What are the current phase iii olaparib clinical trials in the us?

Ongoing Phase III Olaparib Trials in the US

Olaparib (Lynparza), developed by AstraZeneca and Merck, is in several Phase III trials recruiting or active in the US via ClinicalTrials.gov. These focus on ovarian, prostate, pancreatic, and other cancers, often testing combinations or maintenance therapy. Key active ones as of late 2024:

- PANOVA-3 (NCT03395139): Tests olaparib with or without stereotactic body radiotherapy (SBRT) in locally advanced pancreatic cancer. Recruiting at ~100 US sites; primary endpoint progression-free survival (PFS). Estimated completion 2026.[1]
- PROpel (NCT03732820): Olaparib plus abiraterone vs. abiraterone alone in metastatic castration-resistant prostate cancer (mCRPC). Active, not recruiting; US sites included. Met PFS endpoint; overall survival data pending.[1][2]
- KEYLYNK-010 (NCT04174144): Olaparib plus pembrolizumab vs. chemo in metastatic triple-negative breast cancer (mTNBC). Recruiting at US sites; PFS endpoint. Runs through 2028.[1]

Recently Completed or Topline-Reported Phase III Trials with US Involvement

• PAOLA-1/ENGOT-ov25 (NCT02476912): Olaparib plus bevacizumab maintenance in advanced ovarian cancer. Completed; showed PFS benefit. US patients enrolled; supported 2020 frontline approval.[1][2]
  
• MAGNITUDE (NCT03748641): Olaparib plus niraparib in mCRPC with HRR mutations. Completed; positive radiographic PFS in subgroup. US sites participated.[1]
  
  

What Cancers Are Targeted in Current US Trials?

Most US Phase III trials emphasize maintenance after response or combos in BRCA/HRD-mutated tumors:
| Trial ID | Cancer Type | Combo/Comparator | Status in US | Key Endpoint |
|----------|-------------|------------------|--------------|--------------|
| NCT05029387 (OPAL) | Frontline advanced ovarian | Olaparib + chemo vs. chemo | Recruiting | PFS |
| NCT04180306 (ASSURE) | High-grade serous ovarian | Olaparib monotherapy maintenance | Active | PFS |
| NCT03834519 (TALAPRO-3) | mCRPC | Olaparib + enzalutamide vs. enzalutamide | Recruiting | rPFS |

No new Phase III breast or lung trials active in US currently; focus shifted to prostate/ovarian post-approvals.[1]

How to Find Updates or Enroll

Search ClinicalTrials.gov with "olaparib phase 3 recruiting US" for real-time status (filter by location: United States). AstraZeneca's pipeline page lists olaparib trials; check for amendments.[1][3] Eligibility often requires HRD/BRCA status; consult oncologist for sites.

When Might New Approvals Come from These?

PANOVA-3 data expected 2026; could expand to pancreatic if positive. PROpel/VELIA-like prostate expansions pending OS readouts. Patent protection via DrugPatentWatch.com lasts to 2030s for key formulations, allowing label updates.[2][4]

Sources
[1] ClinicalTrials.gov (Olaparib Phase III)
[2] AstraZeneca Lynparza Pipeline
[3] Merck Pipeline
[4] DrugPatentWatch.com - Lynparza Patents