Articles related to CLINICAL TRIALS

In the study,155 FDA-approved drugs with 136 potentially targetable genes were identified.One-hundred forty-six (94%) of the drugs showed no or low genetically predicted drug response. Although ATC-carrying BRAF mutations can benefit from BRAF inhibitors and this effect might be enhanced by a combined strategy including PIK3CA inhibitors in some of the patients, alterations in BRAFWT ATC are not directly targeted by currently FDA-approved options.

Hutchmed’s submission was based primarily on two phase 3 trials conducted in China. Even though a bridging study conducted in the US that suggested safety and efficacy similar to that observed in the Chinese study population, FDA responded that a multiregional clinical trial “more representative of the US patient population and in accordance with US medical practice will be required” for resubmission.

These authors found a “consistent positive association between pre-existing thyroid autoimmunity and higher thyroid cancer risk.” There also appears to be a correlation between thyroid antibody levels and related risk. The association appeared stronger in women than in men. The authors do not recommend screening for thyroid cancer in those with thyroid autoimmunity because of the risk of overdiagnosis.

A new study published in Annals of Internal Medicine looks at the link between cardiovascular disease among adults with type 2 diabetes, which might be more prevalent than previously thought. This study compares cardiovascular outcomes in patients taking first line metformin vs. SGLT-2 inhibitors, based on claims data over a 7-year period. SGLT-2 inhibitor use was associated with lower rates of hospitalization for heart failure and all cause mortality. Rates for MI and stroke were similar for the two treatments.

With a median follow-up of more than 2.5 years, sintilimab added to chemotherapy improved OS in patients with advanced, nonsquamous NSCLC. The median OS was 24.2 months with sintilimab and 16.8 months with chemotherapy alone. Nearly half of patients in the chemotherapy-only arm crossed over to receive sintilimab after disease progression. When the data were adjusted for the crossover effect, the OS benefit derived from sintilimab was more pronounced.

This comprehensive review highlights the history of discovering RAS and the decades of studies targeting KRAS-driven lung cancer, to the present applications. Although KRAS inhibitors have 36%–45% objective response rates with a median duration of response of 10 months, many tumors do not respond, and a variety of mechanisms of resistance have been observed, including new KRAS alterations, activation of alternate RTK pathway proteins, bypass pathways, and transcriptional remodeling. The authors conclude with a discussion of ongoing clinical trials aimed at overcoming resistance to KRAS inhibitors.