Comparison of 3 ALK inhibitors’ phase 2 trials

All of these results are based on 5 phase 2 trials. However the conditions of each trial may differ in important ways. For example, it is my understanding that the trial for brigatinib was limited to healthier patients while the trial for ceritinib included almost every available patient. There may be other differences as well. Definitions for the acronyms are at the bottom.

While the data is similar to previously posted data, this data is more complete and up to date. They are also easier to compare.

2 trials, one all Crizotinib resistant, the other all ALK inhibitor naive

Crizotinib resistant
patients        140
ORR              38.6%
DCR              77.1%
CNS ORR     33%
PFS               5.7 months
DOR             9.7 months

ALK inhibitor naive patients
patients        124
ORR              63.7%
DCR              89.5%
CNS ORR     58%
PFS               11.1 months
DOR             9.3 months

CNS metastases
“the ORR, DOR, and PFS for patients with brain metastases at baseline were similar with those reported for the overall population of these studies


2 studies both all Crizotinib resistant patients

.                     global              U.S. & Canada
patients        138                   87
ORR              50.0%.            47.8%
DCR              79.5%              79.7%
CNS ORR    57.1%.              68.8%
PFS               8.9 months     6.3 months
DOR             11.2 months    7.5 months


One trial of 78 patients
Only healthier patients
Last patient enrolled July 2014
Median time on treatment = 12.6 months

Crizotinib resistant patients
patients         70
ORR               71%
PFS                 13.4 months
DOR               9.3 months

ALK inhibitor naive patients
patients         8
ORR               100%
PFS                 not available yet
DOR               not available yet

All patients with CNS metastases
ORR                53% of measurable
CNS PFS        15.6 months


CNS = central nervous system = the brain and spine

CNS ORR = objective response of tumors in CNS

DCR = disease control rate = ORR plus stable patients

DOR = duration of response = time from documentation of tumor response to disease progression

ORR = objective response rate = average shrinkage of 30% on longest dimensions of measured tumors in a CT or MRI scan

PFS = progression free survival = Time from randomization or study enrollment until disease progression or death

This entry was posted in alectinib - Alecensa from Chugai - Roche - GenenTech, Brain metastases, brigatinib-Alunbrig from Takeda, ceritinib - Zykadia from Novartis, Lung cancer, Potential Treatments, Research, Resistance to treatment. Bookmark the permalink.

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