Global and North American phase II
studies of alectinib in the crizotinib-failure
setting
1.
Barlesi, et al. ECC 2015; 2. Ou, et al. J Clin Oncol 2015; 3. NCT01801111
4. Shaw, et al. WCLC 2015; 5. Shaw, et al. Lancet Oncol 2015; 6. NCT01871805
•
Locally advanced or metastatic
NSCLC
•
ALK
+ disease
•
Prior crizotinib treatment
•
ECOG PS 0–2
•
Global (NP28673) n=138
1–3
•
North American (NP28761) n=87
4–6
Alectinib
600mg BID
PD
1
2
ORR by IRC
Co-primary endpoint for NP28673: ORR by
IRC in patients with prior chemotherapy
Endpoints
CNS ORR, CNS DoR, PFS, DCR, safety
INDICACIÓN NO APROBADA, EN INVESTIGACIÓN