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Jorge Nieva



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    MA 07 - ALK, ROS and HER2 (ID 673)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Advanced NSCLC
    • Presentations: 1
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      MA 07.02 - Response to Ensartinib in TKI Naïve ALK+ NSCLC Patients (ID 10247)

      15:45 - 17:30  |  Author(s): Jorge Nieva

      • Abstract
      • Presentation
      • Slides

      Background:
      Ensartinib is a novel, potent anaplastic lymphoma kinase (ALK) small molecule tyrosine kinase inhibitor (TKI) with additional activity against MET, ABL, Axl, EPHA2, LTK, ROS1, and SLK. Ensartinib has demonstrated significant anti-tumor activity in both ALK TKI-naïve and crizotinib-resistant NSCLC patients. We report on data from ALK TKI treatment naïve patients.

      Method:
      Pts with advanced solid tumors and ECOG PS 0-1 were treated with ensartinib 225 mg qd on a continuous 28-day schedule. In expansion phase, pts were required to have measurable ALK+ NSCLC with tissue confirmed centrally via FISH or IHC. Asymptomatic brain metastases were allowed. Targeted NGS of cfDNA was performed retrospectively at baseline and on study and compared with tissue results.

      Result:
      As of 01Apr2017, 102 pts enrolled. In the ALK TKI naïve cohort, 15 (8 female, 7 male) ALK+ NSCLC pts treated at doses ≥ 200 mg evaluable for response. 4 pts had received prior chemotherapy. Median age 59 (34-80) yrs, 60% had ECOG PS 1. Partial response (PR) achieved in 13 pts (87%). Six pts had ALK detected via plasma NGS. In two patients who did not respond to ensartinib, tissue was positive via FISH and plasma was negative. Seven patients had insufficient plasma for NGS evaluation. Median PFS in the initial 13 evaluable ALK+ pts was 25.6 mos with the longest being 44+ mos. The PFS for all patients is still maturing. In 3 pts with central nervous system (CNS) target lesions and no prior radiation, 1 had a complete response (CR) and 2 had PR for an ORR of 100%. Most common drug-related AEs (>20% of pts) included rash (54%), nausea (34%), pruritus (26%), vomiting (25%), and fatigue (21%). Most AEs were Grade (G) 1-2. Most common G3 tx-related AE was rash (12 pts).

      Conclusion:
      Ensartinib was well-tolerated and induced responses in ALK TKI naïve ALK+ NSCLC pts, including pts with CNS lesions. Enrollment is ongoing in the phase 3 study of ensartinib vs. crizotinib in ALK TKI naïve NSCLC patients.

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    P1.11 - Patient Advocacy (ID 697)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Patient Advocacy
    • Presentations: 1
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      P1.11-004 - Impact of Liquid Biopsy on the Treatment of Low-Income Lung Cancer Patients (ID 8840)

      09:30 - 16:00  |  Presenting Author(s): Jorge Nieva

      • Abstract
      • Slides

      Background:
      A number of patients with lung cancer receive their oncologic care at safety net hospitals that primarily treat low-income patients. These hospitals lack resources for rapid tissue biopsy and do not routinely offer liquid biopsies. Up to 25% of patients with non-small cell lung cancer (NSCLC) have insufficient tissue recovered on biopsy for genotyping. Guardant360 is a non-invasive cell-free circulating tumor DNA (cfDNA) test providing comprehensive genomic profiling of genes recommended by the National Comprehensive Cancer Network (NCCN).

      Method:
      We enacted a program at Los Angeles County-USC Medical Center aimed at increasing patient access to Guardant360. For testing costs, qualified patients were enrolled in the testing company's financial assistance program, subject to meeting financial eligibility criteria. Additionally, patients had access to a mobile phlebotomy service. We identified patients with metastatic NSCLC who had undergone Guardant360 testing between August 2016 and February 2017. Medical records were reviewed for results of molecular testing (tissue and cfDNA) and the impact of Guardant360 on clinical decision-making. We also reviewed tissue-based testing for EGFR mutations and ALK rearrangements ordered at Los Angeles County-USC Medical Center on 664 patients with lung cancer from 2005 to 2015.

      Result:
      Guardant360 testing was sent on 10 patients with NSCLC, 9 with adenocarcinoma and one with squamous histology. Seven had somatic mutations on cfDNA analysis with 3 of these seven patients having a targetable mutation, as defined by NCCN. Tissue was sent for molecular testing on 5 of the 10 patients with four patients having cfDNA results concordant with tissue results. For the remaining five patients, there was either insufficient tissue for testing (N=3) or testing was not ordered (N=2). In this cohort of uninformative tissue results, cfDNA results found one patient with an ALK rearrangement, one patient with a KRAS mutation, and no targetable mutations in three patients. The patient with ALK rearrangement had therapy changed based on Guardant360 results. On review of tissue-based testing for 664 patients, ordered at Los Angeles County-USC Medical Center, there were no ALK and EGFR testing results available for 79% and 75.8% of patients, respectively.

      Conclusion:
      Liquid-based biopsies can be useful in identifying patients with targetable mutations. Implementation of programs that give patients access to liquid biopsy in resource-limited environments, in which over 75% had incomplete tissue results, has the potential to impact care. This data highlights the potential benefit of liquid biopsy and illustrates how this program lead to changes in therapy for some patients.

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