NCI Corner - Interview with Shakun Malik, MD

NCI Corner - Interview with Shakun Malik, MD

Regulatory Agency Perspective
Feb 01, 2017
Posted: February 2017

By Erik J. Maclaren, PhD

2017 Mesothelioma Clinical Trials Planning Meeting

Malignant mesothelioma is one of the most difficult cancers to control using existing therapies. Due to the rarity of this disease, randomized trials for potential new treatments are lacking. In order to facilitate clinical trials in patients with malignant mesothelioma, the NCI, the IASLC, and the Mesothelioma Applied Research Foundation have organized a Clinical Trials Planning Meeting (CTPM) for mesothelioma in March 2017. This meeting will bring together experts in the field to evaluate the most current data and propose clinical trials for promising agents. IASLC Lung Cancer News spoke with one of the co-chairs of the mesothelioma CTPM, Shakun Malik, MD, Head of Thoracic Cancer Therapeutics at the NCI Cancer Therapy Evaluation Program (CTEP), about recent advances in mesothelioma treatment and the goals of the meeting.

Q: Are there any advances on the horizon for the treatment of mesothelioma?

A: Yes, we are hoping so. There are a number of ongoing trials that are producing encouraging preliminary results, including immunotherapies as single agents and or in combination as first-line treatments and or in second-line treatment for recurrent metastatic disease. Anti-mesothelin antibodies, including antibodies and antibody-drug conjugates, are also promising.

Q: What are the prospects for using a master protocol along the lines of the Lung-MAP (SWOG S1400) trial in mesothelioma?

A: This is one of the agenda items that we are going to be discussing in the upcoming CTPM. The most important consideration for designing any master protocol is whether there are multiple cancer targets that have shown some preliminary, preclinical, or clinical evidence of activity in that particular disease. A master protocol like Lung-MAP in squamous cell lung cancer was based on data from The Cancer Genome Atlas that identified a number of potential targets for which the drugs were available, and conducting a master protocol simultaneously was thought to be more efficient than conducting clinical trials with each of the targets separately.

Q: How can the NCI and FDA influence the development of treatments for mesothelioma?

A: The NCI funds CTPMs, like the mesothelioma meeting in March, to bring together people from academia, the NCI, the FDA, and the pharmaceutical industry to discuss the current science and preliminary evidence that will support initiating trials that have a strong scientific rationale and that are feasible. The NCI leadership mandate for these meetings is to come up with proposals for 2 to 3 trials that could eventually be funded through the National Clinical Trials Network.

The eventual goal is to provide patients with more drug options that are clinically meaningful. The FDA presence at these types of meetings helps us understand how to efficiently navigate the approval process. Lung-MAP is a good example of coordination, not only between the NCI and the FDA, but also a public-private partnership with the pharmaceutical industry. It really is a team effort, and everyone has worked together to make such efforts happen.