Articles related to CLINICAL TRIALS

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.

In this trial of nivolumab + chemotherapy vs. chemotherapy alone, nivolumab prolonged EFS by nearly 11 months and improved the pathologic complete response rate more than tenfold. There was also a trend toward improved OS with nivolumab. The study also reported an EFS improvement with nivolumab in both squamous and non-squamous NSCLC. Grade 3-4 treatment-related adverse events occurred in 34% of patients in the nivolumab arm and 37% of those in the chemotherapy-alone arm.

Nivolumab plus ipilimumab added to standard of care chemotherapy did not improve outcomes as 1st line therapy for unresectable or metastatic bladder cancers with PD-L1 expression > 1%.

In this 15-minute CME activity, two experts provide a rundown of multiple disease factors to consider, evolving clinical trial data, and the various therapeutic options available in the second and subsequent lines of therapy for patients with locally advanced or metastatic urothelial carcinoma.