New Data Cement Lynparza's Worth in Early Breast Cancer

2022-03-17

奥拉帕利乳腺癌免疫疗法

AstraZeneca and Merckannounced that Lynparza reduced the risk of death by 32% in patients with germline BRCA-mutated HER2-negative early breast cancer who had completed local treatment and either a neoadjuvant or adjuvant chemotherapy.

The news is also significant because Lynparza is the first poly-ADP ribose polymerase (PARP) inhibitor drug to show an overall survival benefit in early breast cancer, opening up a myriad of opportunities for immuno-oncology drugs.

Lynparza was tested in the OlympiA trial, an international, double-blind, placebo-controlled Phase III clinical trial. Led by the Breast International Group and several other organizations in addition to AstraZeneca and Merck, the massive trial’s endpoint was invasive disease-free survival.

AstraZeneca and Merck presented the data at a European Society for Medical Oncology Virtual Plenary. Primary results from the trial were also published in The New England Journal of Medicine. The study showed Lynparza reduced the risk of death in breast cancer patients by 32% versus placebo. The three-year survival rate increased from 89.1% with placebo to 92.8% with Lynparza. At four years, the survival rate was 86.4% with placebo and 89.8% with the drug.

Lynparza's performance in the OlympiA trial is glowing, but it’s also not surprising, as the latest data is consistent with previous studies. The drug has proved so successful in previous trials that it is already approved in the U.S., EU and Japan to treat patients with gBRCAm, HER2-negative, metastaticbreast cancer previously treated with chemotherapy.

In fact, the U.S. Food and Drug Administration approved Lynparza just last week as the first and only targeted adjuvant therapy with an indication specifically for patients with gBRCAm, HER2-negative high-risk early breast cancer.

Safety and tolerability results were also in line with previous data.

While the statistics alone are impressive, there are several other reasons the study is significant. All patients in the study had mutations in the BRCA gene, which makes breast cancer more difficult to treat. Additionally, Lynparza is the first PARP inhibitor to ever show an overall survival benefit in patients with earlybreast cancer. PARPs, a category of protein that helps damaged cells repair themselves, include BRCA1 and BRCA2 genes, which are known to cause breast, ovarian and prostate cancer. When the protein mutates, it causes cancer.

PARP inhibitors, including Lynparza, are immunotherapy drugs that target mutated cancer cells and trap the strands of DNA when they break apart to replicate. Lynparza may also be useful in treating other kinds of cancers caused by genetic mutations.

“These exciting results further support how LYNPARZA could significantly change the way people with germline BRCA-mutated early breast cancer are treated,” said Susan Galbraith, executive vice president of oncology R&D at AstraZeneca. “The OlympiA trial is the first time we’ve seen a PARP inhibitor deliver survival benefit in early breast cancer, highlighting the importance of persistent innovation in tackling cancer early.”

OlympiA’s study is great news for cancer patients, as well as for pharmaceutical sales. Immuno-oncology drugs are a market expected to top $34 billion by 2030. AstraZeneca is the world’s top-earning company in terms of immuno-oncology drugs, with $13.66 billion in revenue from that category of drugs alone in 2021. Lynparza was listed as a top seller from AstraZeneca.

Merck is also a leader in terms of immuno-oncology drug sales, with Lynparza standing out as one of its most profitable products.

The profits for both of these companies will continue to skyrocket if Lynparza is approved for use in other cancers. Currently, the drug is being tested in trials for prostate cancer, liver cancer and biliary tract cancer.

机构

AstraZeneca KK