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Ref Type
PMID
Authors A.Prelaj, A.Bottiglieri, C.Proto, G.Lo Russo, D.Signorelli, R.Ferrara, G.Galli, A.De Toma, G.Viscardi, M.Brambilla, R.Lobefaro, S.Manglaviti, M.Occhipinti, A.Labianca, R.Gallucci, G.Molino, N.Zilembo, F.G.Greco, V.Torri, M.C.Garassino
Title Poziotinib in advanced NSCLC with EGFR or HER2 exon 20 insertion mutation: Initial results from a single site expanded access program
URL https://www.sciencedirect.com/science/article/pii/S0923753420416989
Abstract Text Background: Treatment of metastatic Non-Small Cell Lung Cancer (mNSCLC) patients (pts) with EGFR or HER2 exon 20 insertion mutation (i-mut) still remains an unmet clinical need. Up to now the standard of care, is platinum-based chemotherapy (PL) +/- immunotherapy (IO). Poziotinib (POZ), a new generation Tyrosine Kinase Inhibitor (TKI) is currently under investigation as a potential target therapy. This real-life compassionate use study aim is to describe the activity and toxicity (TOX) of POZ in mNSCLC pts with exon 20 i-mut. Methods: Pts were treated within an expanded access program (EAP) at Istituto Nazionale Tumori of Milan. POZ (16 mg or less) was administrated orally QD and dose reduction for TOX was allowed. All necessary data were collected [e.g.: treatment outcome and Adverse Events (AEs)]. Efficacy endpoints were median Progression-Free Survival (mPFS), Overall Response Rate (ORR), Disease Control Rate (DCR) assessed by RECIST v1.1. TOX and Overall Survival (mOS) were also evaluated. Results: Among 29 pts, median age was 59 years (25-80), most were female (76%), Performance Status 0-1 (83%), EGFR i-mut (72%) and pre-treated (93%) with a median of 1 prior therapy (0-6)(e.g.: PL, TKIs, IO). 72% started POZ at a dose 16 mg. At baseline bone, brain, liver, metastases, and pleural/pericardial effusion were present in 83%, 55%, 41% and 65% of pts, respectively. At data cut-off, progression occurred in 17/29 (58%) and death in 10/29 (34%). Median follow-up was 8 months (mo) (CI95% 4.1 – 11.8 mo), the mPFS was 5.6 mo (CI95% 3.6–7.1 mo) and the mOS 9.5 mo (CI95% 5.1–not-reached mo). The ORR was 27.6% (EGFR 19%, HER2 50%) and DCR 69% confirmed by a central review. 100% of pts experienced AEs, 89% a dose interruption and 76% a dose reduction. G3-4 AEs were reported in 66% of pts and were: skin rash (50%), gastrointestinal toxicities (31%, mostly diarrhea) mucositis (7%), paronychia (3%). One G5 pneumonitis possible drug-related occurred. Conclusions: POZ demonstrated clinical activity in mNSCLC pts with EGFR and HER2 exon 20 i-mut. Reported TOX rate was high leading to a frequent dose interruption and reduction possibly reducing PFS in patients with good ORR and DCR. ZENITH20, an ongoing trial is evaluating lower dose and new dose schedule (e.g. BID).

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References