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M. Edelman



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    MA16 - Novel Strategies in Targeted Therapy (ID 407)

    • Event: WCLC 2016
    • Type: Mini Oral Session
    • Track: Chemotherapy/Targeted Therapy/Immunotherapy
    • Presentations: 1
    • Now Available
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      MA16.10 - Lung-MAP (S1400) Lung Master Protocol: Accrual and Genomic Screening Updates (Now Available) (ID 3995)

      M. Edelman

      • Abstract
      • Presentation
      • Slides

      Background:
      Lung-MAP (S1400), is a master protocol that incorporates genomic testing of tumors through a next generation sequencing (NGS) platform (Foundation Medicine) and biomarker-driven (matched) therapies for patients with squamous cell lung cancer (SCCA) after progression on first-line chemotherapy.

      Methods:
      The Lung-MAP trial, activated June 16, 2014, includes 3 matched- and 1 non-match study. Matched studies include: S1400B evaluating taselisib, a PI3K inhibitor, S1400C evaluating palbociclib, a CDK 4/6 inhibitor and, S1400D evaluating AZD4547, an FGFR inhibitor. The non-match study S1400I tests nivolumab + ipilimumab vs. nivolumab. Two studies have closed: S1400E evaluating rilotumumab an HGF monoclonal antibody + erlotinib closed 11/26/2014 and S1400A evaluating MEDI4736 in non-match pts, closed 12/18/2015.

      Results:
      From June 16, 2014 to June 15, 2016, 812 pts were screened and 292 pts registered to a study: 116 to S1400A, 27 to S1400B, 53 to S1400C, 32 to S1400D, 9 to S1400E and 55 to S1400I. Demographics: Screening was successful for 705 (87%) of screened eligible pts. Median age 67 (range 35-92); male 68%; ECOG PS 0-1 88%, PS 2 10%; Caucasian 85%, Black 9%, other 5%; never/former/current smokers 4%/58%/36%. Table 1 displays biomarker prevalence; 39% of pts matched; 33.9%, 4.8%, and 0.3% with 1, 2, and all 3 biomarkers, respectively. Tumor mutation burden (TMB) was available for 636 (90.4%) of eligible pts. The distribution of TMB is: 126 (19.8%) low (≤5 mutations Mb), 415 (65.1%) intermediate (6-19 mutations/Mb), and 96 (15.1%) high (≥20 mutations/Mb). The median TMB was 10.1.

      Conclusion:
      Genomic screening is feasible as part of this master protocol designed to expedite drug registration, confirm anticipated prevalence of targeted alterations in SCCA and reveal intermediate or high TMB in most (80.2%) pts. Treatment results are not yet available as patients continue to accrue. Clinical trial information: NCT02154490

      Total FGFR CDK PIK3CA
      FGFR (15.9%) 12.9% 2.4% 0.6%
      CDK (18.8%) 14.6% 1.8%
      PIK3CA (8.8%) 6.4%
      Biomarker prevalence and overlap.


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    P3.02c - Poster Session with Presenters Present (ID 472)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      P3.02c-027 - Phase I and PK Study of the Folate Receptor-Targeted Small Molecule Drug Conjugate (SMDC) EC1456 in Advanced Cancer: Lung Cancer Subset (Now Available) (ID 5202)

      M. Edelman

      • Abstract
      • Slides

      Background:
      EC1456 is composed of folic acid conjugated through a releasable linker system to a potent microtubule inhibitor, tubulysin B hydrazide. EC1456 targets folate receptor (FR)-expressing cancer cells, which occur in approximately 60% of NSCLC cases and 14% of SCLC.

      Methods:
      The objectives of the ongoing Phase 1 are to determine the safety, PK, and optimal dosing schedule of EC1456 in advanced cancer pts. FR expression (not required for enrollment) is characterized in all pts using [99m]Tc-etarfolatide.

      Results:
      63 pts were dosed weekly (QW) or twice-weekly (BIW), for 2 consecutive weeks of a 3-week cycle. 8 NSCLC and 3 SCLC pts received doses ranging from 1.0-12.5 mg/m[2]. Toxicities are primarily Grade (Gr) 1 and 2. Common adverse events (AE) are GI, fatigue, and metabolic changes. Gr 3 infusion reaction (4.5 mg/m[2]) and Gr 3 headache (10.0 mg/m[2]) were seen in the QW cohort. The safety profile in lung cancer pts was similar to the overall population.

      BIW (N=32) QW (N=31) BIW Lung (N=4) QW Lung (N=7)
      All Drug Related All Drug Related All Drug Related All Drug Related
      ≥ 1 AE 32 (100%) 25 (78%) 29 (94%) 23 (74%) 4 (100%) 4 (100%) 7 (100%) 4 (57%)
      ≥ 1 grade 3 or 4 AE 19 (59%) 6 (19%) 14 (45%) 4 (13%) 2 (50%) 0 (0%) 1 (14%) 0 (0%)
      ≥ 1 serious AE 12 (38%) 2 (6%) 14 (45%) 5 (16%) 1 (25%) 0 (0%) 2 (29%) 0 (0%)
      Serious drug related AEs Constipation (2/63 pts); Abd pain, Anemia, Headache, Infusion reactions, and SVT(1/63 pts each)
      Response and durability of response is demonstrated in the figure: Figure 1



      Conclusion:
      EC1456 is well tolerated, with early indications of efficacy suggested by durable stable disease, and responses in this refractory population. Updated safety, PK, and efficacy data will be presented at the meeting.

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    YI01b - Scientific Mentoring (ID 415)

    • Event: WCLC 2016
    • Type: Young Investigator Session
    • Track:
    • Presentations: 1
    • Now Available
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      YI01b.01 - Important Factors for a Professional Career (Now Available) (ID 6739)

      M. Edelman

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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