FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2516996537> ?p ?o ?g. }

• W2516996537 endingPage "8045" @default.
• W2516996537 startingPage "8045" @default.
• W2516996537 abstract "8045 Background: P is a fully human anti-HER3 antibody that inhibits HER3 binding with its ligand heregulin (HRG). Preclinically, P enhances anti-tumor activity with EGFR inhibitors, prevents HER3 reactivation after anti-EGFR treatment, and inhibits HRG-dependent activation. Phase Ib showed that P, with E (150mg/day PO), was tolerated at 18mg/kg IV q3w. Methods: This Ph2 randomized, placebo-controlled double-blind study assessed safety and efficacy of P+E vs. placebo (Pbo)+E in E-naïve sbjs with advanced NSCLC (2nd or later line). 215 sbjs were randomized to: 1) High Dose [HD]: P 18 mg/kg IV q3w; 2) Low Dose [LD]: P: 18 mg/kg IV X 1, 9 mg/kg IV q3w maintenance; or 3) Pbo q3wk. All subjects received E 150 mg/day PO. Endpoints included PFS (primary), and OS and safety (secondary). HRG, measured as mRNA, was prospectively hypothesized to be the primary predictive biomarker before database lock. High/Low HRG cutoff was set at the median of the blinded data. Results: 212 sbjs comprised the ITT. Median (m) PFS for ITT for HD, LD, and Pbo arms was 1.4 mos (HR 0.98), 2.5 mos (HR 0.77), and 1.6 mos, respectively (p=NS). 101 sbjs (51 HRG high) had adequate tissue for HRG testing. PFS was significantly improved in the HRG high subgroup (Table). HRG low subgroup showed no improvement in PFS (HR 0.92) and OS (HR 1.05) vs. Pbo. Grade >3 AE’s (HD, LD, Pbo) included: diarrhea (11.4%, 8.5%, 4.2%) and rash (5.7%, 7.0%, 2.8%). Conclusions: P showed improved PFS in the HRG high, but not in the ITT population. P safety was similar to Pbo with the exception of manageable rash and gastrointestinal effects. HRG appears to be a predictive biomarker for P, confirming preclinical findings (Schneider et al, Yonesaka et al, ASCO 2014). HERALD is the first randomized Pbo controlled trial in NSCLC to report a predictive biomarker for HER3. Based on these results, a 2-part (A, confirmation of HRG predictive value; B, pivotal HRG high only) Phase 3 study was initiated. Clinical trial information: NCT01211483. High dose P + E Low dose P + E Pooled doses P + E E alone (Pbo) mPFS (mos) 3.4 3.0 3.0 1.4 PFS HR (95% CI) 0.37 (0.16, 0.85)* 0.29 (0.13, 0.66)† 0.32 (0.16, 0.67)† mOS (mos) 6.1 10.7 9.7 5.0 OS HR (95% CI) 1.15 (0.50, 2.61) 0.60 (0.25, 1.41) 0.81 (0.39, 1.67) Log-rank p value: *<0.03, †<0.003)." @default.
• W2516996537 created "2016-09-16" @default.
• W2516996537 creator A5001486324 @default.
• W2516996537 creator A5003307503 @default.
• W2516996537 creator A5004940520 @default.
• W2516996537 creator A5026119562 @default.
• W2516996537 creator A5027438799 @default.
• W2516996537 creator A5029143856 @default.
• W2516996537 creator A5075710937 @default.
• W2516996537 creator A5077011628 @default.
• W2516996537 creator A5077459059 @default.
• W2516996537 creator A5081813742 @default.
• W2516996537 date "2014-05-20" @default.
• W2516996537 modified "2023-09-23" @default.
• W2516996537 title "Phase 2 HERALD study of patritumab (P) with erlotinib (E) in advanced NSCLC subjects (SBJs)." @default.
• W2516996537 doi "https://doi.org/10.1200/jco.2014.32.15_suppl.8045" @default.
• W2516996537 hasPublicationYear "2014" @default.
• W2516996537 type Work @default.
• W2516996537 sameAs 2516996537 @default.
• W2516996537 citedByCount "13" @default.
• W2516996537 countsByYear W25169965372015 @default.
• W2516996537 countsByYear W25169965372016 @default.
• W2516996537 countsByYear W25169965372017 @default.
• W2516996537 countsByYear W25169965372018 @default.
• W2516996537 countsByYear W25169965372019 @default.
• W2516996537 countsByYear W25169965372021 @default.
• W2516996537 countsByYear W25169965372022 @default.
• W2516996537 countsByYear W25169965372023 @default.
• W2516996537 crossrefType "journal-article" @default.
• W2516996537 hasAuthorship W2516996537A5001486324 @default.
• W2516996537 hasAuthorship W2516996537A5003307503 @default.
• W2516996537 hasAuthorship W2516996537A5004940520 @default.
• W2516996537 hasAuthorship W2516996537A5026119562 @default.
• W2516996537 hasAuthorship W2516996537A5027438799 @default.
• W2516996537 hasAuthorship W2516996537A5029143856 @default.
• W2516996537 hasAuthorship W2516996537A5075710937 @default.
• W2516996537 hasAuthorship W2516996537A5077011628 @default.
• W2516996537 hasAuthorship W2516996537A5077459059 @default.
• W2516996537 hasAuthorship W2516996537A5081813742 @default.
• W2516996537 hasConcept C121608353 @default.
• W2516996537 hasConcept C126322002 @default.
• W2516996537 hasConcept C142724271 @default.
• W2516996537 hasConcept C204787440 @default.
• W2516996537 hasConcept C27081682 @default.
• W2516996537 hasConcept C2778087573 @default.
• W2516996537 hasConcept C2779438470 @default.
• W2516996537 hasConcept C71924100 @default.
• W2516996537 hasConcept C90924648 @default.
• W2516996537 hasConceptScore W2516996537C121608353 @default.
• W2516996537 hasConceptScore W2516996537C126322002 @default.
• W2516996537 hasConceptScore W2516996537C142724271 @default.
• W2516996537 hasConceptScore W2516996537C204787440 @default.
• W2516996537 hasConceptScore W2516996537C27081682 @default.
• W2516996537 hasConceptScore W2516996537C2778087573 @default.
• W2516996537 hasConceptScore W2516996537C2779438470 @default.
• W2516996537 hasConceptScore W2516996537C71924100 @default.
• W2516996537 hasConceptScore W2516996537C90924648 @default.
• W2516996537 hasIssue "15_suppl" @default.
• W2516996537 hasLocation W25169965371 @default.
• W2516996537 hasOpenAccess W2516996537 @default.
• W2516996537 hasPrimaryLocation W25169965371 @default.
• W2516996537 hasRelatedWork W122825480 @default.
• W2516996537 hasRelatedWork W1988920656 @default.
• W2516996537 hasRelatedWork W2029727153 @default.
• W2516996537 hasRelatedWork W2117027134 @default.
• W2516996537 hasRelatedWork W2748952813 @default.
• W2516996537 hasRelatedWork W2809672044 @default.
• W2516996537 hasRelatedWork W2899084033 @default.
• W2516996537 hasRelatedWork W3031052312 @default.
• W2516996537 hasRelatedWork W3032375762 @default.
• W2516996537 hasRelatedWork W4233016836 @default.
• W2516996537 hasVolume "32" @default.
• W2516996537 isParatext "false" @default.
• W2516996537 isRetracted "false" @default.
• W2516996537 magId "2516996537" @default.
• W2516996537 workType "article" @default.