GSK highlights new data in non-small cell lung cancer and endometrial cancer at the European Society for Medical Oncology (ESMO) Congress 2023, reinforcing potential of[...]

GSK plc will present data at the ESMO Congress 2023 (20-24 October) focusing on Jemperli (dostarlimab) and Zejula (niraparib) that further demonstrate advancements in immuno-oncology and gynaecologic cancers and improving patient outcomes.

Advancing research for patients with NSCLC

GSK will share updates from the PERLA trial evaluating dostarlimab plus chemotherapy versus pembrolizumab plus chemotherapy in the first-line treatment of metastatic non-squamous NSCLC. Expanding upon the primary data presentedat the ESMO Immuno-Oncology Congress 2022, late-breaking results at ESMO 2023 (LBA64) will highlight a positive numerical trend in OS outcomes, favouring dostarlimab plus chemotherapy vs. pembrolizumab plus chemotherapy. The PERLA phase II trial is a randomised, double-blind trial of 243 patients and is the largest global head-to-head trial of programmed death receptor-1 (PD-1) inhibitors in this patient population.

In the PERLA trial, the median OS for patients receiving dostarlimab plus chemotherapy was 19.4 months (95% CI: 14.5-NR) versus 15.9 months (95% CI: 11.6-19.3) for patients receiving pembrolizumab plus chemotherapy, after a median follow-up of 20.7 months (17.3-24.0) and 21.6 months (18.3-24.1), respectively (HR: 0.75: [95% CI: 0.53-1.05]). An additional analysis with greater OS maturity is planned and will be reported at a later date. Safety profiles in this secondary analysis were similar and consistent with those previously reported in the primary analysis for the PERLA trial.

Data from PERLA supports the company's ambition for dostarlimab to become its backbone immuno-oncology therapy when used alone and in combination with standard of care and future novel cancer therapies.

Updates from the RUBY clinical trial

GSK will also present updates from Part 1 of the phase III RUBY clinical trial evaluating dostarlimab in combination with chemotherapy compared to standard of care chemotherapy in patients with primary advanced or recurrent endometrial cancer. During a mini oral presentation (740MO), results from an exploratory analysis of the RUBY trial will show the effect of dostarlimab plus chemotherapy on PFS and OS across molecular classifications initially defined by The Cancer Genome Atlas, including mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H), no specific molecular profile (NSMP) and tumour protein 53 aberrant (TP53mut) subgroups.

In the analysis, PFS and OS results favoured patients treated with dostarlimab plus chemotherapy in the dMMR/MSI-H, TP53mut and NSMP subgroups, with the largest benefit observed in the dMMR and TP53mut groups. This exploratory analysis will provide insights into how molecular classification may help further the understanding of which patients are most likely to derive benefit from treatment.

GSK will also present results (750P) from the RUBY trial focusing on investigator-assessed progression-free survival 2 (PFS2). PFS2 is a secondary endpoint for the trial, defined as the time from treatment randomisation to progression on the first subsequent anticancer therapy following study treatment or death by any cause. The presentation will also include OS results after adjustment for subsequent use of immuno-therapy (dostarlimab, pembrolizumab, durvalumab, nivolumab or pembrolizumab with lenvatinib). The results show PFS benefits are sustained beyond first progression and further support the OS benefits in patients treated with dostarlimab plus chemotherapy vs. chemotherapy alone despite the use of subsequent therapies.

Safety profiles in both analyses were similar and consistent with those previously reported for the RUBY trial.

Exploring real-world experience with first-line maintenance therapy in ovarian cancer

Presentation of an analysis (789P) of real-world data of patients with epithelial ovarian cancer, obtained from a national United States electronic healthcare record-derived de-identified database, will shed new light on treatment duration and causes of discontinuation among individuals receiving niraparib in the first-line maintenance setting. The analysis found that patients with epithelial ovarian cancer who are taking first-line maintenance niraparib for more than 90 days have a longer time to treatment discontinuation than all other patients in the analysis. Findings will contribute to the understanding of effective clinical management of toxicity early in the maintenance period, which may help patients stay on treatment and experience the full therapeutic benefit of niraparib.

Collaborating to improve patient care

GSK is supporting investigator-sponsored studies and fostering scientific collaborations with both experienced investigators and networks, who are involved in the continuum of care of patients living with cancer. In addition to GSK's presentations at ESMO, there will be seven additional GSK-supported investigator-sponsored study presentations.

Public link

Please use the above public link if you want to share this noodl on another website.