Immutep Limited, an Australian biotech company developing LAG-3-related immunotherapy treatments for cancer and autoimmune disease, has announced new interim data from second-line NSCLC (non-small cell lung cancer) patients (Part B) in its phase 2 TACTI-002 trial.
The data was presented at the IASLC 2022 World Conference of Lung Cancer (WCLC 2022) in Vienna, Austria, and is also available on the company’s website.
This part of TACTI-002 (Part B), evaluates Immutep’s lead product candidate, eftilagimod alpha (efti or IMP321) in combination with MSD’s KEYTRUDA (pembrolizumab) in a total of 36 patients with PD- X refractory metastatic NSCLC who were not pre-selected for their PD-L1 status.
In this second-line setting, patients were treated with pembrolizumab, an anti-PD-1 therapy, in combination with efti despite having confirmed disease progression on PD-X-based therapy in the first-line setting.
This was to evaluate whether efti in combination with pembrolizumab might provide a benefit for patients that would otherwise move on to chemotherapy in the second line.
Typically this standard of care second-line chemotherapy would be just single-agent taxane chemotherapy, as the majority of patients received platinum-based doublet chemotherapy plus chemotherapy plus PD-X therapy in the first-line setting. Thus, the enrolled patients were advanced in their disease with limited treatment options.
Immutep CSO and CMO, Frederic Triebel, said: “It is encouraging to see efti in combination with pembrolizumab continues to report promising antitumor and safety results in second-line NSCLC. In particular, efti in combination with pembrolizumab is demonstrating sustained survival compared with standard of care chemotherapy regimens, and favorable safety and tolerability. Of course, for patients with such advanced disease, having a chemo-free alternative could mean a very real difference to their quality of life.”
“Furthermore, these results provide promising insights into how efti may provide a meaningful patient benefit in other PD-X refractory indications in the future,” he said.
TACTI-002 investigator, Martin Forster of the UCL Cancer Institute and University College London Hospital NHS Foundation, London, UK, said: “The TACTI-002 trial is showing 36.5 percent of patients have survived for at least 18 months when receiving efti in combination with pembrolizumab. The median overall survival is 9.7 months which is a meaningful survival benefit, plus disease control and durability have also continued favorably as the trial has advanced. All these results support further clinical investigation of efti in combination with pembrolizumab in PD-X resistant NSCLC patients.”
Condition of patients
All enrolled patients had confirmed progressive disease on or after standard of care first-line therapy with PD-X monotherapy (33 percent) or a combination of PD-X therapy and platinum-based doublet chemotherapy (67 percent). These patients are therefore resistant to PD-X-based therapy and are referred to as “PD-X refractory.” Per standard clinical practice, they would otherwise usually go on to single-agent chemotherapy if they received combination with PD-X therapy and platinum-based doublet chemotherapy in first-line or, alternatively, go on to doublet chemotherapy if they received PD-X monotherapy in first-line.
A vast majority (75 percent) of enrolled patients had a PD-L1 tumor proportion score (TPS) of less than 50 percent.
Immutep said efti in combination with pembrolizumab continues to be safe and well-tolerated, with no new safety signals. Efti’s good safety profile to date compares favorably to the standard of care chemotherapy options.
About the TACTI-002 trial
TACTI-002 (two active immunotherapies) is being conducted in collaboration with Merck and Co., Inc., Rahway, NJ, (known as MSD outside the U.S. and Canada).
The study is evaluating the combination of eftilagimod alpha (efti) with MSD’s KEYTRUDA (pembrolizumab) in patients with second-line head and neck squamous cell carcinoma or non-small cell lung cancer in the first and second line.
The trial is a phase 2, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study taking place in study centers across Australia, Europe, and the U.S.