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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Keytruda (pembrolizumab) (PD1 inhibitor) + ImmuFact (eftilagimod alpha) (APC activator, MHC II agonist) |
| Direction: | Sensitive |
Evidence:
Title:
Immutep Receives FDA Fast Track Designation for LAG-3 Therapeutic Eftilagimod Alpha for First Line Non-Small Cell Lung Cancer
Published date:
10/04/2022
Excerpt:
Immutep Limited...announced the United States Food and Drug Administration (FDA) has granted Fast Track designation to eftilagimod alpha (efti or IMP321) in combination with pembrolizumab for the treatment of 1st line non-small cell lung cancer (NSCLC). Efti is the Company’s first-in-class soluble LAG-3 clinical stage candidate which activates antigen presenting cells (APC) to engage both the innate and adaptive immune system to target solid tumors...Fast Track designation has been granted for the development of efti in combination with pembrolizumab in 1st line treatment of Stage IIIB/IV NSCLC patients expressing PD-L1 Tumor Proportion Score ≥1%, not amenable to EGFR/ALK based therapy.
Source:
Title:
1312MO - Combining the antigen-presenting cell activator eftilagimod alpha (soluble LAG-3) and pembrolizumab: Overall survival data from the first line non-small cell lung carcinoma (NSCLC) cohort of TACTI-002 (phase II)
Published date:
10/16/2023
Excerpt:
E + P shows encouraging OS results in line with excellent ORR, PFS and DOR in 1st line NSCLC overall and in all PD-L1 subgroups.
Title:
Immutep’s Efti in Combination with Pembrolizumab Achieves Excellent Initial Overall Survival Benefit in 1st Line Non-Small Cell Lung Cancer
Published date:
05/17/2023
Excerpt:
Immutep Limited...announces that efti, a soluble LAG-3 protein and first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) achieved robust initial Overall Survival (OS) in 1st line non-small cell lung cancer (1L NSCLC) patients in the Phase II TACTI-002 trial....an initial median OS of 25 months has been attained in those 1L NSCLC patients (N=58) who have a PD-L1 Tumor Proportion Score (TPS) of >1%...
Trial ID:
Source:
Title:
11MO - Final data from a phase II study (TACTI-002) of eftilagimod alpha (soluble LAG-3) & pembrolizumab in 2nd line metastatic NSCLC pts resistant to PD-1/PD-L1 inhibitors
Published date:
03/23/2023
Excerpt:
We report updated results from Part B of the TACTI-002 trial: 2nd-line PD-1/PD-L1-resistant non-small cell lung carcinoma (NSCLC) patients (pts) treated with efti plus pembrolizumab (P)….All PD-L1 subgroups were included: 39% with TPS <1% and 82% with TPS <50%....Vast majority (83%) of pts showed deceleration (50%) in tumor growth or shrinkage (33%) of target lesions. Median PFS was 2.1 months with PFS rate at 6 m of 25%. 44% were alive at 12 m with median OS of 9.7 m....Efti + pembrolizumab is safe and shows encouraging signs of antitumor activity in NSCLC pts resistant to PD-1/PD-L1 inhibitors, warranting further investigation.
Trial ID:
Source:
Title:
TACTI-002: A Phase II Study of Eftilagimod Alpha (Soluble LAG-3) & Pembrolizumab in 2nd line PD-1/PD-L1 Refractory Metastatic NSCLC
Published date:
07/12/2022
Excerpt:
Progression free survival rate at 6 m was 26 % and 73 % were alive at 6 m. Analysis of tumor growth kinetics showed a deceleration of tumor growth or shrinkage of target lesions in 74 % of evaluable pts...Efti in combination with pembrolizumab is safe and shows encouraging signs of antitumor activity in truly PD-1/PD-L1 refractory 2nd line NSCLC pts.
Source:
Title:
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
Published date:
05/26/2022
Excerpt:
Pts with untreated metastatic NSCLC, unselected for PD-L1 expression were recruited. Responses were observed in all PD-L1 subgroups (Table). 24/28 (86%) responses were already confirmed...E + P is safe and shows encouraging antitumor activity in first-line metastatic NSCLC patients unselected for PD-L1...
DOI:
10.1200/JCO.2022.40.16_suppl.9003
Trial ID:
Source:
Title:
790 A phase II study (TACTI-002) of eftilagimod alpha (a soluble LAG-3 protein) with pembrolizumab in PD-L1 unselected patients with metastatic non-small cell lung(NSCLC) or head and neck carcinoma(HNSCC)
Published date:
11/09/2020
Excerpt:
Pts from all PD-L1 tumor expression subgroups were recruited. Pts received a median of 4 (1-25) pembrolizumab and 5.5 (1-22) efti administrations….Efti plus pembrolizumab is safe and shows encouraging antitumor responses in NSCLC and HNSCC patients.
DOI:
10.1136/jitc-2020-SITC2020.0790
Source:
Title:
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
Published date:
09/14/2020
Excerpt:
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. Efti in combination with pembrolizumab is safe and shows encouraging antitumor activity in 1st line NSCLC across all PD-L1 expression levels.
Trial ID:
Source:
Title:
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.
Published date:
05/13/2020
Excerpt:
Efti in combination with pembrolizumab is safe and shows encouraging antitumor activity in all comer PD-L1 1st line NSCLC and 2nd line HNSCC.
DOI:
10.1200/JCO.2020.38.15_suppl.3100
Trial ID:
