Dr. Larry Copeland, Professor of Obstetrics and Gynecology, at The Ohio State University College of Medicine, and Vice President at the Gynecologic Oncology Group (GOG) Foundation, Inc.

  • Larry J. Copeland, MD, professor of medicine, gynecologic oncology at the Ohio State University Wexner Medical Center, and vice president of the Gynecologic Oncology Group (GOG) Foundation, Inc., provided updated data from an open-label, two-stage phase II study (GOG 0265) of ADXS-HPV in patients with persistent or recurrent cervical cancer.
    • Dr. Copeland described the current unmet medical need for new effective treatment options for persistent/recurrent cervical cancer, noting that the current 1-year survival in this population is approximately 10%–15%.
    • Following encouraging survival results generated from a clinical trial executed in India evaluating ADXS-HPV in relapsed/refractory cervical cancer, the GOG initiated a US-based study in a similar patient population.
    • The GOG 0265 study was designed for expansion if a predefined efficacy threshold of 20% 12-month survival was met during the first stage of patient enrollment. Dr. Copeland expanded on the recent press release documenting achievement of this trial milestone, noting that among the 26 patients who received the per-protocol 3 doses of ADXS-HPV, 7 (27%) were alive at 1 year and an additional 6 patients were still on study but with less than 12 months of follow-up. The trial will now open to an additional 37 patients.
    • Based on the growing body of evidence for Lm-LLO immunotherapy in the management of cervical cancer, the GOG plans to commence the phase III AIM2CERV trial in 2015 to study ADXS-HPV in patients with high-risk, locally advanced cervical cancer.