Lynparza (olaparib)

LYNPARZA® is geïndiceerd voor 4 therapeutische indicaties. Klik op de icoontjes voor meer informatie.

Over Lynparza

Over Lynparza

Werkingsmechanisme

Olaparib is een sterke remmer van menselijke poly (ADP-ribose) polymerase-enzymen (PARP-1, PARP-2 en PARP-3) en het is aangetoond dat dit middel de  groei van bepaalde tumorcellijnen in vitro en degroei van tumoren in vivo remt, ofwel als opzichzelfstaande behandeling of in combinatie met gevestigde chemotherapieën.1

Samenvattend: BRCAm tumoren hebben een unieke moleculaire biologie die hen gevoelig maakt voor PARP-remming.3,4

Lynparza® remt PARP op twee manieren:†3-4

• Door de enzymatische activiteit te remmen3-4

• Door de vorming van gevangen PARP-DNA complexen te verhogen3-4

Samenvatting van de resultaten

POLO trial: studie design6

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

Progressie vrije overleving6

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

Objectieve response rate6

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.
ICR=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.

Veiligheidsprofiel

Het veiligheidsprofiel dat werd waargenomen in POLO6 was in overeenstemming met het algemene veiligheidsprofielvan LYNPARZA®1.

Nevenwerkingen gerapporteerd in ≥15% van patiënten in 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.

Genetische testing

gBRCAm = germline mutated breast cancer gene.