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Lung Cancer Immunotherapy Shows Promise in Mid-Stage Trial
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.