Lynparza™ (olaparib)

LYNPARZA® est indiqué dans 4 indications thérapeutiques. 

Lynpara (olaparib) est le premier inhibiteur de PARP (Poly-ADP-Ribose-Polymérase), qui permet aux femmes atteintes d'un cancer de l’ovaire récidivant sensible au platine avec une mutation BRCA (BReast CAncer) de prolonger la survie sans progression1-3 

À propos de Lynparza

À propos de Lynparza

Mécanisme d’action

L’olaparib est un puissant inhibiteur des enzymes poly (ADP-ribose) polymérase humaines (PARP-1,PARP-2 et PARP-3) et il a été montré qu’il inhibait la croissance de certaines lignées de cellules tumorales in vitro et la croissance tumorale in vivo soit en monothérapie soit en association avec des chimiothérapies de référence.1

Pour résumer: les tumeurs BRCAm ont une biologie moléculaire unique qui les rend sensibles à l’inhibition de la PARP.3,4

Lynparza® inhibe la PARP de deux façons:†3-4

  • En inhibant l’activité enzymatique3-4
  • En augmentant la formation de complexes PARP-ADN piégés3-4
*Healthy cells may also be affected by Lynparza®.
†Based on preclinical data. The exact mechanism of action of Lynparza® remains the subject of research.
BRCAm = breast cancer gene mutation; PARP = poly ADP-ribose polymerase inhibitor; ADP = adenosine diphospate; HRR = homologous recombination repair.

 

Résumé des résultats

POLO trial: Plan de l’étude6

BICR = Blinded independent Central Review; BID = twice daily; gBRCAm = germline mutated breast cancer gene; mg = miligram; n = number; PFS = progression-free survival; ORR = objective response rate; OS = overall survival; RECIST = Response Evaluation Criteriain Solid Tumours

Survie sans progression6

CI = confidence interval; HR = hazard ratio; PFS = progression-free survival.

Taux de réponse objectif 6

Both complete responses in the Lynparza® group were ongoing at the time of data cutoff.6
*Data from BICR analysis according to modified RECIST, version 1.1, in patients with measurable disease after platinum-based therapy (n=130).6
†Based on Kaplan-Meier estimates.
BICR=blinded independent central review; NC=not calculable; ORR=objective response rate; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors.
Adapted from Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ Park JO, Hochhauser D, Arnold D, Oh DY, et al.Maintenance Olaparib for germline BRCA-mutated metastatic pancreatic cancer. N Engl J Med. 2019;381:317-27.

Profil de sécurité

Le profil de sécurité observé dans l’étude POLO6 était conforme au profil de sécurité général de Lynparza®1.

 Effets secondaires rapportés chez ≥15% des patients dans l’étude POLO6

*Includes AEs of any grade that occurred in ≥15% of the patients in the safety population of either trial group during the trial intervention or up to 30 days after discontinuation. AEs graded according to NCI CTCAE, version 4.0.6
†Includes anaemia, decreased haemoglobin level, decreased red blood count, decreased haematocrit, erythropaenia, macrocytic anaemia, normochromic anaemia, normochromic normocytic anaemia, and normocytic anaemia.6
AEs = adverse events; gBRCAm=germline BRCA-mutated; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.
Adapted from Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ Park JO, Hochhauser D, Arnold D, Oh DY, et al.Maintenance Olaparib for germline BRCA-mutated metastatic pancreatic cancer. N Engl J Med. 2019;381:317-27.

 

Contrôle génétique

gBRCAm = germline mutated breast cancer gene

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