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Kimberly Harrow



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    P1.13 - Targeted Therapy (Not CME Accredited Session) (ID 945)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.13-02 -  eXalt3: Phase 3 Randomized Study Comparing Ensartinib to Crizotinib in Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer Patients (ID 13294)

      16:45 - 18:00  |  Author(s): Kimberly Harrow

      • Abstract
      • Slides

      Background

      Ensartinib (X-396) is a novel, potent ALK small molecule tyrosine kinase inhibitor (TKI). It is well-tolerated and has shown promising activity in NSCLC patients in a phase 1/2 study in patients that were both ALK TKI naïve and patients that received prior crizotinib, as well as those with CNS metastases. The safety profile of ensartinib appears to be different from other ALK TKIs.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      In this global, phase 3, open-label, randomized study, approximately 270 patients with ALK+ NSCLC who have received no prior ALK TKI and up to one prior chemotherapy regimen will be randomized with stratification by prior chemotherapy (0/1), performance status (0-1/2), brain metastases at screening (absence/presence), and geographic region (Asia /other), to receive oral ensartinib (225 mg, once daily) or crizotinib (250mg, twice daily) until disease progression or intolerable toxicity.

      Eligibility also includes patients ≥ 18 years of age, stage IIIB or IV ALK+ NSCLC. Patients are required to have measurable disease per RECIST 1.1, adequate organ function, and an ECOG PS of ≤2. Adequate tumor tissue (archival or fresh biopsy) must be available for central testing. The primary endpoint is progression-free survival assessed by independent radiology review based on RECIST v. 1.1 criteria. Secondary efficacy endpoints include overall survival, response rates (overall and central nervous system [CNS]), PFS by investigator assessment, time to response, duration of response, and time to CNS progression. The study has > 80% power to detect a superior effect of ensartinib over crizotinib in PFS at a 2-sided alpha level of 0.05.

      Phase 3 recruitment began in June, 2016 and currently has 98 active sites in 21 countries. The duration of recruitment will be approximately 28 months. This study is registered with ClinicalTrials.Gov as NCT02767804.

      4c3880bb027f159e801041b1021e88e8 Result

      Section not applicable

      8eea62084ca7e541d918e823422bd82e Conclusion

      Section not applicable

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P1.13-03 - Ensartinib Treatment Beyond Disease Progression in Stage IV ALK+ Non-Small Cell Lung Cancer (ID 13293)

      16:45 - 18:00  |  Author(s): Kimberly Harrow

      • Abstract
      • Slides

      Background

      Anaplastic Lymphoma Kinase (ALK) positive non-small cell lung cancer (NSCLC) patients (pts) benefit from receiving ALK tyrosine kinase inhibitors (TKIs); however, despite initial activity, resistance invariably develops. Disease progression (PD) is sometimes limited to progression which occurs in only one or a few sites and may not occur systemically. Local treatment with radiation while continuing treatment with ensartinib may enable prolonged benefit beyond progression.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients who were ALK TKI naïve or had received prior ALK treatment received ensartinib 225mg QD until PD or unacceptable toxicity or investigator discretion. The primary endpoint was safety and tolerability, and the secondary endpoint was pharmacokinetic and preliminary biological activity. Tumor assessment was performed locally every 8 weeks. Post-progression treatment with ensartinib was allowed if the investigator felt the patient was still receiving benefit from ensartinib. Cycles were approximately every 28 days, and radiation therapy after Cycle 1 for isolated CNS metastases was permitted if there was no evidence of progressive disease elsewhere. Post-progression treatment data were captured and analyzed.

      4c3880bb027f159e801041b1021e88e8 Result

      As of the data cut-off (May 01, 2018), 12 pts with progression continued ensartinib treatment post progression (67% with progression only in the CNS, 75% of which had CNS lesions at baseline and 33% with progression only outside the CNS). Of the 12 pts, half of the patients were ALK TKI naïve and half had received at least one prior ALK TKI. Six pts received radiation therapy at the time of initial progression. The initial median Progression Free Survival (PFS) of the 12 pts with post progression treatment was 15.7 months and median secondary PFS (date of initial progression to the date of second progression or end of treatment) was 5.7 months for a combined duration of therapy of 23.8 months. A significantly longer duration of continued therapy was observed in patients who received radiation treatment than those who did not 8.6 mos vs 3.5 mos. The secondary PFS was longer in treatment naïve pts than in pts who received a prior ALK TKI, 7.7 mos vs 5 mos. After the initial progression, excluding lesions treated with radiation therapy, secondary stable disease was observed in 92% of patients. No new or additional safety risk was identified in the pts post progression.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Ensartinib may have clinical benefit in selected patients with NSCLC if continued post-progression. Secondary PFS was longer in patients treated with radiation therapy. Ensartinib was generally well tolerated in these patients treated post progression.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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