Novartis drug shows cancer promise
pharmafile | June 5, 2013 | News story | Research and Development, Sales and Marketing | ASCO, Cancer, Novartis
A Novartis drug which has been given breakthrough therapy designation by the FDA has demonstrated early promise in patients with lung cancer – and the company says it intends to file the compound early next year.
LDK378, a selective inhibitor of anaplastic lymphoma kinase (ALK), has shown a ‘marked’ clinical response in patients with non-small cell lung cancer (NSCLC). Phase III trials are planned to start in the next few months.
Phase I data presented this week at the American Society of Clinical Oncology (ASCO) meeting in Chicago showed a 60% overall response rate in 78 patients with ALK+ NSCLC taking LDK378 at 750 mg per day.
These patients were a mixture of those who had progressed during or after therapy with Pfizer’s NSCLC drug Xalkori (crizotinib), or who had not been previously treated with Xalkori.
Response rate in those who were crizotinib-naïve (62%) was slightly higher than in those who had taken the Pfizer drug (59 per cent).
“These results confirm that LDK378 has activity in patients with ALK+ NSCLC, including those who have progressed on crizotinib, as well as those who haven’t taken crizotinib,” said lead investigator Alice Shaw, of the Massachusetts General Hospital Cancer Center in Boston.
“LDK378 may become another standard targeted therapy for these ALK-positive patients,” she added.
NSCLC is by far the most common form of lung cancer and around 3-8% of patients who have the condition also have the ALK gene mutation.
As well as the 78 patients treated at 750 mg per day, another 36 patients took 400-750 mg/day in a study which is continuing to enrol patients.
Median length of response for patients treated at 400 mg/day or higher was 8.2 months, with a median progression-free survival of 8.6 months. Meanwhile the six-month duration of response rate at 750 mg per day was 61 per cent.
“Based on these data showing the potential of LDK378, we are developing a robust clinical program to move it forward as quickly as possible,” said Hervé Hoppenot, president, Novartis Oncology.
The most frequent adverse events were nausea, diarrhoea, vomiting and fatigue.
Two Phase II trials are recruiting patients worldwide: the first is focusing on patients with ALK+ NSCLC who were previously treated with chemotherapy and crizotinib, while the second is looking at LDK378 in patients who are crizotinib-naïve.
Boehringer Ingelheim has also shown off some impressive NSCLC data at ASCO this week, its investigational oral triple angiokinase inhibitor nintedanib extending the life of patients by 2.3 months when it is added to chemotherapy as a second-line treatment.
Nintedanib blocks three growth factor receptors: vascular endothelial (VEGFR 1-3), platelet-derived (PDGFR alpha and beta) and fibroblast (FGFR 1-3) – a range which could put it ahead of the field.
Adam Hill
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