Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Advertising

Press Release

LYNPARZA TABLETS RECEIVE EU APPROVAL FOR THE TREATMENT OF PLATINUM-SENSITIVE RELAPSED OVARIAN CANCER

Novartis
Posted on: 11 May 18

Women with platinum-sensitive ovarian cancer now have access to maintenance therapy with AstraZeneca and MSD’s Lynparza, regardless of BRCA status

Lynparza has over five years’ efficacy and safety follow-up data

New formulation reduces dosing to two tablets twice daily

AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the European Medicines Agency (EMA) has approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status.

Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: “With this new approval for Lynparza, we will now be able to offer more women with platinum-sensitive ovarian cancer, regardless of their BRCA status, a chance to achieve long-term disease control with an oral medicine that has a well-characterised safety and tolerability profile.”

 

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “This is an important development for the thousands of women in Europe living with advanced ovarian cancer, historically a difficult-to-treat disease. Working with AstraZeneca, we are able to bring this innovative, targeted treatment that helps delay progression of the disease to a broader group of women.”

 

The EU approval was based on two randomised trials, SOLO-2 and Study 19, which showed that Lynparza reduced the risk of disease progression or death for platinum-sensitive relapsed ovarian cancer patients compared to placebo.

 

Table 1. Summary of key efficacy results from randomised trials:

Analysis

SOLO-2

(germline BRCA-mutated platinum-sensitive relapsed)

n=295

Study 19

(platinum-sensitive relapsed)

n=265

Lynparza

Placebo

Lynparza

Placebo

Reduction in the risk of disease progression or death (PFS)

70%

(HR 0.30 [95% CI, 0.22-0.41], p<0.0001; median 19.1 vs 5.5 months)*

65%

(HR 0.35 [95% CI, 0.25-0.49], p<0.00001; median 8.4 vs 4.8 months)*

         

* By investigator-assessed analysis

 

In SOLO-2, the investigator-assessed analysis of PFS was supported with a blinded, independent, central radiological review of PFS, which showed a two-year difference in median PFS between Lynparza and placebo (HR 0.25 [95% CI, 0.18-0.35], p<0.0001; median 30.2 months vs 5.5 months). Overall survival (OS) data from SOLO-2 is currently immature.

 

In the final analysis of Study 19, with greater than five years of follow-up, the significant improvement in PFS translated into improvements in other key efficacy endpoints, regardless of BRCA status (Table 2). Additionally, the analysis showed 13% of patients treated with Lynparza remained progression-free and on therapy for five years or more years.

 

Table 2. Summary of other key efficacy endpoints from Study 19:

Analysis

Study 19

(platinum-sensitive relapsed)

n=265

Lynparza

Placebo

Time to first subsequent therapy or death*

HR 0.39 (95% CI, 0.30-0.52), p<0.00001;

median 13.3 months vs. 6.7 months

OS

HR 0.73 (95% CI, 0.55-0.95), p=0.02138**;

median 29.8 vs. 27.8 months***

* statistical tests not adjusted for multiplicity

** P-value considered nominal as criterion for statistical significance (P<0.0095) not met

*** not adjusted for treatment crossover

 

The most frequently observed adverse reactions across clinical trials in patients receiving Lynparza monotherapy (≥ 10%) were nausea, vomiting, diarrhoea, dyspepsia, fatigue, headache, dysgeusia, decreased appetite, dizziness and anaemia. The majority of patients on Lynparza remained on the starting dose and only 6-11% of patients discontinued treatment due to an adverse event.

 

Approximately half of women with high grade epithelial ovarian cancer are expected to have deficiencies in homologous recombination repair (HRR), an important DNA damage response (DDR) pathway. Mutations most often occur within one of the BRCA genes, however other gene mutations can also impact the HRR pathway. While there are currently no routine tests to identify patients with these deficiencies beyond BRCA mutations, responsiveness to platinum-based chemotherapy can predict sensitivity to PARP inhibition.

 

Lynparza, the first PARP inhibitor approved, was initially licensed in Europe as a capsule formulation for women with BRCA-mutated platinum-sensitive relapsed ovarian cancer. The new tablet formulation, which reduces dosing from eight capsules twice daily to two tablets twice daily, will now be available for a broader group of women with platinum-sensitive relapsed ovarian cancer.

 

Lynparza tablets were also recently submitted to the EMA for approval in patients with BRCA-mutated, HER2-negative metastatic breast cancer based upon the successful Phase III OlympiAD trial.

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 11/05/2018

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.