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2021-03-09| R&DTrials & Approvals

After Cardiovascular Disease, Novartis’ Rare Disease Drug Flops in Late-Stage Lung Cancer Study

by Ruchi Jhonsa
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Novartis has been laboring around for the last few years to expand the market for Ilaris, an anti-inflammatory drug that’s currently approved to treat a few rare inflammatory indications, but those efforts have turned in mixed results, first for heart disease and now for lung cancer indication.

On March 9th, Novartis announced that Ilaris (canakinumab), an inhibitor of interleukin-1 beta combined with chemotherapy agent, failed to bring a positive change in the overall survival of lung cancer patients who had failed to respond to previous platinum-based chemotherapy and PD-L1 inhibitor immunotherapy.

Despite the failure of this trial (CANOPY-2), “these data give valuable insights into IL-1beta inhibition,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer at Novartis. The company will continue “evaluating canakinumab for non-small cell lung cancer in earlier treatment settings.”

The two earlier setting Phase 3 trials will evaluate the combination of canakinumab with Merck’s Keytruda plus chemotherapy (CANOPY-1 study) and canakinumab as adjuvant therapy (CANOPY-A). In detail, the Canopy-1 trial will evaluate whether the Ilaris-keytruda-chemo combo is able to prevent cancer progression or improve survival in newly diagnosed NSCLC patients.

The idea being that inhibition of IL-1beta driven inflammation by Ilaris may lead to a tumor microenvironment more susceptible to anti-PD-L1 therapies. The data from the trial is expected in the second half of 2021. CANOPY-A trial would evaluate canakinumab alone as adjuvant therapy that would determine whether the treatment could successfully lessen the chance of lung cancer coming back after primary treatments such as surgery.

 

Serendipitous Cancer Effect

Novartis launched the Canopy studies in 2018 after serendipitously discovering lower than expected rates of lung cancer mortality among heart failure patients in the Phase 3 cardiovascular Cantos trial.

In the trial, Novartis found a 51% reduction in death from any cancer and a 77% reduction in death from lung cancer. Novartis believes that Ilaris’s negative effect on cancer progression could result from suppression of pro-tumor inflammation by the drug. Pro-tumor inflammation is known to drive cancer-promoting mechanisms while suppressing anti-tumor immune responses.

However, given that there is no prior evidence of the drug’s efficacy in NSCLC cases where the disease has spread as well as its low efficacy in the interim analysis of the CANOPY-1 trial, some analysts feared that the drug would fail in cancer indications. But they also believed that administration of the drug earlier in the setting might benefit the patients.

 

Expanding ILARIS Beyond Rare Disease

When companies were pushing forward their anti-inflammatory medications for controlling the COVID-19 pandemic, Novartis also tried its luck with Ilaris, hoping that its treatment would reduce the overactive immune reactions seen with COVID-19 infection.

However, results showed that Ilaris met neither of the study goals. After 29 days, about 90% of Ilaris-treated patients were alive without needing ventilation, roughly similar to the number of patients on placebo. Moreover, 4.9% of patients died on treatment compared to 7.2% on placebo-a difference that was statistically non-significant. Prior to this, Novartis also tried to expand the usage of the drug in a cardiovascular indication. But the company could not get it past the USFDA in this indication due to insufficient data.

Related Article: Phase 2 Trial Setback of Investigational IBS Drug Prompts Arena to Ponder Strategic Alternatives

 

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