Merrill Lynch and Rachel McMinn on ESMO:
ARIA, TSRO: next gen ALK data evolving
New data for ARIA’s ALK inhibitor ‘113 showed impressive activity in patients with active brain lesions (8/10 showed radiographic brain improvement; duration of benefit ongoing), and overall activity in Xalkori failures remained robust (N=19/31, 61%). The mixed update on tolerability is that ‘113 is indeed associated with dose dependent increases in hypoxia (shortness of breath) following an early signal discussed at ASCO; however, the events appear to occur early, only at >90mg doses, and the toxicity is reversible with steroid support and drug interruption. All ongoing studies are dose titrating patients with 90 mg for a week and then increasing to 180 mg thereafter. First in human TSRO data for TSR-011 showed initial evidence of activity in Xalkori failures but data are too early to directly compare to other products in development. Overall, there is clear evidence that next generation ALK inhibitors will have a place following Xalkori, but more mature data are needed to gauge where each product will fit in.