التفاصيل البيبلوغرافية
| العنوان: |
Nivolumab monotherapy or combination with ipilimumab with or without cobimetinib in previously treated patients with pancreatic adenocarcinoma (CheckMate 032) |
| المؤلفون: |
Callahan, Margaret, Amin, Asim, Kaye, Frederic J, Morse, Michael A, Taylor, Matthew H, Peltola, Katriina J, Sharma, Padmanee, O'Reilly, Eileen M, Meadows Shropshire, Stephanie, O'Brien, Shaun, Tschaika, Marina, Le, Dung T |
| المساهمون: |
Bristol Myers Squibb |
| المصدر: |
Journal for ImmunoTherapy of Cancer ; volume 12, issue 2, page e007883 ; ISSN 2051-1426 |
| بيانات النشر: |
BMJ |
| سنة النشر: |
2024 |
| مصطلحات موضوعية: |
Cancer Research, Pharmacology, Oncology, Molecular Medicine, Immunology, Immunology and Allergy |
| الوصف: |
Background Pancreatic cancer is one of the deadliest cancer types and represents a major unmet medical need. CheckMate 032 investigated safety and efficacy of nivolumab monotherapy and nivolumab plus ipilimumab with/without cobimetinib in advanced/metastatic solid tumors, including pancreatic cancer. Methods In the original pancreatic cancer cohort, previously treated patients (≥1 prior regimen) with advanced/metastatic pancreatic adenocarcinoma were assigned to nivolumab 3 mg/kg every 2 weeks (monotherapy arm) or nivolumab 1 mg/kg and ipilimumab 1 mg/kg or 3 mg/kg every 3 weeks for four doses, followed by nivolumab 3 mg/kg every 2 weeks (combination arm). A subsequent modified pancreatic cohort (one or two prior regimens) received nivolumab 3 mg/kg every 2 weeks, ipilimumab 1 mg/kg every 6 weeks, and cobimetinib 60 mg orally once daily for 21 days on and 7 days off (triplet arm). The primary endpoint was investigator-assessed objective response rate (ORR). Secondary endpoints were investigator-assessed progression-free survival (PFS), PFS rate, overall survival (OS), OS rate, safety, and tolerability. Additionally, ORR, PFS, and duration of response were assessed by blinded independent central review (BICR) in the triplet arm. Results 18 patients received nivolumab monotherapy, 21 received nivolumab plus ipilimumab, and 30 received nivolumab plus ipilimumab plus cobimetinib. In the triplet arm, partial responses were observed in two patients per investigator (ORR 6.7% (95% CI 0.8% to 22.1%)) and in three patients per BICR (ORR 10% (95% CI 2.1% to 26.5%)); no responses were observed in the other arms. Median (95% CI) PFS per investigator was 1.4 (1.3 to 2.0), 1.4 (1.2 to 2.7), and 3.0 (1.5 to 4.1) months for the monotherapy, nivolumab plus ipilimumab, and triplet arms, respectively. Median (95% CI) OS was 5.1 (2.0 to 9.0) months, 4.0 (1.9 to 5.6) months, and 6.2 (3.9 to 11.4) months, respectively. Most treatment-related adverse events were grade 2 or less. Conclusions Nivolumab with or without ipilimumab did not ... |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.1136/jitc-2023-007883 |
| الإتاحة: |
https://doi.org/10.1136/jitc-2023-007883Test |
| حقوق: |
http://creativecommons.org/licenses/by-nc/4.0Test/ |
| رقم الانضمام: |
edsbas.4E2471F8 |
| قاعدة البيانات: |
BASE |
