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Primo Lara



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    OA05 - Clinical Trials in IO (ID 899)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 13:30 - 15:00, Room 106
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      OA05.02 - Epacadostat Plus Pembrolizumab in Patients with Non-Small Cell Lung Cancer: Phase 1/2 Results from ECHO-202/KEYNOTE-037 (ID 13535)

      13:40 - 13:50  |  Author(s): Primo Lara

      • Abstract
      • Presentation
      • Slides

      Background

      Epacadostat (E) is a potent, highly selective inhibitor of the indoleamine 2, 3-dioxygenase 1 (IDO1) enzyme. ECHO-202/KEYNOTE-037 is an open-label, phase 1/2 study of E + pembrolizumab (P) in patients (pts) with advanced tumors (NCT02178722). We report updated efficacy and safety data for the phase 1 and 2 non-small cell lung cancer (NSCLC) cohort as of 8 Jan 2018 data cutoff.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Adult pts with prior platinum-based therapy (tx), no prior immune checkpoint inhibitors, and those intolerant to EGFR-targeted therapy were eligible. Pts could receive E (25, 50, 100, or 300 mg twice daily [BID]) + P (2 mg/kg or 200 mg every 3 weeks [Q3W]) during phase 1; maximum tolerated dose was not achieved. E (100 mg BID) + P (200 mg Q3W) tx doses were selected for phase 2 evaluation. Efficacy was assessed by RECIST v1.1 criteria. Programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) was evaluated using the 22C3 pharmDx assay. IDO1 status was measured by RNAScope. Safety was assessed in pts receiving ≥1 E + P dose.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 70 pts (phase 1, n=12; phase 2, n=58) were evaluated. Median age was 63 years and 57% of pts were female. EGFR mutation status (+/-/not available) was 10%/71%/19%; KRAS status was 19%/26%/56%, respectively. Most pts had adenocarcinoma (70%), a history of smoking (76%), and 0–1 prior lines of tx (64%). PD-L1 TPS results were available in 55/70 pts; IDO1 status (+/-) in 41/70 pts. Overall, the objective response rate (ORR; complete response [CR] + partial response [PR]) and disease control rate (CR + PR + stable disease [SD]) were 29% (20/70; 17 PR) and 50% (35/70; 15 SD), respectively. ORR was 22% (2/9) in pts with TPS ≥50% and 0–1 prior tx; for pts with TPS <50% and 0–1 prior tx, ORR was 22% (5/23). ORR for pts with IDO1+ and IDO1- tumors were 24% (6/25) and 19% (3/16), respectively. At data cutoff, 10/20 responses were ongoing. Median progression-free survival (PFS) was 4.0 mo (90% confidence interval, 2.1–6.2 mo); PFS rates at 6, 12, and 18 mo were 43% (33%–53%), 31% (22%–40%), and 17% (10%–26%), respectively. Grade ≥3 treatment-related adverse events (TRAEs) were reported in 27% of pts; 3 pts discontinued due to TRAEs; and no TRAEs led to death.

      8eea62084ca7e541d918e823422bd82e Conclusion

      The E + P combination was generally well tolerated and associated with promising responses in pts with NSCLC.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    OA11 - Thymic and Other Thoracic Tumours: Targeted Therapies, Biomarkers and Neo/Adjuvant Radiotherapy (ID 919)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Thymoma/Other Thoracic Malignancies
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 13:30 - 15:00, Room 205 BD
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      OA11.02 - A Population-Based Study of Incidence and Survival Trends of 1,588 Thymic Malignancies: Results from the California Cancer Registry (ID 12459)

      13:40 - 13:50  |  Author(s): Primo Lara

      • Abstract
      • Presentation
      • Slides

      Background

      Thymic malignancies (TM) are rare with sparse population-based epidemiologic literature. According to data collected by the National Cancer Institute from 1973 to 2006, the incidence of thymomas is 0.13 per 100,000 person-years in the United States.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We used data from the California Cancer Registry (CCR), a comprehensive population-based state registry to examine TM incidence and survival trends in California from 1988 to 2015. Cases were specified by site (thymus), histology (thymic carcinoma and thymoma), and behavior (malignant). Primary endpoints were cause-specific survival (CSS) and overall survival (OS). Age-adjusted incidence rates were calculated in SEER*Stat, and Joinpoint regression was used to analyze incidence trends. Hazard ratios (HR) for CSS and OS were calculated using a Cox proportional hazards regression model controlling for relevant baseline variables including age, gender, stage, and year of diagnosis, among others.

      4c3880bb027f159e801041b1021e88e8 Result

      We identified 1,588 TM cases in California from 1988 to 2015 with an annual percent increase of 2.08% (95% CI: 1.3%, 2.9%; p < 0.0001). The incidence of TM in 2015 was 0.277 per 100,000. Thymic carcinoma histology was associated with worse CSS across all stages, including localized (HR 7.56, 95% CI 1.44, 39.78), regional (HR 4.23, 95% CI 2.55, 7.01), and remote (HR 2.09, 95% CI 1.37, 3.19) disease. Compared to no treatment, surgery with or without radiation was associated with improved CSS in localized (surgery: HR 0.05 (95% CI 0.01 to 0.35), surgery + radiation: HR 0.12 (95% CI 0.02 to 0.84)) and regional disease (surgery: HR 0.11 (95% CI 0.04 to 0.29), surgery + radiation: HR 0.15 (95% CI 0.06 to 0.36)). Chemotherapy and radiation was also associated with improved CSS in regional disease (HR=0.22 (95% CI 0.07 to 0.63) and remote disease (5.16 (0.37, 71.94)), though the latter was not statistically significant.

      8eea62084ca7e541d918e823422bd82e Conclusion

      This is a population-based study of TMs from the CCR that identifies baseline variables significantly associated with CSS. TM incidence appears to be increasing over time. Advanced stage and thymic carcinoma were found to be associated with worsened CSS, which is consistent with previous studies. Treatment incorporating surgery was associated with improved CSS in local and regional disease, as was chemoradiation in regional disease. Improvement in CSS trended towards significance in patients with remote thymic neoplasms treated with chemoradiation. These findings provide a more contemporary database for future TM outcomes research.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.13 - Targeted Therapy (Not CME Accredited Session) (ID 979)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.13-26 - Outcomes of Patients with Metastatic Lung Cancer Presented in a Multidisciplinary Molecular Tumor Board (ID 12838)

      12:00 - 13:30  |  Author(s): Primo Lara

      • Abstract
      • Slides

      Background

      With the adoption of broad genomic profiling, interpretation of genomic data in NSCLC has become increasingly complex. Approved targeted therapies against oncogenic driver mutations have improved clinical outcomes for patients whose lung cancers harbor these genomic alterations. However, for other patients, the benefit of broad genomic sequencing is not fully proven. Multidisciplinary molecular tumor boards (MTB) may improve clinical outcomes by appropriately matching targeted treatments.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We retrospectively reviewed clinical, pathologic, and molecular data of metastatic lung cancer patients presented at the UC Davis MTB from January 2016 through May 2017. Genomic alterations were identified by hybrid capture-based comprehensive genomic profiling to a median coverage depth of >500X for 315 cancer-related genes (FoundationOne®).

      4c3880bb027f159e801041b1021e88e8 Result

      Out of 48 patients presented, 19 (39.6%) had lung cancer. Fourteen patients (73.7%) had adenocarcinoma, 1 SCLC, 1 squamous, 2 neuroendocrine, and 1 mixed histology. Seventeen patients were available for follow-up.

      Median number of prior treatments was 2 (range: 0-7) and median number of prior targeted therapies was 2 (range: 0-5). On average, each tumor sample had 5.3 genomic alterations (range 2 – 14). Every sample had ³1 actionable mutation, in that matched targeted therapy was available in the form of an FDA-approved drug for NSCLC, FDA-approved drug in another tumor type, or genomically informed clinical trial. Tumors harbored an EGFR mutation (N=7), HER2 amplification (N=2), BRAF V600E (N=2), or mutation in BRCA1 (N=1), KIT (N=1), or PTCH1 (N=1). All 7 patients with an EGFR mutation had previously received EGFR-targeted therapy, six with progressive disease (PD) on prior EGFR-TKI.

      Thirteen patients (76.5%) received targeted therapy, including FDA-approved therapy for NSCLC (N=4), FDA-approved therapy for another tumor type (N=6), or a genomically informed clinical trial (N=3). The other four patients were either on an immunotherapy clinical trial (N=2) or could not tolerate treatment (N=2). Out of the 13 patients who received targeted therapy, 4 patients had a partial response (31%) (3 EGFR, 1 BRAF V600E), all other patients had stable disease or PD. Median PFS on MTB-selected treatment was 4.8 months (range: 25% 2.2 – 75% 10.7 months).

      8eea62084ca7e541d918e823422bd82e Conclusion

      MTB at an academic medical center matched a high percentage of patients to either a targeted treatment or clinical trials with targeted therapies or immunotherapy. A subset of patients had clinical benefit to targeted therapies in this pretreated population. Multidisciplinary expertise at MTB can guide treatment for NSCLC, but new targeted treatments are needed to improve clinical outcomes.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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