Merck halts Phase 3 Lynparza for futility

Merck (NYSE:MRK) has announced that it will stop the Phase 3 LYNK-003 trial focused on Lynparza (olaparib) with or without bevacizumab for patients with unresectable or metastatic colorectal cancer.

Two experimental arms in the trial, one focused on Lynparza as monotherapy or in combination with the immunotherapy drug bevacizumab, will be suspended.

The primary endpoint of the trial was progression-free survival.

The study focused on patients without progression after first-line therapy.

Merck made the decision after receiving feedback from an independent Data Monitoring Committee (DMC) following review from an interim analysis.

The PARP inhibitor Lynparza was first developed by KuDOS Pharmaceuticals and the University of Pennsylvania.

AstraZeneca acquired KuDOS Pharmaceuticals in 2005.

In 2021, the drug jointly earned AstraZeneca and Merck $3.7 billion.

The two companies continue to develop Lynparza for a variety of on…

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Lynparza cut death risk by one-third in adjuvant treatment of germline BRCA-mutated high-risk early breast cancer

Lynparza (olaparib) significantly reduced death risk when treating germline BRCA-mutated high-risk early breast cancer in the Phase 3 OlympiA study, according to AstraZeneca (LON: AZN).

Lynparza recently became the first FDA-approved medicine targeting BRCA mutations in the same type of cancer.

The drug is the first poly(ADP-ribose) polymerase (PARP) inhibitor to show an overall survival benefit in early breast cancer, according to AstraZeneca.

AstraZeneca developed the drug with Merck & Co. (NYSE:MRK), a company known as MSD outside of the U.S.

The OlympiA study showed that olaparib had a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

Patients in the study had received earlier local treatment and standard neoadjuvan…

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AstraZeneca’s and Merck’s Lynparza wins new breast cancer approval from FDA

The poly(ADP-ribose) polymerase inhibitor Lynparza (olaparib) has become the first FDA-approved medicine targeting BRCA mutations in early breast cancer.

The drug was developed by AstraZeneca (NSDQ:AZN) and Merck & Co. (NYSE:MRK), which is known as MSD outside of the U.S.

Lynparza is already approved for a number of other indications. FDA approved the drug to treat advanced ovarian cancer in 2014. Indications followed for maintenance treatment of ovarian cancer and for germline BRCA-mutated metastatic breast cancer, pancreatic and advanced ovarian cancer. In 2020, FDA granted additional indications related to ovarian cancer and prostate cancer.

The most recent indication of Lynparza covers the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer.

The indication is limited to patients who have received prior chemotherapy before or after surgery.

In weighing the decision, FDA revie…

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