- The Phase III trial investigating canakinumab plus standard of care (SoC) did not meet its primary endpoint of a greater chance of patient survival without the need for invasive mechanical ventilation, or its key secondary endpoint of reduced COVID-19 mortality, compared with SoC1
- Ilaris® (canakinumab) remains an effective treatment option for its approved indications, with a well-characterized safety profile 2,3. The safety profile of canakinumab plus SoC in CAN-COVID was comparable to placebo plus SoC1
- Interim Day 29 results will be submitted for peer-reviewed publication to further support the scientific understanding of COVID-19 infection and potential treatments
- Novartis further strengthened its pandemic response efforts by collaborating with Molecular Partners to develop two DARPin® therapies for potential use against COVID-194. In addition, a Phase III trial for ruxolitinib in COVID-19 is ongoing, with preliminary results expected by year end5
“Though the CAN-COVID trial did not show the patient benefit we were hoping for, it helps improve the scientific understanding of COVID-19 and the role of interleukin-1β inhibition,” said
In the trial, the primary endpoint of survival without the need for mechanical ventilation was 88.8% for canakinumab plus SoC vs 85.7% for placebo plus SoC (P=0.29)1. The key secondary endpoint of COVID-19-related mortality up to 4 weeks was 4.9% for canakinumab plus SoC vs 7.2% for placebo plus SoC (P=0.33)1. Both the primary and key secondary endpoints trended in favor of canakinumab but did not reach statistical significance1. No new safety signals for canakinumab were identified1.
This interim analysis will be submitted to a peer-reviewed journal in the coming weeks. The CAN-COVID results do not affect any other ongoing trials for canakinumab, including investigations for the treatment of non-small cell lung cancer (NSCLC)7-9.
As part of its continued efforts to support the global pandemic response, Novartis in October announced a collaboration with
About CAN-COVID
CAN-COVID is a Phase III, multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of canakinumab plus standard of care (SoC) in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome (CRS)6. Patients were hypoxic but not requiring intubation or invasive mechanical ventilation6. The primary endpoint was to demonstrate the benefit of canakinumab plus SoC vs placebo plus SoC in increasing the chance of survival without the need for invasive mechanical ventilation up to Day 296. The key secondary endpoint was to reduce the COVID-19-related death rate during the 4-week period after trial treatment6. The trial enrolled 454 patients at multiple centers across the US,
About canakinumab
Canakinumab is biologic medicine used in the treatment of a number of rare, debilitating auto-inflammatory diseases, for which there are limited options available. It is a monoclonal antibody that binds to and neutralizes interleukin-1 beta (IL-1β), blocking its action2,3,10. Excessive production of IL-1β plays a prominent role in certain inflammatory diseases and immune responses11,12. Canakinumab is an established medicine approved under the trade name Ilaris® in approximately 60 countries including the US,
Novartis response to COVID-19 pandemic
Novartis is making multiple contributions to the global effort to combat the COVID-19 pandemic and support the stability of global healthcare systems. The company has committed to donating
Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the
About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
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References
1. | Novartis Data on File 2020. |
2. | |
3. | |
4. | Novartis Media Release. Novartis announces collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19 [online] |
5. | ClinicalTrials.gov. Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID). NCT04362137. Available from: https://clinicaltrials.gov/ct2/show/NCT04362137 [Last accessed: November 2020]. |
6. | Clinicaltrials.gov. Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia (CAN-COVID). NCT04362813. Available from: https://clinicaltrials.gov/ct2/show/NCT04362813 [Last accessed: November 2020]. |
7. | 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). NCT03631199. Available from: https://clinicaltrials.gov/ct2/show/NCT03631199 [Last accessed: November 2020]. |
8. | 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). NCT03626545. Available from: https://clinicaltrials.gov/ct2/show/NCT03626545 [Last accessed: November 2020]. |
9. | ClinicalTrials.gov. 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 |
10. | Rondeau JM, Ramage P, Zurini M, et al. The molecular mode of action and species specificity of canakinumab, a human monoclonal antibody neutralizing IL-1beta. MAbs. 2015;7(6):1151-1160. |
11. | Agostini L, Martinon F, Burns K, et al. NALP3 forms an IL-1beta-processing inflammasome with increased activity in Muckle-Wells autoinflammatory disorder. Immunity. 2004;20(3):319-325. |
12. | Park YH, Wood G, Kastner DL, et al. Pyrin inflammasome activation and RhoA signaling in the autoinflammatory diseases FMF and HIDS. Nat Immunol. 2016;17(8):914-921. |
13. | Novartis.com. COVID-19 Novartis response. Available from: https://www.novartis.com/coronavirus/response [Last accessed: November 2020]. |
14. | Clinical trials.gov. Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia. NCT04382053. Available from: https://clinicaltrials.gov/ct2/show/NCT04382053 [Last accessed: November 2020]. |
15. | Clinical trials.gov. Study of Efficacy and Safety of MAS825 in Patients With COVID-19 (MAS-COVID). NCT04382651. Available from: https://clinicaltrials.gov/ct2/show/NCT04382651 [Last accessed: November 2020]. |
16. | Novartis Media Release. AAVCOVID vaccine program from Mass. Eye and Ear and Mass General Enters Manufacturing Agreement with Gene Therapy Leader AveXis, a |
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