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• W2889866282 abstract "9015 Background: TAK-788 is an investigational TKI with potent, selective preclinical activity against activating EGFR and HER2 mutations, including exon 20 insertions. We report the first results of a phase 1/2 first-in-human, open-label, multicenter study of TAK-788 (NCT02716116). Methods: Pts with advanced NSCLC refractory to standard therapy received daily oral doses (5–120 mg) of TAK-788 in the ongoing dose-escalation phase (3+3 design). Preliminary antitumor activity (by RECIST v1.1), safety, and PK are reported for pts receiving ≥1 dose. Results: As of 8 September 2017, 34 pts (median age, 60 y; female, 65%; ≥2 prior anticancer therapies, 88%; Table) were treated and 10 remain on TAK-788 at data cutoff. AUC0-24,ss increased in a dose-proportional manner over the dose range with effective t1/2 of ∼16 (range 6–28) h. Most common treatment-emergent AEs (TEAEs; ≥20% of pts): diarrhea (47%), nausea (26%), fatigue (21%). Grade ≥3 TEAEs in ≥2 pts (excluding disease progression): dyspnea (n = 3, 9%); anemia, asthenia, dehydration, lung infection, pleural effusion, pneumonia, pneumonitis (n = 2 each, 6%). Two DLTs, both pneumonitis, were reported (80 mg, grade 3; 120 mg, grade 5). Of 14 evaluable pts, 3 had PR (80 mg, n = 2, both confirmed; 120 mg, single PR awaiting confirmation), 6 had SD (40 mg, n = 3; 80 mg, n = 2; 120 mg, n = 1), and 5 had PD as best response (40 mg, n = 3; 80 mg, n = 1; 120 mg, n = 1); all pts with PR or SD had EGFR exon 20 insertions. Conclusions: TAK-788 exhibits antitumor activity in pts with EGFR exon 20 insertions with an AE profile consistent with other EGFR TKIs. Phase 2 will begin after determination of the RP2D, with 4 molecularly defined cohorts in NSCLC.Clinical trial information: NCT02716116.Baseline characteristics. 5 mg (n = 4) 10 mg (n = 5) 20 mg (n = 5) 40 mg (n = 6) 80 mg (n = 7) 120 mg (n = 7) Total (n = 34) Mutation type,a % Common EGFR mutations (exon 19 deletion / L8585R) 25 20 0 0 0 0 6 EGFR-T790M+ 0 0 0 0 14 0 3 EGFR exon 20 insertion 50 40 60 83 71 57 62 HER2 0 20 40 17 14 29 21 aOne pt (20 mg) had both EGFR and HER2 mutations; 1 pt (80 mg) had EGFR exon 20 insertion + T790M." @default.
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• W2889866282 date "2018-05-20" @default.
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• W2889866282 title "First report of safety, PK, and preliminary antitumor activity of the oral EGFR/HER2 exon 20 inhibitor TAK-788 (AP32788) in non–small cell lung cancer (NSCLC)." @default.
• W2889866282 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.9015" @default.
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