US-based pharmaceutical company MSD has published results from a Phase III trial of a potential combination therapy for ovarian cancer.
The KEYLYNK-001 study evaluated a treatment regimen combining Keytruda (pembrolizumab) and chemotherapy followed by maintenance with Lynparza, with or without bevacizumab, among subjects with breast cancer gene (BRCA) non-mutated advanced epithelial ovarian cancer.
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The randomised, double-blind trial’s primary endpoints focused on progression-free survival (PFS) in subjects with programmed cell death ligand 1 (PD-L1) expression.
It enrolled 1,367 subjects who received several treatment combinations, including Keytruda with Lynparza, with or without bevacizumab.
Subjects received Keytruda and chemotherapy for five cycles, after the Keytruda and Lynparza combination, or a placebo for up to nearly two years.
Analysis by an independent Data Monitoring Committee showed that the KEYTRUDA and LYNPARZA combination regimen had a notable impact on PFS.
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By GlobalDataDespite this, the study did not meet its secondary endpoint of overall survival (OS), with Keytruda’s role in the intention-to-treat population still unclear.
Both Keytruda and Lynparza’s safety profiles were consistent with prior individual therapy studies.
MSD Research Laboratories global clinical development vice-president Dr Gursel Aktan said: “For people living with ovarian cancer, there remains an unmet need for new treatment options that have the potential to improve outcomes.
“KEYLYNK-001 is the first positive Phase III trial for Keytruda plus Lynparza, highlighting our commitment to research that may help address the global impact of women’s cancers.”
In the US, Lynparza is approved for three ovarian cancer indications, all requiring a Food and Drug Administration (FDA) approved companion diagnostic.
Keytruda is a humanised monoclonal antibody designed to improve the immune system’s ability to recognise and combat malignant cells.
Last month, MSD announced that its Phase III ZENITH trial of Winrevair (sotatercept-csrk) for treating pulmonary arterial hypertension met its primary endpoint.
