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Ahmet Sezer



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    P1.14 - Targeted Therapy (ID 182)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Targeted Therapy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.14-15 - Lorlatinib in ALK- or ROS1-Positive Non-Small Cell Lung Cancer Patients: Experience from an Early Access Program in Turkey (ID 1971)

      09:45 - 18:00  |  Author(s): Ahmet Sezer

      • Abstract

      Background

      Lorlatinib, a third generation ALK and ROS1 inhibitor, is indicated for the treatment of patients with ALK+ metastatic NSCLC whose disease has progressed on crizotinib and at least one second-generation ALK inhibitor. The aim of this study is to evaluate the efficacy and safety of lorlatinib in an Expanded Access Program (EAP) in Turkey.

      Method

      The EAP was open-label, multicenter, and single-arm. Patients were eligible to receive lorlatinib (100 mg p.o/day) if they had advanced stage ALK- or ROS1-positive NSCLC and had progressed on crizotinib and/or second generation ALK inhibitors such as ceritinib or alectinib. The primary endpoint was PFS with lorlatinib. Secondary endpoints were objective response rate, overall survival, and safety.

      Result

      Between February 2017 and December 2018, a total of 91 patients were admitted to the EAP at 27 oncology centers in Turkey. Eleven patients died before receiving the drug. Four patients were excluded from the EAP because of lost of the follow-up. Of the 76 patients who received drug, 13 were excluded from the analysis due to inability to access patient information. Six of these 13 patients were on lorlatinib treatment at the time of data collection. The median age of patients was 53.5 (17-84) years. Of 63 evaluable patients, 55 (87.3%) had ALK+ NSCLC and 8 (12.7%) had ROS1+ NSCLC. All patients had adenocarcinoma histology, and 54% (n=34) had brain metastasis before lorlatinib treatment. Twenty-one patients received lorlatinib as third-line treatment (mostly after chemotherapy and crizotinib). Median follow-up was 9.1 months. Five patients died before the first evaluation of response. In patients who received at least 1 dose of lorlatinib, median PFS was 12.6 months, and 1-year PFS rate was 53%. In ALK+ patients, median PFS was 14.7 months and 1-year PFS rate was 55%. In ROS1+ patients, median PFS was 9.1 months and 1-year PFS rate was 47%. In patients who received only crizotinib prior to lorlatinib, median PFS was 14.8 months and 1-year PFS rate was 59%. In patients who received ≥2 ALK inhibitors prior to lorlatinib, median PFS was 5.1 months and 1-year PFS rate was 27%. One-year OS rate was 65%. In response-evaluable patients (n=55), the ORR and DCR were 68.6% and 87.0% all patients. However, ORR and DCR were 69.6% and 87.0% for ALK+ and 62.5% and 87.5% for ROS1+ patients. Of response-evaluable 55 patients, the frequency of brain metastasis before lorlatinib was 54.5% (n=30). In only 7 patients (12.7%), brain metastasis developed under lorlatinib treatment. CNS control rate with lorlatinib was 87.3%. Dose reduction occurred in 9 patients (14.3%). Reasons for discontinuation of treatment were disease progression (n=17, 26.8%), adverse events (n=2, 3.2%), death (n=13, 20.6%), and unknown reasons (n=13, 20.6%).

      Conclusion

      In this EAP, lorlatinib showed systemic activity in patients with advanced ALK+ or ROS1+ NSCLC, regardless of CNS metastases and previous TKI treatment.