PAKT Trial Studies Capivasertib for Metastatic Triple-Negative Breast Cancer

By Adam Hochron
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With triple-negative breast cancer (TNBC) accounting for between 10% and 15% of breast cancer diagnoses, there is a constant need for new treatment methods to help these patients. A recent clinical study looked at the impact of adding capivasertib, an AKT inhibitor to paclitaxel as a first-line therapy. 

While chemotherapy is still the standard treatment method, its use is often limited in duration because of toxicity and patients’ developed resistance. Authors of the study, with results published in the Journal of Clinical Oncology, noted that “treatment results for patients with metastatic TNBC remain poor compared with results for those with other subtypes.” The authors also said that the average survival is currently around one year, making newer novel treatments “urgently needed.” 


Cancer cells. Source: Getty

Patients enrolled in the PAKT phase 2 trial were assigned either capivasertib and paclitaxel or placebo and paclitaxel. The trial was conducted between May 2014 and June 2017 at 42 academic medical centers in Europe and Asia, with a total of 140 patients. The primary endpoint was progression-free survival (PFS). Researchers also looked at several secondary endpoints, including overall survival (OS), tumor response, and safety. 

Mean PFS was 5.9 months in the capivasertib and paclitaxel group, compared with 4.2 months for patients in the placebo group. In the capivasertib and paclitaxel group, the median OS was 19.1 months, compared with 12.6 months for the placebo group. 

In terms of safety, the most common grade 3 and above adverse events in the dual drug group was diarrhea (13%). Patients also reported developing infections, neutropenia, rash, and fatigue. 

In addition to the overall results, the researchers also reported better outcomes in patients with PIK3CA/AKT1/PTEN-altered tumors. 

The researchers stated that this study isl “one of the few to demonstrate PFS and OS benefits in metastatic TNBC.”

“The numbers and types of subsequent treatments after progression were comparable between treatment groups, suggesting the observed differences resulted from the study treatment,” the authors said. “Together with the LOTUS trial, the PAKT study provides important evidence that AKT inhibition might be able to improve patient outcomes in this difficult-to-treat subtype of breast cancer, but confirmatory and adequately powered phase 3 trials are required.”

 

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