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Ref Type Journal Article
PMID (31540980)
Authors Gerber DE, Infante JR, Gordon MS, Goldberg SB, Martín M, Felip E, Martinez Garcia M, Schiller JH, Spigel DR, Cordova J, Westcott V, Wang Y, Shames DS, Choi Y, Kahn R, Dere RC, Samineni D, Xu J, Lin K, Wood K, Royer-Joo S, Lemahieu V, Schuth E, Vaze A, Maslyar D, Humke EW, Burris HA
Title Phase Ia Study of Anti-NaPi2b Antibody-Drug Conjugate Lifastuzumab Vedotin DNIB0600A in Patients with Non-Small Cell Lung Cancer and Platinum-Resistant Ovarian Cancer.
Journal Clinical cancer research : an official journal of the American Association for Cancer Research
Vol 26
Issue 2
Date 2020 Jan 15
URL
Abstract Text This phase I trial assessed the safety, tolerability, and preliminary antitumor activity of lifastuzumab vedotin (LIFA), an antibody-drug conjugate of anti-NaPi2b mAb (MNIB2126A) and a potent antimitotic agent (monomethyl auristatin E).LIFA was administered to patients with non-small cell lung cancer (NSCLC) and platinum-resistant ovarian cancer (PROC), once every 3 weeks, by intravenous infusion. The starting dose was 0.2 mg/kg in this 3+3 dose-escalation design, followed by cohort expansion at the recommended phase II dose (RP2D).Overall, 87 patients were treated at doses between 0.2 and 2.8 mg/kg. The MTD was not reached; 2.4 mg/kg once every 3 weeks was selected as the RP2D based on overall tolerability profile. The most common adverse events of any grade and regardless of relationship to study drug were fatigue (59%), nausea (49%), decreased appetite (37%), vomiting (32%), and peripheral sensory neuropathy (29%). Most common treatment-related grade ≥3 toxicities among patients treated at the RP2D (n = 63) were neutropenia (10%), anemia (3%), and pneumonia (3%). The pharmacokinetic profile was dose proportional. At active doses ≥1.8 mg/kg, partial responses were observed in four of 51 (8%) patients with NSCLC and 11 of 24 (46%) patients with PROC per RECIST. All RECIST responses occurred in patients with NaPi2b-high by IHC. The CA-125 biomarker assessed for patients with PROC dosed at ≥1.8 mg/kg showed 13 of 24 (54%) had responses (≥50% decline from baseline).LIFA exhibited dose-proportional pharmacokinetics and an acceptable safety profile, with encouraging activity in patients with PROC at the single-agent RP2D of 2.4 mg/kg.

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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
Unknown unknown lung non-small cell carcinoma not applicable DNIB0600A Phase I Actionable In a Phase I trial, DNIB0600A (lifastuzumab vedotin) treatment demonstrated a safe profile, but resulted in limited efficacy in patients with non-small cell lung cancer receiving a dose of 1.8-2.8 mg/kg, which included a partial response in 8% (4/51) of patients regardless of Slc34a2 expression and a partial response in 12% (3/26) of patients with over expression of Slc34a2 (PMID: 31540980; NCT01363947). 31540980
Unknown unknown ovarian cancer not applicable DNIB0600A Phase I Actionable In a Phase I trial, DNIB0600A (lifastuzumab vedotin) treatment demonstrated a safe profile and resulted in efficacy in patients with platinum-resistant ovarian cancer receiving a dose of 1.8-2.8 mg/kg, which included a partial response in 46% (11/24) of patients regardless of Slc34a2 expression and a partial response in 50% (11/22) of patients with over expression of Slc34a2 (PMID: 31540980; NCT01363947). 31540980