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Novartis' (NVS) NSCLC Drug Fails to Meet Primary Endpoint
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Novartis (NVS - Free Report) announced that its late-stage study on pipeline candidate canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1β), in combination with the chemotherapy agent docetaxel was not successful.
The phase III CANOPY-2 study 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 immunotherapy. The study did not meet its primary endpoint of overall survival (OS).
Nevertheless, two phase III CANOPY studies are ongoing, evaluating canakinumab in first-line and adjuvant settings. CANOPY-1, a phase III study, is evaluating canakinumab in combination with immunotherapy and chemotherapy (final results expected before the end of the year). Another phase III study, CANOPY-A, is evaluating canakinumab as an adjuvant therapy and has enrolled more than 950 patients to date and is expected to enroll a total of 1,500 patients.
We note that 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. This study evaluated canakinumab as a secondary prevention measure for cardiovascular events in patients following a heart attack. These patients were also at high risk for inflammatory cancers, like lung cancer, due to advanced age, smoking history and other clinical risk factors. As a result, Novartis launched three, large-scale, randomized, phase III studies and a phase II study to evaluate canakinumab as a potential treatment option in NSCLC.
Lung cancer is widely prevalent, accounting for more than 2 million new cases diagnosed each year. Among these, NSCLC is the most common type and accounts for approximately 85% of lung cancer diagnoses, resulting in nearly 1.7 million new cases each year.
Novartis’ Tafinlar + Mekinist is already approved for NSCLC and a potential approval of another candidate will strengthen this franchise. Tabrecta is also approved for NSCLC.
The stock has lost 11.4% in the year so far compared with the industry’s decline of 3.5%.
Competition is stiff in the NSCLC space from other targeted drug therapies and immunotherapies. Pfizer’s (PFE - Free Report) Xalkori is approved for NSCLC. Merck’s (MRK - Free Report) immuno-oncology drug, Keytruda, is also approved for NSCLC. Last year, Eli Lilly and Company (LLY - Free Report) obtained FDA approval for Cyramza in combination with Tarceva, for the first-line treatment of NSCLC patients with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
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Novartis' (NVS) NSCLC Drug Fails to Meet Primary Endpoint
Novartis (NVS - Free Report) announced that its late-stage study on pipeline candidate canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1β), in combination with the chemotherapy agent docetaxel was not successful.
The phase III CANOPY-2 study 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 immunotherapy. The study did not meet its primary endpoint of overall survival (OS).
Nevertheless, two phase III CANOPY studies are ongoing, evaluating canakinumab in first-line and adjuvant settings. CANOPY-1, a phase III study, is evaluating canakinumab in combination with immunotherapy and chemotherapy (final results expected before the end of the year). Another phase III study, CANOPY-A, is evaluating canakinumab as an adjuvant therapy and has enrolled more than 950 patients to date and is expected to enroll a total of 1,500 patients.
We note that 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. This study evaluated canakinumab as a secondary prevention measure for cardiovascular events in patients following a heart attack. These patients were also at high risk for inflammatory cancers, like lung cancer, due to advanced age, smoking history and other clinical risk factors. As a result, Novartis launched three, large-scale, randomized, phase III studies and a phase II study to evaluate canakinumab as a potential treatment option in NSCLC.
Lung cancer is widely prevalent, accounting for more than 2 million new cases diagnosed each year. Among these, NSCLC is the most common type and accounts for approximately 85% of lung cancer diagnoses, resulting in nearly 1.7 million new cases each year.
Novartis’ Tafinlar + Mekinist is already approved for NSCLC and a potential approval of another candidate will strengthen this franchise. Tabrecta is also approved for NSCLC.
The stock has lost 11.4% in the year so far compared with the industry’s decline of 3.5%.
Competition is stiff in the NSCLC space from other targeted drug therapies and immunotherapies. Pfizer’s (PFE - Free Report) Xalkori is approved for NSCLC. Merck’s (MRK - Free Report) immuno-oncology drug, Keytruda, is also approved for NSCLC. Last year, Eli Lilly and Company (LLY - Free Report) obtained FDA approval for Cyramza in combination with Tarceva, for the first-line treatment of NSCLC patients with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
See the 5 high-tech stocks now>>