With regular screening, many cases of breast cancer are detected early. And in some patients at high risk of tumor recurrence, treatments are deployed around the surgery to increase the chances of recovery.
Now supported by further successful clinical trials, AstraZeneca and Merck are considering a HER2 negative niche in the post-surgical breast cancer market to further expand their PARP inhibitor blockbuster Lynparza.
Use of Lynparza after surgery in early high-risk HER2-negative breast cancer reduced risk of disease recurrence or death by 42% compared to placebo, according to data presented in plenary from the American Society of Clinical Oncology Virtual Meeting.
The results of the Phase 3 OlympiA trial involved patients whose tumors carry BRCA 1/2 mutations, which account for about 5% of all breast cancer cases in the United States and predispose women to aggressive disease.
At three years, about 85.9% of Lynparza patients were still alive without invasive breast cancer, compared to 77.1% in the placebo group.
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Lynparza is now the first PARP inhibitor to claim a victory that, as ASCO said, “could change the standard of care in adjuvant systemic therapy” for early germ-producing breast cancer with BRCA1 / 2 and HER2 mutations -negative. And it’s a home run.
Two breast cancer experts SVB Leerink spoke to before the data came to light said a 30% reduction in the so-called invasive disease-free survival marker would be clinically significant enough to prompt doctors to adopt Lynparza in patients with early breast cancer. The 42% of Lynparza easily crossed this threshold.
Previously, Eli Lilly’s CDK4 / 6 inhibitor, Verzenio, reported a 25.3% reduction in the risk of cancer recurrence when used as an adjuvant therapy for early HR-risk breast cancer. positive and HER2-negative. And that was also seen as a practice-changing improvement.
RELATED: ESMO: Verzenio de Lilly Pressures Pfizer with Practice-Changing Win in Early Breast Cancer
In the OlympiA trial, Lynparza was actually given after current standard chemotherapy used before or after surgery. The diet was designed that way, rather than trying to replace chemotherapy with Lynparza, as AZ and Merck try to “give the best possible therapy to achieve a cure,” explained Dave Fredrickson, business leader. AZ oncology, in an interview.
Lynparza has also been shown to reduce the risk of distant tumor recurrence or death by 43%.
Key information as to whether Lynparza can help patients live longer was not mature at interim analysis with a median follow-up of 2.5 years, but the survival curve was moving in favor of Lynparza with a reduction of 32 % of risk of death. The study is continuing to read overall survival data.
Prior to the early victory in breast cancer, Lynparza was the first PARP inhibitor authorized to treat metastatic breast cancer with BRCA mutation thanks to the FDA green light in 2018.
Fredrickson described the latest Lynparza trial as part of AstraZeneca’s “explicit strategy” to intervene early in the line of treatment of its cancer drugs on different types of tumors.
Tagrisso, the company’s best-selling product, recently entered early stage EGFR mutated non-small cell lung cancer after showing that its use after surgery could reduce the risk of disease recurrence. or 83% death compared to placebo in patients with stage II and IIIA disease. And several studies are testing its PD-L1 inhibitor Imfinzi as a pre- or post-surgical treatment for different cancers.
RELATED: AstraZeneca’s Tagrisso, Imfinzi Slow Down By COVID-19, But Growth Is Coming: Exec
AZ is currently trying to refine Lynparza’s advantage amid increasing competition from Zejula, GlaxoSmithKline’s rival PARP inhibitor, and OlympiA has once again taken a step ahead.
Despite a single approval that covers HRD-negative ovarian cancer in the so-called first-line interview setting, Zejula still fell short of Lynparza in terms of sales. In the first quarter, Zejula had revenue of Â£ 88million ($ 124million), while Lynparza made $ 543million from AZ.
The next big step for Lynparza will be data from the PROpel trial later this year, which could take the drug one-line in the treatment sequence for newly diagnosed castration-resistant prostate cancer.