Novartis’ Zykadia more effective than chemo, new study shows

pharmafile | October 13, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Alcensa, Novartis, Roche, Xalkori, ceritinib, crizotinib, lung cancer, zykadia 

Phase III results for Novartis’ cancer drug Zykadia (ceritinib) have revealed it as more effective than chemo at halting progression of non-small-cell lung cancer (NSCLC). The good news follows the drug’s recent successes in treating advanced anaplastic lymphoma kinase-positive (ALK-positive) NSCLC.

In the first third-stage study to investigate whether 231 ALK-positive NSCLC patients previously treated with Xalkori would benefit from Zykadia (crizotinib) over chemotherapy. The findings reported that median progression-free survival for ceritinib was 5.4 months compared to 1.6 months for chemotherapy, and overall response rate was 39.1% compared to 6.9%. However, there was no difference in overall survival in either treatment.

Lead author professor Giorgio Scagliotti, head of the Department of Oncology, University of Turin, Italy commented: “Progression-free survival was significantly lengthened with ceritinib compared to chemotherapy. We did not observe an improvement in overall survival with ceritinib, probably because the patients who crossed over diluted the potential benefit.”

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“This study opens up a new treatment paradigm after crizotinib failure. It would be logical now to give a sequence of active drugs, starting with crizotinib in first line and moving to ceritinib in second line,” he continued.

Dr Alice Shaw, director of thoracic oncology at the Massachusetts General Hospital Cancer Centre in Boston, added: “Single arm studies have suggested that ceritinib and alectinib could be standard options in the second line setting after crizotinib has failed. But the positive effect on progression-free survival in this phase III study confirms that there is greater benefit using a second ALK inhibitor over standard chemotherapy. This will establish sequential crizotinib followed by a second generation ALK inhibitor as the standard treatment for patients with metastatic ALK positive lung cancer.”

This news will surely boost the company’s efforts in the field as it competes with Roche’s newer treatment Alcensa, who currently leads the sales race with $74 million compared to Zykadia’s $48 million.

Matt Fellows

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