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HOWARD WEST



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    MA03 - Clinomics and Genomics (ID 119)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA03.12 - Discussant - MA03.09, MA03.10, MA03.11 (Now Available) (ID 3725)

      10:30 - 12:00  |  Presenting Author(s): HOWARD WEST

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    MA13 - Going Back to the Roots! (ID 139)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA13.05 - Nab-Paclitaxel Maintenance in Squamous Non-Small Cell Lung Cancer (NSCLC): Updated Results of the Phase III ABOUND.sqm Study  (Now Available) (ID 294)

      14:00 - 15:30  |  Author(s): HOWARD WEST

      • Abstract
      • Presentation
      • Slides

      Background

      Background: nab-Paclitaxel maintenance therapy after nab-paclitaxel/carboplatin induction in patients with advanced squamous NSCLC was evaluated in the phase III, randomized, controlled, open-label, multicenter ABOUND.sqm trial. At the 12-month follow-up, there was no statistically significant difference in progression-free survival (PFS) between patients randomized to maintenance nab-paclitaxel + best supportive care (BSC) vs BSC alone. However, a trend of an overall survival (OS) advantage was observed with nab-paclitaxel + BSC vs BSC alone. Here we report the 18-month follow-up of OS.

      Method

      Methods: Patients (aged ≥ 18 years) with histologically or cytologically confirmed stage IIIB/IV squamous NSCLC and no prior chemotherapy were eligible. Patients received four 21-day cycles of nab-paclitaxel 100 mg/m2 (days 1, 8, and 15) plus carboplatin AUC 6 (day 1) as induction. Patients with radiologically assessed complete or partial response or stable disease without clinical progression after 4 cycles were randomized 2:1 to maintenance nab-paclitaxel 100 mg/m2 (days 1 and 8 of each 21-day cycle) plus BSC or BSC alone until disease progression. The primary efficacy analysis was performed on the ITT population. PFS from randomization into the maintenance part of the study was the primary endpoint. Secondary endpoints included safety, OS (from randomization), and response.

      Result

      Results: 420 patients received induction therapy; 202 were randomized to maintenance nab-paclitaxel + BSC (n = 136) or BSC alone (n = 66). The median PFS in patients in the nab-paclitaxel + BSC arm vs those in the BSC-alone arm was 3.1 vs 2.6 months (HR, 0.85; P = 0.349), respectively; the median OS was 17.8 vs 12.2 months (HR, 0.71; P = 0.058), respectively. The overall response rate was 69.1% vs 57.6% (RRR, 1.20; P = 0.087). Following the maintenance part, 73.5% (nab-paclitaxel + BSC) and 68.2% (BSC alone) of patients received subsequent anti-cancer treatment. Over the entire study, the most frequent grade 3/4 TEAEs were neutropenia (53.1% vs 50.0%) and anemia (33.1% vs 32.3%); only peripheral neuropathy occurred in ≥ 5% of patients during maintenance (13.1% in the nab-paclitaxel + BSC arm).

      Conclusion

      Conclusion: Although PFS and OS differences were not statistically significant in the ITT population, the 18-month follow-up of OS demonstrated the feasibility of nab-paclitaxel maintenance therapy for patients with anced squamous NSCLC.

      ClinicalTrials.gov identifier: NCT02027428

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-127 - Antitumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 in NSCLC with EGFR Exon 20 Insertions (ID 1302)

      09:45 - 18:00  |  Author(s): HOWARD WEST

      • Abstract
      • Slides

      Background

      We report results of a phase 1/2 open-label, multicenter study of TAK-788 (NCT02716116), an oral investigational EGFR/HER2 inhibitor.

      Method

      Patients with advanced, previously treated NSCLC received daily TAK-788 in dose escalation and expansion cohorts based on tumor genotype. Antitumor activity was determined for patients with EGFR exon 20 insertions who received TAK-788 160 mg QD. Safety is reported for all patients across all doses and at 160 mg. To improve gastrointestinal tolerability, food intake instructions in this ongoing study were amended to allow for administration with or without a low-fat meal based on emerging clinical pharmacokinetic data in a healthy volunteer study (data on file).

      Result

      As of 14 Sep 2018, 101 patients (median age, 61 y; female, 70%; ≥2 prior anticancer therapies, 76%; brain metastases, 53%) were treated with TAK-788 at 5–180 mg QD. RP2D was determined to be 160 mg QD. 28 patients with EGFR exon 20 insertions were treated with 160 mg QD during dose escalation or in expansion cohort 1 (3.6 months on treatment; 3.8 treatment cycles [medians]); 24 patients remain on treatment. At data cutoff, best response (RECIST v1.1) among 26 patients with ≥1 disease assessment was PR, n=14; SD, n=9; and PD, n=1 (objective response rate, 54%; 95% CI: 33.4%–73.4%); 2 patients were unevaluable. 7/14 objective responses (all PR) were confirmed (6 awaiting confirmation; 1 unconfirmed PR at 160 mg QD); median time to response in these 14 patients was 56 days. 23/26 patients (89%; 95% CI: 69.9%–97.6%) achieved disease control. 23/24 evaluable patients with EGFR exon 20 insertions treated at 160 mg QD had decreased target lesion measurements (median best percent change, -32.6% [-79.1%–3.8%]). Most common TEAEs (≥20%) in patients treated with 160 mg QD: diarrhea (85%), rash (43%), nausea (41%), vomiting (30%), decreased appetite (28%), stomatitis (22%); grade ≥3 TEAEs (≥5%): diarrhea (26%); hypokalemia, nausea, stomatitis (7% each). Among patients treated with 160 mg QD, median dose intensity was 93%, rate of dose reduction due to AEs was 21.7%, and rate of treatment discontinuation due to AEs was 10.9%. There was no clear trend that response to TAK-788 was enriched in any single EGFR exon 20 insertion variant.

      Conclusion

      In NSCLC patients with EGFR exon 20 insertions, TAK-788 demonstrated antitumor activity and a safety profile consistent with other EGFR TKIs.

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    P1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 186)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.16-28 - The Humanistic Burden of ALK+ NSCLC: Findings from the ALKConnect Patient Insight Network and Research Platform (ID 1404)

      09:45 - 18:00  |  Author(s): HOWARD WEST

      • Abstract
      • Slides

      Background

      The ALKConnect Patient Insight Network (www.alkconnect.com) is a patient-centered online registry that provides support to and collects information from patients living with Anaplastic Lymphoma Kinase-Positive (ALK+) Non-Small Cell Lung Cancer (NSCLC). The objectives of this study were to: (1) describe the characteristics of patients in ALKConnect; (2) quantify patients’ preferences, ALK+ NSCLC symptom burden, and health-related quality of life (HRQoL); and (3) determine whether disease treatment and employment status were associated with HRQoL.

      Method

      Study inclusion criteria were US adults (18 years or older) living with ALK+ NSCLC who have internet access, and willingness to answer e-surveys. Cross-sectional ‘real-world’ data that were collected included demographics, disease history and status, comorbidities, treatments, patient preferences, and HRQoL (MD Anderson Symptom Inventory lung cancer module [MDASI-LC]), reported as symptom severity and interference in activities of daily living (walking, activity, work, relations with others, enjoyment, and mood) caused by symptoms. Data were reported descriptively overall and by subgroups of interest (e.g., treatments, employment status) where sample sizes permitted. Associations between patient treatment history and employment status and HRQoL were analyzed.

      Result

      Data for 104 patients were available. Median age was 53.0 years (range 22-90), 67.3% were female, 84.0% were White (n=84), 12.0% were Asian (n=12), and 40.0% (n=40) were employed. Most patients were treated with ALK tyrosine kinase inhibitors (TKIs) (83.7% [n=87] ALK TKI only). Among treatment-associated preferences, preventing disease progression, shrinking tumor size, and maintaining HRQoL were perceived to be the most important treatment attributes. An additional 3-month delay in disease progression was perceived to be meaningful by 57.7% (n=60) of patients. MDASI-LC inventory data (from n=75 patients) showed that the most bothersome patient-reported symptoms were fatigue, sleep disturbance, drowsiness, difficulty remembering, and constipation. Interference on patient HRQoL was greatest for work and activity. Statistically-significant associations were observed between HRQoL and treatment with ALK TKIs (Symptom Severity p=0.0062, Interference p=0.0016), number of prior ALK TKIs (Symptom Severity p=0.1487, Interference p=0.0137), and employment status (Symptom Severity p=0.0201, Interference p=0.0210).

      Conclusion

      ALKConnect gathered humanistic burden data directly from patients with ALK+ NSCLC. Participants reported that the most burdensome symptoms were fatigue, sleep disturbance, and drowsiness, and that symptoms interfered most with work and general activity. A 3-month delay in cancer progression and HRQoL were important treatment attributes. Patients’ HRQoL was positively associated with ALK TKI treatment and the ability to maintain employment status, suggesting that these aspects may be important for ALK+ NSCLC patients’ well-being.

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