GSK highlights scientific advances across its growing oncology portfolio at ESMO Virtual Congress 2020
LONDON, Sept. 15, 2020 /PRNewswire/ -- GlaxoSmithKline plc will present new data at the upcoming European Society for Medical Oncology (ESMO) Virtual Congress 2020, underscoring its commitment to advancing its growing oncology portfolio, which includes the recent European Commission (EC) and US Food and Drug Administration (FDA) approvals of BLENREP (belantamab mafodotin) for patients with relapsed/refractory multiple myeloma, and the FDA approval of a new indication in first-line ovarian cancer for ZEJULA (niraparib).
Reflecting the increasing depth and breadth of GSK's innovative research in oncology, investigators will present 13 abstracts covering a range of approved and investigational therapies, focused on science related to the immune system, the use of human genetics and other research platforms.
GSK presentations at ESMO will focus on research intended to improve outcomes for women with high unmet medical needs, including data related to the safety and efficacy of ZEJULA in patients with advanced, recurrent or resistant ovarian cancer. Investigators also will present a late-breaking presentation: "Safety and Antitumor Activity of Dostarlimab in Patients (Pts) with Advanced or Recurrent DNA Mismatch Repair Deficient (dMMR) or Proficient (MMRp) Endometrial Cancer (EC): Results from GARNET."
Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "This year we have achieved strong momentum for our oncology pipeline, with 14 assets in clinical development across four key research areas. Recent approvals for BLENREP in multiple myeloma and a new indication for ZEJULA in first-line ovarian cancer have delivered new treatment options for patients with unmet needs, and we look forward to sharing new data from our oncology pipeline at ESMO."
A list of additional presentations focused on GSK therapies at ESMO can be found below:
Patient-Reported Outcomes (PRO) in Patients (Pts) Receiving Niraparib in the PRIMA/ENGOT-OV26/GOG-3012 Trial
Efficacy and Safety of Niraparib in Older Patients (Pts) with Advanced Ovarian Cancer (OC): Results from the PRIMA/ENGOT-OV26/GOG-3012 Trial
MOONSTONE/GOG-3032: A Phase II, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Niraparib + Dostarlimab in Patients with Platinum-Resistant Ovarian Cancer
JASPER: Efficacy and Safety of First-Line (1L) Niraparib Plus a Programmed Death Receptor 1 Inhibitor (PD-1i) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Safety and Efficacy of Dostarlimab in Patients (Pts) with Recurrent/Advanced Non-Small Cell Lung Cancer (NSCLC)
Patient-Reported Outcomes (PROs) in the GARNET Trial in Patients (Pts) with Advanced or Recurrent Mismatch Repair Deficient/Microsatelite Instability-High (dMMR/MSI-H) Endometrial Cancer (EC) Treated with Dostarlimab
The Relationship Between Overall Survival (OS), Progression-Free Survival (PFS), and Objective Response Rate (ORR) in Immune Checkpoint Inhibitor Clinical Trials of Head and Neck Squamous Cell Carcinoma (HNSCC): A Systematic Review and Meta-analysis
Matching-Adjusted Indirect Comparisons (MAIC) of Safety Between Single-Agent Belantamab Mafodotin Versus Selinexor Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma (RRMM)
A Phase II/III, Randomized, Placebo-Controlled Study of Bintrafusp Alfa with Gemcitabine Plus Cisplatin as First-Line Treatment of Biliary Tract Cancer
Long-Term Follow-Up of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-? and PD-L1, in Patients with Pretreated Biliary Tract Cancer
Three-Year Follow-up of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-? and PD-L1, for Second-Line (2L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Phase 2 Study of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-? and PD-L1, in Platinum-Experienced Advanced Cervical Cancer
GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK's pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody-drug conjugates and cell therapy, either alone or in combination.
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.
Important information for BLENREP in the EU
BLENREP is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Important safety information
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Warnings and precautions: Corneal adverse reactions have been reported with BLENREP (keratopathy or microcyst-like epithelial changes in corneal epithelium with or without changes in visual acuity, blurred vision, and dry eye symptoms). Ophthalmic examinations including assessment of visual acuity and slit lamp examination, should be performed at baseline, before the subsequent 3 treatment cycles and during treatment as clinically indicated. Patients experiencing corneal adverse reactions may require dose modifications or treatment discontinuation based on severity of findings. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported with BLENREP. These should be managed promptly and treatment with BLENREP should be interrupted until the corneal ulcer has healed. Due to the risk of thrombocytopenic events, complete blood counts should be obtained at baseline and monitored during treatment. Patients on concomitant anticoagulant treatments may require more frequent monitoring and should be managed with a dose delay or reductions. If a moderate or severe infusion-related reaction occurs, interrupt infusion and provide supportive treatment. Once symptoms resolve, resume at a lower infusion rate. If anaphylactic or life-threatening infusion reaction, BLENREP should be permanently discontinued.
Undesirable effects: The most commonly-reported adverse reactions were keratopathy and thrombocytopenia. The most commonly reported serious adverse reactions were pneumonia, pyrexia and infusion related reactions.
Very common (?1/10): Pneumonia, thrombocytopenia, anaemia, lymphopenia, leukopenia, neutropenia, keratopathy, blurred vision events, dry eye, nausea, diarrhoea, pyrexia, fatigue, increased aspartate aminotransferase, increased gamma glutamyltransferase and infusion related reactions.
Common (?1/1000 to <1/10): Upper respiratory tract information, photophobia, eye irritation, vomiting and increased creatine phosphokinase.
Refer to the BLENREP Prescribing Information for a full list of adverse events and the complete important safety information.
Important Information for ZEJULA in the EU
Zejula approved indication:
Zejula is indicated as monotherapy for the maintenance treatment of adult patients with platinum–sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum–based chemotherapy.
Important Safety Information
Contraindications: Hypersensitivity to niraparib or to any of the excipients and breast-feeding.
Warnings and precautions: Test complete blood counts weekly for the first month of treatment, then monthly thereafter. If a patient develops severe persistent haematologic toxicity including pancytopenia that does not resolve within 28 days following interruption, Zejula should be discontinued. Due to the risk of thrombocytopenia, anticoagulants and medicinal products known to reduce the thrombocyte count should be used with caution. If MDS and/or AML are confirmed while being prescribed Zejula , treatment should be discontinued, and the patient treated appropriately. Hypertension, including hypertensive crisis, has been reported with the use of Zejula. Pre–existing hypertension should be adequately controlled before starting Zejula treatment. Zejula should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy. Patients with galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine. Tartrazine may cause allergic reactions. Paediatric safety and efficacy has not yet been established.
Undesirable effects: The most common serious adverse reactions were thrombocytopenia and anaemia.
Very common (?1/10): urinary tract infection, thrombocytopenia, anaemia, neutropenia, decreased appetite, insomnia, headache, dizziness, dysgeusia, palpitations, hypertension, dyspnea, cough, nasopharyngitis, nausea, constipation, vomiting, abdominal pain, diarrhoea, dyspepsia, back pain, arthralgia, fatigue, asthenia.
Common (?1/1000 to <1/10): bronchitis, conjunctivitis, leukopenia, hypokalemia, anxiety, depression, tachycardia, epistaxis, dry mouth, abdominal distension, mucosal inflammation (including mucositis), stomatitis, photosensitivity, rash, myalgia, oedema peripheral, Gamma-glutamyl transferase increased, AST increased, blood creatinine increased, ALT increased, blood alkaline phosphatase increased, weight decreased.
Refer to the Zejula Prescribing Information for a full list of adverse events and the complete important safety information.
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q2 Results and any impacts of the COVID-19 pandemic.
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