دورية أكاديمية
Efficacy and Safety of Rovalpituzumab Tesirine Compared With Topotecan as Second-Line Therapy in DLL3-High SCLC: Results From the Phase 3 TAHOE Study
| العنوان: | Efficacy and Safety of Rovalpituzumab Tesirine Compared With Topotecan as Second-Line Therapy in DLL3-High SCLC: Results From the Phase 3 TAHOE Study |
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| المساهمون: | Fiona Blackhall, Kevin Jao, Laurent Greillier, Byoung Chul Cho, Konstantin Penkov, Noemi Reguart, Margarita Majem, Kristiaan Nackaerts, Konstantinos Syrigos, Karin Hansen, Wolfgang Schuette, Jeremy Cetnar, Federico Cappuzzo, Isamu Okamoto, Mustafa Erman, Seppo W Langer, Terufumi Kato, Harry Groen, Zhaowen Sun, Yan Luo, Poonam Tanwani, Laura Caffrey, Philip Komarnitsky, Niels Reinmuth, Cho, Byoung Chul |
| بيانات النشر: | Elsevier |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Adult, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols / therapeutic use, Benzodiazepinones, Humans, Immunoconjugates* / therapeutic use, Intracellular Signaling Peptides and Proteins, Lung Neoplasms* / drug therapy, Membrane Proteins, Middle Aged, Small Cell Lung Carcinoma* / drug therapy, Topotecan / therapeutic use, Delta-like protein 3, Rovalpituzumab tesirine, Small cell lung cancer, Topotecan |
| الوصف: | Introduction: DLL3, an atypical Notch ligand, is expressed in SCLC tumors but is not detectable in normal adult tissues. Rovalpituzumab tesirine (Rova-T) is an antibody-drug conjugate containing a DLL3-targeting antibody tethered to a cytotoxic agent pyrrolobenzodiazepine by means of a protease-cleavable linker. The efficacy and safety of Rova-T compared with topotecan as second-line therapy in patients with SCLC expressing high levels of DLL3 (DLL3-high) was evaluated. Methods: The TAHOE study was an open-label, two-to-one randomized, phase 3 study comparing Rova-T with topotecan as second-line therapy in DLL3-high advanced or metastatic SCLC. Rova-T (0.3 mg/kg) was administered intravenously on day 1 of a 42-day cycle for two cycles, with two additional cycles available to patients who met protocol-defined criteria for continued dosing. Topotecan (1.5 mg/m2) was administered intravenously on days 1 to 5 of a 21-day cycle. The primary end point was overall survival (OS). Results: Patients randomized to Rova-T (n = 296) and topotecan (n = 148) were included in the efficacy analyses. The median age was 64 years, and 77% had the extensive disease at initial diagnosis. The median OS (95% confidence interval) was 6.3 months (5.6-7.3) in the Rova-T arm and 8.6 months (7.7-10.1) in the topotecan arm (hazard ratio, 1.46 [95% confidence interval: 1.17-1.82]). An independent data monitoring committee recommended that enrollment be discontinued because of the shorter OS observed with Rova-T compared with topotecan. Safety profiles for both drugs were consistent with previous reports. Conclusions: Compared with topotecan, which is the current standard second-line chemotherapy, Rova-T exhibited an inferior OS and higher rates of serosal effusions, photosensitivity reaction, and peripheral edema in patients with SCLC. A considerable unmet therapeutic need remains in this population. ; open |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1556-0864 1556-1380 |
| العلاقة: | JOURNAL OF THORACIC ONCOLOGY; J01909; OAK-2021-06177; https://ir.ymlib.yonsei.ac.kr/handle/22282913/185456Test; T202104161; JOURNAL OF THORACIC ONCOLOGY, Vol.16(9) : 1547-1558, 2021-09 |
| DOI: | 10.1016/j.jtho.2021.02.009 |
| الإتاحة: | https://doi.org/10.1016/j.jtho.2021.02.009Test https://ir.ymlib.yonsei.ac.kr/handle/22282913/185456Test |
| حقوق: | CC BY-NC-ND 2.0 KR |
| رقم الانضمام: | edsbas.6C266F77 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 15560864 15561380 |
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| DOI: | 10.1016/j.jtho.2021.02.009 |