Key Ongoing Olaparib Trials by Cancer Type
Olaparib (Lynparza), a PARP inhibitor, is in multiple phase 3 trials targeting cancers with DNA repair deficiencies like BRCA mutations. Notable examples include:
- Ovarian Cancer: The PAOLA-1/ENGOT-ov25 trial tests olaparib plus bevacizumab as first-line maintenance in advanced cases, with ongoing long-term follow-up for progression-free survival [1]. Another, PAOLA-2/ENGOT-ov34, combines olaparib with durvalumab and bevacizumab in newly diagnosed advanced ovarian cancer [2].
- Prostate Cancer: PROpel evaluates olaparib plus abiraterone in metastatic castration-resistant prostate cancer (mCRPC), showing improved radiographic progression-free survival; recruitment is complete but follow-up continues [3]. TALAPRO-3 assesses niraparib-olaparib (a fixed-dose combo) as first-line monotherapy or with abiraterone in BRCA-mutated mCRPC [4].
- Pancreatic Cancer: The phase 3 POLO trial follow-up and extensions explore olaparib maintenance in germline BRCA-mutated metastatic pancreatic cancer [5]. Upcoming POLO-2 tests olaparib combinations in similar patients.
Trials in Breast and Other Cancers
- Breast Cancer: OlympiA continues long-term monitoring of olaparib as adjuvant therapy in high-risk HER2-negative BRCA-mutated early breast cancer, focusing on overall survival [6]. A phase 3 trial (NCT05162795) combines olaparib with pembrolizumab in triple-negative breast cancer [7].
- Other Types: In small cell lung cancer, a phase 2 trial (NCT03315146) tests olaparib maintenance post-chemoradiotherapy [8]. For endometrial cancer, a phase 2 study (NCT04124986) evaluates olaparib with durvalumab in advanced/recurrent disease [9]. Early-phase trials target ATM-mutated cancers like biliary tract (NCT04400364) [10].
When Do These Trials End and What Are the Risks?
Most trials run through 2025-2027, with primary endpoints met in some (e.g., PROpel) but overall survival data pending. Risks include anemia (common in 40% of patients), myelodysplastic syndrome (rare, <2%), and limited efficacy in non-BRCA tumors. Check ClinicalTrials.gov for recruitment status, as COVID delays shifted timelines [1][2].
[1]: ClinicalTrials.gov - PAOLA-1
[2]: ClinicalTrials.gov - PAOLA-2
[3]: ClinicalTrials.gov - PROpel
[4]: ClinicalTrials.gov - TALAPRO-3
[5]: ClinicalTrials.gov - POLO
[6]: ClinicalTrials.gov - OlympiA
[7]: ClinicalTrials.gov - Pembrolizumab + Olaparib
[8]: ClinicalTrials.gov - SCLC Trial
[9]: ClinicalTrials.gov - Endometrial Trial
[10]: ClinicalTrials.gov - Biliary Tract Trial