Cleveland Clinic Cancer Center experts present data at 2018 ASCO Annual Meeting

Friday, June 1, 2018, CLEVELAND: At the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, researchers from Cleveland Clinic Cancer Center will present data from several new studies, including a prospective clinical trial examining non-small cell lung cancer cells' response to immunotherapy; research on germline testing for melanoma; and interim results from a study testing a vaccine for glioblastoma.

"Clinical research is critical to the development of treatment options we can offer patients that extend their lives and improve their quality of life," said Brian Bolwell, M.D., FACP, chairman of Cleveland Clinic Taussig Cancer Institute. "Clinical trials, involving immunotherapy and genomics in particular, are a priority for our cancer center and the research we are presenting at ASCO is a testament to that."

* Abstract 12001 title: Prospective clinical evaluation of blood-based tumor mutational burden (bTMB) as a predictive biomarker for atezolizumab (atezo) in 1L non-small cell lung cancer (NSCLC): Interim B-F1RST results; Dr. Vamsidhar Velcheti, oral presenter; Tuesday, June 5

Vamsidhar Velcheti, M.D., FACP, FCCP a medical oncologist at Cleveland Clinic, will announce, in an oral presentation, the interim results of the first prospective trial looking at blood-based tumor mutational burden (bTMB) as a predictive biomarker for atezolizumab (atezo) in 1L non-small cell lung cancer. Patients on this clinical trial had a blood-based test for circulating tumor DNA mutation burden before participating in the trial, allowing researchers to perform a post-trial comparison on whether the cancer's genomics were a predictor of response to immunotherapy. Early data, gathered from more than 20 sites, has shown progression-free survival.

Dr. Velcheti is also an author on a study that was the first to examine ALT-803, an IL-15 superagonist, in combination with nivolumab in patients with metastatic non-small cell lung cancer. A portion of the results were published in Lancet Oncology in April, and at ASCO, updates will be presented. Lastly, Dr. Velcheti was also one of the key investigators in a first-in-human phase 1 clinical trial of loxo-292, a drug targeting RET-fusion positive non-small cell lung cancer, which will be presented at ASCO. This treatment is showing promise in patients with lung cancer harboring this rare form of genomic alteration, and offers a therapeutic alterative with targeted therapy.

* Abstract 2041 title: Phase II trial of SurVaxM combined with standard therapy in patients with newly diagnosed glioblastoma; Dr. Manmeet Ahluwalia, poster presenter; Saturday, June 2

Manmeet Ahluwalia, M.D., a Cleveland Clinic medical oncologist specializing in neuro-oncology, will present a poster on the interim results from a multicenter Phase II study of SurVaxM in patients with newly diagnosed glioblastoma. SurVaxM, is a first-of-its-kind, patented peptide mimic immunotherapeutic vaccine that targets survivin, a cell-survival protein present in most cancers, and is designed to control tumor growth and recurrence. Patients received four priming doses of SurVaxM (500 mcg) with Montanide and sargramostim (100 mcg) every two weeks, followed by adjuvant temozolomide and maintenance SurVaxM every 12 weeks until progression.

Analysis of the first 55 patients showed progression-free survival was 96.3 percent measured from diagnosis and 62.8 percent from first immunization. The 12-month overall survival was 90.9 percent from diagnosis and 70.8 percent from first immunization. The regimen was generally well tolerated and immunization-related adverse events were mild with no serious adverse events attributable to SurVaxM. Researchers concluded standard therapy plus SurVaxM appears promising in glioblastoma compared to standard therapy alone, and the use of SurVaxM is safe in glioblastoma. A randomized, prospective trial of SurVaxM in glioblastoma is planned.

Dr. Ahluwalia is also part of a multi-institutional team examining the efficacy of using tumor DNA to guide treatment for patients with glioblastoma. He and investigators from several leading institutions are participating in a new collaborative effort called ALLELE, to generate prospective clinical genomics and inform treatment decisions such as clinical trial participation in patients with newly diagnosed glioblastoma. The latest data from their work will be presented as an oral at ASCO.

* Abstract 1588 title: Multiplex germline testing in selected melanomas presenting to oncology clinic; Dr. Pauline Funchain, poster presenter; Saturday, June 2

Also at ASCO 2018, Pauline Funchain, M.D., a Cleveland Clinic medical oncologist specializing in melanoma, will present a poster focused on multiplex germline testing in selected melanoma patients. Dr. Funchain's objective was to establish the usefulness of germline testing in the oncologic melanoma population.

In Dr. Funchain's research, a cohort of patients selected based on family or personal history of multiple cancers were offered germline testing with a multiplex panel comprised of 12 genes related to melanoma and 69 additional cancer-related genes not known to be related to melanoma. Dr. Funchain and team concluded that multiplex germline testing in this group resulted in an 18.5 percent mutation-positive rate. Nearly half were identified in genes not previously associated with melanoma, and all genes identified related to increased risks of other cancers. She concluded that patients with melanoma, particularly with a personal or family history of other cancers, may benefit from germline testing, and more data will be required to further refine testing guidelines for melanoma.

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About Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Among Cleveland Clinic's 52,000 employees are more than 3,600 full-time salaried physicians and researchers and 14,000 nurses, representing 140 medical specialties and subspecialties. Cleveland Clinic's health system includes a 165-acre main campus near downtown Cleveland, 11 regional hospitals, more than 150 northern Ohio outpatient locations – including 18 full-service family health centers and three health and wellness centers – and locations in Weston, Fla.; Las Vegas, Nev.; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2017, there were 7.6 million outpatient visits, 229,000 hospital admissions and 207,000 surgical cases throughout Cleveland Clinic's health system. Patients came for treatment from every state and 185 countries. Visit us at clevelandclinic.org. Follow us at twitter.com/ClevelandClinic. News and resources available at newsroom.clevelandclinic.org.

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