GSK to present new data in oncology pipeline and portfolio at ESMO Congress 2021
GlaxoSmithKline (GSK) plc will present new data across the company’s oncology pipeline and portfolio at the upcoming European Society for Medical Oncology (ESMO) Congress 2021 (16-21 September), including new data on Jemperli (dostarlimab) and Zejula (niraparib), as well as early-stage research in immuno-oncology and oncology cell therapy. With 13 presentations at the meeting (12 GSK-sponsored and one GSK-supported), GSK will demonstrate its momentum in advancing dostarlimab and niraparib, and provide new insights into investigational therapies through early-stage research.
The data being presented at ESMO reflect GSK’s commitment to strengthening its oncology pipeline across its focus areas of immuno-oncology, synthetic lethality and oncology cell therapy. GSK has a diverse portfolio and pipeline, including three marketed oncology medicines and 16 assets in clinical development that leverage the science of the immune system, human genetics and advanced technologies to address a variety of tumour types.
Presentations from the phase I GARNET study will address anti-tumour activity by tumour mutational burden in patients with recurrent or advanced endometrial cancer (Abstract #76P) in addition to treatment-related adverse events occurring during the study (Abstract #991P). GSK will also present a real-world analysis of the demographics and survival outcomes in patients from England with advanced or recurrent endometrial cancer following platinum-based doublet therapies (Abstract #812P).
Dostarlimab is the first anti-PD-1 monotherapy approved for endometrial cancer in the European Union (EU) and received a conditional approval in April for the treatment of women with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. The treatment also received accelerated approval in the United States (US) for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, who have progressed on or following prior treatment with a platinum-containing regimen.
Last month, the FDA granted accelerated approval of an additional indication for dostarlimab for the treatment of adult patients with dMMR recurrent or advanced solid tumours, as determined by an FDA-approved test, who have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The new indication for dostarlimab is the fourth approval for GSK oncology in less than 1.5 years, demonstrating GSK’s unyielding commitment to address the unmet needs of cancer patients.
Results from the phase III PRIMA trial will examine quality-adjusted time without symptom or toxicity of niraparib in patients with advanced ovarian cancer (Abstract #738P). Additionally, GSK will present real-world analyses from three studies in patients with advanced ovarian cancer across the UK, France and US.
Niraparib is a once-daily oral monotherapy maintenance treatment approved for women with first-line platinum-responsive advanced ovarian cancer regardless of biomarker status in the US and the EU. The research that will be presented at ESMO bolsters the understanding of the use of this poly (ADP-ribose) polymerase (PARP) inhibitor for maintenance treatment in ovarian cancer.
GSK will also present a trial in progress poster on the recently initiated phase III ZEAL-1L study in advanced or metastatic non-small cell lung cancer, expanding the company’s clinical development programme into other solid tumours to potentially bring niraparib to more patients.
Dostarlimab is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2. In addition to GARNET, dostarlimab is being investigated in other registrational enabling studies, as monotherapy and as part of combination regimens, including in women with recurrent or primary advanced endometrial cancer, women with stage III or IV non-mucinous epithelial ovarian cancer, and in patients with other advanced solid tumours or metastatic cancers.
Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. The collaboration has resulted in three monospecific antibody therapies that have progressed into the clinic. These are: dostarlimab, a PD-1 antagonist; cobolimab, (GSK4069889), a TIM-3 antagonist; and GSK4074386, a LAG-3 antagonist. GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of each of these Products under the Agreement.
Jemperli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies.
Zejula is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
Source:http://pharmabiz.com/NewsDetails.aspx?aid=142439&sid=2
The data being presented at ESMO reflect GSK’s commitment to strengthening its oncology pipeline across its focus areas of immuno-oncology, synthetic lethality and oncology cell therapy. GSK has a diverse portfolio and pipeline, including three marketed oncology medicines and 16 assets in clinical development that leverage the science of the immune system, human genetics and advanced technologies to address a variety of tumour types.
Presentations from the phase I GARNET study will address anti-tumour activity by tumour mutational burden in patients with recurrent or advanced endometrial cancer (Abstract #76P) in addition to treatment-related adverse events occurring during the study (Abstract #991P). GSK will also present a real-world analysis of the demographics and survival outcomes in patients from England with advanced or recurrent endometrial cancer following platinum-based doublet therapies (Abstract #812P).
Dostarlimab is the first anti-PD-1 monotherapy approved for endometrial cancer in the European Union (EU) and received a conditional approval in April for the treatment of women with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. The treatment also received accelerated approval in the United States (US) for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, who have progressed on or following prior treatment with a platinum-containing regimen.
Last month, the FDA granted accelerated approval of an additional indication for dostarlimab for the treatment of adult patients with dMMR recurrent or advanced solid tumours, as determined by an FDA-approved test, who have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The new indication for dostarlimab is the fourth approval for GSK oncology in less than 1.5 years, demonstrating GSK’s unyielding commitment to address the unmet needs of cancer patients.
Results from the phase III PRIMA trial will examine quality-adjusted time without symptom or toxicity of niraparib in patients with advanced ovarian cancer (Abstract #738P). Additionally, GSK will present real-world analyses from three studies in patients with advanced ovarian cancer across the UK, France and US.
Niraparib is a once-daily oral monotherapy maintenance treatment approved for women with first-line platinum-responsive advanced ovarian cancer regardless of biomarker status in the US and the EU. The research that will be presented at ESMO bolsters the understanding of the use of this poly (ADP-ribose) polymerase (PARP) inhibitor for maintenance treatment in ovarian cancer.
GSK will also present a trial in progress poster on the recently initiated phase III ZEAL-1L study in advanced or metastatic non-small cell lung cancer, expanding the company’s clinical development programme into other solid tumours to potentially bring niraparib to more patients.
Dostarlimab is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2. In addition to GARNET, dostarlimab is being investigated in other registrational enabling studies, as monotherapy and as part of combination regimens, including in women with recurrent or primary advanced endometrial cancer, women with stage III or IV non-mucinous epithelial ovarian cancer, and in patients with other advanced solid tumours or metastatic cancers.
Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. The collaboration has resulted in three monospecific antibody therapies that have progressed into the clinic. These are: dostarlimab, a PD-1 antagonist; cobolimab, (GSK4069889), a TIM-3 antagonist; and GSK4074386, a LAG-3 antagonist. GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of each of these Products under the Agreement.
Jemperli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies.
Zejula is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
Source:http://pharmabiz.com/NewsDetails.aspx?aid=142439&sid=2
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