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
- Phase III CANOPY-2 trial did not meet primary endpoint of overall survival in patients with advanced or metastatic non-small cell lung cancer whose cancer progressed while on or after previous treatments1
- Canakinumab development program continues; two Phase III non-small cell lung cancer clinical trials are ongoing in first-line and adjuvant settings2,3
- The CANOPY clinical trial program is designed to help answer critical questions about the role of interleukin-1 beta (IL-1β) in pro-tumor inflammation in lung cancer, with multiple clinical trials investigating canakinumab in different stages of disease using distinct treatment combinations2-5
Basel, March 9, 2021 — Novartis announced today the Phase III CANOPY-2 study evaluating canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1β), in combination with the chemotherapy agent docetaxel, did not meet its primary endpoint of overall survival (OS)1. The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy4. Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings2,3. Novartis and CANOPY-2 investigators will analyze the study data and are expected to submit its findings for presentation at an upcoming medical meeting.
“While results from the CANOPY-2 trial are not what we hoped for in patients with advanced or metastatic non-small cell lung cancer who have been treated with other lines of therapy, these data give us valuable insights into IL-1β inhibition,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer at Novartis. “Ongoing Phase III studies in non-small cell lung cancer continue, evaluating canakinumab in earlier treatment settings. We sincerely thank the patients and clinical investigators involved in the CANOPY-2 study for their partnership.”
CANOPY-1, a Phase III study evaluating canakinumab in combination with immunotherapy and chemotherapy, is expected to report final results before the end of the year2. CANOPY-A, another Phase III study, is investigating canakinumab as an adjuvant therapy and has enrolled more than 950 patients to date and is expected to enroll a total of 1,500 patients3.
About canakinumab (ACZ885)
Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to human interleukin-1beta (IL-1β)6,7 and neutralizes IL-1β activity by blocking its interaction with its receptors8. By neutralizing IL-1β, preliminary evidence suggests that canakinumab inhibits pro-tumor inflammation (PTI) to 1) enhance anti-tumor immune response; 2) reduce tumor cell proliferation, survival and invasiveness; and 3) impair angiogenesis8. Pro-tumor inflammation enables tumor development by driving cancer-causing processes and by suppressing anti-tumor immune responses9,10. Canakinumab is a first-in-class interleukin-1beta (IL-1β) inhibitor of PTI in non-small cell lung cancer10.
About the CANOPY program
Novartis launched the CANOPY study program after observing significantly lower than expected rates of lung cancer mortality among patients in the Phase III cardiovascular CANTOS trial. The CANTOS trial evaluated canakinumab as a secondary prevention measure for cardiovascular events in patients following a heart attack (CRP≥2 mg/L)8,9. Patients in the CANTOS trial were also at high risk for inflammatory cancers, like lung cancer, due to advanced age, smoking history and other clinical risk factors8,9. Based on these findings, Novartis launched three, large-scale, randomized, Phase III clinical trials and a Phase II clinical trial to investigate canakinumab as a potential treatment option in non-small cell lung cancer (NSCLC).
- 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 and Lung Cancer
Lung cancer is the most common cancer worldwide, accounting for more than 2 million new cases diagnosed each year11. There are two main types of lung cancer – small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)12. NSCLC accounts for approximately 85% of lung cancer diagnoses, resulting in nearly 1.7 million new cases each year11,13. Currently, the five-year survival rate for lung cancer is less than 20%14, decreasing further when the disease is diagnosed at later stages15. The majority of people with NSCLC are diagnosed with advanced or Stage III or IV disease16, and treatment options are limited for people with lung cancer who experience cancer growth or progression while on standard of care treatments17-19. More people die of lung cancer every year than any other cancer type11. Novartis is committed to developing best-in-class treatments for lung cancer patients around the world. With a focus on both targeted, personalized medicine and the role of newer, immuno-oncology therapies, the lung cancer drug development program at Novartis is among the most robust in the industry. With research activities informed by long-term relationships with leading lung cancer thought leaders and patient advocates, Novartis is focused on reimagining the treatment of lung cancer.
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,” “potentially,” “can,” “will,” “expected,” “committed,” “evaluating,” “continue,” “ongoing,” “approximately,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for canakinumab, either alone or in combination with docetaxel or pembrolizumab, or regarding potential future revenues from canakinumab, either alone or in combination with docetaxel or pembrolizumab. 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 canakinumab, either alone or in combination with docetaxel or pembrolizumab 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 canakinumab, either alone or in combination with docetaxel or pembrolizumab, separately or in combination, 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 US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
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.
Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact firstname.lastname@example.org
References (to be updated to reflect order in final release).
- 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-1β. MAbs. 2015;7(6):1151-1160.
- Novartis data on file: Clinical Trial Protocol CACZ885M2301.
- Ridker PM, Thuren T, Zalewski A, et al. Interleukin-1β 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.
# # #
Novartis Media Relations
|Anja von Treskow||Mary Curtin Creaser|
|Director, Strategy & Financial Communications||Director, Global Oncology Communications,|
|+41 79 392 8697 (mobile)||Solid Tumors|
|email@example.com||+1 862 345-4102 (mobile)|
|Novartis US External Communications|
|+1 862 579 8456|
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
|Samir Shah||+41 61 324 7944||Sloan Simpson||+1 862 778 5052|
|Thomas Hungerbuehler||+41 61 324 8425|
|Isabella Zinck||+41 61 324 7188|
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
NetJets Shares First Biannual Global Sustainability Program Progress Update15.4.2021 16:09:19 CEST | Press release
The World's Largest Private Aviation Company Furthers Its Commitment to Sustainable Aviation COLUMBUS, Ohio, April 15, 2021 (GLOBE NEWSWIRE) -- NetJets, the leader in private aviation with more than 760 aircraft worldwide, today releases its first biannual update following the launch of its expanded Global Sustainability Program in October 2020. Since the program announcement, NetJets has taken its commitment to sustainability a step further, acquiring a stake in WasteFuel®, a next generation waste-to-fuel business that transforms landfill waste into sustainable aviation fuel (SAF). NetJets will also purchase 100 million gallons of SAF over the next decade. This represents one of the largest SAF offtakes in the aviation industry and by far the largest in private aviation. In addition to sustainable fuel, NetJets’ initiative focuses on consumer and corporate carbon offsetting. This includes offsetting NetJets’ administrative and training flights, as well as its two corporate offices in
Rovio Entertainment's new team-based RPG Darkfire Heroes releases worldwide today on iOS and Android15.4.2021 15:00:00 CEST | Press release
Rovio’s new team-based RPG Darkfire Heroes releases worldwide today on iOS and Android Espoo, Finland – 15 April 2021 – Build a powerful party of heroes and embark on an adventure for the ages in Rovio Entertainment’s newest game, Darkfire Heroes. The game is available to download for free now worldwide on the App Store and Google Play after a successful soft launch period in select regions. Darkfire Heroes is a strategic team-based RPG set in a rich fantasy world. Players must assemble a powerful team of heroes to take on hordes of baddies. There is a collection of over 60 heroes at launch, each with their own unique style, abilities, and attacks. Choose the right heroes to take into battle, outfit them with powerful gear, and unleash powerful spells against enemies. There’s a substantial campaign for those looking for a single-player experience, but also a PvP arena for players that crave a bit of competition. A new IP in Rovio’s game portfolio, Darkfire Heroes is the first release f
Mid-Hudson Co-Operative Insurance Company Selects Verisk’s Sequel to Deploy Integrated Underwriting and Claims Solutions Following Migration to ISO Electronic Rating Content15.4.2021 14:00:00 CEST | Press release
JERSEY CITY, N.J., April 15, 2021 (GLOBE NEWSWIRE) -- Mid-Hudson Co-Operative Insurance Company (MHC) has selected Verisk’s Sequel to provide underwriting and claims solutions to underpin migration to ISO Electronic Rating Content™ (ERC) for rating support. New York-based MHC is a member of the National Association of Mutual Insurance Companies and provides personal, commercial and farm insurance via New York state agency Statewide Underwriting Services. Verisk’s ISO ERC solution helps insurers stay current and implement the necessary updates ISO makes to its advisory loss costs, rules and forms for a range of insurance classes and reduces the time and effort required to analyze regular ISO updates, eliminating tedious work and quickening ratings workflows. Eddie Harper President and CEO of Statewide Underwriting Services said of the agreement, “We were impressed by both the Sequel technology and expertise and the fact that Sequel is a Verisk solution was an important component in our
COVIS PHARMA GROUP Announces Top-line Safety and Efficacy Data from a Phase 3 Placebo-Controlled COVID-19 Study Using Inhaled Corticosteroid (ciclesonide)15.4.2021 13:00:00 CEST | Press release
ZUG, Switzerland, April 15, 2021 (GLOBE NEWSWIRE) -- Covis Pharma Group (the “Company”), a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses, announced today top-line results from a 400 patient phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ciclesonide metered-dose inhaler in non-hospitalized patients 12 years of age and older with symptomatic COVID-19 infection. The primary endpoint of the study was time to alleviation of COVID-19-related symptoms of cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell, defined as symptom-free for a continuous period of ≥ 24 hours by Day 30. A sub-group analysis showed that time to alleviation of cough was the most improved symptom in the ciclesonide arm compared to the placebo arm by 6 days in 75% of the populati
Talenom strengthens its business in the financial management of associations by acquiring Balance-Team Oy and raises its net sales guidance15.4.2021 12:30:00 CEST | Press release
Talenom Plc Inside information 15 April 2021 at 13:30 EEST Talenom strengthens its business in the financial management of associations by acquiring Balance-Team Oy and raises its net sales guidance Talenom Plc has acquired the Helsinki-based Balance-Team Oy, which specialises in financial management for associations. Talenom already has a business unit focused on associations and foundations, which, with the acquisition of Balance-Team Oy will make Talenom a leading provider of financial management services for nonprofit organisations in Finland. The share capital of Balance-Team Oy will be transferred to Talenom on 15 April 2021. The acquired company was formed on 1 April 2021 in a demerger in which non-accounting activities and assets were separated from the company. Net sales of the transferred accounting business for the financial year ended 31 December 2020 were 2.7 million euros (31 December 2019: 2.8 million euros) and EBITDA was 1.0 million euros (31 December 2019: 1.0 million
$125M Growth Round Fuels Keyfactor and PrimeKey Merger to Bring Machine Identity Management to the Mainstream15.4.2021 12:00:00 CEST | Press release
First-Ever Merger Between Certificate Automation and Certificate Authority Providers Set to Impact IAM Strategy for Enterprises CLEVELAND and STOCKHOLM, Sweden, April 15, 2021 (GLOBE NEWSWIRE) -- Keyfactor® and PrimeKey® today announced their intent to merge under the Keyfactor brand while committing to increased investments across all product lines. Keyfactor is the pioneer of PKI as-a-Service, and the recognized leader in certificate lifecycle automation and crypto-agility solutions. PrimeKey’s EJBCA® software offers the most powerful and flexible certificate authority (CA) supporting DevOps, IoT, manufacturing and enterprise use cases. The merger forms an industry-first machine identity management platform, combining Keyfactor’s certificate lifecycle automation with PrimeKey’s EJBCA. The new platform will provide end-to-end machine identity management – with flexible and highly scalable certificate issuance and automated deployment of machine identities across complex enterprise and
$125M i nya investeringar boostar Keyfactor och PrimeKeys fusion och mission att leverera komplett hantering av digitala identiteter15.4.2021 12:00:00 CEST | Pressemelding
Den första sammanslagningen som kombinerar certifikatshantering med -utgivning siktar på att gemensamt göra global skillnad för företags IAM-strategier CLEVELAND och STOCKHOLM, Sverige, April 15, 2021 (GLOBE NEWSWIRE) -- Keyfactor® och PrimeKey® tillkännager sin avsikt att gå samman till en företag under namnet Keyfactor, med ökade investeringar i samtliga produktlinjer. Keyfactor är pionjär inom Public Key Infrastructure (PKI) as-a-Service, och ledande inom livscykelautomatisering för digitala certifikat och lösningar inom kryptoagilitet. PrimeKeys EJBCA® är den mest kraftfulla och samtidigt mest flexibla mjukvaran inom certifikatsutgivning, så kallad Certificate Authority (CA), för DevOps, IoT, industrier samt företag. Sammanslagningen innebär marknadens första identitetshanteringsplattform för digitala identiteter och kombinerar Keyfactors livscykelautomatisering med PrimeKeys EJBCA. Den nya plattformen kommer att erbjuda en helhetslösning för hantering av digitala identiteter, med