Note that this drug is not new - it is fully approved for ALK+ NSCLC and has been since 2015.
It's not clear why these data are just coming out now or what is different from the original trials run in this setting.
It's not clear why these data are just coming out now or what is different from the original trials run in this setting.
[0] https://www.nejm.org/doi/full/10.1056/NEJMoa2027187
>>>>Five-year data indicate a significant progression-free survival benefit, with 60% of patients free of progression.
So far im with you.
>>>>Even after 60.2 months of follow-up, the median progression-free survival has not yet been reached [1]
This sounds awful? Or contradictory at best?
> This sounds awful? Or contradictory at best?
No, quite amazing. At 5 years more than 50% of participants are progression-free. That's indeed off the charts for a metastatic lung cancer.
Not exactly. FDA granted it an orphan drug designation in 2014, and then full approval for second- or third-line therapies in 2018 (on the basis of a Phase I/II study). The Phase III study (NCT03052608) is the gift that keeps on giving - it ran 2017-2020, and the progression-free survival in the lorlatinib arm is 60% vs 8% for the control.