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Durvalumab + Olaparib phase

AstraZeneca · Phase 3 active Small molecule

Durvalumab + Olaparib phase is a PD-L1 inhibitor + PARP inhibitor combination Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Metastatic or locally advanced ovarian cancer (BRCA-mutant or HRD-positive), Metastatic non-small cell lung cancer with BRCA mutations or HRD. Also known as: Maintenance phase.

Durvalumab blocks PD-L1 to enhance immune activation while olaparib inhibits PARP to impair DNA repair, together leveraging immunotherapy and synthetic lethality in homologous recombination-deficient tumors.

Durvalumab blocks PD-L1 to enhance immune activation while olaparib inhibits PARP to impair DNA repair, together leveraging immunotherapy and synthetic lethality in homologous recombination-deficient tumors. Used for Metastatic or locally advanced ovarian cancer (BRCA-mutant or HRD-positive), Metastatic non-small cell lung cancer with BRCA mutations or HRD.

Likelihood of approval
64.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Oncology Phase 3 boost +3.0pp
    Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
  • Big-pharma sponsor +3.0pp
    AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030 —
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameDurvalumab + Olaparib phase
Also known asMaintenance phase
SponsorAstraZeneca
Drug classPD-L1 inhibitor + PARP inhibitor combination
TargetPD-L1 and PARP1/PARP2
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

Durvalumab is a PD-L1 inhibitor that restores T-cell-mediated anti-tumor immunity by blocking the PD-L1/PD-1 checkpoint. Olaparib is a PARP inhibitor that causes synthetic lethality in BRCA-mutant or homologous recombination-deficient cancers by preventing DNA repair. The combination aims to enhance immunogenicity while exploiting DNA repair defects.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Durvalumab + Olaparib phase

What is Durvalumab + Olaparib phase?

Durvalumab + Olaparib phase is a PD-L1 inhibitor + PARP inhibitor combination drug developed by AstraZeneca, indicated for Metastatic or locally advanced ovarian cancer (BRCA-mutant or HRD-positive), Metastatic non-small cell lung cancer with BRCA mutations or HRD.

How does Durvalumab + Olaparib phase work?

Durvalumab blocks PD-L1 to enhance immune activation while olaparib inhibits PARP to impair DNA repair, together leveraging immunotherapy and synthetic lethality in homologous recombination-deficient tumors.

What is Durvalumab + Olaparib phase used for?

Durvalumab + Olaparib phase is indicated for Metastatic or locally advanced ovarian cancer (BRCA-mutant or HRD-positive), Metastatic non-small cell lung cancer with BRCA mutations or HRD.

Who makes Durvalumab + Olaparib phase?

Durvalumab + Olaparib phase is developed by AstraZeneca (see full AstraZeneca pipeline at /company/astrazeneca).

Is Durvalumab + Olaparib phase also known as anything else?

Durvalumab + Olaparib phase is also known as Maintenance phase.

What drug class is Durvalumab + Olaparib phase in?

Durvalumab + Olaparib phase belongs to the PD-L1 inhibitor + PARP inhibitor combination class. See all PD-L1 inhibitor + PARP inhibitor combination drugs at /class/pd-l1-inhibitor-parp-inhibitor-combination.

What development phase is Durvalumab + Olaparib phase in?

Durvalumab + Olaparib phase is in Phase 3.

What are the side effects of Durvalumab + Olaparib phase?

Common side effects of Durvalumab + Olaparib phase include Fatigue, Nausea, Anemia, Immune-mediated pneumonitis, Diarrhea, Thrombocytopenia.

What does Durvalumab + Olaparib phase target?

Durvalumab + Olaparib phase targets PD-L1 and PARP1/PARP2 and is a PD-L1 inhibitor + PARP inhibitor combination.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing