Dosing and adverse reaction management strategies for LYNPARZA® in combination with bevacizumab1

PAOLA-1 is the first phase 3 trial to investigate a PARP inhibitor combination regimen against an active and established maintenance therapy: bevacizumab1-4

 

 

Test to Treat: THE PAOLA-1 REGIMEN1,4,5

In PAOLA-1, <8% of patients had no prior cytoreductive surgery.4
LYNPARZA® treatment was continued for up to 2 years or until progression of the underlying disease or unacceptable toxicity. Patients with evidence of disease at 2 years, who in the opinion of the treating physician could derive further benefit from continuous treatment, could be treated beyond 2 years.1
In PAOLA-1, bevacizumab was administered for at least 3 cycles in combination with platinum-based chemotherapy prior to being administered as maintenance therapy in combination with LYNPARZA®.6

 

 

Per PAOLA-1 protocol

• Bevacizumab was administered for at least 3 cycles in combination with platinum-based chemotherapy6

  • Only in the case of interval debulking surgery, 2 cycles of bevacizumab in combination with the last 3 cycles of platinum-based chemotherapy were permitted6
Per FDA-approved label

• LYNPARZA® is indicated in combination with bevacizumab for first-line maintenance treatment of patients with HRD-positive* advanced ovarian cancer in complete or partial response to first-line platinum-based chemotherapy1

 

 

 

 

Recommended dosing1
  • Continue LYNPARZA® treatment for up to 24 months or until disease progression or unacceptable toxicity
  • Patients with a complete response at 24 months should stop treatment
  • Patients with evidence of disease at 24 months, who in the opinion of the treating physician could derive further benefit from continuous treatment, can be treated beyond 24 months
  • When used with LYNPARZA®, the recommended dose of bevacizumab is administered every 3 weeks for a total duration of up to 15 months, including the period given with chemotherapy and given as maintenance

Gene panels without measures of genomic instability do not capture all HRD status and are not FDA-approved companion diagnostics for LYNPARZA®.

Review the dosing information for LYNPARZA® monotherapy

Dosing and administration of LYNPARZA®

If a dose of LYNPARZA® is missed, the next normal dose should be taken at its scheduled time1

Please refer to the bevacizumab package insert for more information on the management of ARs related to bevacizumab and bevacizumab dose adjustments.

LYNPARZA® dose modifications due to Adverse Reactions (ARs) in PAOLA-14,7:

Anemia (4%) and nausea (3%) were reported to cause discontinuation rates ≥ 2%, all other ARs leading to discontinuation occurred with a frequency of 1% or below6,7

Recorded ARs occurred during study treatment or up to 30 days after discontinuation of the intervention6

Please refer to the bevacizumab package insert for more information on the management of ARs related to bevacizumab and bevacizumab dose adjustments.

8 out of 10 women remained on LYNPARZA® as prescribed, in combination with bevacizumab, without discontinuing due to ARs7

BRCAm, BRCA mutation; CTCAE, Common Terminology Criteria for Adverse Events; HRD, homologous recombination deficiency; PARP, poly (ADP-ribose) polymerase; PARPi, PARP inhibitor; VEGFi, vascular endothelial growth factor inhibitors.

Assessing the severity of anemia

The National Cancer Institute (NCI) defines the grades for anemia8,9

NCI CTCAE Grade Description
1 Hemoglobin (Hgb) <LLN–10.0 g/dL; <LLN–6.2 mmoI/L; <LLN–100 g/L 
2 Hgb <10.0–8.0 g/dL; <6.2–4.9 mmoI/L; <100–80 g/L
3 Hgb <8.0 g/dL; <4.9 mmoI/L; <80 g/L; transfusion indicated
4 Life-threatening consequences; urgent intervention indicated
5 Death
Presentation
A disorder characterized by a reduction in the amount of hemoglobin in 100 mL of blood. Signs and symptoms of anemia may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability.

References: 1. LYNPARZA®. Summary of Product Characteristics. 2. Harter P, Mouret-Reynier M, Pignata S, et al. Efficacy of maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed, advanced ovarian cancer in the phase III PAOLA-1/ ENGOT-ov25 trial. Gynecol Oncol. 2022;164(2):254-264. 3. Ray-Coquard I, Pautier P, Pignata S, et al. Phase III PAOLA-1/ENGOT-ov25: maintenance olaparib with bevacizumab in patients with newly diagnosed, advanced ovarian cancer treated with platinum-based chemotherapy and bevacizumab as standard of care. Poster presented at: ESMO 2019; September 27-October 1, 2019; Barcelona, Spain. 4. Ray-Coquard I, Pautier P, Pignata S, et al; PAOLA-1 Investigators. Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. N Engl J Med. 2019;381(25):2416-2428. 5. Myriad MyChoice® CDx Technical Information. Myriad Genetic Laboratories, Inc. Accessed May 2025. Available at: https://bit.ly/myChoiceCDxSpecs. 6. Ray-Coquard I, Pautier P, Pignata S, et al; PAOLA-1 Investigators. Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. PAOLA-1 Protocol. N Engl J Med. 2019;381(25):2416-2428. 7. LYNPARZA®. Prescribing Information. 8. Common Terminology Criteria for Adverse Events (CTCAE). Version 5.0. National Cancer Institute. Published November 27, 2017. Accessed May 2025. Available at: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ ctcae_v5_quick_reference_8.5x11.pdf. 9. Ray-Coquard I, Pautier P, Pignata S, et al; PAOLA-1 Investigators. Olaparib plus bevacizumab as first- line maintenance in ovarian cancer. Supplementary Appendix. N Engl J Med. 2019;381(25):2416-2428.

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