Lynparza (olaparib)

Safety Information

PAOLA-1: Adverse events were consistent with the established safety profiles of Lynparza and bevacizumab individually2

Adverse events reported in ≥6% of all patients in the ITT population in PAOLA-12

Adapted from: Ray-Coquard I, et al. 2019
Adverse events were graded according to CTCAE version 4.03.
† Includes patients with anaemia, a decreased haemoglobin level, a decreased haematocrit, a decreased red-cell count, erythropenia, macrocytic anaemia, normochromic anaemia, normochromic normocytic anaemia, or normocytic anaemia. ‡ Includes patients with a decreased lymphocyte count, lymphopenia, a decreased B-lymphocyte count, or a decreased T-lymphocyte count. § Includes patients with neutropenia, febrile neutropenia, neutropenic sepsis, neutropenic infection, a decreased neutrophil count, idiopathic neutropenia, granulocytopenia, a decreased granulocyte count, or agranulocytosis. ¶ Includes patients with leukopenia or a decreased white-cell count. || The data include patients with thrombocytopenia, decreased platelet production, a decreased platelet count, or a decreased plateletcrit.
ITT=intention to treat population

 

Adverse events of special interest for Lynparza in PAOLA-12

AA=aplastic anaemia;AML=acute myeloid leukaemia; ILD=interstitial lung disease; MDS=myelodysplastic syndrome

 

Dose modifications and discontinuations of Lynparza vs. placebo due to AEs in PAOLA-1:2*

*No dose reductions of bevacizumab were permitted, however skipped doses to manage toxicity were permitted.

  • No new safety signals were identified for Lynparza with the addition of bevacizumab1,2,21
  • Overall, the full safety profile showed that the Lynparza + bevacizumab regimen was tolerable1,2,21

Refer to the relevant Summary of Product Characteristics before prescribing to help minimise the risks associated with the use of this new combination.1

† Includes patients with anaemia, haemoglobin decreased, red blood cell count decreased and haematocrit decreased
*Only adverse event occurring in >15% of patients at any grade are included in the above table
**Adverse event data from the primary data cut-offs (DCO) of SOLO-1 (DCO 17 May 2018) and SOLO-2 (DCO 19 September 2016) as full adverse event information from later data cut-offs have not yet been reported
AE=adverse event; gBRCAm=germline BRCA1/2-mutated; NR=not reported at the final DCO20

*Primary DCO (DCO 17 May 2018) used for pneumonitis/ILD incidence in SOLO-1 as updated data have not yet been reported for the latest DCO (DCO 5 March 2020)
**Unless noted adverse event data from the latest data cut-offs (DCO) of SOLO-1 (DCO 5 March 2020) and SOLO-2 (DCO 3 February 2020) AML=acute myeloid leukaemia; gBRCAm=germline BRCA1/2-mutated; ILD=interstitial lung disease; MDS=myelodysplastic syndrome; PSR=platinum-sensitive relapsed

  • Across all maintenance trials (PAOLA-1, SOLO-1, SOLO-2 and Study 19), 80–~90% of women remained on Lynparza treatment without an adverse reaction-related discontinuation2,4,16,20
  • The majority of adverse reactions were resolved through dose reductions or dose
     interruptions1–3,16,18,20
  • Across these pivotal trials, Lynparza had no significant difference in health-related quality of life (HRQoL) outcomes when compared to placebo2,16,17

Summary of dose modifications and discontinuations throughout the key Lynparza maintenance ovarian cancer trials; PAOLA-1, SOLO-1, SOLO-2 and Study 19:­1–4,16,18–20

*Dose modification and discontinuation data from long-term follow-up of SOLO-1 (DCO 5 March 2020),8 SOLO-2 (DCO 3 February 2020),19 and Study 19 (DCO 9 May 2016)18
gBRCAm=germline BRCA1/2-mutated; PSR=platinum-sensitive relapsed

Safety data from these pivotal trials of Lynparza maintenance monotherapy (SOLO-1, SOLO-2 and Study 19) show that the majority of AEs associated with Lynparza have been of mild to moderate severity (CTCAE Grade 1 or 2) and generally did not require treatment discontinuation.1,3,4,16,20