Results from a Phase 3 clinical trial, NALA, evaluating Puma Biotechnology's (PBYI +3.2%) Nerlynx (neratinib) + Roche chemo agent Xeloda (capecitabine) (N + C) compared to Novartis' (NVS +1.6%) Tykerb (lapatinib) + Xeloda (L + C) showed a treatment advantage. The data were cited in an abstract to be presented at ASCO.
Progression-free survival rates for N + C at months 6 and 12 were 47% and 38%, respectively, compared to 29% and 15% for L + C. Overall survival (OS) at the two time points was also higher in the N + C group, 90% and 88% versus 73% and 67%.
The overall response rate (ORR) in patients with measurable disease at study entry in the N + C arm was 33% but the difference (27% in the L + C arm) was not statistically significant.
On the safety front, the incidences of treatment-related adverse events were comparable, although the rate of serious (Grade 3) diarrhea was 24% in the N + C group versus 13% in the L + C group.
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