Lynparza (olaparib) får ”positive opinion” av CHMP för behandling av patienter med platinakänslig ovarialcancer

Lynparza (olaparib) får ”positive opinion” av CHMP för behandling av patienter med platinakänslig ovarialcancer
AstraZeneca och MSD’s nya  Lynparza tablett  rekommenderas för underhållsbehandling oavsett BRCA status.

AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending a marketing authorisation of 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. Lynparza is recommended for treatment in this setting regardless of patients’ BRCA mutationstatus.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The data show that Lynparza provides long-term disease control, delaying the need for further chemotherapy for this broader group of women with platinum-sensitive relapsed ovarian cancer, irrespective of their BRCA status. It also offers a well-characterised safety and tolerability profile, which is critical to help enable patients to stay on treatment.”

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “We welcome this positive opinion based upon data which indicate the potential impact for Lynparza asmaintenance therapy for women with platinum-sensitive relapsed ovarian cancer. We look forward to our continued work with AstraZeneca to bring Lynparza to patients in the EU.”

The CHMP recommendation is based on two randomised trials, SOLO-2 and Study 19, which showed Lynparzareduced the risk of disease progression or death for platinum-sensitive relapsed patients compared to placebo.

Summary of key efficacy results from randomised trials:

Analysis SOLO-2 [germline BRCA-mutated] 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<0.0001; median 8.4 vs 4.8 months)*
Reduction in the risk of death (OS) Data not yet mature 27% (HR 0.73 [95% CI, 0.55-0.95], P=0.02138**; median 29.8 vs 27.8 months)***

PFS = progression-free survival; OS = overall survival

* By investigator-assessed analysis

** 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.

Lynparza, the first poly ADP-ribose polymerase (PARP) inhibitor approved, was initially licensed as a capsule formulation. The new tablet formulation will reduce dosing from 8 capsules twice daily to 2 tablets twice daily.

Lynparza is available in nearly 60 countries and has treated more than 20,000 patients globally. It has the broadest clinical development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to bring Lynparza to more patients across multiple cancers. In January 2018, Lynparza was approved by the US FDA for use in metastatic breast cancer, becoming the first PARP inhibitor licensed beyond ovarian cancer.