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AstraZeneca, Merck's Lynparza shrinks ovarian tumors in post-approval study

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AstraZeneca, Merck's Lynparza shrinks ovarian tumors in post-approval study

AstraZeneca PLC and Merck & Co. Inc. said Dec. 20 that their ovarian cancer drug Lynparza shrunk tumors and extended survival in a late-stage study, the fourth trial to show a benefit for the drug.

The companies evaluated Lynparza tablets in a phase 3 trial, called Solo-3, in 266 patients with ovarian cancer that tested positive for the BRCA mutation and which came back after two or more lines of treatment.

An earlier trial dubbed Solo-1 made waves at the annual European oncology conference two months ago, when it showed that it cut the risk of the disease progressing or returning by 70%.

U.K.-based AstraZeneca and Kenilworth, N.J.-based Merck conducted the study to fulfill a post-approval commitment with the U.S. Food and Drug Administration, which approved the drug in the U.S. on Dec. 19 as first-line maintenance therapy for BRCA-mutated advanced ovarian cancer.

The Solo-3 study showed that patients treated with Lynparza demonstrated a statistically significant and clinically meaningful improvement in objective response rate — the percentage of patients whose tumors shrunk following treatment and the trial's main goal — compared to those treated with chemotherapy.

Subjects given Lynparza also demonstrated a statistically significant and clinically meaningful improvement in progression-free survival — or the length of time a patient stays alive without the disease getting worse — compared to the chemotherapy group.

Lynparza is also approved by the U.S. FDA to treat patients with BRCA-mutated breast cancer and certain ovarian cancer mutations and was granted orphan drug designation by the regulator for treating pancreatic cancer. The therapy is also being developed for prostate cancer.