Experimental Drug Extends Lung Cancer Survival by 18 Months

Novartis presented results from clinical trials of Zykadia at the European Society of Medical Oncology Congress.

Novartis recently announced positive results from its phase 2 clinical trial, ASCEND-3, which explored Zykadia (ceritinib) in patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC).

A blinded independent review committee found that patients taking Zykadia as their first ALK inhibitor after chemotherapy had progression-free survival of 18.4 months, according to a press release from Novartis. These latest findings are consistent with the results of the phase 1 ASCEND-1 trial.

Zykadia is a selective inhibitor of anaplastic lymphoma kinase, which fuses with other genes and promotes cancer growth. Included in the ASCEND-3 trial were 124 patients with ALK+ non-small cell lung cancer who received up to 3 lines of chemotherapy, and had not received treatment with an ALK inhibitor, according to Novartis.

In a sub-analysis, the scientists found that patients with brain metastases had an overall response rate of 63% (95% CI: 48.3-76.6%). Approximately 39.5% of all patients included had brain metastases.

They also found that these patients also experienced a disease control rate of 83.7% (95% CI: 70.3-92.7).

Patients without brain metastases demonstrated an overall response rate of 64% (95% CI: 52.1-74.8) and a disease control rate of 88% (95% CI: 78.4-94.4), according to Novartis.

“The unfortunate reality of ALK+ NSCLC is that advancement is needed to delay disease progression in these patients,” said lead investigator Dr Enriqueta Felip. “These data, coupled with a compelling response in the sub-analysis of patients with baseline brain metastases, provide greater evidence of Zykadia's potential efficacy in the ALK-naïve population.”

Scientists also found that 94.7% of patients experienced a decrease in tumor burden.

Zykadia was approved in the European Union for patients with ALK-positive advanced non-small cell lung cancer previously treated with crizotinib. It has also received accelerated approval in the United States for patients with ALK-positive metastatic non-small cell lung cancer who are intolerant to, or have progressed, on crizotinib.

Overall, it has received approval in more than 55 countries. The most common adverse reactions included diarrhea, nausea, and vomiting.

Results from the ASCEND-3 clinical trial were presented at the Annual European Society for Medical Oncology Congress (ESMO) along with data from the phase 3 ASCEND-5 clinical trial that investigated progression free survival in previously treated patients who then either received Zykadia or chemotherapy.

“Novartis is committed to extending lives of patients with difficult-to-treat forms of cancer, and these data presented at ESMO affirm our desire to improve outcomes for those with metastatic NSCLC, specifically,” said Alessandro Riva, MD, global head, Oncology Development and Medical Affairs, Novartis Oncology. “With our first-line Phase III results forthcoming as well as ongoing brain metastases studies, we look forward to sharing further evidence of Zykadia's full potential.”