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Research & Development
Genentech to Present New Positive Data from Its Broad Cancer Immunotherapy Programme
10 October 2018 - - US-based biotechnology company Genentech will present new results from a number of studies across its oncology portfolio of approved and investigational medicines at the European Society for Medical Oncology 2018 Congress, taking place from October 19-23 in Munich, Germany, the company said.
Genentech is a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY).
These data include positive Phase III results from Genentech's cancer immunotherapy development program across multiple tumor types, positive Alecensa (alectinib) data from the Phase III ALESIA study and new pivotal data for entrectinib, a tumor-agnostic investigational medicine that targets NTRK gene fusion-positive solid tumors.
Primary results will be presented from the positive, Phase III, randomized IMpassion130 study investigating Tecentriq plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) as an initial (first-line) treatment for people with unresectable locally advanced or metastatic triple-negative breast cancer, an aggressive type of the disease, which currently has limited treatment options.
As reported earlier this year by Genentech, the combination of Tecentriq plus chemotherapy (nab-paclitaxel) significantly reduced the risk of disease worsening or death (progression-free survival, PFS) in the intention-to-treat and the PD-L1-positive populations, and showed an encouraging overall survival improvement at this interim analysis in people whose disease expresses the PD-L1 protein, a subgroup determined by PD-L1 biomarker testing.
Pivotal data from the positive Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA trials will be presented on entrectinib (RXDX-101) for the treatment of people with NTRK gene fusion-positive solid tumors.
Molecular profiling and next-generation sequencing will play a critical role in identifying people most likely to benefit from entrectinib.
Genentech is combining comprehensive genomic profiling with precision medicines, like entrectinib, in order to offer patients more personalized healthcare solutions.
Entrectinib has been granted Breakthrough Therapy Designation by the US Food and Drug Administration for the treatment of NTRK gene fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or have no acceptable standard therapies.
Key data to be presented at ESMO cover advances from Genentech's lung cancer program, including a combination approach using the cancer immunotherapy Tecentriq with targeted therapies and a range of different chemotherapies.
OS and PFS data will be presented for the first time from the positive Phase III IMpower130 study, a multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and nab-paclitaxel) versus chemotherapy (carboplatin and nab-paclitaxel) alone for advanced non-squamous non-small cell lung cancer (NSCLC).
PFS data will also be presented for the first time from the positive Phase III ALESIA study, a randomized, multicenter, open-label study evaluating the efficacy and safety of Alecensa versus crizotinib in Asian patients with treatment-naive anaplastic lymphoma kinase -positive advanced NSCLC.
Updated data will be presented from a Phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin (bevacizumab) as treatment for patients with unresectable or advanced hepatocellular carcinoma. HCC is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide.
Earlier this summer the FDA granted BTD for Tecentriq in combination with Avastin as an initial (first-line) treatment for people with advanced or metastatic HCC. Data at ESMO include longer follow-up and data from patients with hepatitis B virus, a major driver of the disease.
Neurotrophic tyrosine receptor kinase fusion-positive cancer occurs when the NTRK1/2/3 genes fuse with other genes, resulting in altered TRK proteins (TrKA/TrKB/TrKC) that can activate signaling pathways involved in proliferation of certain types of cancer.
NTRK gene fusions are tumor-agnostic, meaning they are present in tumors irrespective of site of origin. These fusions have been identified in a broad range of solid tumor types, including lung, head and neck, salivary, pancreatic, breast and thyroid.
There is a high unmet medical need for treatments for people with life-threatening and hard-to-treat NTRK fusion-positive tumors.
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
Genentech is a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY).
These data include positive Phase III results from Genentech's cancer immunotherapy development program across multiple tumor types, positive Alecensa (alectinib) data from the Phase III ALESIA study and new pivotal data for entrectinib, a tumor-agnostic investigational medicine that targets NTRK gene fusion-positive solid tumors.
Primary results will be presented from the positive, Phase III, randomized IMpassion130 study investigating Tecentriq plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) as an initial (first-line) treatment for people with unresectable locally advanced or metastatic triple-negative breast cancer, an aggressive type of the disease, which currently has limited treatment options.
As reported earlier this year by Genentech, the combination of Tecentriq plus chemotherapy (nab-paclitaxel) significantly reduced the risk of disease worsening or death (progression-free survival, PFS) in the intention-to-treat and the PD-L1-positive populations, and showed an encouraging overall survival improvement at this interim analysis in people whose disease expresses the PD-L1 protein, a subgroup determined by PD-L1 biomarker testing.
Pivotal data from the positive Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA trials will be presented on entrectinib (RXDX-101) for the treatment of people with NTRK gene fusion-positive solid tumors.
Molecular profiling and next-generation sequencing will play a critical role in identifying people most likely to benefit from entrectinib.
Genentech is combining comprehensive genomic profiling with precision medicines, like entrectinib, in order to offer patients more personalized healthcare solutions.
Entrectinib has been granted Breakthrough Therapy Designation by the US Food and Drug Administration for the treatment of NTRK gene fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or have no acceptable standard therapies.
Key data to be presented at ESMO cover advances from Genentech's lung cancer program, including a combination approach using the cancer immunotherapy Tecentriq with targeted therapies and a range of different chemotherapies.
OS and PFS data will be presented for the first time from the positive Phase III IMpower130 study, a multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and nab-paclitaxel) versus chemotherapy (carboplatin and nab-paclitaxel) alone for advanced non-squamous non-small cell lung cancer (NSCLC).
PFS data will also be presented for the first time from the positive Phase III ALESIA study, a randomized, multicenter, open-label study evaluating the efficacy and safety of Alecensa versus crizotinib in Asian patients with treatment-naive anaplastic lymphoma kinase -positive advanced NSCLC.
Updated data will be presented from a Phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin (bevacizumab) as treatment for patients with unresectable or advanced hepatocellular carcinoma. HCC is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide.
Earlier this summer the FDA granted BTD for Tecentriq in combination with Avastin as an initial (first-line) treatment for people with advanced or metastatic HCC. Data at ESMO include longer follow-up and data from patients with hepatitis B virus, a major driver of the disease.
Neurotrophic tyrosine receptor kinase fusion-positive cancer occurs when the NTRK1/2/3 genes fuse with other genes, resulting in altered TRK proteins (TrKA/TrKB/TrKC) that can activate signaling pathways involved in proliferation of certain types of cancer.
NTRK gene fusions are tumor-agnostic, meaning they are present in tumors irrespective of site of origin. These fusions have been identified in a broad range of solid tumor types, including lung, head and neck, salivary, pancreatic, breast and thyroid.
There is a high unmet medical need for treatments for people with life-threatening and hard-to-treat NTRK fusion-positive tumors.
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
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