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news.Avant Immunotherapeutics and Pfizer have presented new data from two Phase II studies for CDX-110, an investigational immunotherapeutic vaccine that targets the tumor-specific molecule epidermal growth factor receptor variant III, in patients with newly diagnosed EGFRvIII-positive glioblastoma multiforme.
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In the Activate study, median survival time was 26 months (95% CI: 21.6, infinity) and median time-to-progression (TTP) was 14.2 months. Median survival in a historical matched cohort was 15.2 months with median time to progression of 7.13 months. No significant adverse events were seen in this study.
Preliminary results from the Act II study currently estimate median overall survival to be 33.1 months, although the median has not yet been reached. The survival of a matched historical control group was 14.3 months and a subgroup treated with temozolomide (TMZ) of 15.2 months. Overall TTP was 16.6 months compared with 6.4 months for the historical control group. In this study, CDX-110 was generally well-tolerated with primary toxicity reported as local injection site reactions.
The Activate trial studied CDX-110 vaccine in 21 patients with newly diagnosed EGFRvIII-expressing glioblastoma multiforme (GBM) who had undergone surgical resection followed by conformal radiation therapy with concurrent oral temozolomide (75mg/m2 per day) without tumor progression. CDX-110 mixed with granulocyte-macrophage colony stimulating factor (GM-CSF) (142mcg) was administered intradermally.
The Act II study enrolled a total of 23 patients. The patient population and treatment scheme were similar to Activate, except that no early placebo was given and two dose schedules of maintenance temozolomide were studied (13 patients received 200mg/m2 daily times five every 28 days, while 10 received 100mg/m2 daily times 21 days every 28 days for a maximum of 12 cycles). Monthly CDX-110 vaccination mixed with GM-CSF was given on day 21 of each cycle until tumor progression.
John Sampson, associate professor of neurosurgery at Duke University Medical Center, said: “Vaccination with CDX-110 together with standard of care temozolomide in patients with GBM increased time to progression and overall survival compared with a matched historical control group in these Phase II studies. This treatment is being further studied in a randomized Phase IIb/III trial to confirm these results.”