SABCS 2016 - Ricardo Alvarez

🎥 Dec 15, 2016 📺 Touch Medical Media ⏱ 4m 👁 81 views

Ricardo Alvarez discusses the rationale, methodology, and design of the Study 219 phase Ib/II trial of eribulin in combination with ...

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About Ricardo Alvarez

Ricardo Alvarez, who previously served as Medical Director of the Breast Cancer Center and Director of Cancer Research at Cancer Treatment Centers of America, has discussed the use of next-generation genomic sequencing in advanced cancer patients. At ESMO 2018, he presented data from approximately 8,000 samples from 7,600 patients collected over five years, noting that 28 to 30 percent of mutations were actionable and could be treated with targeted therapy. He stated that patients receiving biomarker-directed treatment responded better and that the program helped identify clinical trials, though he cited cost and limited trial access as barriers, with some patients receiving off-label treatments. Alvarez has also described his work at Clinica Esperanza, an HIV clinic in San Francisco serving mostly Latino, uninsured, or underinsured patients. He outlined a multidisciplinary model of care that includes harm reduction counseling and artistic programs to improve self-esteem and medication adherence. He noted that advocacy efforts helped over 120 patients obtain political asylum, which he said transformed their lives by enabling employment and other opportunities.

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Transcript (4 segments)

Ricardo Alvarez0:19

Good morning. My name is Ricardo Alvarez, I am the director of breast cancer research at Cancer Treatment Center of America, CTCA in Atlanta, and a clinical associate professor at GU St. University in Georgia.

The study 219 is a novel combination of two agents. One of the agents is very well-known, eribulin, in combination with a molecule that is pegylated recombinant human hyaluronidase, and this is a new concept to treat patients with advanced cancer. This study 219 is a randomized Phase 1b/Phase 2 clinical trial for patients with HER2-negative breast cancer that failed first or second line of prior chemotherapy. The novelty of this combination is the pegylated recombinant human hyaluronidase enzyme. The concept is that first the target is going to be the microenvironment, followed by the treatment with the microtubule inhibitor.

A patient with advanced cancer receives this new compound, pegylated recombinant human hyaluronidase. What we try to do is 24 hours later they will receive the chemotherapy. We know that cancer is not only cancer cells; cancer cells need to learn about the context, the microenvironment. Microenvironment is the area where all these cancer cells live. The rationale for the combination of these two agents is the first experimental agent will degra date the microenvironment, the glycosaminoglycans, into different proteins, and secondly the chemotherapy will take care of the cancer cells.

The study design is a Phase 1b and Phase 2 clinical trial. In Phase 1b, the primary endpoint is we will have between six to twelve patients to obtain the recommended dosage for the Phase 2. These are a group of patients with HER2-negative breast cancer with one or two previous lines of chemotherapy. We will take all the data from safety and efficacy. We will also have multiple time points of pharmacokinetics and pharmacodynamics. After we collect this number of patients, we will have the recommended doses for Phase 2, and we will launch the Phase 2 clinical trial. The endpoints for the Phase 2 clinical trial are overall response rate as a secondary endpoint, progression-free survival, and overall survival. Another important point of this clinical trial is biomarker-driven clinical trial, so we will target only the patients with high hyaluronan in this case, so we will use this as a novel biomarker to identify a population that might be sensitive to this combination.