Phase II Trial of Lung Cancer Drug Imprime PGG Completes Patient Enrollment

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 Completes Enrollment of Second Phase 2b Lung Cancer Trial

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).

Bevacizumab and weekly paclitaxel for non-squamous non small cell lung cancer patients: A retrospective study

Combination of bevacizumab and weekly paclitaxel showed synergitic effects, anti-tumor efficacy and a good toxicity profile for patients with breast cancer but has never been evaluated in non small cell lung cancer (NSCLC). We retrospectively reviewed safety and efficacy of this regimen in metastatic non-squamous NSCLC as fourth-line therapy or beyond.

In our experience, combination of bevacizumab and weekly paclitaxel exhibited acceptable toxicity and had encouraging anti-tumor efficacy as fourth-line treatment or beyond for non-squamous NSCLC patients, supporting further evaluation in larger prospective studies.

Avastin-Taxol Regimen May Be Effective Late-Line Treatment for Advanced Non-Squamous NSCLC

A retrospective study assessed the use of weekly bevacizumab (Avastin) along with paclitaxel (Taxol) every 3 weeks in patients with advanced non-squamous, non-small cell lung cancer (NSCLC) who had previously received at least three rounds of treatment. The Avastin-Taxol combination was found to be an effective antitumor treatment. Some patients experienced serious side effects, including one death. However, overall toxicity was deemed acceptable compared to typical chemotherapy results in similar patients.

Tarceva May Be More Effective in Advanced NSCLC When Combined with Other Targeted Therapies

An analysis of multiple clinical trials compared erlotinib (Tarceva) alone to combining Tarceva with other targeted therapies as second-line treatment for advanced non-small cell lung cancer (NSCLC). In the various trials, Tarceva was combined with bevacizumab (Avastin), bortezomib (Velcade), everolismus (Afinitor), sorafenib (Nexavar), sunitinib (Sutent), entinostat, tivantinib, and R1507. While combined therapy produced more side effects, it was more effective than Tarceva alone. Notably, the trials included many patients who had not been tested for mutations in the EGFR and KRAS genes. In patients who had EGFR mutations and/or lacked KRAS mutations, Tarceva alone tended to control cancer progression better than combined therapy, highlighting the importance of biomarker testing to identify which patients are most likely to benefit from different therapies.

Avastin-Containing Chemotherapy May Be Safe in Lung Cancer Patients with Brain Metastases

Bevacizumab (Avastin), which is approved for treatment of a number of advanced-stage cancer types, is commonly avoided in patients with brain metastases (cancer that has spread to the brain) because of fear of brain hemorrhages (bleeding in the brain). A retrospective study of 52 patients with advanced non-small cell lung cancer (NSCLC) who had received chemotherapy containing Avastin found no cases of serious bleeding events and no significant differences in survival or treatment side effects between patients with or without brain metastases. Avastin may therefore be a safe treatment option in NSCLC with brain metastases.

Research paper: