TECENTRIQ® in Combination with ABRAXANE® receives accelerated approval for people with PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
Top-line results announced from the international Phase 3 study evaluating adjuvant therapy with ABRAXANE in combination with gemcitabine vs. gemcitabine alone for patients with surgically resected pancreatic cancer
SUMMIT, NJ, USA I March 12, 2019 I Celgene Corporation (NASDAQ: CELG) today announced two updates for ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in the treatment of metastatic triple-negative breast cancer and early stage pancreatic cancer.
Genentech, a member of the Roche Group, recently announced the accelerated approval of TECENTRIQ® (atezolizumab) in combination with ABRAXANE® for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). This combination is the first cancer immunotherapy regimen approved for breast cancer and is based on results from the Phase 3 IMpassion130 study, which demonstrated that the combination of TECENTRIQ plus ABRAXANE compared to ABRAXANE monotherapy, as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (progression-free survival) in patients with metastatic or unresectable locally advanced triple negative breast cancer (TNBC) in the PD-L1 positive populations who had not received chemotherapy for metastatic disease.
“This is the second approval from the U.S. Food and Drug Administration of a PD-1/PD-L1 antibody in combination with ABRAXANE,” said Alise Reicin, M.D., President, Global Clinical Development for Celgene. “ABRAXANE continues to be studied with immunotherapy agents as a combination partner across a range of solid tumors.”
In addition, the Celgene-sponsored, pivotal, Phase 3 apact® study evaluating the investigational use of ABRAXANE in combination with gemcitabine following surgical resection (adjuvant treatment) in patients with pancreatic cancer did not achieve the primary endpoint of improvement in disease-free survival, as confirmed by independent radiological review, compared to gemcitabine alone. Overall survival, a secondary endpoint of the study, was improved, reaching nominal statistical significance, with ABRAXANE in combination with gemcitabine compared to gemcitabine alone. The safety profile observed in the apact study was consistent with previously reported studies of ABRAXANE. Data from apact will be submitted to a future medical meeting.
Currently, there are more than 130 studies evaluating the use of ABRAXANE in patients with pancreatic cancer in combination with more than 50 novel agents.
About apact
apact is an international, multicenter, randomized, open-label, controlled Phase 3 study (ClinicalTrials.gov, NCT01964430) to assess the efficacy of ABRAXANE in combination with gemcitabine versus gemcitabine alone as adjuvant therapy for patients with surgically resected pancreatic adenocarcinoma. The primary endpoint of the study was the independent assessment of disease-free survival (DFS); secondary endpoints included overall survival (OS) and safety. The study enrolled 866 patients randomized 1:1 to receive either ABRAXANE 125 mg/m2 followed by gemcitabine 1000 mg/m2, or gemcitabine 1000 mg/m2 monotherapy. Treatment was administered intravenously, weekly on Days 1, 8, and 15 of a 28-day cycle for a total of 6 cycles.
About Pancreatic Cancer
Each year, more than 350,000 people worldwide are diagnosed with pancreatic cancer – one of the deadliest cancers – with the majority of cases diagnosed in late stage. Despite advances in therapy over the past two decades that have led to doubled 5-year survival rates, pancreatic cancer 5-year survival is still only in the single digits – 8% – due to the complex nature of the disease and lack of symptoms until the disease has progressed.
Even among patients with localized pancreatic cancer, for whom surgery is potentially curative, survival remains poor and the rate of relapse is high. However, adjuvant chemotherapy has been proven to significantly improve survival compared with surgery alone. Despite the noted improvements with chemotherapy following surgery, recurrence rates of pancreatic cancer are still high with 69 to 75% of patients having a relapse within 2 years. There remains a high unmet medical need for more effective adjuvant therapies.
About Triple Negative Breast Cancer
Breast cancer is the second most common cancer among women in the United States. According to the American Cancer Society, it is estimated that about 266,000 American women will be diagnosed with invasive breast cancer in 2018, and nearly 41,000 will die from the disease. Approximately 10-20 percent of breast cancers are triple negative breast cancer (TNBC). TNBC is an aggressive form of the disease with a high unmet need. It can be more difficult to treat because it is not sensitive to hormone therapy or medicines that target HER2.
TECENTRIQ® is a registered trademark of Genentech, a member of the Roche Group.
About ABRAXANE in Pancreatic Cancer
In September 2013, the U.S. Food and Drug Administration (FDA) approved ABRAXANE in combination with gemcitabine as first-line treatment of patients with metastatic pancreatic cancer. The current indication remains unchanged and clinical trials continue building on the foundation of ABRAXANE in combination with gemcitabine for a new wave of potential treatments, such as an ongoing Phase 2 cooperative group trial with SWOG S1505 (ClinicalTrials.gov, NCT02562716) investigating the safety and effectiveness of ABRAXANE in combination with gemcitabine as neoadjuvant treatment for localized pancreatic head adenocarcinoma.
ABRAXANE is not approved for the adjuvant treatment of pancreatic cancer.
About ABRAXANE
Indications
ABRAXANE is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non–small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
ABRAXANE is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com.
SOURCE: Celgene
Post Views: 36
TECENTRIQ® in Combination with ABRAXANE® receives accelerated approval for people with PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
Top-line results announced from the international Phase 3 study evaluating adjuvant therapy with ABRAXANE in combination with gemcitabine vs. gemcitabine alone for patients with surgically resected pancreatic cancer
SUMMIT, NJ, USA I March 12, 2019 I Celgene Corporation (NASDAQ: CELG) today announced two updates for ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in the treatment of metastatic triple-negative breast cancer and early stage pancreatic cancer.
Genentech, a member of the Roche Group, recently announced the accelerated approval of TECENTRIQ® (atezolizumab) in combination with ABRAXANE® for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). This combination is the first cancer immunotherapy regimen approved for breast cancer and is based on results from the Phase 3 IMpassion130 study, which demonstrated that the combination of TECENTRIQ plus ABRAXANE compared to ABRAXANE monotherapy, as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (progression-free survival) in patients with metastatic or unresectable locally advanced triple negative breast cancer (TNBC) in the PD-L1 positive populations who had not received chemotherapy for metastatic disease.
“This is the second approval from the U.S. Food and Drug Administration of a PD-1/PD-L1 antibody in combination with ABRAXANE,” said Alise Reicin, M.D., President, Global Clinical Development for Celgene. “ABRAXANE continues to be studied with immunotherapy agents as a combination partner across a range of solid tumors.”
In addition, the Celgene-sponsored, pivotal, Phase 3 apact® study evaluating the investigational use of ABRAXANE in combination with gemcitabine following surgical resection (adjuvant treatment) in patients with pancreatic cancer did not achieve the primary endpoint of improvement in disease-free survival, as confirmed by independent radiological review, compared to gemcitabine alone. Overall survival, a secondary endpoint of the study, was improved, reaching nominal statistical significance, with ABRAXANE in combination with gemcitabine compared to gemcitabine alone. The safety profile observed in the apact study was consistent with previously reported studies of ABRAXANE. Data from apact will be submitted to a future medical meeting.
Currently, there are more than 130 studies evaluating the use of ABRAXANE in patients with pancreatic cancer in combination with more than 50 novel agents.
About apact
apact is an international, multicenter, randomized, open-label, controlled Phase 3 study (ClinicalTrials.gov, NCT01964430) to assess the efficacy of ABRAXANE in combination with gemcitabine versus gemcitabine alone as adjuvant therapy for patients with surgically resected pancreatic adenocarcinoma. The primary endpoint of the study was the independent assessment of disease-free survival (DFS); secondary endpoints included overall survival (OS) and safety. The study enrolled 866 patients randomized 1:1 to receive either ABRAXANE 125 mg/m2 followed by gemcitabine 1000 mg/m2, or gemcitabine 1000 mg/m2 monotherapy. Treatment was administered intravenously, weekly on Days 1, 8, and 15 of a 28-day cycle for a total of 6 cycles.
About Pancreatic Cancer
Each year, more than 350,000 people worldwide are diagnosed with pancreatic cancer – one of the deadliest cancers – with the majority of cases diagnosed in late stage. Despite advances in therapy over the past two decades that have led to doubled 5-year survival rates, pancreatic cancer 5-year survival is still only in the single digits – 8% – due to the complex nature of the disease and lack of symptoms until the disease has progressed.
Even among patients with localized pancreatic cancer, for whom surgery is potentially curative, survival remains poor and the rate of relapse is high. However, adjuvant chemotherapy has been proven to significantly improve survival compared with surgery alone. Despite the noted improvements with chemotherapy following surgery, recurrence rates of pancreatic cancer are still high with 69 to 75% of patients having a relapse within 2 years. There remains a high unmet medical need for more effective adjuvant therapies.
About Triple Negative Breast Cancer
Breast cancer is the second most common cancer among women in the United States. According to the American Cancer Society, it is estimated that about 266,000 American women will be diagnosed with invasive breast cancer in 2018, and nearly 41,000 will die from the disease. Approximately 10-20 percent of breast cancers are triple negative breast cancer (TNBC). TNBC is an aggressive form of the disease with a high unmet need. It can be more difficult to treat because it is not sensitive to hormone therapy or medicines that target HER2.
TECENTRIQ® is a registered trademark of Genentech, a member of the Roche Group.
About ABRAXANE in Pancreatic Cancer
In September 2013, the U.S. Food and Drug Administration (FDA) approved ABRAXANE in combination with gemcitabine as first-line treatment of patients with metastatic pancreatic cancer. The current indication remains unchanged and clinical trials continue building on the foundation of ABRAXANE in combination with gemcitabine for a new wave of potential treatments, such as an ongoing Phase 2 cooperative group trial with SWOG S1505 (ClinicalTrials.gov, NCT02562716) investigating the safety and effectiveness of ABRAXANE in combination with gemcitabine as neoadjuvant treatment for localized pancreatic head adenocarcinoma.
ABRAXANE is not approved for the adjuvant treatment of pancreatic cancer.
About ABRAXANE
Indications
ABRAXANE is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non–small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
ABRAXANE is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com.
SOURCE: Celgene
Post Views: 36
