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CEL-SCI Corporation (NYSE:CVM) announced on May 4, 2020 that it had achieved the targeted number of events for its IT MATTERS trial for head and neck cancer. The trial enrolled its first patients in 2011 in the US, Canada, UK, France and 20 other countries. The primary endpoint for the study is an overall survival benefit of 10% over standard of care alone in defined areas of the head and neck. 928 patients were ultimately enrolled in the trial, with the final individual added in September 2016.
The trial had three arms including:
1) Multikine plus CIZ (1) followed by SOC
2) Multikine (CIZ-exclusion) followed by SOC
3) SOC therapy as the active comparator
Only the M+CIZ and SOC groups were used as events for purposes of the trial. Over the near nine year duration of the trial, an independent data monitoring committee (IDMC) performed periodic checks approximately every 6 months to ensure patient interests were met and the trial was conducted ethically.
Now that the final event has taken place, there will be additional steps that occur over the next few months as data is validated and analyzed. CEL-SCI reported that the data is now being prepared for lock and analysis. The company’s two contract research organizations (CROs), ICON and Ergomed, will generate remaining queries, verify data, complete the medical review and build the final database. ICON will perform the data analysis and control.
Our experience with event-based trials suggests that it can take from two to three months to complete the follow up steps after the last event is reported. Possible finalizing steps include:
‣ Follow up safety visits
‣ Adjudication of events
‣ Follow up with discontinued patients
‣ Data base lock
‣ Analysis of primary and secondary endpoints
‣ Full review of dataset and safety results
‣ Presentation of results at major oncology conference
‣ Publication of results in journals
Once the full dataset is available, CEL-SCI will meet with the FDA and other regulatory authorities to develop a plan for the submission of a biologics license application (BLA). We note that the coronavirus situation may hinder our ability to estimate a timeline; however, in our conversations with a number of management teams, there have been few reported delays related to clinical trials and data analysis. CEL-SCI management did not provide any guidance regarding timelines for the post-trial events prior to reporting topline or full data; therefore, any report of data could be different from the 2 to 3 month range that we forecast.
Guidance was not provided regarding which conference is appropriate for presenting data. While the pandemic has forced the cancellation of many conferences over the next months, by Fall we believe that conferences will be held virtually if not in person. The mid-September European Society for Medical Oncology Congress (ESMO) may be an appropriate target conference for CEL-SCI’s Multikine results to be presented. The ESMO Immuno-Oncology Congress in the second week of December may be appropriate as well.
We congratulate CEL-SCI on the completion of their nine year trial for Multikine and eagerly await topline results. As we have explained in our research, we believe that Multikine will, more likely than not, be safe and effective. Our belief is based on earlier Phase II results where the longer-than-expected length of the trial and the IDMC’s consistent recommendation to continue the trial suggest extended life compared to historical precedents.
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1. CIZ: Cyclophosphamide 300 mg/m2 (x1,IV, day -3); Indomethacin 25mg tid, po (day 1 to 24 hrs prior to surgery) + 15 - 45mg Zinc (as Multivitamin) i.d., p.o. The CIZ exclusion group was added to gain additional information on the mechanism of action and toxicity of Multikine.