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United States : LYNPARZA (olaparib) Significantly Delays Disease Progression in Phase 3 First-Line SOLO-1 Trial for Ovarian Cancer.

AstraZeneca and Merck, known as MSD outside the United States and Canada, announced positive results from the randomized, double-blinded, placebo-controlled, Phase 3 SOLO-1 trial of LYNPARZA (olaparib) tablets.

Women with BRCA-mutated (BRCAm) advanced ovarian cancer treated first-line with LYNPARZA maintenance therapy had a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo. The safety and tolerability profile of LYNPARZA was consistent with previous trials. Based upon these data, AstraZeneca and Merck plan to initiate discussions with health authorities regarding regulatory submissions.

Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said, For the first time, we see a significant and clinically impactful improvement in progression-free survival in the first-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor. The SOLO-1 data reinforce the importance of knowing BRCA status at diagnosis, as this may enable women with BRCA-mutated ovarian cancer to receive LYNPARZA earlier. We would like to thank the investigators, hospitals and most of all the patients who took part in this trial, without whom medical advancements would not be possible.

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, Building on the strong data weve seen with LYNPARZA to date, the data from SOLO-1 reinforce LYNPARZAs ability to provide meaningful disease control with a well-characterized safety and tolerability profile. We look forward to presenting the full data set for SOLO-1 at a future medical meeting and working with the regulatory authorities to bring LYNPARZA to women with ovarian cancer in the first-line maintenance setting as quickly as possible.

LYNPARZA is not currently FDA-approved for 1st-line ovarian maintenance treatment. LYNPARZA is indicated for the maintenance treatment of recurrent ovarian cancer in response to platinum-based chemotherapy regardless of BRCA mutation status, and for the treatment of advanced ovarian cancer patients with a gBRCA-mutation previously treated with three or more lines of chemotherapy. Physicians should select advanced ovarian cancer patients for therapy based on a FDA-approved companion diagnostic. Please see Indications for LYNPARZA (olaparib) 100 mg in the U.S. below.

Additionally, the ongoing GINECO/ENGOTov25 Phase 3 trial, PAOLA-1, is testing the effect of LYNPARZA in combination with bevacizumab as a first-line maintenance treatment in women with newly diagnosed advanced ovarian cancer, regardless of their BRCA status. Results are expected in 2019.

Indications for LYNPARZA (olaparib) 100 mg in the U.S.

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

In patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

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Publication:Mena Report
Date:Jul 2, 2018
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