Novartis provides update on Phase III study evaluating canakinumab (ACZ885) as second or third-line treatment in combination with chemotherapy in non-small cell lung cancer

- CANOPY-1?(NCT03631199)?is?a Phase III trial?evaluating canakinumab as a first-line treatment for locally advanced or metastatic NSCLC in combination with?pembrolizumab?and platinum-based?doublet chemotherapy2
- CANOPY-2 (NCT03626545)?is a Phase III trial?investigating the role of canakinumab?in combination with the chemotherapy agent docetaxel?in second- or?third-line therapy versus?docetaxel?alone in NSCLC.?Part 1 of the CANOPY-2 trial?? a?safety run-in study to determine the appropriate dosage,?was previously presented at ASCO 2019. Part 2 of the trial, reported today, evaluated overall survival (OS)4
- CANOPY-A (NCT03447769)?is a Phase III trial studying canakinumab in the adjuvant setting, following surgical resection and cisplatin-based chemotherapy.?The adjuvant study is designed to determine if treatment with canakinumab can prevent cancer relapse3
- CANOPY-N (NCT03968419)?is a non-registrational Phase II neoadjuvant trial evaluating canakinumab in combination with pembrolizumab among patients with?resectable?NSCLC prior to their planned surgery5
- Novartis Data on File
- ClinicalTrials.gov. Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (CANOPY-1). Available at:?https://clinicaltrials.gov/ct2/show/NCT03631199. Accessed on February 9, 2021.
- ClinicalTrials.gov. Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A (Canopy-A). Available at:?https://www.clinicaltrials.gov/ct2/show/NCT03447769. Accessed on February 9, 2021.
- ClinicalTrials.gov. Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy (CANOPY-2). Available at:?https://clinicaltrials.gov/ct2/show/NCT03626545. Accessed on February 9, 2021.
- ClinicalTrials.gov. A Randomized, Open-label, Phase II Study of Canakinumab or Pembrolizumab as Monotherapy or in Combination as Neoadjuvant Therapy in Subjects With Resectable Non-small Cell Lung Cancer (CANOPY-N). Available at:?https://clinicaltrials.gov/ct2/show/NCT03968419. Accessed on February 9, 2021.
- Dhimolea E, mAbs 2010;2:3?13; 3. Ilaris [Prescribing Information T2016-102].
- Rondeau JM, Ramage P, Zurini M, Gram H. The molecular mode of action and species specificity of canakinumab, a human monoclonal antibody neutralizing IL-1?. MAbs. 2015;7(6):1151-1160.
- Novartis data on file: Clinical Trial Protocol CACZ885M2301.
- Ridker PM, Thuren T, Zalewski A, et al. Interleukin-1? inhibition and the prevention of recurrent cardiovascular events: rationale and design of the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS).?Am Heart J. 2011;162:597?605.
- Lu H, Ouyang W, Huang C. Inflammation, a key event in cancer development.?Mol Cancer Res. 2006;4(4):221-233.
- World Health Organization. Cancer. Available at:?https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed on February 9, 2021.
- Lemjabbar-Alaoui H, Hassan O, Yang UW, et al. Lung cancer: biology and treatment options.?Biochim Biophys Acta. 2015. 1856(2):189-210.
- American Cancer Society. About Lung Cancer. Available at?https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html. Accessed February 9, 2021.
- Siegel R, Miller K, Jemal A. Cancer statistics, 2020.?CA Cancer J Clin. 2020;70(1):7-30.
- Rami-Porta R, Asamura H, Traves W, et al. Lung cancer ? major changes in the American Joint Committee on Cancer eight edition cancer staging manual.?CA Cancer J Clin. 2017;67:138.
- Mascaux C, Tomasini P, Greillier L, et al. Personalised medicine for non-small cell lung cancer.?Eur Respir Rev. 2017;26:170066.
- National Comprehensive Cancer Network Guidelines. Non-small cell lung cancer. Version 3. 2020.
- Sandler A, Gray R, Perry M, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small cell lung cancer.?New Engl J Med. 2006; 355: 2452-2550.
- Gadgeel S, Rodriguez-Abreu D, Speranza G, et al. Updated analysis from KEYNOTE-189: pembrolizumab or placebo plus pemetrexed and platinum for previously untreated metastatic nonsquamous non-small cell lung cancer.?J Clin Oncol. 2020; 38:1505-1517.
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Novartis Media Relations? E-mail:?media.relations@novartis.comAnja von Treskow | Mary Curtin Creaser |
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