HAMPTON, NJ, USA I August 23, 2017 I Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that patient enrollment has been completed in the Company’s Phase 2b METRIC study of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB. Glembatumumab vedotin is an antibody-drug conjugate that targets and binds to gpNMB, a protein expressed by multiple tumor types, including breast cancer. Overexpression of gpNMB has been shown to promote the migration, invasion and metastasis of the disease. It is highly expressed in triple negative breast cancers, where it is associated with increased risk of recurrence and poor clinical outcome.
“We are extremely grateful to the METRIC investigators and the patients and families who supported this trial,” said Anthony Marucci, Co-Founder, President and Chief Executive Officer of Celldex Therapeutics. “Patients with triple negative breast cancer have very limited treatment options. We believe glemba holds significant promise as a potential new targeted treatment for patients with this devastating disease and look forward to topline data, likely in the second quarter of 2018.”
The METRIC study is a randomized Phase 2b study of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB. In this indication, overexpression is defined as greater than or equal to 25% of tumor cells testing positive for gpNMB. Patients are randomized 2 to 1 to either glembatumumab vedotin or to capecitabine, also known by the tradename Xeloda®, as a comparator. In total, 327 patients were enrolled into METRIC. The primary endpoint of the study is progression-free survival (PFS), which is defined as the time from randomization to the earlier of disease progression or death due to any cause. The study calls for 203 progression events for evaluation of the primary endpoint, which will be assessed based on an independent, central reading of patient scans. The sum of the data, including the secondary endpoints of response rate, overall survival, duration of response and safety, will be important in assessing clinical benefit. The Company projects that topline primary endpoint data should be available in the second quarter of 2018, but it could occur earlier or later based on the rate of events in the study.
Xeloda® is a registered trademark of Genentech, Inc.
About Glembatumumab Vedotin
Glembatumumab vedotin is a fully human monoclonal antibody-drug conjugate (ADC) that targets glycoprotein NMB (gpNMB). gpNMB is a protein overexpressed by multiple tumor types, including breast cancer, melanoma, lung cancer, uveal melanoma and osteosarcoma. gpNMB has been shown to be associated with the ability of the cancer cell to invade and metastasize and to correlate with reduced time to progression and survival in breast cancer. The gpNMB-targeting antibody, CR011, is linked to a potent cytotoxic, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. Glembatumumab vedotin is designed to be stable in the bloodstream but to release MMAE upon internalization into gpNMB-expressing tumor cells, resulting in a targeted cell-killing effect. Glembatumumab vedotin is in development for the treatment of locally advanced or metastatic breast cancer with an initial focus in triple negative disease, stage III and IV melanoma, squamous cell lung cancer and uveal melanoma.
About Celldex Therapeutics, Inc.
Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline includes antibodies, antibody-drug conjugates and other protein-based therapeutics derived from a broad set of complementary technologies which have the ability to engage the human immune system and/or directly inhibit tumors to treat specific types of cancer or other diseases. Visit www.celldex.com.
SOURCE: Celldex Therapeutics
Post Views: 187
HAMPTON, NJ, USA I August 23, 2017 I Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that patient enrollment has been completed in the Company’s Phase 2b METRIC study of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB. Glembatumumab vedotin is an antibody-drug conjugate that targets and binds to gpNMB, a protein expressed by multiple tumor types, including breast cancer. Overexpression of gpNMB has been shown to promote the migration, invasion and metastasis of the disease. It is highly expressed in triple negative breast cancers, where it is associated with increased risk of recurrence and poor clinical outcome.
“We are extremely grateful to the METRIC investigators and the patients and families who supported this trial,” said Anthony Marucci, Co-Founder, President and Chief Executive Officer of Celldex Therapeutics. “Patients with triple negative breast cancer have very limited treatment options. We believe glemba holds significant promise as a potential new targeted treatment for patients with this devastating disease and look forward to topline data, likely in the second quarter of 2018.”
The METRIC study is a randomized Phase 2b study of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB. In this indication, overexpression is defined as greater than or equal to 25% of tumor cells testing positive for gpNMB. Patients are randomized 2 to 1 to either glembatumumab vedotin or to capecitabine, also known by the tradename Xeloda®, as a comparator. In total, 327 patients were enrolled into METRIC. The primary endpoint of the study is progression-free survival (PFS), which is defined as the time from randomization to the earlier of disease progression or death due to any cause. The study calls for 203 progression events for evaluation of the primary endpoint, which will be assessed based on an independent, central reading of patient scans. The sum of the data, including the secondary endpoints of response rate, overall survival, duration of response and safety, will be important in assessing clinical benefit. The Company projects that topline primary endpoint data should be available in the second quarter of 2018, but it could occur earlier or later based on the rate of events in the study.
Xeloda® is a registered trademark of Genentech, Inc.
About Glembatumumab Vedotin
Glembatumumab vedotin is a fully human monoclonal antibody-drug conjugate (ADC) that targets glycoprotein NMB (gpNMB). gpNMB is a protein overexpressed by multiple tumor types, including breast cancer, melanoma, lung cancer, uveal melanoma and osteosarcoma. gpNMB has been shown to be associated with the ability of the cancer cell to invade and metastasize and to correlate with reduced time to progression and survival in breast cancer. The gpNMB-targeting antibody, CR011, is linked to a potent cytotoxic, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. Glembatumumab vedotin is designed to be stable in the bloodstream but to release MMAE upon internalization into gpNMB-expressing tumor cells, resulting in a targeted cell-killing effect. Glembatumumab vedotin is in development for the treatment of locally advanced or metastatic breast cancer with an initial focus in triple negative disease, stage III and IV melanoma, squamous cell lung cancer and uveal melanoma.
About Celldex Therapeutics, Inc.
Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline includes antibodies, antibody-drug conjugates and other protein-based therapeutics derived from a broad set of complementary technologies which have the ability to engage the human immune system and/or directly inhibit tumors to treat specific types of cancer or other diseases. Visit www.celldex.com.
SOURCE: Celldex Therapeutics
Post Views: 187
