According to a recent study, sacituzumab govitecan was safe and significantly beneficial over chemotherapy in treating metastatic breast cancer. This study's result were published in the journal, Lancet.

The TROPiCS-02 was a randomized, phase 3, multi-centre, open-label trial that included 543 patients with confirmed hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+ and HER2-). They were randomly assigned in a 1:1 ratio to receive either sacituzumab govitecan (n=272) or chemotherapy (n=271; eribulin, vinorelbine, capecitabine, or gemcitabine). The patients had received at least one previous endocrine therapy, a taxane, as well as a CDK4/6 inhibitor in any setting and 2-4 previous chemotherapy regimens for metastatic disease. The study's primary endpoint was progression-free survival while the secondary endpoints included objective response rate (ORR), overall survival, and patient-reported outcomes.

At the end of the study, it was observed that sacituzumab govitecan significantly improved overall survival. Also, ORR was significantly improved with sacituzumab govitecan as was time to deterioration of global health status and quality of life. The safety profile of sacituzumab govitecan was in accordance with those of the ASCENT trial and primary analysis of TROPiCS-02.

Based on the results of this study, it can be concluded that sacituzumab govitecan may be used as a new treatment option for patients with  pretreated metastatic breast cancer as it may demonstrate statistically significant and clinically meaningful benefits with a manageable safety profile.

According to a recent study, first-line nivolumab plus chemotherapy increased overall survival in patients with advanced or metastatic esophageal adenocarcinoma (EAC) or gastric/gastroesophageal junction cancer (GC/GEJC) when compared to chemotherapy alone. This study’s results were published in the Journal of Clinical Oncology.

The CheckMate 649 trial included 1,581 patients who were concurrently randomly assigned to nivolumab plus chemotherapy or chemotherapy in a 1:1 ratio. The EQ-5D and Functional Assessment of Cancer Therapy-Gastric (FACT-Ga), which comprised the Gastric Cancer subscale (GaCS) and FACT-General (FACT-G), were used to measure health-related quality of life (HRQoL). Longitudinal changes in HRQoL were measured in the PRO analysis population which included patients with baseline and ≥1 postbaseline assessments.

It was found that in the PRO analysis population (n=1,360) PRO questionnaire completion rates were mostly >80% during treatment. Nivolumab plus chemotherapy did not result in an increase in the patient-reported symptom burden. Mean improved changes for FACT-Ga total, GaCS, and EQ-5D visual analog scale in patients with a combined positive score (CPS) of ≥5 from baseline were greater with nivolumab plus chemotherapy. Based on the FACT-Ga total score and GaCS, nivolumab plus chemotherapy decreased the risk of symptom deterioration compared to chemotherapy in CPS ≥5 and all randomly assigned populations. Also, the time to deterioration was longer and the risk of definitive deterioration in HRQoL was reduced with nivolumab plus chemotherapy.

Based on the above results, it can be concluded that first-line nivolumab plus chemotherapy may demonstrate stable or better on-treatment HRQoL in patients with advanced/metastatic non-HER2-positive GC/GEJC/EAC and may also show decreased risk of definitive HRQoL deterioration.

According to a recent study, alirocumab may reduce low-density lipoprotein cholesterol (LDL-C) and other lipid parameters in pediatric patients with heterozygous familial hypercholesterolemia (HeFH) who have not achieved sufficient control with statins. This study’s findings were published in the journal, JAMA pediatrics.

In this phase 3, randomized clinical trial, 153 pediatric patients aged 8-17 years with HeFH, LDL-C levels of 130 mg/dL or higher, and undergoing statin or other lipid-lowering therapy (LLT) were randomly assigned to receive subcutaneous alirocumab or a placebo and dosed every 2 weeks (Q2W) or every 4 weeks (Q4W). The dosage depended on weight (if <50 kg then 40 mg for Q2W or 150 mg for Q4W; if ≥50 kg then 75 mg for Q2W or 300 mg for Q4W) and was adjusted at week 12 if LDL-C was 110 mg/dL or higher at week 8. Following the 24-week double-blind phase, patients could continue alirocumab treatment in an 80-week open-label phase. The primary endpoint of the study was the percentage change in LDL-C from baseline to week 24 in each group.

Alirocumab demonstrated statistically significant decreases in LDL-C compared to the placebo in both groups at week 24. The least squares mean difference in percentage change from baseline was -43.3% for the Q2W group and -33.8% for the Q4W group. A hierarchical analysis of secondary efficacy endpoints revealed notable enhancements in other lipid parameters at weeks 12 and 24 with alirocumab. The findings from the open-label period were consistent with those from the double-blind period.

Based on the above results, it can be concluded that alirocumab dosed every two weeks or every four weeks may lower LDL-C levels and improve other lipid parameters in pediatric patients with HeFH who have not achieved adequate control with statins.

A recent study found that mirvetuximab soravtansine-gynx (MIRV) targeting folate receptor α (FRα) showed a significant benefit over chemotherapy in the treatment of platinum-resistant, high-grade serous ovarian cancer. This study’s results were published in The New England Journal of Medicine.

This phase 3, global, confirmatory, open-label, randomized, controlled trial included 453 participants who were randomized in a 1:1 ratio to receive 6 mg per kilogram of adjusted ideal body weight of MIRV every 3 weeks (N=227) or chemotherapy that included paclitaxel, pegylated liposomal doxorubicin, or topotecan (n=226). The primary end point of the study was progression-free survival. The key secondary analytic end points of the study included overall survival, objective response, and participant-reported outcomes.

It was observed that the median progression-free survival with MIRV and chemotherapy was 5.62 months and 3.98 months, respectively. An objective response occurred in 42.3% and 15.9% of the participants in the MIRV and chemotherapy groups, respectively. The overall survival was found to be significantly longer with MIRV than with chemotherapy (16.46 months vs. 12.75 months). Similarly, during the treatment period, fewer adverse events of grade 3 or above, SAEs (serious adverse events) of any grade, and events leading to discontinuation, occurred with MIRV compared to chemotherapy.

Based on the above results, it can be concluded that treatment with MIRV may show a significant benefit with respect to progression-free survival, overall survival, and objective response among participants with platinum-resistant, FRα-positive ovarian cancer. Thus, it may be safe and efficacious for use.