Eftilagimod alpha is a LAG-3 fusion protein that is being investigated around multiple cancers. If approved this LAG-3 fusion protein is going to be first in class and may have the ability to change or modify the current NSCLC treatment practices being followed. The drug showed positive results in its recently published data in May and was found to be beneficial when compared to historical controls and reported an initial median overall Survival of 25 months in NSCLC patients with >1% PD-L1 expression. 

These initial positive results of the drug seem to be good enough to build the base for upcoming advanced-stage trials and based on these promising results the data monitoring committee has further recommended extending the OS follow-up collection to show mature 3-year and potentially 5-year survival rates of this novel IO-IO combination. The drug also received fast-track designation in first-line NSCLC from the US FDA. 

As per the data cutoff of August 2023, the company presented the overall survival results in the ESMO session. In the TACTI-002 study,  the Intention-to-treat population had a median  OS of 20.2 and was observed where ~75% of the patients had PD-L1 score <50% including 35% less than 1%. The DoR was estimated to be 21.6 months. 

Promising efficacy results were seen across all the subgroups with a median OS of 35.5 months in the ≥1%  TPS group. And for TPS≥50% was not reached despite a long follow-up period. 

In terms of safety, no new safety concern was seen with these report results. 

KOL insights

“In contrast to other combinations of immunotherapy, which are effective primarily in patients with high PD-L1 expression, or combinations of immunotherapy with chemotherapy, which depend on potentially toxic chemotherapy to enhance effectiveness, efti is facilitating long-lasting, profound responses in patients, irrespective of their PD-L1 expression levels. Importantly, it maintains a favorable safety profile that is consistent with that of anti-PD-1 monotherapy.” -– Catalan Institute of Oncology  

Conclusion

The combination of  Eftilagimod Alpha and KEYTRUDA yielded promising efficacy findings hence encouraging its development in initial lines of setting. The drug seems to have a long-lasting response with favorable efficacy and safety profiles. LAG-3 fusion protein is found to be an interesting class with many trials in different indications. If approved the drug could make a sizable contribution in the field of NSCLC. 

Note: The therapeutics segment is experiencing significant NSCLC clinical trial activity, which is further expected to drive Non-Small Cell Lung Caner market growth in the coming years.