| Title: |
Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial |
| Authors: |
Rizvi, N.A.; Cho, B.C.; Reinmuth, N.; Lee, K.H.; Luft, A.; Ahn, M.J.; Heuvel, M. van den; Cobo, M.; Vicente, D.; Smolin, A.; Moiseyenko, V.; Antonia, S.J.; Moulec, S. Le; Robinet, G.; Natale, R.; Schneider, J.; Shepherd, F.A.; Geater, S.L.; Garon, E.B.; Kim, E.S.; Goldberg, S.B.; Nakagawa, K.; Raja, R.; Higgs, B.W.; Boothman, A.M.; Zhao, L.; Scheuring, U.; Stockman, P.K.; Chand, V.K.; Peters, S. |
| Source: |
Jama Oncology, 6, 5, pp. 661-674 |
| Publication Year: |
2020 |
| Collection: |
Radboud University: DSpace |
| Subject Terms: |
Radboudumc 9: Rare cancers RIMLS: Radboud Institute for Molecular Life Sciences |
| Description: |
Contains fulltext : 225429.pdf (Publisher’s version ) (Open Access) ; IMPORTANCE: Checkpoint inhibitors targeting programmed cell death 1 or its ligand (PD-L1) as monotherapies or in combination with anti-cytotoxic T-lymphocyte-associated antigen 4 have shown clinical activity in patients with metastatic non-small cell lung cancer. OBJECTIVE: To compare durvalumab, with or without tremelimumab, with chemotherapy as a first-line treatment for patients with metastatic non-small cell lung cancer. DESIGN, SETTING, AND PARTICIPANTS: This open-label, phase 3 randomized clinical trial (MYSTIC) was conducted at 203 cancer treatment centers in 17 countries. Patients with treatment-naive, metastatic non-small cell lung cancer who had no sensitizing EGFR or ALK genetic alterations were randomized to receive treatment with durvalumab, durvalumab plus tremelimumab, or chemotherapy. Data were collected from July 21, 2015, to October 30, 2018. INTERVENTIONS: Patients were randomized (1:1:1) to receive treatment with durvalumab (20 mg/kg every 4 weeks), durvalumab (20 mg/kg every 4 weeks) plus tremelimumab (1 mg/kg every 4 weeks, up to 4 doses), or platinum-based doublet chemotherapy. MAIN OUTCOMES AND MEASURES: The primary end points, assessed in patients with ≥25% of tumor cells expressing PD-L1, were overall survival (OS) for durvalumab vs chemotherapy, and OS and progression-free survival (PFS) for durvalumab plus tremelimumab vs chemotherapy. Analysis of blood tumor mutational burden (bTMB) was exploratory. RESULTS: Between July 21, 2015, and June 8, 2016, 1118 patients were randomized. Baseline demographic and disease characteristics were balanced between treatment groups. Among 488 patients with ≥25% of tumor cells expressing PD-L1, median OS was 16.3 months (95% CI, 12.2-20.8) with durvalumab vs 12.9 months (95% CI, 10.5-15.0) with chemotherapy (hazard ratio [HR], 0.76; 97.54% CI, 0.56-1.02; P = .04 [nonsignificant]). Median OS was 11.9 months (95% CI, 9.0-17.7) with durvalumab plus tremelimumab (HR vs chemotherapy, ... |
| Document Type: |
article in journal/newspaper |
| Language: |
unknown |
| Relation: |
https://repository.ubn.ru.nl//bitstream/handle/2066/225429/225429.pdf; https://hdl.handle.net/2066/225429; https://doi.org/10.1001/jamaoncol.2020.0237 |
| DOI: |
10.1001/jamaoncol.2020.0237 |
| Availability: |
https://hdl.handle.net/2066/225429; https://repository.ubn.ru.nl//bitstream/handle/2066/225429/225429.pdf; https://doi.org/10.1001/jamaoncol.2020.0237 |
| Accession Number: |
edsbas.A93ED26A |
| Database: |
BASE |