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
Krebs, Matthew G
AffiliationMedical Oncology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain;
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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 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.
CitationMajem 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.
JournalAnnals of Oncology
TypeMeetings and Proceedings