On September 1, 2022 GSK plc (LSE/NYSE: GSK) reported that it will present new findings from across its diverse oncology portfolio and pipeline at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 (9-13 September), including presentations on Zejula (niraparib) and Jemperli (dostarlimab), as well as early-stage research in immuno-oncology and real-world evidence assessing treatment patterns and outcomes (Press release, GlaxoSmithKline, SEP 1, 2022, View Source [SID1234618863]). The research being presented will further demonstrate the potential of GSK’s approved therapies and commitment to exploring new approaches that target key pathways and maximise anti-tumour activity.
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Hesham Abdullah, SVP, Global Head of Oncology Development, GSK said: "The long-term data we are presenting at ESMO (Free ESMO Whitepaper) further our understanding of the role of Zejula and Jemperli to treat certain ovarian and endometrial cancers, highlighting our commitment to gynaecological cancers, and will provide the oncology community with deeper insights to inform treatment decisions and help optimise outcomes for patients. We look forward to presenting research that continues to explore the full potential of our approved and investigational therapies, as we seek to improve outcomes for more patients."
Transforming the lives of patients with gynaecologic malignancies
A long-term, ad-hoc analysis from the phase III PRIMA (ENGOT-OV26/GOG-3012) study evaluating niraparib as a maintenance monotherapy in patients with first-line ovarian cancer following a response to platinum-based chemotherapy (presentation #530P) will reinforce the role of this poly (ADP-ribose) polymerase (PARP) inhibitor for this difficult-to-treat cancer.
Long-term data in mismatch repair-deficient solid tumours
Updated results from the GARNET trial will further demonstrate the potential of dostarlimab, a programmed cell death receptor-1 (PD-1) blocking antibody, in the treatment of advanced solid tumours. This includes a longer-term analysis from cohorts A1 and F of the study, evaluating overall survival (OS) and progression-free survival (PFS) in certain patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours (presentation #549P), showcasing our commitment across tumour types.
Understanding real-world outcomes to advance patient care
GSK will also present a real-world analysis of patients with dMMR/microsatellite instability-high (MSI-H) endometrial cancer who received early access to dostarlimab via the temporary authorisation for use (ATU) programme in France, highlighting the need for patient access to new treatment regimens (presentation #553P).
Findings also will be presented from primary and secondary research demonstrating the variation in perspectives of regulators, payors, oncologists, and patients on non-OS or surrogate endpoints, and potential strategies to bridge gaps in value attribution (presentation #1317MO).
Full list of GSK’s presentations at ESMO (Free ESMO Whitepaper):
Zejula
Abstract Name
Presenter
Presentation Details
PRIMA/ENGOT-OV26/GOG-3012 study: updated long-term PFS and safety
A. González-Martín
#530P
Phase 1b study of elimusertib (ATRi; BAY 1895344) in combination with niraparib (PARPi) in patients with advanced solid tumors
T. Yap
#494TiP
Jemperli
Abstract Name
Presenter
Presentation Details
Efficacy of dostarlimab in endometrial cancer (EC) by molecular subtype: a post hoc analysis of the GARNET study
A. Oaknin
#547P
Progression-free survival (PFS) and overall survival (OS) in advanced/recurrent (AR) mismatch repair deficient/microsatellite instability–high or proficient/stable (dMMR/MSI-H or MMRp/MSS) endometrial cancer (EC) treated with dostarlimab in the GARNET study
A. Tinker
#548P
Progression-free survival (PFS) and overall survival (OS) in patients (pts) with mismatch repair deficient (dMMR) solid tumors treated with dostarlimab in the GARNET study
T. Andre
#549P
Real-world data on dostarlimab in post-platinum mismatch repair deficient (dMMR)/ microsatellite instability high (MSI-H) advanced/recurrent (A/R) endometrial cancer: descriptive analysis of the French cohort Temporary Authorization of Use (ATU)
M. Rodrigues
#553P
Pipeline
Abstract Name
Presenter
Presentation Details
METEOR-1: A phase 1 study of the safety and efficacy of the protein arginine methyltransferase 5 (PRMT5) inhibitor GSK3326595 in advanced solid tumors
S. Postel-Vinay
#456MO
Phase 2 study of anti-TIGIT GSK4428859A (GSK’859A)/EOS-448 + anti-CD96 GSK6097608 (GSK’608) + anti–PD-1 dostarlimab in non-small cell lung cancer (NSCLC)
D. Spigel
#1189TiP
Real-world outcomes
Abstract Name
Presenter
Presentation Details
Non-OS endpoints in oncology: strategies to bridge the gap in value attribution by regulators, payors, oncologists, and patients
A. Fameli
#1317MO
Frequency and impact of retreatment in relapsed refractory multiple myeloma (RRMM): Real-world survey conducted in 5 European countries (United Kingdom, France, Germany, Italy, Spain)
A. Bailey
#642P
Treatment patterns, outcomes, and physician decision-making in multiple myeloma: a real-world European study
A. Ribbands
#644P
Full list of investigator-sponsored studies and supported collaborative studies at ESMO (Free ESMO Whitepaper):
Zejula
Abstract Name
Presenter
Presentation Details
NIRVANA-1: A multicentre randomized study comparing carboplatin-paclitaxel (CP) followed by niraparib (nira) to CP–bevacizumab (bev) followed by nira-bev in patients with FIGO Stage III ovarian high-grade epithelial cancer and no residual disease after upfront surgery
G. Freyer
#615TiP
Lete-cel
Abstract Name
Presenter
Presentation Details
Prevalence and clinical characteristics of metastatic synovial sarcoma (mSS) patients with tumours expressing NY-ESO-1 antigen (NY+) and who are HLA-A*02:01, *02:05 or *02:06 allele positive (HLA+): Cohort study from the French Sarcoma Group
A. Dufresne
#1503P
About ovarian cancer
Ovarian cancer is the 8th most common cancer in women worldwide.[1]Despite high response rates to platinum-based chemotherapy in the front-line setting, approximately 85% of patients will experience disease recurrence.[2] Once the disease recurs, it is rarely curable, with decreasing time intervals to each subsequent recurrence.
About endometrial cancer
Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. It is the most common gynaecologic cancer in the US and second most common gynaecologic cancer globally.[3] Approximately 15-20% of women with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.[4]
About multiple myeloma
Multiple myeloma is the third most common form of blood cancer in the US.[5] An estimated 35,000 Americans are diagnosed with the disease annually and nearly half (13,000 people) will die from it.[6] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[7]
About dostarlimab
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.[8]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 (GSK4057190), 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 assets under the Agreement.
Important Information for JEMPERLI in the EU
Indication
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.
Refer to the JEMPERLI Prescribing Information for a full list of adverse events and the complete important safety information in the EU.
About niraparib
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.
Important Information for ZEJULA in the EU
Indication
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.
Refer to the ZEJULA Prescribing Information for a full list of adverse events and the complete important safety information in the EU.
GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, tumour cell targeting therapies 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.