In a phase 2 study of 24 patients with biliary cancer, Aliqopa in combination with Gemzar and chemotherapy led to a six-month progression-free survival rate of 51% with a median overall survival of 13.7 months.
Adding Aliqopa (copanlisib) to gemcitabine and cisplatin did not improve progression-free survival (PFS) in patients with biliary tract cancers, according to data published in Cancer.
In addition, study findings determined that patients with low PTEN (a protein that helps control many cell functions, including cell division and cell death) levels may derive a greater benefit from this combination.
“For locally advanced or metastatic disease, the combination of gemcitabine and cisplatin had been considered the standard of care for biliary tract cancer,” the study authors wrote.
In this phase 2 study, researchers treated 24 patients (median age, 64 years; 62.5% women) with advanced or unresectable biliary tract cancer with Aliqopa, gemcitabine and cisplatin. All patients received at least one dose of the drug. The primary end point was PFS at six months. Secondary end points included response rate, safety and median OS/PFS.
At six months, PFS was 51%, with a median of 6.2 months. PFS decreased to 28% at 12 months.
The median OS for all patients was 13.7 months.OS at six months was 74% then 52% at 12 months.
Of the 19 patients who were evaluated for response rates, 31.6% achieved a partial response and 57.9% had stable disease.
The most common severe side effects included anemia (lack of healthy red blood cells; 25%), decreased neutrophil count (low white blood cell counts; 45.83%), hypertension (high blood pressure; 20.8%) and increased lipase (a potential indicator of pancreatitis; 25%).
The study authors also assessed PTEN status in 20 patients. Of these patients, nine had a low PTEN expression and 11 had a high PTEN expression. Patients with a low PTEN expression had a median PFS of 8.5 months compared with 4.6 months in those with a high PTEN expression. The median OS for patients with a low expression was 17.9 months and 7 months for those with a high expression.
“(Aliqopa) may be more effective and increase survival in patients with low PTEN expression levels. Furthers studies are needed to confirm this,” the study authors wrote.
A limitation of this study is its small sample size, which emphasizes the need for future studies.
“Because low PTEN expression is seen in up to 70% of patients with (biliary tract cancers) and because our study suggested higher PFS and OS in this population, further study is warranted regarding the efficacy of gemcitabine, cisplatin and (Aliqopa) in patients with advanced (biliary tract cancers) specifically demonstrating low PTEN expression,” the study authors wrote.
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