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June 28, 2018

AstraZeneca and Merck reports positive data from SOLO-1 trial

AstraZeneca and Merck have reported positive results from the Phase III SOLO-1 trial of Lynparza (olaparib) for the treatment of BRCA-mutated (BRCAm) ovarian cancer.

AstraZeneca and Merck have reported positive results from the Phase III SOLO-1 trial of Lynparza (olaparib) for the treatment of BRCA-mutated (BRCAm) ovarian cancer.

The randomised, double-blinded, placebo-controlled, multicentre trial was designed to analyse the efficacy and safety of Lynparza as the first-line maintenance monotherapy compared with placebo in the enrolled patients.

As part of the study, 391 patients with a deleterious or suspected deleterious BRCA1 or BRCA2 mutation who were in clinical complete or partial response following platinum-based chemotherapy were randomised at 2:1 ratio to receive 300mg Lynparza or placebo twice daily.

“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.”

The primary endpoint of the SOLO-1 was progression-free survival, while key secondary endpoints included time to second-disease progression or death and overall survival.

Findings of the trial showed that the patients treated first-line with Lynparza maintenance therapy had a statistically significant and clinically meaningful improvement in progression-free survival compared to the placebo.

The safety and tolerability profile of Lynparza was also reported to be consistent with previous trials.

AstraZeneca global medicines development executive vice-president and chief medical Officer Sean Bohen 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 poly ADP ribose polymerase (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.”

On the basis of the latest findings, AstraZeneca and MSD plan to begin discussions with relevant health authorities regarding regulatory submissions.

In addition, the companies are currently conducting the GINECO/ENGOTov25 Phase III trial, PAOLA-1, to evaluate the effect of Lynparza in combination with bevacizumab as a first-line maintenance treatment in women with newly diagnosed advanced ovarian cancer, irrespective of their BRCA status.

Results from the trial are expected to be available next year.

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