Novartis top-line results for CANOPY-1 Phase III study support further evaluation of canakinumab in lung cancer

  • CANOPY-1 Phase III study did not meet its primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC)1
  • Potentially clinically meaningful improvements in both PFS and OS were observed among pre-specified subgroups of patients with inflammatory biomarkers; additional analyses are ongoing1
  • Results support continued study of canakinumab in earlier stages of lung cancer, as potential adjuvant and neoadjuvant therapies, and further evaluation of Pro-Tumor Inflammation in all lung cancer settings1
  • Patients in the CANOPY-A study more closely reflect the earlier CANTOS study population than those in the CANOPY-1 trial2,3,4; CANTOS was the first study to suggest that the inhibition of interleukin-1beta (IL-1β) may play a role in lung cancer3
  • Canakinumab showed no unexpected safety signals when combined with pembrolizumab plus platinum-based chemotherapy

Novartis blazoned moment that the Cover-1 Phase III study didn’t demonstrate the statistically significant primary endpoints of overall survival ( Zilches) and progression-free survival (PFS) in cases treated with canakinumab (ACZ885) combined with pembrolizumab plus platinum- grounded fellow chemotherapy, compared to cases entering placebo in combination with pembrolizumab plus platinum- grounded fellow chemotherapy1. The trial data, still, showed potentially clinically meaningful advancements in both PFS and Zilches inpre-specified groups of cases grounded on the birth seditious biomarker, hs-CRP, as well as other biomarker- defined groups. These data support farther evaluation of canakunimab in lung cancer.
“ Cover-1 provides critical perceptivity into the treatment of this ruinous complaint, and we will continue to dissect the data and conclusions, as well as their implicit clinical counteraccusations,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. “ While this trial didn’t confirm the benefit for all cases we hoped for, we’re amped by the overall Cover-1 findings as they support our commitment to continue studying canakinumab in lung cancer. We partake our gratefulness and thanks to the Cover-1 study cases and clinical investigators for their cooperation.”
The comprehensive Cover clinical trial program continues with Cover-A, a Phase III study probing canakinumab as an adjuvant remedy (after surgery) 2, and Cover-N, a Phase II study in the neoadjuvant setting (before surgery) 5. Registration for both trials is ongoing2,. Cases in the Cover-A trial more nearly reflect the before CANTOS study population than those in the Cover-1 trial2,. CANTOS was the first study to show that blocking the IL-1β seditious signal may potentially reduce lung cancer’s prevalence and mortality3.
About canakinumab (ACZ885)
Canakinumab is a mortal monoclonal antibody that binds with high affinity and selectivity to mortal interleukin-1beta (IL-1β) and neutralizes IL-1β exertion by blocking its commerce with its receptors9,. By negativing IL-1β, primary substantiation suggests that canakinumab may inhibitPro-Tumor Inflammation (PTI) to 1) enhanceanti-tumor vulnerable response; 2) reduce excrescence cell proliferation, survival, and invasiveness; and 3) vitiate angiogenesis11. PTI enables excrescence development by driving cancer-causing processes and suppressinganti-tumor vulnerable responses3,. Canakinumab is a implicit first-in- class IL-1β asset of the PTI pathway in NSCLC6.

About the Cover program
Novartis launched the Cover study program after observing significantly lower than anticipated rates of lung cancer mortality among cases in the Phase III cardiovascular CANTOS trial. The CANTOS trial estimated canakinumab as a secondary forestallment measure for cardiovascular events in cases following a heart attack3,. Cases in the CANTOS trial also were at high threat for seditious cancers, like lung cancer, due to advanced age, smoking history, and other clinical threat factors3,. Grounded on these findings, Novartis launched three large-scale, randomized, Phase III clinical trials and a Phase II clinical trial to probe canakinumab as a implicit treatment option innon-small cell lung cancer (NSCLC).
Cover-A (NCT03447769) is a double-eyeless, placebo- controlled Phase III trial studying canakinumab in the adjuvant setting following surgical resection and cisplatin- grounded chemotherapy, if required2. The adjuvant study is designed to determine if treatment with canakinumab can help cancer relapse2.
Cover- N (NCT03968419) is a Phase II neoadjuvant trial assessing canakinumab either as monotherapy or in combination with pembrolizumab among cases with resectable NSCLC previous to their planned surgery5.
Cover-1 (NCT03631199) was a double-eyeless, placebo- controlled Phase III trial assessing canakinumab as a first- line treatment for locally advanced or metastatic NSCLC in combination with pembrolizumab and platinum- grounded fellow chemotherapy4. As reported moment, the trial didn’t met its primary endpoints of overall survival ( Zilches) and progression-free survival (PFS) 1.
Cover-2 (NCT03626545) was a double-eyeless, placebo- controlled Phase III trial probing the part of canakinumab in combination with the chemotherapy agent docetaxel in alternate-or third- line remedy versus docetaxel alone in NSCLC12. In March 2021, Novartis blazoned that the trial didn’t meet its primary endpoint, and data were presented at the European Society of Medical Oncology (ESMO) 2021 Congress13.
Novartis and lung cancer
Lung cancer is one of the most common cancers worldwide, counting for further than 2 million new cases diagnosed each year14. Further people die of lung cancer every time than any other cancer14. There are two main types of lung cancer — small cell lung cancer (SCLC) andnon-small cell lung cancer (NSCLC) 15. NSCLC accounts for roughly 85 of lung cancer judgments
About Novartis
Novartis is reimagining drug to ameliorate and extend people’s lives. As a leading global drugs company, we use innovative wisdom and digital technologies to produce transformative treatments in areas of great medical need. In our hunt to find new drugs, we constantly rank among the world’s top companies investing in exploration and development. Novartis products reach nearly 800 million people encyclopedically and we’re chancing innovative ways to expand access to our rearmost treatments. About people of further than 140 ethnicities work at Novartis around the world.

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