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LYNPARZA (olaparib) - Ovaire

https://www.has-sante.fr/#
Opinions on drugs - Posted on May 07 2021

Reason for request

New indication

Key points

Favourable opinion for reimbursement in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.

What therapeutic improvement?

Therapeutic improvement compared to bevacizumab as monotherapy.

Role in the care pathway?

The initial treatment of advanced ovarian cancer (FIGO stage III or IV) is based on maximum surgical resection, followed by chemotherapy combining platinum and taxane. Bevacizumab can be used in combination with this first-line chemotherapy, irrespective of homologous recombination deficiency (HRD) status.

Bevacizumab may be continued and used as monotherapy for maintenance treatment, for a maximum period of 15 months. Its use is irrespective of HRD status and only concerns patients having received it in combination with first-line chemotherapy (since bevacizumab can be introduced in the first or second cycle).

In the event of BRCA1/2 mutation (homologous recombination deficiency), olaparib as monotherapy is a maintenance treatment with an MA in this indication. Irrespective of HRD status, niraparib as monotherapy is a maintenance treatment with an MA in this indication.

Role of the medicinal product in the care pathway

LYNPARZA (olaparib), in combination with bevacizumab is a first-line maintenance treatment option for advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency positive status defined by either a BRCA1/2 mutation and/or genomic instability.

In the absence of comparative data, its role compared to niraparib or olaparib as monotherapy cannot be specified in patients with homologous recombination deficiency.

The Committee also highlights the absence of efficacy and safety data for the olaparib + bevacizumab combination in patients with a cardiovascular history.

In addition, given the important potential risk of myelodysplastic syndrome/acute myeloid leukaemia, the Committee recommends careful investigation of any cytopenia developing during treatment with olaparib + bevacizumab.

 

 

 


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of LYNPARZA (olaparib), in combination with bevacizumab, is substantial in the new MA indication.


Clinical Added Value

minor

Considering:

  • the results from a subgroup analysis that was preplanned, but not incorporated in the methods to take into consideration inflation of the α overall alpha risk, suggesting the superiority of the olaparib + bevacizumab combination, compared to bevacizumab as monotherapy, in terms of progression-free survival (HR=0.33 [CI95%: 0.25-0.45]), with respective medians of 37.2 months and 17.7 months, in a phase 3, randomised, double-blind study;

and despite:

  • a higher toxicity, with the occurrence of grade ≥ 3 adverse events in more than one in two patients (58.1%, including 34% treatment-related), permanent discontinuation of treatment due to an adverse event in 20.9% of patients (including 18% treatment-related) and, in particular, the onset of myelodysplastic syndrome/acute myeloid leukaemia (identified as important potential risks in the RMP);
  • the absence of any formal conclusion that can be drawn based on the quality-of-life results;

the Transparency Committee considers that LYNPARZA (olaparib), in combination with bevacizumab, provides a minor clinical added value (CAV IV) compared to bevacizumab as monotherapy.

 

 

 


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