Wednesday, Immutep Restricted IMMP released preliminary topline outcomes from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Part IIb trial evaluating eftilagimod alpha (efti) together with Merck & Co Inc’s MRK Keytruda (pembrolizumab) as first-line therapy of recurrent/metastatic head and neck squamous cell carcinoma sufferers (1L HNSCC) with adverse PD-L1 expression.
The investigational immuno-oncology mixture demonstrates an general response price (ORR) of 26.9% and illness management price (DCR) of 57.7% in 26 sufferers whose tumors don’t categorical PD-L1, which compares favorably to historic controls.
Martin Forster, TACTI-003 Investigator, said, “These preliminary topline leads to the first-line setting for sufferers with head and neck squamous cell cancers that don’t categorical PD-L1 are encouraging.
A complete of 33 sufferers with recurrent or metastatic HNSCC have been enrolled in Cohort B.
The 26 sufferers reported in the present day symbolize these presently accessible with sufficiently lengthy sufficient follow-up time as per protocol and the place the info cleansing has sufficiently progressed on the time of information cut-off in February.
The ultimate variety of evaluable sufferers in Cohort B is predicted to be increased, and extra knowledge, together with full response price, might be launched along with Cohort A knowledge.
Regarding the randomized Cohort A of the TACTI-003 trial evaluating the protection and efficacy of efti together with Keytruda as in comparison with Keytruda monotherapy, 138 sufferers with PD-L1 optimistic tumors have been enrolled at over 30 facilities globally.
Information assortment, cleansing, and evaluation proceed for TACTI-003, and the corporate expects to report the first endpoint (general response price from Cohorts A & B in H1 CY2024.
Head and neck squamous cell carcinoma (HNSCC) is the sixth most typical most cancers by incidence worldwide, with 890,000 new instances and 450,000 deaths reported in 2018.
Efti has obtained FDA Quick Observe designation in 1L HNSCC no matter PD-L1 expression.
Final month, Immutep introduced security and preliminary efficacy knowledge from the first-ever 90mg dosing of eftilagimod alpha (efti) together with weekly paclitaxel in sufferers from the protection lead-in (N=6) of the AIPAC-003 Part 2/3 trial.
Value Motion: IMMP shares are up 14.90% at $2.89 on the final test Wednesday.
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