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Initial results from a phase II study (TACTI-002) of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients with PD-L1 unselected first-line metastatic non-small cell lung carcinoma
Majem, M. Felip, E. Doger, B. Akay, M. Carcereny, E. Clay, T. Krebs, Matthew G Peguero, J. Triebel, F.
Majem, M.
Felip, E.
Doger, B.
Akay, M.
Carcereny, E.
Clay, T.
Krebs, Matthew G
Peguero, J.
Triebel, F.
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Abstract
Background: 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 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 in combination than
observed with pembrolizumab alone. We hereby report initial results of the non-small
cell lung cancer (NSCLC) part (NCT03625323).
Methods: The study has a Simon’s 2-stage design, with objective response rate (ORR)
as primary endpoint (EP). Secondary EPs include tolerability, disease control rate
(DCR), progression free survival (PFS), PK, PD and immunogenicity. Treatment naïve
PD-L1 unselected NSCLC patients (pts) are eligible for part A. Initially, 17 pts were
recruited in stage 1, with an additional 19 pts enrolled into stage 2 if a pre-specified
threshold is reached. Efti is administered as 30 mg SC injection every 2 wks for 8
cycles and then every 3 wks for 9 cycles with pembrolizumab (200 mg IV infusion
every 3 wks for up to 2 yrs).
Results: Between Mar 2019 and May 2020 33 pts were enrolled into stages 1 + 2. The
median age was 67 yrs (range 53-84) and 70 % were male. ECOG PS 0:1 was 42 % and
58 % respectively. Pts from all PD-L1 subgroups were recruited. Pts received a median
of 5 pembrolizumab and 7 efti administrations. All pts in stage 1 (n¼17) were
evaluable. Nine pts (53 %) had a partial response (iPR) and five (29 %) had stable
disease according to iRECIST representing an ORR (DCR) of 53 % (82 %). Responses
were observed among all PD-L1 subgroups with 1/3 iPRs in <1%, 3/6 iPRs in 1-49 %,
3/4 iPRs in 50% and 2/4 in the NE group. The most common (> 10 %) adverse
events (AEs) were cough (29 %), asthenia (24 %), decreased appetite (18 %), dyspnea
(18 %), fatigue (17 %), diarrhea (15 %) and nausea (12 %). Seven (7; 41 %) pts are still
on therapy and median PFS is not yet reached (follow-up of 9+ months). The
threshold (r>4) for opening of stage 2 was reached and initial data for stage 2 pts will
be presented at the meeting.
Conclusions: Efti in combination with pembrolizumab is safe and shows encouraging
antitumor activity in 1st line NSCLC across all PD-L1 expression levels.
Description
Date
2020
Publisher
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Keywords
Type
Meetings and Proceedings
Citation
Majem M, Felip E, Doger B, Akay M, Carcereny E, Clay T, et al. 1266P Initial results from a phase II study (TACTI-002) of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients with PD-L1 unselected first-line metastatic non-small cell lung carcinoma. Annals of Oncology. 2020;31:S818-S.