Lynparza® (olaparib) phase iii solo-2 trial demonstrates significant progression-free survival benefit for women with BCRA-mutated ovarian cancer

Lynparza reduced risk of disease progression by 70 per cent, extending disease-free lives by an average of over two years based on independent evaluation

MISSISSAUGA, ON, March 16, 2017 /CNW/ – AstraZeneca recently presented data from the confirmatory Phase III SOLO-2 trial demonstrating a statistically significant and clinically meaningful improvement of progression-free survival (PFS) among patients treated with Lynparza® (olaparib) compared to placebo. The results were presented at the 2017 Society for Gynecologic Oncology Annual Meeting on Women’s Cancer in National Harbor, Maryland.

The SOLO-2 trial was designed to determine the efficacy of Lynparza tablets (300mg twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive relapsed, germline BRCA-mutated ovarian cancer. Results from the trial provide additional evidence to support the use of Lynparza as a standard of care for patients with platinum-sensitive relapsed, BRCA-mutated ovarian cancer, and findings demonstrate that the efficacy and safety profile with Lynparza tablets was consistent with previous studies.1

The trial met its primary endpoint and Lynparza demonstrated a 70 per cent reduced risk of progression based upon investigator assessed PFS. This means patients taking Lynparza as a maintenance therapy can have a much longer progression-free interval with no detriment to quality of life, compared to no treatment, which has been the traditional approach. The result is further supported by the PFS as measured by the Blinded Independent Central Review (BICR) evaluation showing that the median PFS was over two years. See table below for details.1

Analysis Median progression-free survival, months Hazard ratio
Investigator-assessed analysis Lynparza 19.1 0.30 (95% CI, 0.22-0.41), P<0.0001
Placebo 5.5
Blinded Independent Central Review Lynparza 30.2 0.25 (95% CI, 0.18-0.35), P<0.0001
Placebo 5.5

“The results of SOLO-2 further demonstrate the efficacy and significant clinical value of Lynparza for women faced with this devastating disease that strikes when women are in the prime of their lives,” said Dr. Allan Covens, Professor and Chair of the Division of Gynecologic

Oncology at the University of Toronto and Sunnybrook Health Sciences Centre. “This study shows that this treatment can make a meaningful difference for patients with BRCA-mutated ovarian cancer, potentially extending their cancer-free lives by over two years.”

Lynparza was granted a Notice of Compliance with Conditions (NOC/c) by Health Canada on April 29, 2016, based on meaningful evidence of clinical efficacy, safety and long-term tolerability, becoming the first and only PARP (poly ADP-ribose polymerase) inhibitor approved as a maintenance treatment for patients with platinum-sensitive relapsed BRCA-mutated ovarian cancer.2

“Treatment options available for women with ovarian cancer are extremely limited, so these results come as good news,” said Elisabeth Baugh, CEO, Ovarian Cancer Canada. “Every day, five Canadian women are lost to this disease, making the need for access to treatment options all the more urgent. Lynparza is a targeted treatment with potential to enable certain women to spend more time with their loved ones, and we look forward to it becoming more broadly available as quickly as possible.”

Lynparza has been reimbursed and available to patients in many countries since 2015, including the UK, Australia, France, Norway, Denmark and Sweden, on the basis of the Phase II Study 19 trial. Both the pan-Canadian Oncology Drug Review (pCODR) and Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS) did not recommend public funding for Lynparza at the time of initial submission and required results from the Phase III SOLO-2 trial. AstraZeneca is now working quickly and collaboratively with pCODR and INESSS to provide the results of the confirmatory SOLO-2 trial.

“AstraZeneca is optimistic that the SOLO-2 data will address the previous uncertainty of pCODR and INESSS and is hopeful for positive recommendations and provincial funding for Lynparza,” said Karen Heim, Vice President, Patient Access & Established Brands, AstraZeneca Canada. "We want to ensure Canadian women with ovarian cancer have access to this innovative, targeted treatment.”

About Lynparza® (olaparib)

Lynparza is a first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. It is the first PARP inhibitor to be approved as a maintenance therapy for patients with platinum-sensitive relapsed BRCA-mutated (germline or somatic) ovarian cancer. Health Canada’s Notice of Compliance with Conditions for Lynparza follows the announcement of the approval of Lynparza by the FDA on December 19, 2014 and in the European Union on December 18, 2014. AstraZeneca is conducting multiple Lynparza Phase III studies across a variety of indications and tumour types. Lynparza® is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc.

About SOLO-2

SOLO-2 was a Phase III, randomized, double-blind, placebo-controlled, multicentre trial designed to determine the efficacy of Lynparza tablets as a maintenance monotherapy

compared with placebo, in patients with platinum-sensitive relapsed or recurrent gBRCA-mutated (BRCAm) ovarian cancer. The trial, conducted in collaboration with the European Network for Gynaecological Oncological Trial Groups (ENGOT) and Groupe d’Investigateurs National pour l’Etude des Cancers de l’Ovaire et du sein (GINECO), randomized 295 patients with documented germline BRCA1 or BRCA2 mutations who had received at least two prior lines of platinum-based chemotherapy and were in complete or partial response. Eligible patients were randomized to receive 300mg Lynparza tablets twice daily or placebo tablets twice daily.1

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on three important areas of healthcare: Cardiovascular and Metabolic disease; Oncology; and Respiratory, Inflammation and Autoimmunity. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ more than 675 employees across the country and our AstraZeneca Canada headquarters are located in Mississauga, Ontario. For more information, please visit the company’s website at www.astrazeneca.ca.

CONTACT

Michelle Marchione, Senior Manager, Corporate Communications
AstraZeneca Canada
Tel: 905-803-5749
Email: michelle.marchione@astrazeneca.com

References

1 Pujade-Lauraine, J.A., et al. Treatment with olaparib monotherapy in the maintenance setting significantly improves progression-free survival in patients with platinum-sensitive relapsed ovarian cancer: Results from the phase III SOLO2 study. In: Society of Gynecologic Oncology Annual Meeting on Women’s Cancer; March 12 – 15, 2017; National Harbor, MD, USA.

2 LYNPARZA® (olaparib) Product Monograph. Accessed March 9, 2017. Available at: https://www.astrazeneca.ca/content/dam/az-ca/downloads/productinformation/LYNPARZA-Product-Monograph-EN.pdf.