CEL-SCI Corporation revealed pivotal advancements in its immunotherapy drug Multikine (Leukocyte Interleukin, Injection) for head and neck cancer treatment, during its debut presentation at the European Society for Medical Oncology (ESMO) Congress in Spain on October 22, 2023.
The selection criteria for the target population, now finalized, were meticulously derived from a comprehensive Phase 3 randomized controlled trial, expert guidance from regulatory authorities, and esteemed immuno-oncologists affiliated with the University of California San Diego Cancer Center and Yale Medical School.
According to the disclosed data, Multikine demonstrated remarkable efficacy, particularly in patients with tumors exhibiting low PD-L1 expression, encompassing nearly 70% of the study cohort. Noteworthy, this subgroup typically responds less favorably to immune checkpoint inhibitors like Keytruda and Opdivo, which perform optimally in tumors with heightened PD-L1 expression.
Furthermore, the Multikine target population can now be readily identified upon initial diagnosis, pre-surgery, utilizing standard cancer screening tests, marking a significant stride in timely intervention.
The pivotal revelation lies in the five-year survival rates: Multikine-treated patients exhibited a staggering 73% survival rate, in stark contrast to a mere 45% survival rate for control subjects who did not receive Multikine. This achievement slices the five-year risk of mortality in half for the Multikine-treated group compared to the control. The results present a 28% absolute survival advantage (p=0.0015), buttressed by a hazard ratio of 0.35 (95% CIs [0.18, 0.66], Wald p=0.0012). These figures denote an emphatically significant statistical triumph, underlining the potential breakthrough.
Moreover, the hazard ratio for Multikine versus control, at 0.35, signifies that Multikine-treated patients experienced approximately 65% lower risk of mortality at any given point. CEL-SCI’s announcement emphasized that no existing head and neck cancer therapy has demonstrated such a substantial five-year survival benefit. Additionally, the confidence interval’s upper bound of 0.66 augments CEL-SCI’s optimism that a confirmatory trial in the target population is poised for success.
An equally compelling revelation pertains to pre-surgery disease downstaging, indicating improved survival rates. This phenomenon signifies a lower stage of disease post-Multikine therapy compared to pre-treatment. Graphical representation corroborates that Multikine-treated patients with downstaging exhibit markedly enhanced survival prospects. This finding bears profound significance, boasting a p-value below 0.0002.
CEL-SCI Corporation’s groundbreaking strides in head and neck cancer treatment with Multikine have ignited substantial market response. Post-announcement, the company’s stock experienced a notable surge, reflecting the profound impact of this development on the pharmaceutical landscape.
At the time of this publication, CEL-SCI Corp stock (CVM) has witnessed a surge.
Current Price: $1.51
Change : +0.44
Change (%): (41.29%)
Source: Tomorrow Events Market Data
The demonstrated efficacy of Multikine, coupled with its potential to revolutionize the prognosis of head and neck cancer patients, positions CEL-SCI Corporation on a promising trajectory towards imminent approval, offering a beacon of hope for those currently facing unmet medical needs.