MRK - Immutep: Positive Efti Treatment Data Leads To Late-Stage Programs

2024-07-15 13:54:02 ET

Summary

• Immutep Limited achieved positive results in the phase 2b study, using efti + Keytruda for the treatment of patients with 1st-line head and neck squamous cell carcinoma; Both PD-L1 positive and negative patients.
• Company to meet with FDA to be in a position to initiate a phase 3 study using efti + Keytruda for the treatment of patients with 1st-line HNSCC.
• Merck supply collaboration agreement in place to advance phase 3 study, using efti + Keytruda + chemotherapy for the treatment of 1stline NSCLC patients.
• Keytruda had become one of the top-selling drugs in 2023, with sales exceeding $25 billion; Efti has shown to help double several efficacy measures when added to Keytruda.

Immutep Limited ( IMMP ) recently reported results from two cohorts from its phase 2b TACTI-003 study using efti [eftilagimod alfa] for recurrent/metastatic 1st-line head and neck squamous cell carcinoma [HNSCC] patients. The first set of results was based on this entire patient population, regardless of PD-L1 expression. The other set of positive results released a few weeks later was based on this same patient population, but for such patients with negative PD-L1 expression. With this positive data on hand, this biotech is going to approach the FDA to get a phase 3 study going targeting one or both of these 1st-line HNSCC patient populations.

This is one program, which is already moving towards late-stage development. One other program, already underway in phase 3 testing, would be the phase 3 TACTI-004 trail. This specific late-stage study is using efti in combination with Keytruda + chemotherapy for the treatment of patients with 1st-line non-small cell lung cancer. Both of these programs are being done as a supply collaboration agreement with Merck ( MRK ), where this big pharma is providing supply of Keytruda to run these studies. Immutep still retains rights to efti for now....

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