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See the DrugPatentWatch profile for Lynparza

Lynparza (olaparib) – Key Clinical Trial Highlights

Trial Phase Indication Design & N Major Findings (FDA‑relevant endpoints) Status
SOLO1 I/II First‑line maintenance in advanced ovarian cancer with BRCA mutation 379 pts; 2‑arm, open‑label Median PFS 19.1 mo vs 5.5 mo (placebo). 4‑year OS benefit (85% vs 73%). FDA‑approved 2014.
SOLO2 III Maintenance after platinum‑responsive ovarian cancer BRCA‑wildtype 595 pts; 2‑arm, randomized Median PFS 10.8 mo vs 5.5 mo (placebo). FDA‑approved 2019.
SOLO3 II/III Maintenance in relapsed ovarian cancer BRCA‑mutated 310 pts; 2‑arm Median PFS 11.8 mo vs 5.4 mo. FDA‑approved 2020.
OlympiAD II First‑line metastatic HER2‑negative breast cancer BRCA1/2 mutated 394 pts; 2‑arm Median PFS 7.6 mo vs 5.1 mo. FDA‑approved 2018.
NOVA II Metastatic castration‑resistant prostate cancer BRCA‑mutated 523 pts; 2‑arm Median PFS 8.6 mo vs 3.9 mo. FDA‑approved 2020.
PROfound III Metastatic castration‑resistant prostate cancer with HRR gene alterations 604 pts; 2‑arm Median PFS 7.4 mo vs 3.3 mo. FDA‑approved 2020.
Study 201 II Pancreatic cancer BRCA‑mutated 100 pts; 1‑arm ORR 15 % (partial). Investigational.
PROpel/PROpel‑C III Metastatic prostate cancer (no HRR) + abiraterone 1,600 pts; 3‑arm 9.0 mo vs 7.5 mo (p < 0.001). Ongoing (positive interim).
PROTECT II Triple‑negative breast cancer (TNBC) BRCA‑mutated 120 pts; 1‑arm ORR 18 % (PR 9 %). Early phase.

How to Find Current Trials

Platform What to Search
ClinicalTrials.gov Enter “olaparib” or “Lynparza”; filter by “Recruiting” or “Active, not recruiting”.
FDA’s Drugs@FDA Look up Lynparza; the “Clinical Studies” tab lists pivotal trials.
EMA’s Clinical Trial Register European perspective.
Oncology‑specific registries e.g., ASCO, ESMO conference abstracts.

Typical Trial Design Elements for Olaparib

  • Randomization – usually 1:1 to olaparib vs. placebo or standard of care.
  • Endpoints – Progression‑Free Survival (PFS) is primary; Overall Survival (OS), Objective Response Rate (ORR), and safety profile are secondary.
  • Biomarker stratification – BRCA1/2 mutation status; other homologous recombination repair (HRR) gene alterations (ATM, PALB2, CHEK2).
  • Dosing – 300 mg orally twice daily (standard for most indications) with a 5‑day “dose‑on, dose‑off” cycle in some regimens.

What’s Happening Now?

  • PROpel (prostate) and PROTECT (TNBC) are currently recruiting; early results suggest benefit even in non‑BRCA patients.
  • Olaparib + pembrolizumab combinations are under exploration in phase I/II for a broad range of solid tumors.
  • Quadruple‑arm trials (e.g., SOLO‑4) are testing olaparib as first‑line in BRCA‑mutated ovarian cancer with additional immunotherapy or targeted agents.
  • Real‑world evidence studies are assessing olaparib use in community oncology settings (post‑approval safety, adherence, and outcomes).

Key Take‑Home Points

  • Lynparza has robust phase‑III data supporting its use in several BRCA‑mutated cancers.
  • Olaparib works best when the tumor has a defect in the HRR pathway; gene testing (tumor and/or germline) is essential before prescribing.
  • Side‑effects: nausea, fatigue, anemia, and rare cases of myelodysplastic syndrome/AML. Monitoring CBC and renal function is standard.
  • Clinical trials provide an opportunity for patients to access cutting‑edge therapy and contribute to evidence generation, especially for rare cancer subtypes.

Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice. If you’re considering participation in a trial, consult with your oncologist or a clinical trial specialist to discuss eligibility, risks, and benefits.



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