GlaxoSmithKline plc GSK presented positive detailed data from the phase III PRIMA study evaluating its PARP inhibitor, Zejula (niraparib), as monotherapy for maintenance therapy of women with first-line ovarian cancer who have received platinum-based chemotherapy. Data demonstrated that Zejula, when given as monotherapy, significantly reduced the risk of disease progression or death by 38%, irrespective of biomarker status.
The company had announced in July that the PRIMA study met its primary endpoint of progression free survival (“PFS”). Detailed data from the study were presented at the 2019 European Society for Medical Oncology (“ESMO”) congress.
Zejula is currently approved as a maintenance treatment for patients with recurrent ovarian cancer.
Shares of Glaxo have rallied 10.8% so far this year against the industry’s decrease of 0.6%.
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The PRIMA study evaluated Zejula monotherapy in women who responded to first-line treatment with platinum-based chemotherapy including those with high risk of disease progression. Data from the study showed that risk of disease progression was reduced by 60%, 50% and 32% in patients with BRCA-mutant tumors, HRD-positive BRCA wild type tumors and HRD-negative tumors, respectively.
Glaxo claims that Zejula is the first PARP inhibitor to achieve significant improvement in PFS as monotherapy in first-line maintenance setting for ovarian cancer.
Moreover, a pre-planned interim analysis of overall survival (“OS”) showed that OS was numerically favorable for Zejula compared to placebo in overall population. Interim OS showed that 91% of patients were alive at 24 months compared to 85% for placebo in HRD-positive ovarian cancer patient group, while 81% of HRD-negative patients were alive at 24 months versus 59% for placebo.
Notably, Zejula was added to Glaxo’s portfolio, following the acquisition of Tesaro in January this year. The drug generated sales of £99 million in the first half of 2019.
Apart from the PRIMA study, Zejula is being evaluated in the pivotal phase III BRAVO study to treat patients with germline BRCA-mutated, metastatic breast cancer. The drug is also being examined in several combination studies. Zejula in combination with Merck’s MRK anti-PD-1 inhibitor, Keytruda (pembrolizumab) is being studied for treating metastatic triple-negative breast cancer and advanced platinum-resistant ovarian cancer. Moreover, Zejula plus Roche’s RHHBY Avastin (bevacizumab) is being studied in patients with recurrent, platinum-sensitive ovarian cancer.
In June, the FDA granted priority review to Glaxo’s supplemental new drug application (sNDA), looking to expand Zejula’s label for treating ovarian cancer in patients who have received three or more chemotherapy regimens. The FDA is expected to make a decision on Oct 24, 2019.
Meanwhile, AstraZeneca AZN also presented encouraging data at ESMO from a phase III study evaluating its PARP inhibitor, Lynparza, in combination with Roche’s Avastin as first-line maintenance treatment for newly-diagnosed advanced ovarian cancer, irrespective of biomarker status or outcome from previous surgery. Data from the study showed that the combination regimen reduced the risk of disease progression or death by 41%. AstraZeneca develops Lynparza in collaboration with Merck. The drug is already approved in the first-line maintenance setting for ovarian cancer patients who have responded to platinum-based chemotherapy.
Zacks Rank
Glaxo currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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