Drs. Grace Dy, right, and Kelvin Lee are part of the team leading U.S. clinical studies of CIMAvax, an immunotherapy that has shown promise in treating lung cancer.

With Safety Analysis Now Complete, Roswell Park Moves Forward With Expanded Study of CIMAvax

Final results from early-phase lung cancer study show combination of Cuban immunotherapy, nivolumab is safe

  • Research team presenting final phase I results at AACR Annual Meeting
  • Results show promising efficacy in patients with PD-L1-low NSCLC tumors
  • Expanded second phase open to patients with some lung and head/neck cancers

ATLANTA — Final results from the first U.S. clinical study of a Cuban immunotherapy show that CIMAvax-EGF, a treatment targeting a particular cancer survival protein, epidermal growth factor (EGF), is safe and showed promising efficacy as part of a treatment combination with nivolumab (Opdivo) in patients with advanced non-small cell lung cancer (NSCLC). Principal Investigator Grace Dy, MD, will share these findings in a presentation at the American Association for Cancer Research (AACR) Annual Meeting 2019 in Atlanta.

CIMAvax effectively starves cancer cells by stimulating an immune response against circulating EGF, which the cells need to grow and proliferate. The now-completed phase I clinical study led by Dr. Dy evaluated the safety of combining CIMAvax with nivolumab, an anti-PD1 “checkpoint inhibitor” that is the standard therapy for patients with treatment-resistant or recurrent NSCLC.

The team reports that the combination of these two immunotherapies was safe and well-tolerated. They observed promising efficacy in patients whose tumors have low PD-L1 expression and who would not, therefore, be likely to respond well to nivolumab alone. And biomarker analysis shows that more patients developed strong antibody responses to CIMAvax at early time points with this combination, compared to results from earlier studies where patients were given CIMAvax alone.

“We posited that CIMAvax and nivolumab may work better together than they do alone, and results from this early-phase study suggest that this is the case, particularly for those patients whose tumors are PD-L1-negative,” notes Dr. Dy, Chief of Thoracic Oncology and Associate Professor of Oncology in the Roswell Park Department of Medicine. “We look forward to looking more fully at efficacy as we move forward with our phase II study.”

A phase II study (NCT02955290) is ongoing at Roswell Park, now expanded to include two additional groups of participants as well as those with recurrent NSCLC:

  1. Patients with advanced, recurrent squamous-cell head and neck cancer, who will receive the CIMAvax-nivolumab combination
  2. Patients with advanced NSCLC evidencing high PD-L1 levels, who will receive CIMAvax in combination with pembrolizumab (Keytruda) as firstline or initial treatment for NSCLC

Nearly $4 million in donations is funding Roswell Park’s initial CIMAvax clinical trials. These studies are being conducted in collaboration with scientists from the Centro de Inmunología Molecular (CIM) in Havana, Cuba, and Innovative Immunotherapy Alliance, an historic biotech venture formed by Roswell Park and the CIM.

AACR 2019 presentation details

Abstract CT088 / 12 — Final results of the Phase I study of nivolumab in combination with CIMAvax, an epidermal growth factor(EGF)-depleting immunotherapy in patients (pts) with advanced non-small cell lung cancer (NSCLC): Focus on biomarker analyses

Monday, April 1, 1 to 5 p.m. EDT, Georgia World Congress Center, Section 16


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.

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Annie Deck-Miller, Senior Media Relations Manager
716-845-8593; annie.deck-miller@roswellpark.org