Swiss drug maker Novartis AG (NVS) revealed Wednesday that its investigational compound LDK378 (ceritinib) demonstrated an overall response rate of 58 percent in patients with advanced anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC), according to the clinical trial results published in the New England Journal of Medicine (NEJM).
The data from the trial also showed that LDK378 achieved a median progression-free survival of seven months in adults with ALK+ NSCLC who received 400 mg or higher of LDK378 per day. LDK378 is indicated for patients with this type of lung cancer, where prior therapies have failed.
"The majority of patients in the study experienced a clinical response to LDK378. In addition, responses were seen in untreated lesions in the central nervous system in patients who previously received crizotinib," said lead investigator Alice Shaw, MD, PhD, Massachusetts General Hospital Cancer Center, Boston.
NEJM noted that the data from the trials served as the basis for the first regulatory filing to the U. S. Food and Drug Administration for LDK378 with action expected later this year. The FDA had designated LDK378 as a Breakthrough Therapy in lung cancer in March 2013 for the treatment of ALK+ NSCLC.
LDK378 is a selective inhibitor of a cancer target called ALK. Because it is an investigational compound, the safety and efficacy profile of it has not yet been established. Access to LDK378 is available only through carefully controlled and monitored clinical trials. Because of the uncertainty of clinical trials, there is no guarantee that LDK378 will become commercially available.
The data that was published by NEJM was from a study that evaluated 114 ALK+ NSCLC patients treated with LDK378, including patients who had progressed during or following treatment with a commonly prescribed ALK inhibitor called crizotinib and those who had not received prior treatment with an ALK inhibitor. The study is ongoing.
NSCLC is the most common type of lung cancer, accounting for 85 to 90 percent of all cases, with 2 to 7 percent of those patients having the ALK gene rearrangement that increases the growth of cancer cells.
Preliminary data from this publication were first presented at the 2013 American Society of Clinical Oncology annual meeting.
"We are pleased that the FDA has accepted our application, and we look forward to working with the FDA and health authorities worldwide to bring this important treatment option to patients in need as swiftly as possible," said Alessandro Riva, President, Novartis Oncology ad interim and Global Head, Oncology Development and Medical Affairs.
Novartis noted that two Phase II clinical trials are currently fully enrolled and ongoing as well as two Phase III clinical trials are ongoing and are actively recruiting patients worldwide to further evaluate LDK378 in patients with ALK+ NSCLC.
NVS closed Wednesday's regular trading session at $81.11, down $0.76 or 0.93% on a volume of 1.18 million shares.
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