10-year follow-up results of leukocyte interleukin injection are promising in locally advanced primary SCCHN

A reading of long-term data from the Phase 3 IT-MATTERS trial highlighted the potential of leukocyte interleukin injection as a treatment for patients with locally advanced primary squamous cell carcinoma of the head and neck. neck, oral cavity and soft palate.

Long-term follow-up data demonstrated the promise of leukocyte interleukin (Multikine) injection via a peritumoral plus perilymphatic route and a non-chemotherapeutic dose of cyclophosphamide (CIZ) followed by standard treatment in a population of Patients With Previously Untreated Locally Advanced Primary Squamous Cell Carcinoma of the Head and Neck (SCCHN), Oral Cavity, and Soft Palate, According to Published IT-MATTERS (NCT01265849) Phase 3 Trial Results on ClinicalTrials.1.2

The researchers reported that in the intent-to-treat (ITT) population, the overall response rate (ORR) in the experimental arm was 8.1% (n=32/395) versus 0.0% in standard of care (SOC) population (n = 0/394). Additionally, in the patient population at low risk of recurrence, the ORR was 15.2% (n=24/158) in the injection and CIZ arm versus 0.0% in the standard treatment arm (n=0/ 168;2 to face Fisher Exact P-value <.0000001 a total of patients in the experimental arm showed complete responses.>

A total of 928 patients were included in the study to assess the efficacy and clinical benefit of leukocyte interleukin injection in a population of patients with locally advanced primary squamous cell carcinoma of the head and neck, of the oral cavity and the soft palate. The injection uses natural immunoregulatory cytokines and may be the first investigational immunotherapeutic to be used in the first-line neoadjuvant setting in a previously untreated population before standard of care.

A total of 3 randomized treatment arms were included in the study: 3 consecutive weeks of supraphysiological doses of the injection 5 times per week by both peritumoral and perilymphatic routes plus CIZ following standard therapy and zinc multivitamins every days from day 1 of injection to 1 day prior to surgery (n = 3/7); 3-week injection regimen minus CIZ before standard of care (n = 1/7); and standard of care alone (n = 3/7). The standard of care was identical in all arms and consisted of a bifurcated treatment pathway after surgery, including a radiation therapy-only cohort and a concurrent chemoradiotherapy cohort. The treatment strategy was determined based on pathology and medical judgment.

Additional study results that will be presented to the FDA indicated that an objective response prior to surgery appeared to predict improved overall survival (OS) and a significant reduction in mortality. For the ITT population, the mortality rate was 22.2% in responders to leukocyte interleukin injection versus 54.1% in non-responders (HR, 0.301; 95% CI, 0.16 -0.566 Bilateral Fisher Exact P-value <.0001 in patients who were at lower risk of recurrence these rates the two respective arms ci two-sided fisher extract>P-value = .0101).

Investigators also reported a 5-year OS benefit of 14.1% in the experimental group among those at low risk of recurrence, with OS rates of 62.7% versus 48.6% in the care group. standard. Additionally, the median OS in the low-risk population was 101.7 months in the peritumoral injection plus CIZ arm, versus 55.2 months in the standard treatment arm. The investigators also reported confirmation of progression-free survival for patients in the low risk of recurrence cohort among those treated with the injection plus CIZ compared to standard of care. In addition, the incidence of adverse effects (AEs) and serious AEs were comparable between the 2 treatment arms.

References

  1. Efficacy and safety study of leukocyte interleukin, injection (LI) to treat cancer of the oral cavity (IT-MATTERS). Clinical tests. Last updated August 19, 2022. Accessed August 22, 2022. https://bit.ly/3AcUqBu
  2. CEL-SCI Corporation announces Multikine® Phase 3 results in head and neck cancer published on Clinicaltrials.gov. Press release. CEL-SCI Corporation. August 19, 2022. Accessed August 22, 2022. https://bwnews.pr/3PGQ6Ae

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