 8, 2024.
SOURCE: Amgen
Post Views: 1,825
