AstraZeneca
AZN
along with partner
Merck
MRK
announced additional positive data from the phase III OlympiA study, which evaluated their PAR inhibitor, Lynparza, in gremline BRCA-mutate (gBRCAm) early breast cancer.
Data from the OlympiA study demonstrated that Lynparza showed a statistically significant improvement in overall survival (OS), a key secondary endpoint, compared to placebo. In fact, the drug reduced the risk of death by 32%. The studies also demonstrated that the drug improved the three-year survival rate to 92.8% and the four-year survival rate to 89.8% compared to 89.1% and 86.4%, respectively, in patients who were administered placebo. These analyses are based on Kaplan-Meier estimates.
Per the press releases issued by AZN and MRK, Lynparza is the first and currently the only PARP inhibitor that has demonstrated such OS benefits in early breast cancer indication.
In the year so far, AstraZeneca and Merck’s shares have risen 6.4% and 1.9%, respectively. During the same period, the
industry
has increased 0.3%.
Image Source: Zacks Investment Research
We remind investors that last week, Lynparza
received
label expansion from the FDA as an adjuvant treatment for patients with gBRCAm HER2-negative high-risk early breast cancer previously treated with chemotherapy either before or after surgery. This approval was based on data from the OlympiA study, which achieved its primary endpoint of statistically significant and clinically meaningful improvement in invasive disease-free survival. Lynparza reduced the risk of invasive breast cancer recurrence, second cancers or death by 42% as compared to placebo.
The recent approval granted Lynparza access to a wider patient population. Per management, nearly 91% of all breast cancer patients in the United States are diagnosed at an early stage of the disease. The results from the OlympiA study show that Lynparza not only reduces the risk of recurrence in high-risk early breast cancer patients but also improves OS.
Please note that Lynparza is also approved for another breast cancer indication. The drug is approved as a treatment of gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy.
Overall, Lynparza is approved for four cancer types — ovarian, breast, prostate and pancreatic — in various patient populations. Both Merck and AstraZeneca are evaluating Lynparza in a range of tumor types.
Lynparza is being jointly developed and commercialized by both AstraZeneca and Merck. The drug generated product sales of $2.35 billion for AstraZeneca in 2021 and alliance revenues of $989 million for Merck.
Other PARP inhibitors available in the market include
Glaxo
’s
GSK
Zejula and
Clovis Oncology
’s
CLVS
Rubraca and Pfizer’s Talzenna.
While Glaxo’s Zejula is approved only for an ovarian cancer indication, Clovis’ Rubraca is approved for BRCA mutated ovarian cancer and metastatic castrate-resistant prostate cancer indications.
A broad development program on Rubraca is currently underway across a variety of solid tumors. Clovis is looking to expand Rubraca’s label into additional cancer types like breast and gastroesophageal cancers, among others.
Conversely, Glaxo’s Zejula is being evaluated for additional ovarian cancer stages and non-small cell lung cancer and breast cancer.
Zacks Rank
Both Merck and AstraZeneca currently carry 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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