Updated results of a phase 2 study indicate that eftilagimod alpha (soluble LAG-3 protein) is safe and has antitumor activity when combined with pembrolizumab as first-line therapy for metastatic non-small cell lung cancer regardless of programmed death ligand 1 (PD-L1) status.

Enriqueta Felip, MD, PhD, of Vall d’Hebron Institute of Oncology, Barcelona, Spain, presented the update at the 2022 ASCO Annual Meeting.

Eftilagimod alpha binds to a subset of major histocompatibility complex class II molecules to mediate activation of antigen-presenting cells and CD8 T cells, she explained. The stimulation of antigen-presenting cells and subsequent T-cell recruitment may lead to a stronger antitumor response than that seen with pembrolizumab alone.

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This study, TACTI-002, enrolled 114 patients with untreated locally advanced or metastatic non-small cell lung cancer, unselected for PD-L1 expression. Patients received 30 mg eftilagimod alpha every 2 weeks for 8 cycles and then every 3 weeks for up to 1 year, along with pembrolizumab.

Patients received a median of 7.0 administrations of eftilagimod alpha and 6.0 administrations of pembrolizumab. Median follow-up was 11.2 months.

The overall response rate was 38.6% in the intention-to-treat population (114 patients) and 42.7% in the evaluable population having on-study postbaseline tumor staging (103 patients). The disease control rate was 73.7% and 81.5%, respectively. Responses were observed in all PD-L1 subgroups defined by tumor proportion score.

Interim median progression-free survival was 6.9 months in the intention-to-treat population of unselected patients. It was 8.4 months in patients with a PD-L1 score of 1% or greater and 11.8 months in those with a PD-L1 score of 50% or greater.

The response rate in patients with squamous histology (35% of the cohort) was 35.0% and in those with nonsquamous histology (63% of the cohort) it was 38.9%.

Median exposure to eftilagimod alpha was 23.1 weeks and to pembrolizumab was 21.8 weeks. Eleven patients (9.6%) discontinued the study because of adverse events related to treatment.

The most common treatment-emergent adverse events of any grade were dyspnea (34.2%), asthenia (30.7%), decreased appetite (23.7%), cough (23.7%), anemia (21.1%), fatigue (20.2%), pruritus (19.3%), constipation (17.5%), diarrhea (15.8%), and nausea (15.8%).

According to Dr Felip, these encouraging results indicate that eftilagimod alpha plus pembrolizumab warrants late-stage clinical investigation.

Disclosure: This research was supported by Immutep in collaboration with MSD. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Felip E, Majem M, Doger B, et al. A phase II study (TACTI-002) in first-line metastatic non-small cell lung carcinoma investigating eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab: Updated results from a PD-L1 unselected population. Presented at ASCO 2022; June 3-7, 2022. Abstract 9003.