P1.14-15 Lorlatinib in ALK- or ROS1-Positive Non-Small Cell Lung Cancer Patients: Experience from an Early Access Program in Turkey

Abstract

every scheduled visit (8 weeks) until disease progression. Cobas EGFR Mutation Test v1 and v2 (Roche, USA) was used to detect 42 mutations at EGFR gene in exons 18 to 21, including T790M mutation. Radiological assessment was performed in accordance with RECIST 1.1 criteria. Result: Twenty-seven patients were treated with osimertinib from October 2015 until December 2018. At the beginning of osimertinib treatment only 17/27 (63%) patients had detectable T790M mutation in plasma, but almost all patients 26/27 (96%) had detectable plasma EGFR activating mutations (AM). During osimertinib treatment T790M mutation was cleared from plasma in all 17 patients regardless of response to treatment. On the contrary, only 12/26 (45%) patients had AM plasma clearance. Only 3 of them had had progress at median follow up of 17.5 months, what demonstrates significantly longer progression-free survival (PFS) of patients with AM plasma clearance compared to patients without AM clearance (HR 0.19; 95% CI 0.05 e 0.70, p ¼ 0.01) (Figure 1). Of the 14 patients that progressed during the observation period all had AM reapperance in cfDNA at the time on progression, while T790M only recurred in one. Conclusion: Clearance of EGFR AM in plasma during osimertinib treatment is associated with longer PFS, while clearance of T790M has no impact on survival in our small group of patients. Dynamic changes in EGFR AM might be a useful marker of outcome in patients treated with osimertinib, but further studies are needed.

An International Real-World Analysis of the Efficacy and Safety of Lorlatinib Through Early or Expanded Access Programs in Patients With Tyrosine Kinase Inhibitor–Refractory ALK-Positive or ROS1-Positive NSCLC

“…Others have shown similar results, albeit with much fewer patients. 20,21 In addition, the incidence of AEs was lower in our patients, possibly owing to regional practice differences in the management of AEs. Our study supported the use of lorlatinib for patients with TKI-refractory ALKþ or ROS1þ NSCLC.…”

Testing for EGFR Mutations and ALK Rearrangements in Advanced Non-Small-Cell Lung Cancer: Considerations for Countries in Emerging Markets

“…In response-evaluable patients (n=55), the ORR and disease control rate were 68.6% and 87.0%, respectively; ALK+ patient responses were 69.6% and 87.0%, respectively. 154 Patients receiving erlotinib therapy had significantly improved OS rates compared with patients who received non-TKI treatments (288 versus 119 weeks; p=0.004), whereas PFS rates were not significantly different in patients who did and did not receive erlotinib (32±5 versus 33±3 weeks; p=0.755). Patients expressing both EGFR and KRAS mutations reported the lowest OS rate.…”