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Heather Wakelee



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    JICC01 - Joint IASLC-CAALC-CSCO Session: The Truth and Myth of Oral Anti-VEGFR Inhibitors for Advance NSCLC (ID 276)

    • Event: WCLC 2020
    • Type: Workshop
    • Track: N.A.
    • Presentations: 1
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      JICC01.06 - From Antibody to Small Molecule: What is the Difference? (ID 4265)

      07:00 - 09:00  |  Presenting Author(s): Heather Wakelee

      • Abstract

      Abstract not provided

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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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      P76.85 - Afatinib and Necitumumab in EGFR mutant NSCLC with Acquired Resistance to 1st or 3rd Generation EGFR Tyrosine Kinase Inhibitors (ID 3547)

      00:00 - 00:00  |  Author(s): Heather Wakelee

      • Abstract
      • Slides

      Introduction

      There are no approved targeted therapies for patients (pts) with EGFR mutated NSCLC who develop acquired resistance to frontline 3rd generation (gen) tyrosine kinase inhibitors (TKI) osimertinib (osi), 2nd line osi (T790MPOS after 1st/2nd gen TKI), or frontline 1st/2nd gen TKI and T790MNEG. Dual EGFR blockade with TKI (afatinib) and monoclonal antibody (necitumumab) may overcome resistance in these scenarios.

      Methods

      This was a phase I 3+3 dose escalation of afatinib plus necitumumab in pts with EGFR mutated NSCLC who progressed on 1st gen TKI (T790MNEG), 1st line osi, and subsequent line osi (T790MPOS after 1st/2nd gen TKI). Afatinib was dosed oral daily and necitumumab dosed IV day 1 and 15 of a 28-day cycle. Dose levels (DL) included: DL1 Afatinib 30 mg, Necitumumab 400 mg; DL2 Afatinib 40 mg, Necitumumab 400 mg; DL3 Afatinib 40 mg, Necitumumab 600 mg; DL4 Afatinib 40 mg, Necitumumab 800 mg. Three dose expansion cohorts (15 pts each in above scenarios) are enrolling at the maximum tolerated dose (MTD).

      Results

      Enrollment completed in the phase I portion (07/2017-07/2019): 3 DL1, 3 DL2, 3 DL3, and 4 DL4. Four pts progressed on 1st gen TKI (T790MNEG), 1 pt on 1st line osi, and 8 pts on subsequent line osi (T790MPOS after 1st/2nd gen TKI). Two dose limiting toxicities were observed in DL4, including grade (G) 3 diarrhea and symptomatic G3 rash (delayed DLT given occurrence after first 28 days); therefore, DL3 was the MTD. At the time of data cutoff (Aug 26, 2020), 3 pts have enrolled in dose expansion; 1 pt progressed on 1st line osi, 1 pt progressed on 1st gen TKI (T790MNEG), and 1 pt on subsequent line osi (T790MPOS after 1st/2nd gen TKI). The most common treatment-related adverse events of all grades included rash (88%; 2 G3), diarrhea (56%; 1 G3), paronychia (38%; 0 G3), mucositis (31%; 1 G3), fatigue and vomiting (25% each; 0 G3), fever, headache, nausea, and pruritus (23% each; 0 G3). There was no pneumonitis; 1 pt had G1 hypomagnesemia. Six patients required dose reductions, median of 2. While no objective responses were observed in this heavily pre-treated population (median 4 prior lines of therapy), the disease control rate was 38% (6/16) and all pts with stable disease were on treatment ≥15 weeks. Reasons for treatment discontinuation included disease progression (n=14), toxicity (n=1) and pt decision (n=1).

      Conclusion

      The combination of afatinib and necitumumab had expected toxicities of rash and diarrhea. Trial is ongoing, and the MTD of afatinib 40 mg and necitumumab 600 mg is being tested in 3 dose expansion cohorts.

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    PL04 - A Vision for Clinical Trials in 2020 and Beyond (Japanese, Mandarin, Spanish Translation Available) (ID 145)

    • Event: WCLC 2020
    • Type: Plenary
    • Track: N.A.
    • Presentations: 1
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      PL04.01 - Chair (ID 3917)

      07:00 - 09:00  |  Presenting Author(s): Heather Wakelee

      • Abstract

      Abstract not provided