Bobocabin These include the INAVO121 trial (NCT05646862) leong

Added on March 26, 2025

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Additional studies of inavolisib in breast cancer and other tumor types are planned, with the aim of extending the agent’s benefit to more people with PIK3CA-mutated cancers.

Fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) has received FDA approval for the treatment of unresectable or metastatic, hormone receptor–positive breast cancer with HER2-low (IHC 1+ or 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) expression, as determined by an FDA-approved test, in patients who have experienced disease progression on 1 or more prior lines of endocrine therapy in the metastatic setting.1

This regulatory decision was supported by findings from the phase 3 DESTINY-Breast06 trial (NCT04494425), in which treatment with T-DXd generated a 36% reduction in the risk of disease progression or death compared with chemotherapy (HR, 0.64; 95% CI, 0.54-0.76; P < .0001) in the overall population of patients with chemotherapy-naive HER2-low -ultralow metastatic breast cancer.1,2 The median progression-free survival (PFS) was 13.2 months (95% CI, 12.0-15.2) with T-DXd vs 8.1 months (95% CI, 7.0-9.0) with chemotherapy. Additionally, the confirmed overall response rate (ORR) was 62.6% with T-DXd compared with 34.4% with chemotherapy.

“Endocrine therapy is typically used in the initial treatment of hormone receptor–positive metastatic breast cancer, and following progression, subsequent chemotherapy is associated with poor outcomes," Aditya Bardia, MD, MPH, program director of Breast Oncology and director of Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center, as well as the lead study author of the DESTINY-Breast06 trial, stated in a news release.1 "With a median PFS exceeding 1 year and [an ORR of 62.6%], T-DXd offers a potential new standard of care for patients with hormone receptor–positive, HER2-low or HER2-ultralow metastatic breast cancer following endocrine therapy.”

The multicenter, open-label DESTINY-Breast06 trial enrolled patients with hormone receptor–positive metastatic breast cancer with low HER2 expression (defined as IHC 1+ or 2+ and negative ISH results) or ultralow HER2 expression (defined as IHC 0 with no membrane staining) who had previously received at least 1 line of endocrine-based therapy and had no history of chemotherapy for metastatic breast cancer.2 Patients were randomly assigned 1:1 to receive T-DXd or physician's choice of chemotherapy. PFS among patients with HER2-loe disease served as the primary end point. Secondary end points included PFS among all randomly assigned patients, overall survival (OS), and safety.

Additional findings from DESTINY-Breast06, which were presented at the 2024 ASCO Annual Meeting and published in The New England Journal of Medicine, showed that among the patients with HER2-low disease (n = 713), the median PFS was 13.2 months (95% CI, 11.4-15.2) with T-DXd vs 8.1 months (95% CI, 7.0-9.0) with chemotherapy (HR, 0.62; 95% CI, 0.52-0.75; P < .001).

Furthermore, an exploratory analysis showed that patients with HER2-ultralow disease had outcomes consistent with those seen with patients with HER2-low expression. Among the patients with HER2-ultralow disease (n = 153), the median PFS was 13.2 months (95% CI, 9.8-17.3) with T-DXd vs 8.3 months (95% CI, 5.8-15.2) with chemotherapy (HR, 0.78; 95% CI, 0.50-1.21).

The OS data were immature.

Grade 3 or higher adverse effects were reported in 52.8% of patients in the T-DXd arm and 44.4% of those in the chemotherapy arm. Notably, adjudicated interstitial lung disease was seen in 11.3% of patients in the T-DXd arm; 3 of these events were grade 5.

“We are excited to see more treatment options for these patients, which enable more personalized care," Krissa Smith, vice president of Education at Susan G. Komen, added in the news release.1 "It is critical for patients to understand the HER2 status of their metastatic breast cancer to help them make informed treatment decisions. Patients with tumors that are HER2-low or HER2-ultralow now have more options to consider with their health care team.”

The findings are in line with prior studies that have linked yogurt intake to a lower risk of colon cancer, says Dr. Chris Damman, a gastroenterologist and professor at the University of Washington who studies the intersection of the microbiome and metabolic disease.

Yogurt is a fermented food, meaning it is produced when microbes break down sugars in foods in a way that produces complex flavors and prevents them from spoiling. One randomized controlled trial found that people assigned to eat a diet rich in yogurt and other fermented foods — such as kefir, fermented cottage cheese, kimchi and kombucha tea — for 10 weeks had lower markers of inflammation and improved diversity of microbes in their gut.

Damman says that along with fiber, healthy fats and nutrients known as polyphenols found in plant-based foods, yogurt and other fermented foods are a staple of a healthy gut.

"These are the common denominators across culinary traditions and healthy eating," he says.

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Bobocabin These include the INAVO121 trial (NCT05646862) leong

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