Cited 2 times in
Durvalumab in Combination With Olaparib Versus Durvalumab Alone as Maintenance Therapy in Metastatic NSCLC: The Phase 2 ORION Study
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2023-11-28T03:32:54Z | - |
dc.date.available | 2023-11-28T03:32:54Z | - |
dc.date.issued | 2023-11 | - |
dc.identifier.issn | 1556-0864 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/196848 | - |
dc.description.abstract | Introduction: Increased DNA damage triggered through poly (ADP-ribose) polymerase inhibition may modify tumor immunogenicity, sensitizing tumors to immunotherapy. ORION (NCT03775486) evaluated the combination of olaparib with durvalumab as maintenance therapy in patients with metastatic NSCLC. Methods: ORION is a phase 2, randomized, multicenter, double-blind, international study. Patients with metastatic NSCLC (without activating EGFR or ALK aberrations) and Eastern Cooperative Oncology Group performance status of 0 or 1 were enrolled to receive initial therapy with durvalumab (1500 mg intravenously; every 3 wk) plus platinum-based chemotherapy for four cycles. Patients without disease progression were then randomized (1:1) to maintenance durvalumab (1500 mg; every 4 wk) plus either olaparib (300 mg orally) or placebo (both twice daily); randomization was stratified by objective response during initial therapy and tumor histologic type. The primary end point was investigator-assessed progression-free survival (PFS) (Response Evaluation Criteria in Solid Tumors version 1.1). Results: Between January 2019 and February 2020, 269 of 401 patients who received initial therapy were randomized. As of January 11, 2021 (median follow-up: 9.6 mo), median PFS was 7.2 months (95% confidence interval: 5.3-7.9) with durvalumab plus olaparib versus 5.3 months (3.7-5.8) with durvalumab plus placebo (hazard ratio = 0.76, 95% confidence interval: 0.57-1.02, p = 0.074). Safety findings were consistent with the known profiles of durvalumab and olaparib. Anemia was the most common adverse event (AE) with durvalumab plus olaparib (26.1% versus 8.2% with durvalumab plus placebo). The incidence of grade 3 or 4 AEs (34.3% versus 17.9%) and AEs leading to treatment discontinuation (10.4% versus 4.5%) was numerically higher with durvalumab plus olaparib versus durvalumab plus placebo. Conclusions: Maintenance therapy with durvalumab in combination with olaparib was not associated with a statistically significant improvement in PFS versus durvalumab alone, although numerical improvement was observed. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | JOURNAL OF THORACIC ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antibodies, Monoclonal / adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols* / adverse effects | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lung Neoplasms* / etiology | - |
dc.subject.MESH | Phthalazines / therapeutic use | - |
dc.title | Durvalumab in Combination With Olaparib Versus Durvalumab Alone as Maintenance Therapy in Metastatic NSCLC: The Phase 2 ORION Study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Myung-Ju Ahn | - |
dc.contributor.googleauthor | Igor Bondarenko | - |
dc.contributor.googleauthor | Ewa Kalinka | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Shunichi Sugawara | - |
dc.contributor.googleauthor | Gabriella Gálffy | - |
dc.contributor.googleauthor | Byoung Yong Shim | - |
dc.contributor.googleauthor | Nikolay Kislov | - |
dc.contributor.googleauthor | Rajnish Nagarkar | - |
dc.contributor.googleauthor | Ingel Demedts | - |
dc.contributor.googleauthor | Steven J M Gans | - |
dc.contributor.googleauthor | Dolores Mendoza Oliva | - |
dc.contributor.googleauthor | Ross Stewart | - |
dc.contributor.googleauthor | Zhongwu Lai | - |
dc.contributor.googleauthor | Helen Mann | - |
dc.contributor.googleauthor | Xiaojin Shi | - |
dc.contributor.googleauthor | Maen Hussein | - |
dc.identifier.doi | 10.1016/j.jtho.2023.06.013 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J01909 | - |
dc.identifier.eissn | 1556-1380 | - |
dc.identifier.pmid | 37390980 | - |
dc.subject.keyword | Durvalumab | - |
dc.subject.keyword | Immunotherapy | - |
dc.subject.keyword | NSCLC | - |
dc.subject.keyword | Olaparib | - |
dc.subject.keyword | PARP inhibition | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 18 | - |
dc.citation.number | 11 | - |
dc.citation.startPage | 1594 | - |
dc.citation.endPage | 1606 | - |
dc.identifier.bibliographicCitation | JOURNAL OF THORACIC ONCOLOGY, Vol.18(11) : 1594-1606, 2023-11 | - |
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