Andrew Smith

Articles by Andrew Smith

Expansion Cohorts Guidance Balances Drug Development With Safety, Rigor

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New draft guidelines from the FDA endorse the use of multiple expansion cohorts in first-in-human clinical trials as a means of speeding lifesaving medications to market, but the document warns that the difficulties and dangers of using such complex studies so early in the testing process necessitate unusually careful design and oversight.

Trial Investigators Discuss FDA Draft Guidance on Master Protocols

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Complex drug trials that use a single protocol to test either 1 agent against multiple cancers or multiple agents against 1 cancer can make drug testing faster, cheaper, and more informative, particularly when those trials use the data to constantly improve protocols.

Researchers’ understanding of why patients with cancer do or do not respond to treatment with immune checkpoint inhibition is constantly evolving, with new developments in innate and adaptive immunity, the tumor microenvironment, and more changing the way that immunotherapy is viewed and used. Many researchers are now pointing to the effect that gut microbiota have on patients’ response to checkpoint inhibitors and its implications for the treatment of patients receiving immunotherapy.

Rationale Grows for the Immune-Related Response Criteria

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The overwhelming majority of patients with cancer who appear to progress after they begin immunotherapy will never respond. They will continue to progress, just as quickly as they would with no treatment and just as predicted by the Response Evaluation Criteria in Standard Tumors (RECIST) criteria that have long guided most trial evaluations and many treatment decisions.

T-DM1 in Previously Treated HER2+ Metastatic Breast Cancer

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An analysis of the T-PAS expanded access study of T-DM1 in previously treated HER2+ metastatic breast cancer confirmed existing information on the safety of the combination, and observed significant clinical activity in a patient population that averaged seven prior therapies.

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