Swiss drugmaker Novartis AG reported reported dramatic results Wednesday among late-stage lung cancer patients with its gene-inhibiting drug Zykadia.
Novartis said Zykadia more than doubled the median progression-free survival rate to 16.6 months, compared to 8.1 months for traditional chemotherapy patients, suffering from anaplastic lymphoma kinase-positive nonsmall cell lung cancer.
The drug had a 72.5 percent response rate compared to 26.7 percent for the standard chemotherapy patients. Patients with brain metastases had an even better response rate, 72.7 percent.
The results were presented at the 17th World Conference on Lung Cancer in Vienna.
Overall survival data was not yet available.
"For clinicians, who are constantly working to extend a patient's response to treatment in the first-line setting, the … results are very compelling," said lead investigator Dr. Gilberto de Castro Jr., head of Thoracic Oncology and Head and Neck Cancer clinic in the Clinical Oncology Service of the Institute of Cancer of São Paulo (ICESP), in São Paulo.
The United States already has granted accelerated approval for Zykadia as an alternative treatment for patients who have progressed beyond or cannot tolerate Xalkori, which is made by Pfizer. In Europe, the drug has won conditional approval.
Zykadia will compete with Roche Holding AG’s Alcensa, which resulted in a 66 percent reduction of the risk of cancer progression compared to Xalkori.
Adverse reactions to Zykadia included diarrhea, nausea, vomiting and liver damage. It also can raise blood sugar levels and cause lung inflammation.
The phase III randomized, open-label trial involved 376 patients worldwide Zykadia was given to 189 of the patients, 59 of whom had brain metastases, while 187 were given standard chemotherapy, 62 of whom had brain involvement.
Zykadia, which already has gained approval in 55 countries, is taken orally. It inhibits the anaplastic lymphoma kinase gene, which can fuse with other genes to form an abnormal “fusion protein” that promotes tumor growth.
Novartis announced Sunday at the American Society of Hematology in San Diego its experimental drug CTL019 eliminated blood cancer in 82 percent of the 50 children treated for acute lymphoblastic leukemia. No safety or efficacy profile has yet been developed for the drug, which still is in the investigational stage, but Novartis said it would seek regulatory approval in the U.S. and Europe.