You are here

Lung Cancer Immunotherapy Shows Promise in Mid-Stage Trial

Treatment improves overall response versus antibody/chemotherapy combo (January 7)

Positive results have been reported from a phase II study that compared the immunotherapeutic drug candidate Imprime PGG (Biothera), administered with cetuximab (Erbitux, Eli Lilly/Bristol-Myers Squibb), carboplatin, and paclitaxel, versus the monoclonal antibody and chemotherapy combination alone.

The study’s primary endpoint was the objective response rate (ORR), and a secondary endpoint was overall survival (OS).

The combination of Imprime PGG with cetuximab and carboplatin/paclitaxel showed a statistically significant improvement in the ORR of 48% compared with 23% in the control group (P = 0.048). This improvement was greater in a biomarker-positive subgroup, which had an ORR of 67% (P = 0.009).

Beneficial effects were observed in both squamous and non-squamous NSCLC patients. Among patients with squamous-cell NSCLC, a cancer for which there are few treatment options, the ORR was 100% (n = 6) for biomarker-positive subjects treated with Imprime PGG compared with 30% (n = 10) for subjects in the control group (P = 0.01).

Although the study was not powered for OS, the results indicated a strong trend for improvement in the biomarker-positive subgroup. The median OS for biomarker-positive subjects treated with Imprime PGG was 16.5 months compared with 11.2 months in the control group.

Source: Biothera; January 7, 2013.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs