“Biothera’s investigational cancer immunotherapy Imprime PGG in combination with standard platinum-based doublet chemotherapy and the monoclonal antibody bevacizumab achieved rapid and lasting responses in patients with non-squamous non-small cell lung cancer (NSCLC). Tumor reduction was observed regardless of tumor burden (up to > 30 cm) or location of lesions at baseline (including lung, lymph nodes, adrenals, liver). These findings were presented yesterday during a poster session at the annual meeting of the American Society of Clinical Oncology (abstract #3070).
“During Biothera’s randomized clinical study in non-squamous NSCLC, patients received four to six cycles of Imprime PGG in combination with bevacizumab and carboplatin/ paclitaxel chemotherapy. These treatment cycles were followed by a maintenance therapy phase consisting of bevacizumab with or without Imprime PGG.
“Overall, the objective response rate was 60.4% with Imprime PGG versus 43.5% in the control group. Time to response was short (12 weeks vs. > 16 weeks), and responses were durable with Imprime PGG (10.3 months vs. 5.6 months). In the maintenance phase, further meaningful tumor reductions were observed in 20% of patients in the Imprime PGG group, but none in the control group. These findings were associated with numerical increases in overall survival: at the 1-year mark (following treatment start) 62.8% of patients on Imprime PGG remained alive, compared with 42.7% of patients in the control group.”
“The combination of the investigational cancer immunotherapy Imprime PGG and the monoclonal antibody bevacizumab achieved additional meaningful reductions in tumor burden during the maintenance phase of Biothera’s recent phase 2 clinical trial in non-small cell lung cancer (NSCLC). The new data will be released today at the European Lung Cancer Conference.
“Biothera conducted a randomized Phase 2 clinical study in non-squamous NSCLC in which Imprime PGG was administered in combination with bevacizumab and platinum-based doublet chemotherapy. After four to six cycles of treatment, patients received maintenance therapy of bevacizumab with or without Imprime PGG. Further meaningful reductions in tumor burden (>10mm) were observed in 6 (20%) of patients in the Imprime PGG group, but not in the control group.
“ ‘Patients receiving the combination of Imprime PGG and bevacizumab experienced further reduction in their tumor burden than with bevacizumab therapy alone,’ said Ada Braun, M.D., Ph.D., Biothera Chief Medical Officer. ‘These results highlight the efficacy of Imprime PGG and show the potential for continued tumor regressions on chemotherapy-free maintenance therapy for some patients.’ ”
Adding the drug Imprime PGG to chemotherapy and antibody therapy may be effective for certain patients with non-small cell lung cancer (NSCLC). Imprime PGG contains a molecule called beta glucan, which can stimulate the body’s immune cells to destroy cancer cells. This process may be especially effective in patients with high levels of immune system proteins that bind to beta glucan, so-called antibeta glucan antibodies. In a recent clinical trial, patients with advanced NSCLC received the antibody drug cetuximab (Erbitux) and the chemotherapy agents carboplatin (Paraplatin) and paclitaxel (Taxol/Abraxane), and some were also given Imprime PGG. While survival across all patients was not affected by Imprime PGG treatment, it was increased in Imprime PGG-treated patients with high levels of antibeta glucan antibodies. Seventeen percent of these patients survived 3 years or more, while none of the other patient groups did.
Biothera has completed patient enrollment in a second phase II clinical trial testing a drug called Imprime PGG against non-small cell lung cancer (NSCLC). Imprime PGG redirects the immune system to attack the cancer. The drug also enhances the effectiveness of antibody drugs (drugs in the form of a type of immune system protein) like bevacizumab (Avastin) or cetuximab (Erbitux). The current phase II trial will compare NSCLC patients receiving Imprime PGG in combination with Avastin and chemotherapy to those receiving only Avastin and chemotherapy. Another ongoing phase II trial uses a similar design, but with Erbitux instead of Avastin, and has produced promising preliminary results.
Biothera announced today that it has completed enrollment of its 90-patient Phase 2b clinical study of Imprime PGG, bevacizumab (Avastin) and two chemotherapeutic drugs in non-small cell lung cancer (NSCLC).