When Novartis failed in an attempt to repurpose Ilaris for metastatic non-small cell lung cancer (NSCLC), the Swiss pharma played up signs that it said supported continued exploration of the med in earlier stages of disease. Now, the company has unveiled those data and hopes to prove it’s not a headstrong drug developer that refuses to cut its losses.
Ilaris, or canakinumab, showed benefit “in the right direction” when added to Merck & Co.’s Keytruda and chemotherapy in previously untreated metastatic NSCLC, Jeff Legos, Ph.D., Novartis’ global head of oncology and hematology development, said in an interview with Fierce Pharma.
In newly diagnosed metastatic NSCLC patients, the addition of canakinumab cut the risk of death by 13% and the risk of disease progression or death by 17%. Neither of those improvements was statistically significant. The data, from the phase 3 CANOPY-1 trial, were presented at the American Association for Cancer Research annual meeting.
CANOPY-1 marked the second flop for canakinumab, an FDA-approved inflammatory disease drug, in NSCLC. The interleukin-1 beta inhibitor had previously also failed to tackle previously treated NSCLC in the CANOPY-2 trial.
Still, Legos pointed to several encouraging signs, suggesting canakinumab monotherapy might eventually triumph as an adjuvant treatment that’s given after surgery and chemo in early-stage NSCLC. In that setting, the drug is being tested in the ongoing CANOPY-A study.
The most important insight that gives Novartis hope came from a predefined subgroup analysis based on a marker of inflammation called high-sensitivity C-reactive protein (hsCRP). The marker is a well-established negative prognostic factor for most cancers, including NSCLC, Legos explained.
Novartis divided patients into four groups based on their baseline hsCRP levels. In the lowest quartile, canakinumab reduced the risk of death by 55% and the risk of disease progression or death by 43%. In contrast, for patients with hsCRP levels in the highest quartile, almost no difference was observed between the canakinumab takers and those in the control group.