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(Alliance News) - Pharmaceutical major GlaxoSmithKline PLC on Saturday reported positive results from its phase 3 Prima trial of Zejula in ovarian cancer.
This was the first study to show that a PARP inhibitor significantly improved progression-free survival in patients "with first-line platinum responsive advanced ovarian cancer" "regardless of biomarker status".
PARP is an enzyme in cells that helps to repair damaged DNA, and so inhibiting this enzyme prevents cancer cells from repairing themselves.
Both patients with homologous recombination deficiency - a genetic factor which causes ovarian cells to have difficulty repairing themselves - and without the deficiency "experienced a clinically meaningful and statistically significant benefit".
The drug resulted in a 38% drop in the risk of disease progression or death in the overall study population by 38%. Of those patients with homologous recombination deficiency, the risk of progression was reduced by 50%, versus 32% in those without the deficiency.
Hal Barron, chief scientific officer & president of Research & Development at Glaxo said: "Ovarian cancer is the eighth most commonly occurring cancer in women worldwide and women with this devastating disease have a five-year survival rate of less than 50%. Prima is a landmark study as we believe these data have the potential to fundamentally change how women with ovarian cancer are treated."
Also on Saturday, Glaxo posted positive new data from its Induce-1 study of GSK3359609 in combination with the drug pembrolizumab in patients with head and neck squamous cell carcinoma.
The drug "showed promising anti-tumour activity", combined with pembrolizumab, in this type of cancer for patients who were "PD-1/L1 naive". This means they had not previously been treated with a drug that targets the protein PD-1/L1, a protein which helps cancer cells to evade the immune system.
GSK3359609 is an inducible T cell co-stimulatory agonist antibody, which is intended to "enhance T cell function". T cells are a type of immune cell and enhancing their function could help the immune system to better fight cancer.
Axel Hoos, senior vice president & head of Oncology Research & Development at Glaxo, commented: "Immunotherapies such as GSK3359609 are a critical part of our oncology pipeline and we are encouraged by the INDUCE-1 data demonstrating the potential of this agent to enhance anti-tumour activity beyond what PD-1 blockade alone has demonstrated.
"The clinical responses observed are encouraging and, based on precedent with CTLA-4 or PD-1, we aim to demonstrate the main effect of our ICOS agonist to be on improving survival for patients, which requires further study. Based on these results, we are initiating the INDUCE-3 registrational trial to investigate the potential survival benefit of GSK3359609 with pembrolizumab in first-line recurrent/metastatic HNSCC for patients who are PD-L1 positive."
Shares in Glaxo were up 1.2% at 1,745.36 pence in London on Monday morning.
By Anna Farley; annafarley@alliancenews.com
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