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Lauren Bartolome



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    FP07 - Pathology (ID 109)

    • Event: WCLC 2020
    • Type: Posters (Featured)
    • Track: Pathology, Molecular Pathology and Diagnostic Biomarkers
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      FP07.16 - Trends in Biomarker Testing Among Advanced NSCLC Patients in Oncology Practice Settings in the US (ID 3325)

      00:00 - 00:00  |  Presenting Author(s): Lauren Bartolome

      • Abstract
      • Slides

      Introduction

      The NCCN guidelines for non-small cell lung cancer (NSCLC) state that testing for gene alterations is important to identify patients where targeted therapies may be efficacious, and to avoid therapies that are unlikely to provide clinical benefit. With the availability of genomic biomarker therapies that have shown prolonged median overall survival, there is a need to ensure that patients with NSCLC who may receive targeted biomarker therapies are identified.

      The objective of this study is to understand ALK, BRAF, EGFR, and ROS1 genomic biomarker testing and treatment initiation trends among individuals diagnosed with advanced stages of NSCLC in real-world oncology practice settings.

      Methods

      This retrospective analysis of data from the ConcertAI Patient 360 electronic health record database focused on adult patients diagnosed with advanced (stage IIIb-IV) NSCLC (aNSCLC) from January 2013 – December 2019. Study metrics included the proportion of patients with any biomarker test and specific biomarker tests stratified by year of aNSCLC diagnosis, the time between aNSCLC diagnosis and first biomarker test result, and the time between first biomarker test result to initiation of treatment. The time between aNSCLC diagnosis and biomarker testing were reported as continuous and categorical variables. The time between biomarker testing to initiation of treatment are reported among patients who received their first biomarker test before starting their first line treatment and were tested 30 days prior or 360 days post aNSCLC diagnosis date.

      Table 1: Biomarker testing trends overtime by year of aNSCLC diagnosis

      table 1.png

      Results

      Among 6,876 aNSCLC patients diagnosed from 2013-2019, 3,301 had first line (1L) treatment of which 54.26% were tested for at least one of ALK, BRAF, EGFR, or ROS. Annual trends are presented in Table 1: Biomarker testing trends overtime by year of aNSCLC diagnosis. EGFR testing data were most prevalent overall (49.56%) followed by ALK (40.84%), ROS (27.51%), then BRAF (13.97%). Testing rates increased for all biomarkers over time, with the largest increase observed in BRAF testing. About half of patients were tested within 30 days of aNSCLC diagnosis. Median days from test to treatment were between 15-16 days for ALK, BRAF, EGFR, and ROS1.

      Conclusion

      This snapshot of biomarker testing shows that progress has been made in the proportion of patients tested, however biomarker testing rates in US oncology practices are still suboptimal. Additional research is needed on the reasons or barriers to ordering timely biomarker testing among advanced and metastatic stage NSCLC patients.

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    P09 - Health Services Research/Health Economics - Real World Outcomes (ID 121)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Health Services Research/Health Economics
    • Presentations: 2
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P09.53 - Comparative Effectiveness of Crizotinib versus Entrectinib in ROS1+ Non-Small Cell Lung Cancer (NSCLC) using Clinical Trial and Real-World Data (ID 3528)

      00:00 - 00:00  |  Author(s): Lauren Bartolome

      • Abstract
      • Slides

      Introduction

      Crizotinib and entrectinib are licensed for treating ROS1+ advanced NSCLC.No head-to-head studies of crizotinib versus entrectinib exist; however, a prior analysis compared entrectinib clinical trial outcomes to crizotinib real-world data (RWD). Here, we compared the antitumor activity of entrectinib and crizotinib in clinical trial populations and different crizotinib RWD sources.

      Methods

      PROFILE 1001 (crizotinib), and the integrated analysis of ALKA-372-001, STARTRK-1, and STARTRK-2 (entrectinib) were deemed feasible for indirect treatment comparison (ITC). Simulated treatment comparisons (STC) were performed adjusting mutually reported baseline characteristics (BLC) to simulate the conditional mean adjusting BLC’s in PROFILE 1001 to those reported in the entrectinib studies. BLCs imbalanced between studies and included in the stepwise STC model were: age, sex, ethnicity, ECOG performance status, and smoking status. CNS metastatic status was not available to address across all studies. Outcomes analyzed included progression free survival (PFS), 12-month overall survival (OS12), objective response rate (ORR), and duration of response (DOR). A naïve comparison with crizotinib RWD from Flatiron and US Oncology/McKesson was conducted to evaluate the generalizability of the RWD outcomes to clinical trial cohort; at the time of analysis entrectinib RWD were unavailable.

      Results

      Median PFS of crizotinib (n=53) versus entrectinib (n=53) showed an adjusted STC mean difference (MD) of 2.15 months (95% CI: -16.78, 17.38) favoring crizotinib. Adjusted OS12 risk ratio (RR) was 1.08 (95% CI: 0.87, 1.41) favoring crizotinib. Adjusted ORR was RR=0.90 (95% CI: 0.74, 1.16) favoring entrectinib. Median DOR showed a MD of 4.18 months (95% CI: -18.96, 19.16) favoring crizotinib. Imbalances were observed between crizotinib clinical data versus RWD for the same BLC as for crizotinib clinical data versus entrectinib clinical data (Table). Both a shorter median real-world PFS and OS were observed among crizotinib RWD versus crizotinib clinical data; RWD source influenced outcomes.

      Characteristics

      PROFILE 1001

      (N=53)

      ALKA-372-001/STARTRK-1/STARTRK-2

      [Drilon Lancet Onc 2020]

      (N=53)

      Flatiron Crizotinib [Doebele ASCO 2019]

      (N=69)

      US Oncology [Pfizer Abstract]

      (N=38)

      Sex (Male) n (%)

      23 (43.4)

      19 (35.8)

      30 (49.5)

      13 (34.2)

      Age, years; median (range)

      < 65 n(%)

      38 (71.7)

      16 (42.1)

      ≥ 65 n(%)

      15 (28.3)

      22 (57.9)

      Missing

      Median (range)

      55 (25-81)

      53 (46-61)

      65 (55-73)

      Race n(%)

      White n(%)

      30 (56.6)

      31 (58.5)

      41 (59.4)

      27 (71.1)

      Asian n(%)

      21 (39.6)

      19 (35.8)

      6 (8.7)

      2 (5.3)

      Black or African American n(%)

      2 (3.8)

      3 (5.7)

      2 (5.3)

      Other Race

      22 (31.9)

      Missing

      7 (18.4)

      ECOG PS

      0

      23 (43.4)

      20 (37.7)

      16 (23.2)

      6 (15.8)

      1

      29 (54.7)

      27 (50.9)

      8 (11.6)

      17 (44.7)

      2

      1 (1.9)

      6 (11.3)

      17 (10.1)

      7 (18.4)

      Missing

      38 (55.1)

      8 (21.1)

      Smoking History, n (%)

      Never

      40 (75.5)

      31 (58.5)

      31 (44.9)

      15 (39.5)

      Former/Current

      13 (24.5)

      22 (41.5)

      38 (55.1)

      19 (50)

      Missing

      4 (10.5)

      Histological classification, n (%)

      Adenocarcinoma

      51 (96.2)

      52 (98)

      64 (92.8)

      29 (76.3)

      Squamous cell carcinoma

      1 (1.9)

      3 (4.4)

      5 (13.2)

      Other

      1 (1.9)

      1 (2)

      2 (2.9)

      1 (2.6)

      Missing

      3 (7.9)

      CNS disease present at baseline, n(%)

      N/A

      23 (43)

      17 (24.6)

      2 (5.3)

      Measurable

      5 (9)

      Not measurable

      18 (34)

      Number of prior advanced/metastatic regimens, n (%)

      0

      7 (13.2)

      17 (32.1)

      63 (91.3)**

      1

      22 (41.5)

      23 (43.4)

      2

      12 (22.6)

      13 (24.5)*

      ≥3

      12 (22.6)

      Median (range)

      2 (1-6)

      Clinical practice type, n (%)

      Community

      31 (58.5)

      54 (78.3)

      Academic

      22 (41.5)

      15 (21.7)

      Duration of Follow-up

      62.6 mos

      15.5 mos

      15.3 mos

      Outcomes, Median (95% CI)

      Duration of Response

      24.7 (95% CI: 15.2-45.3)

      24.6 (95% CI: 11.4-34.8)

      Treatment Duration

      14.6 mos

      Time to Treatment Discontinuation

      8.4 (95% CI: 6.2-10.1)

      25.2 (95% CI: 5.2-NE)

      Progression Free Survival

      19.3 (95% CI: 15.2-39.1)

      19 (95% CI: 12.2-36.6)

      Real-world PFS

      8.5 (95% CI: 6.2-10.1)

      Overall Survival

      51.4 (95% CI: 29.3-NE)

      NE (95% CI: 15.1-NE)

      19.9 (95% CI: 15.1-NE)

      36.2 (95% CI: 15.9-NE)

      *Two or mor prior regimens; **≤2 prior lines of therapy

      Conclusion

      While the STC analysis between crizotinib and entrectinib trials suggest numerical superiority for crizotinib in PFS, OS, and DOR and for entrectinib in ORR, these differences were not statistically significant. Limited sample size and data-gaps concealing relevant possible imbalances such as in baseline CNS represent major limitations of this approach. Comparisons to RWD may also have relevant data-gaps impacting balance, but RWD outcomes appear worse than trial datasets, limiting the usefulness of RWD as an artificial control arm versus trial data. In the future, a more accurate comparison using balanced RWD for both entrectinib and crizotinib is needed to draw firmer inferences.

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      P09.56 - Real-World Outcomes Among Patients with ROS1-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) (ID 3513)

      00:00 - 00:00  |  Presenting Author(s): Lauren Bartolome

      • Abstract
      • Slides

      Introduction

      Crizotinib was the first oral targeted agent approved by the FDA, on March 11, 2016, for ROS1-positive advanced non-small cell lung cancer (NSCLC). Data to support the long-term clinical benefit in a real-world setting is limited. The objective of this study was to assess real-world clinical outcomes among patients with ROS1-positive advanced NSCLC treated with crizotinib in the US community oncology setting.

      Methods

      This retrospective observational cohort study used iKnowMed electronic health record (McKesson/US Oncology) data to identify adult patients with ROS1-positive advanced NSCLC who had evidence of initiating crizotinib between January 17, 2013 (addition of crizotinib to NCCN treatment guidelines) and June 1, 2019. All patients were followed from crizotinib initiation until December 1, 2019 to estimate time to treatment discontinuation (TTD), time to next treatment (TTNT) and overall survival (OS). TTD was defined as the time between treatment initiation and treatment discontinuation for any reason or censoring. TTNT was defined as the time between crizotinib initiation and initiation of the next treatment. OS was defined as the time between crizotinib initiation and the date of death due to any cause. Descriptive analysis was used to characterize the study cohort. Kaplan-Meier analyses were used to describe OS, TTD, and TTNT. A Cox proportional hazards model was conducted to determine the association of age, Eastern Cooperative Oncology Group (ECOG) performance status and smoking status with OS.

      Results

      The study cohort included 38 patients diagnosed with ROS1-positive advanced NSCLC who received crizotinib with a median follow-up time of 15.3 months. The median age of the cohort was 68.0 (range: 37.0, 88.0) years and 65.8% were female. Fifty percent were current/former smokers, and 18.4% had an ECOG performance status of ≥2. Overall, 21 (55.3%) patients remained on crizotinib, 10 (26.3%) had evidence of subsequent treatment and 16 (42.1%) died. The median TTD was 25.2 months (95% CI: 5.2, not reached [NR]), and crizotinib discontinuation probabilities at 12, 24, 36 and 48 months were 43.5%, 47.8%, 69.1% and 69.1%, respectively. The median TTNT was 25.0 months (95% CI: 5.2, 61.0), and probabilities of remaining on crizotinib at 12, 24, 36 and 48 months were 57.8%, 54.2%, 33.9% and 33.9%, respectively. The median OS was 36.2 months (95% CI: 15.9, NR), and survival probabilities at 12, 24, 36 and 48 months were 71.9%, 64.9%, 60.5%, and 26.9%, respectively. In the Cox regression model, ECOG performance status of ≥2 was associated with a 4.9-fold higher risk of death (hazard ratio = 4.9; 95% CI: 1.3, 18.4) compared to ECOG performance status of 0-1. No benefits were observed for age and smoking status related to survival.

      Conclusion

      This real-world population is older, has a higher proportion of smokers and has a poorer ECOG performance status than those investigated in prior clinical trials. Still, our findings continue to support the clinical benefit of crizotinib in patients with ROS1-positive advanced NSCLC.

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    P76 - Targeted Therapy - Clinically Focused - EGFR (ID 253)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Targeted Therapy - Clinically Focused
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P76.69 - Real-World Effectiveness of EGFR TKI First-Line Treatment of Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer in US (ID 3350)

      00:00 - 00:00  |  Presenting Author(s): Lauren Bartolome

      • Abstract
      • Slides

      Introduction

      Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are recommended as first-line (1L) treatment for advanced EGFR mutation-positive (EGFRm+) non-small cell lung cancer (NSCLC). This study describes real-world progression free survival (rwPFS) and overall survival (OS) for patients initiating different generations (G) of EGFR TKIs for 1L treatment of advanced EGFRm+ NSCLC in US oncology practices.

      Methods

      In this retrospective study, adult patients diagnosed with advanced (Stage IIIB-IV) EGFRm+ NSCLC between January 1, 2013-September 30, 2018 who initiated 1L treatment with EGFR TKI monotherapy were identified from electronic medical records from US oncology practices available to ConcertAI. Kaplan Meier analyses were used to describe rwPFS and OS from the start of 1L therapy, separately for patients initiating different G of EGFR TKIs. A Cox proportional hazards model was used to evaluate the association of patient characteristics and treatment with risk of progression.

      Results

      The study population included 450 patients initiating 1L EGFR TKI monotherapy: 345 with 1G (erlotinib: 326 patients; gefitinib: 19 patients), 65 with 2G (afatinib), and 40 with 3G (osimertinib). The mean age was 67.6, 64.3, and 69.3 years among patients treated with 1G, 2G, and 3G EGFR TKI, respectively. The proportion of women was 71.0%, 76.9%, and 57.5% among patients treated with 1G, 2G, and 3G EGFR TKI, respectively. The median follow-up from start of 1L treatment to end of data collection was 17.7, 24.6, and 16.2 months for patients treated with 1G, 2G, and 3G EGFR TKI, respectively. During the follow-up period, 73.9%, 70.8%, and 47.5% of patients treated with 1G, 2G, and 3G EGFR TKI, respectively, had documented progression. Median rwPFS was 10.5 months (95% CI: 9.5, 11.8) with 1G EGFR TKI, 13.4 months (11.4, 18.5) with 2G, and 17.5 months (10.8, not reached) with 3G. The Cox model suggested that the following factors were associated with significantly higher risk of progression: 1L treatment with 1G vs 3G EGFR TKI (HR: 2.1; 95% CI: 1.3, 3.3), brain metastasis (1.3; 1.0, 1.6); liver metastasis (1.4; 1.1, 1.9), and exon 21 L858R substitution mutation vs. other EGFR mutations excluding exon 19 deletion (1.4; 1.1, 1.9). Among patients initiating treatment with 1G, 2G, and 3G EGFR TKI, respectively, 59.7%, 47.7%, and 35.0% died during the follow-up period. Median OS was 25.4 months (95% CI: 23.1, 27.4) with 1G EGFR TKI and 31.3 months (25.4, 52.6) with 2G. OS data for patients initiating 3G EGFR TKI were immature. 2L treatment with osimertinib was received by 19.4% and 36.9% of patients who had 1L treatment with 1G and 2G EGFR TKI, respectively.

      Conclusion

      The findings from this study suggest that rwPFS and OS for patients initiating 1L treatment with different G of EGFR TKIs for advanced EGFRm+ NSCLC are consistent with those reported in clinical trials. Risk of progression was associated with 1L treatment with 1G vs 3G EGFR TKI and patient disease characteristics.

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