Encouraging immunologic and clinical responses in early-phase study of Cuban immunotherapy and Opdivo
- Study of CIMAvax and another immunotherapy is underway at Roswell Park
- Lead investigator shares initial findings from first group of patients treated
- Findings suggest that the combination is safe and merits further study
BUFFALO, N.Y. — Initial results from the first North American clinical trial of CIMAvax-EGF show that this Cuban-developed immunotherapy is safe, well tolerated and worthy of further study. Principal Investigator Grace Dy, MD, of Roswell Park Comprehensive Cancer Center shared the findings yesterday at the International Association for the Study of Lung Cancer’s (IASLC’s) 19th World Conference on Lung Cancer (WCLC) in Toronto, Canada.
The poster presentation reports results from the first portion of an ongoing phase I/II study of CIMAvax, an epidermal growth factor (EGF)-depleting immunotherapy, in combination with the checkpoint inhibitor nivolumab (brand name Opdivo) in 13 patients with advanced non-small cell lung cancer (NSCLC). Nivolumab is an anti-PD1 antibody and is a standard therapeutic option in many countries, including the U.S., for patients with treatment-resistant or recurrent NSCLC.
“We found that both nivolumab and CIMAvax can be used at their recommended single-agent doses together safely. And because we also saw durable responses to this combination in patients who would have low probability of therapeutic benefit from immune checkpoint inhibition therapy, such as those whose tumors expressed low levels of PD-L1, including one patient with both low tumor PD-L1 and very low tumor mutation burden, it appears that these two immunotherapies have the potential to work better in combination than they do on their own,” says Dr. Dy, Division Chief for Thoracic Oncology and Associate Professor of Oncology in the Department of Medicine at the Buffalo, NY, cancer center.
“While this is a small study and we will need to verify that these conclusions hold true when we move on to our phase II study,” notes Dr. Dy, “these early hints of clinical activity encourage us to continue exploring this combination approach.”
No patients experienced life-threatening side effects attributable to the combination. One patient — representing 7% of this small study sample — experienced an on-target grade 3 side effect, myocarditis, attributed to nivolumab.
Earlier studies from Cuba have demonstrated a survival benefit for patients with advanced NSCLC who received maintenance doses of CIMAvax. While this initial dose-escalation portion of the ongoing Roswell Park study did not set out to evaluate efficacy, further examinations are underway.
Dr. Dy’s study was presented in collaboration with scientists from the Centro de Inmunología Molecular (CIM) and Innovative Immunotherapy Alliance, a new company spun off from both Roswell Park and the CIM — the first-ever U.S.-Cuban biotech venture.
The World Conference on Lung Cancer is the world’s largest meeting dedicated solely to lung cancer and other thoracic malignancies, attracting more than 7,000 researchers, physicians and specialists from more than 100 countries.
Nearly $4 million in donations is funding Roswell Park’s initial CIMAvax clinical trials.
For more information, please see roswellpark.org/cimavax.
Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@roswellpark.org.
Annie Deck-Miller, Senior Media Relations Manager