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dc.contributor.authorFelip, E.
dc.contributor.authorDoger, B.
dc.contributor.authorMajem, M.
dc.contributor.authorCarcereny, E.
dc.contributor.authorKrebs, Matthew G
dc.contributor.authorPeguero, J. A.
dc.contributor.authorRoxburgh, P.
dc.contributor.authorForster, M.
dc.contributor.authorBajaj, P.
dc.contributor.authorClay, T. D.
dc.contributor.authorTriebel, F.
dc.date.accessioned2020-11-16T07:49:08Z
dc.date.available2020-11-16T07:49:08Z
dc.date.issued2020en
dc.identifier.citationFelip E, Doger B, Majem M, Carcereny E, Krebs MG, Peguero JA, et al. Initial results from a phase II study (TACTI-002) in metastatic non-small cell lung or head and neck carcinoma patients receiving eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab. Journal of Clinical Oncology. 2020;38(15)en
dc.identifier.urihttp://hdl.handle.net/10541/623377
dc.description.abstractBackground: Eftilagimod alpha (efti) is a soluble LAG-3 protein that binds to a subset of MHC class II molecules to mediate antigen presenting cell (APC) activation and then CD8 T-cell activation. The stimulation of the dendritic cell network and subsequent T cell recruitment with efti may lead to stronger anti-tumor responses than observed with pembrolizumab alone. We hereby report initial results of a phase II trial (NCT03625323). Methods: A predefined number of patients (pts) are recruited into this 3-cohort trial irrespective of PD-L1 expression; part A: 1st line, PD-X naïve NSCLC; part B: 2nd line, PD-X refractory NSCLC and part C: 2nd line PD-X naive HNSCC. The study has a Simon's 2-stage design, with objective response rate (ORR) as primary endpoint. Secondary endpoints include disease control rate, progression free and overall survival, PK, PD and immunogenicity. Additional pts (N2) will be recruited for each part if pre-specified thresholds for ORR are met. Up to 109 pts will be enrolled. Efti is administered as 30 mg subcutaneous injection every 2 wks for 8 cycles and then every 3 wks for 9 cycles with pembrolizumab (200 mg intravenous infusion every 3 wks for up to 2 yrs). The study was approved by ethic committees and institutional review boards. Results: Between 04 Mar 19 and 31 Jan 2020, 48 pts were enrolled and evaluated for safety and exposure. The median age was 66 yrs (range 48-84) and 73 % were male. The ECOG was 0 in 50 % and 1 in 50 % of pts, respectively. Pts received a median of 5 (7) and in total 311 (413) pembrolizumab (efti) administrations, respectively. Three pts (6.3 %) discontinued study treatment due to AEs. The most common ( > 10%) adverse events (AEs) being cough (31 %), asthenia (23 %), decreased appetite (19 %), fatigue (19 %), dyspnea (17 %), diarrhea (15 %) and constipation 13 %). From part A all pts (n = 17) were evaluated. Eight pts (47 %) had a partial response (iPR) and six (35 %) had stable disease according to iRECIST representing an ORR (DCR) of 47 % (82 %). irPRs were observed in all different PD-L1 groups ( < 1%; ? 1 % ?49 %; ? 50 %). Ten (10; 59 %) pts are still on therapy (8+ months). In part C stage 1 15/18 pts are evaluable and six (40 %) had an iPR to date. Conclusions: Efti in combination with pembrolizumab is safe and shows encouraging antitumor activity in all comer PD-L1 1st line NSCLC and 2nd line HNSCC. Stage 2 has opened for both parts.en
dc.language.isoenen
dc.titleInitial results from a phase II study (TACTI-002) in metastatic non-small cell lung or head and neck carcinoma patients receiving eftilagimod alpha (soluble LAG-3 protein) and pembrolizumaben
dc.typeMeetings and Proceedingsen
dc.contributor.departmentVall d’Hebron Institute of Oncology (VHIO), Barcelona, Spainen
dc.identifier.journalJournal of Clinical Oncologyen
dc.description.noteen]


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