FDA Approves AstraZeneca and Merck's Lynparza for Pancreatic Cancer

FDA Approval

AstraZeneca and Merck are closing out 2019 on a high note with another approval for its PARP inhibitor Lynparza. This morning the U.S. Food and Drug Administration (FDA) green lit the drug as a maintenance treatment for pancreatic cancer patients.

Specifically, the FDA approved Lynparza (olaparib) as a maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen. Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza, AstraZeneca and Merck said in a joint announcement.

Approval for Lynparza in this indication was based on strong results from the Phase III POLO trial that showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as first-line maintenance therapy. In the trial, Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 months on placebo. Trial data also showed that Lynparza reduced the risk of disease progression or death by 47%. Overall survival, which was a secondary endpoint, at interim analysis was 18.9 months for Lynparza versus 18.1 months for placebo. That did not reach statistical significance, the companies said. The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in prior clinical trials.

Pancreatic cancer is a disease with a high unmet medical need and has the lowest survival rate of the most common cancers. Pancreatic cancer is the only major cancer with a single-digit five-year survival rate in nearly every country, the companies said. In 2018, there were approximately 460,000 new cases diagnosed across the globe. About 80% of those cases were diagnosed after the cancer metastasized, which meant the average survival for those patients was less than a year.

Lynparza is a first-in-class PARP inhibitor. It is the first targeted treatment that blocks DNA damage response in cells and tumors that have a deficiency in homologous recombination repair (HRR), such as BRCA1 and BRCA2 mutations. The drug has been approved for several indications in ovarian and breast cancers and is in line for potential approvals following other strong Phase III results in men with metastatic castration-resistant prostate cancer and late-stage ovarian cancer. And now, the drug can provide some hope for pancreatic cancer patients.

“Patients with advanced pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and limited treatment advances over the last few decades. Lynparza is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer,” Dave Fredrickson, head of AstraZeneca’s oncology business unit said in a statement.

Roy Baynes, head of global clinical development and chief medical officer of Merck Research Laboratories said the expanded approval of Lynparza represents a “significant milestone” for patients and also “supports the value of germline BRCA testing in patients with this disease.”

The newest approval and the latest trial data underscores the increasing importance of PARP inhibitors in cancer. A recent study conducted by UT Southwestern has shown that PARP inhibitors could have broader effectiveness in treating other types of cancer, including ovarian and prostate cancer. In October, a study was released that showed a PARP inhibitor combined with a DNA methyltransferase (DNMT) inhibitor may be a new way of treating some lung cancers.

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