Novartis AG (NYSE:NVS) Unveils Positive ASCEND-3, ASCEND-5 Results

Novartis AG (NYSE:NVS) has recently revealed at the European Society of Medical Oncology (ESMO) Congress 2016 the updated results from ASCEND-3, a Phase 2 clinical trial evaluating Zykadia (ceritinib) for the treatment of anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) patients.

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Positive ASCEND-3 Results

The subjects who had been administered Zykadia as the first ALK inhibitor post-chemotherapy have demonstrated a median progression-free survival (PFS) of 18.40 months.

The updated results are consistent with those from ASCEND-1, the Phase 1 clinical trial under the same clinical development program. The subjects under ASCEND-1 had demonstrated a median PFS OF 18.40 months as well.

The subjects with brain metastases have experienced a 63.30% overall response rate (ORR) and an 83.70% disease control rate (DCR). Meanwhile, those without brain metastases have experienced a 64% ORR and an 88% DCR.

“Novartis is committed to extending the 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,” emphasized Alessandro Riva, M.D., Novartis Oncology Global Head of Oncology Development and Medical Affairs.

ASCEND-5 Results

For the first time, Novartis has also presented highly encouraging results from ASCEND-5, the Phase 3 clinical trial under the same clinical development program. Under ASCEND-5, the company has evaluated the median PFS among subjects who had previously received crizotinib, and one or two regimens of cytotoxic chemotherapy treatments, then received either Zykadia or standard chemotherapy treatments.

The subjects taking Zykadia under the Phase III protocol have demonstrated a median PFS of 5.40 months while those taking standard chemotherapy have demonstrated a median PFS of only 1.60 months.


Zykadia is an oral ALK inhibitor. In Europe, it has been granted a conditional approval for the treatment of adult patients with ALK+ advanced NSCLC who have previously received crizotinib treatment. Meanwhile, in the US, it has been granted an accelerated approval for the treatment of patients with ALK+ metastatic NSCLC who are crizotinib intolerant.

On Wednesday, Novartis closed at $76.37.

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