3655 - Real-World Progression-Free Survival of Patients on Anaplastic Lymphoma Kinase (ALK) Tyrosine Kinase Inhibitors (TKIs) for ALK+ Non-Small Cell Lung Cancer (NSCLC)

Background

Patients with NSCLC characterized by ALK rearrangements may benefit from ALK TKI therapies. Although ALK TKIs have shown improved efficacy relative to conventional chemotherapy, the prognosis for patients with ALK+ NSCLC remains suboptimal. The present study uses real-world evidence to examine progression-free survival (PFS) among patients with ALK+ NSCLC treated with an ALK TKI.

Methods

Patients with advanced ALK+ NSCLC diagnosed and treated with an ALK TKI in 2011-2017 were identified from the Flatiron Health Electronic Health Record (EHR)-derived database. Real-world PFS (rwPFS) was estimated as the time from treatment line start to progression or death, where progression was abstracted from clinician notes and radiology/pathology reports by trained medical reviewers. Analyses examined rwPFS following the patient’s first line containing ALK TKI. For patients who received crizotinib as their first TKI followed by a second ALK TKI, a similar analysis examined rwPFS following their second ALK TKI line. Data were censored at end of follow-up for patients without progression or death. The median and 95% confidence interval (CI) of rwPFS following first and second ALK TKI were obtained from Kaplan-Meier methods.

Results

Of 409 ALK TKI-treated patients with advanced ALK+ NSCLC, mean age was 60.4 years and 51.6% were female. Most patients (n = 379; 92.7%) received crizotinib as their first ALK TKI; of these, 180 (47.5%) were later treated with a second ALK TKI (e.g. ceritinib, alectinib). Median (95% CI) rwPFS was 7.5 (6.6-8.6) months following first ALK TKI; and 6.4 (5.2-8.2) months following second ALK TKI post-crizotinib (including 6.3 [4.3-8.4] months for ceritinib (n = 99) and 7.6 [5.2-13.6] months for alectinib (n = 64)).

Conclusions

In this real-world analysis of patients with advanced ALK+ NSCLC treated with earlier approved ALK TKIs, rwPFS remains short, indicating a clear need for more effective treatments of ALK+ NSCLC.

Clinical trial identification

Legal entity responsible for the study

Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

Funding

Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

Editorial Acknowledgement

Writer: Beth Nordstrom; company: Evidera.

Disclosure

M. Jahanzeb: Research grant: Lilly, Boehringer Ingelheim, Callisto; Research grant and consultant: Ipsen, Roche/Genentech, Pfizer. H.M. Lin: Employment, stock and other ownership: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. X. Pan, A. Desai: Employment: Takeda. B.L. Nordstrom: Employment: Evidera. All other authors have declared no conflicts of interest.