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SGO 2017: New Immunotherapy Axalimogene Filoslisbac Shows Positive Results in Cervical Cancer

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Key Points

  • The final efficacy results of GOG-0265 demonstrated that 38% of patients with heavily pretreated persistent or recurrent metastatic carcinoma of the cervix were alive 12 months following treatment with AXAL.
  • The expected 12-month survival rate of patients enrolled in the study was calculated to be 24.5%.
  • An ongoing complete response of 18.5 months was observed, and the longest ongoing survival is 40.6 months.

A new immunotherapy drug, axalimogene filoslisbac (AXAL), showed improved survival rates for patients with cervical cancer, according to a study presented at the 2017 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer.

Study coauthor Charles Leath, MD, MSPH, an SGO member from the University of Alabama at Birmingham, said that 50 patients with persistent or recurrent metastatic (squamous or non–squamous cell) carcinoma of the cervix were given AXAL as a single agent during the phase II GOG-0265 clinical trial.

Trial Findings

The final efficacy results of GOG-0265 demonstrated that 38% of patients (n = 19/50) with heavily pretreated persistent or recurrent metastatic carcinoma of the cervix were alive 12 months following treatment with AXAL. The GOG-0265 study protocol used a logistic model-based calculation to establish the expected 12-month survival rate. The model identified the key prognostic factors of age, race, and performance status significantly related to survival from a database of approximately 500 patients with persistent or recurrent metastatic carcinoma of the cervix who participated in 17 previous phase II studies. 

Using this model, the expected 12-month survival rate of patients enrolled in the study was calculated to be 24.5%. As a result, the 38% 12-month survival rate of patients treated with AXAL represents a 52% improvement over the expected survival rate. An ongoing complete response of 18.5 months was observed, and the longest ongoing survival is 40.6 months.

“The 12-month survival rate of [AXAL] reached unprecedented levels in this study, which is both impressive and important given the lack of innovation in metastatic cervical cancer,” said Warner K. Huh, MD, Division Director of Gynecologic Oncology at the University of Alabama at Birmingham, and lead investigator of the study.

“At one year, nearly 40% of treated patients were alive, and in this group of patients, this is meaningful,” Dr. Leath said. “The big picture is we now have a treatment that has made it all the way through a phase II trial that appears to have activity for treating recurrent cervical cancer. Because of this activity we have an obligation to evaluate AXAL further to see how else this may help patients with cervical cancer.”

The safety profile was consistent with previous clinical experience. The most common grade 1 or grade 2 treatment-related adverse events were hypotension and symptoms related to cytokine release (eg, nausea, chills, fever). Eighteen out of 50 patients experienced a grade 3 treatment-related adverse event and 2 out of 50 patients experienced grade 4 treatment-related adverse events, which were hypotension and symptoms related to cytokine release. 

The next steps for the drug is to test AXAL in a population of patients newly diagnosed with cervical cancer.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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