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EC approves GSK’s Zejula as first-line monotherapy maintenance treatment in advanced ovarian cancer

London, UK
Saturday, October 31, 2020, 10:00 Hrs  [IST]

GlaxoSmithKline (GSK) announced the European Commission (EC) has approved Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as first-line monotherapy maintenance treatment for adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response following platinum-based chemotherapy. This approval makes Zejula the only PARP inhibitor approved in the European Union for use as a monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.

Dr Hal Barron, chief scientific officer and president R&D, GSK, said: “Over 65,000 women in Europe are diagnosed with ovarian cancer each year. This approval of Zejula means that many more women will have the option to receive this innovative medicine earlier, potentially extending the time they may spend without their devastating cancer progressing.”

In April 2020, the US Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for Zejula in the United States for the same indication, which is supported by data from the pivotal phase 3 PRIMA study that demonstrated a clinically meaningful progression-free survival benefit of Zejula in the first-line maintenance setting. The PRIMA study enrolled patients with newly diagnosed advanced ovarian cancer who responded to first-line treatment with platinum-based chemotherapy, a population with high unmet needs and limited treatment options.

Dr Antonio Gonzalez-Martin, co-director, Department of Medical Oncology, Clinica Universidad de Navarra, Spain, and Primary Investigator for PRIMA, said: “Until now, only women with BRCA-mutant (BRCAm) ovarian cancer, representing just 20% of patients with advanced ovarian cancer, were eligible to be treated with a PARP inhibitor as monotherapy in the first-line maintenance setting. Expanding the potential use of Zejula, regardless of biomarker status, is an important step forward in treating this challenging cancer.”

The primary endpoint in the PRIMA study was progression free survival analysed sequentially, first in the homologous recombination deficient (HRd) population, then in the overall population. The PRIMA study significantly improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd population, Zejula resulted in a 57% reduction in the risk of disease progression or death vs. placebo (HR 0.43; 95% CI, 0.31 to 0.59; p<0.0001) and a 38% reduction in the risk of disease progression or death vs. placebo in the overall population (HR 0.62; 95% CI, 0.50 to 0.76; p<0.001). In addition, there was a 60% reduction in risk of progression in those with BRCA mutation tumours (HR 0.40; 95% CI, 0.27 to 0.62; p<0.001).

Zejula’s safety profile, as demonstrated by the PRIMA results, was consistent with the previously observed clinical safety profile. At initiation of the PRIMA study, patients received a fixed starting dose of 300 mg of Zejula once-daily. The study was later amended to incorporate an individualised starting dose of either 200 mg or 300 mg of Zejula once-daily based on the patient’s baseline weight and/or platelet count. Lower rates of grade 3 and 4 haematologic treatment-emergent adverse events were observed with an individualised starting dose, compared to the overall population, including thrombocytopenia (21% compared to 39%), anaemia (23% compared to 31%) and neutropenia (15% compared to 21%).

Based on these results, the Zejula EU prescribing information has been updated to include the individualised starting dose once-daily based on the patient’s baseline weight and/or platelet count.

Clara MacKay, chief executive officer, World Ovarian Cancer Coalition, said: “Having a new first-line maintenance option for patients with platinum-responsive advanced ovarian cancer in Europe — regardless of BRCA mutation status — speaks to the important role of PARP inhibitors in the fight against ovarian cancer. We are especially delighted that today's approval means that more women in Europe who are diagnosed with ovarian cancer will have this new treatment option. We appreciate the commitment and scientific leadership required to develop innovative new therapies that address unmet needs in women’s cancer.”

In Europe, ovarian cancer is the sixth deadliest cancer among women and more than 65,000 women are diagnosed each year. Despite high response rates to platinum-based chemotherapy in the first-line, approximately 85% of women with advanced ovarian cancer will see their disease return. With each recurrence, the time a woman may spend without her cancer progressing gets shorter.

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.


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