Todd Bauer, MD, associate director, Drug Development, principal investigator, Sarah Cannon Research Institute, discusses how phase I clinical trial programs are evolving and becoming more beneficial for patients with cancer.

Phase I trials have changed dramatically over the last 5 to 10 years. The previous goal of them, Bauer explains, was to determine safe doses of therapies for 15 to 30 patients. Now, pharmaceutical companies are having hundreds of patients enroll on phase I trials to have a proof-of-concept earlier in the drug development process.

This changes who are appropriate phase I patients and whether they are at the end of all possible treatment options or if such a trial would be a reasonable next step in their line of therapy.

Bauer adds that there are phase I studies of more than 20 expansion cohorts with 20 different groups of patients who are not heavily pretreated. The question is, he asks, how do clinicians get the right drugs to the right patients at the right time?

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Dr. Bauer on Evolution of Phase I Trials

Todd Bauer, MD, associate director, Drug Development, Sarah Cannon Research Institute, discusses the emergence of the novel agent rovalpituzumab tesirine (Rova-T) in the treatment of patients with small cell lung cancer (SCLC) in an interview during the IASLC Chicago Multidisciplinary Symposium in Thoracic Oncology.

SCLC, says Bauer, is one of the few cancers that is lacking in targeted therapies. Rova-T, specifically, targets DLL3, a molecule that is expressed in approximately two-thirds of patients with SCLC, making it an excellent marker in this space.

Currently, there are 3 ongoing studies assessing the efficacy of Rova-T. Beyond these trials, Bauer believes oncologists will soon look at Rova-T in a first-line setting, as well as in combination with immunotherapies such as nivolumab (Opdivo) and ipilimumab (Yervoy).

Todd Bauer, MD, associate director, Drug Development, Sarah Cannon Research Institute, discusses the emergence of the novel agent rovalpituzumab tesirine in the treatment of patients with small cell lung cancer in an interview during the IASLC Chicago Multidisciplinary Symposium in Thoracic Oncology.

Dr. Bauer on Rovalpituzumab Tesirine in SCLC

Todd Bauer, MD, associate director, Drug Development, principal investigator, Sarah Cannon Research Institute, discusses the safety and efficacy of single-agent rovalpituzumab tesirine (Rova-T), a delta-like protein 3-targeted antibody-drug conjugate in recurrent/refractory patients with small cell lung cancer (SCLC).

This agent is designed to have a novel approach in that it targets a specific receptor on top of cancer and stem cells prior to releasing a potent chemotherapeutic, Bauer explains. Data show that the agent can be administered safely. Additionally, after receiving a couple doses of treatment, patients are able to take a treatment holiday. If/when disease recurs, treatment can resume, he says.

This antibody-drug conjugate does not release its chemotherapeutic until it reaches the SCLC cells, Bauer adds. When this occurs, the cancer cells internalize and cell death takes place.

Todd Bauer, MD, associate director, Drug Development, principal investigator, Sarah Cannon Research Institute, discusses the safety and efficacy of single-agent rovalpituzumab tesirine (Rova-T), a delta-like protein 3 (DLL3)-targeted antibody-drug conjugate in recurrent/refractory patients with small cell lung cancer (SCLC).

Todd Bauer, MD

Articles

Dr. Bauer on Evolution of Phase I Trials

Dr. Bauer on Rovalpituzumab Tesirine in SCLC

Dr. Bauer on Rovalpituzumab Tesirine in Patients With SCLC