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But there is no benefit for patients receiving chemotherapy.
CEL-SCI Inc.’s release of phase 3 data for the Multikine (Leukocyte interleukin injection) immunotherapy for head and neck cancer blew up the Twitterverse and the investor community on Monday. Data showed a survival benefit for a subpopulation of patients—those not receiving chemotherapy—but did not meet its primary end point of 10% in overall survival in the full study population.
In this long-term study of nine and half years, 380 patients with previously untreated squamous cell carcinoma of the head and neck (SCCHN) received Multikine followed by surgery and radiotherapy (and no chemotherapy). They demonstrated a five-year overall survival benefit of 14.1% (62.7% vs 48.6% for standard of care alone.)
The remaining 543 patients were treated with the same Multikine treatment regimen prior to surgery and radiotherapy with cisplatin chemotherapy or with standard of care treatment, which was surgery followed by radiotherapy with cisplatin chemotherapy. Five additional patients were enrolled but not treated.
Those patients treated with the Multikine treatment regimen prior to surgery and radiotherapy/chemotherapy did not exhibit a survival advantage.
No safety issues were observed with Multikine.
“It’s obvious that the chemotherapy destroyed the immune system benefit from Multikine, but that doesn’t take away from the success of the group who benefitted. This population of 380 people have a statistically significant, meaningful, durable immune response. We’ve shown, with its own P value and hazard ratio, that Multikine before surgery and radiation gives patients a much improved survival with no safety issues,” Geert Kersten, CEL-SCI CEO said in an interview.
Trading of CEL-SCI stock was halted at least three times on Monday as its share price fell, and critics on Twitter took the company to task for trying to spin the outcomes of the trial.
“The stock market values you today, but not a single scientist values you that way,” Kersten said. “They look at the data. They look at the P value. They look at the hazard ratio. It’s nonsense to say this study failed. For half of the patients, it was an unbelievable success. The study said two things: We have to wait longer for survival benefit than for surgery or radiation or chemo. For immunotherapy, survival benefit takes longer to show. And we show clearly cisplatin chemotherapy destroys the immune response.”
Kersten pointed out that the patient population in the study was based on NCCN guidelines of radiation or radiation with chemotherapy, and this was specified in the protocol (NCT01265849).
“We spelled this out in the protocol 10 years ago. It was spelled out in the statistical analysis plan before database lock, and results were produced prior to being unblinded,” he said.
Multikine had previously been give Orphan drug Designation from the FDA for patients with squamous cell carcinoma. The company plans to seek FDA approval, but Kersten said there is no timeline for submitting the application. “We are waiting on final permits on the manufacturing facility, and then we will file for FDA approval,” Kersten said.
CEL-SCI has partnered with Teva in Israel and Orient Europharma in Singapore for development of Multikine outside of the United States and Europe.