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Wednesday, Immutep Limited (NASDAQ:IMMP) released preliminary topline results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial evaluating eftilagimod alpha (efti) in combination with Merck & Co Inc’s (NYSE:MRK) Keytruda (pembrolizumab) as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with negative PD-L1 expression.
The investigational immuno-oncology combination demonstrates an overall response rate (ORR) of 26.9% and disease control rate (DCR) of 57.7% in 26 patients whose tumors do not express PD-L1, which compares favorably to historical controls.
Martin Forster, TACTI-003 Investigator, stated, “These preliminary topline results in the first-line setting for patients with head and neck squamous cell cancers that do not express PD-L1 are encouraging.
A total of 33 patients with recurrent or metastatic HNSCC have been enrolled in Cohort B.
The 26 patients reported today represent those currently available with sufficiently long enough follow-up time as per protocol and where the data cleaning has sufficiently progressed at the time of data cut-off in February.
The final number of evaluable patients in Cohort B is expected to be higher, and additional data, including complete response rate, will be released together with Cohort A data.
Concerning the randomized Cohort A of the TACTI-003 trial evaluating the safety and efficacy of efti in combination with Keytruda as compared to Keytruda monotherapy, 138 patients with PD-L1 positive tumors have been enrolled at over 30 centers globally.
Data collection, cleaning, and analysis continue for TACTI-003, and the company expects to report the primary endpoint (overall response rate from Cohorts A & B in H1 CY2024.
Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer by incidence worldwide, with 890,000 new cases and 450,000 deaths reported in 2018.
Efti has received FDA Fast Track designation in 1L HNSCC regardless of PD-L1 expression.
Last month, Immutep announced safety and initial efficacy data from the first-ever 90mg dosing of eftilagimod alpha (efti) in combination with weekly paclitaxel in patients from the safety lead-in (N=6) of the AIPAC-003 Phase 2/3 trial.
Price Action: IMMP shares are up 14.90% at $2.89 at the last check Wednesday.
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