Cancer Drug Tafinlar Receives Breakthrough Therapy Designation for Lung Cancer

The application for dabrafenib (Tafinlar) as a treatment for certain lung cancer cases has been given a boost with the U.S. Food and Drug Administration (FDA) designating it a breakthrough therapy. Tafinlar is being investigated as a therapy for patients with non-small cell lung cancer (NSCLC) who have a mutation called BRAF V600E in the BRAF gene and have received at least one previous round of chemotherapy. In a recent clinical trial, Tafinlar exhibited antitumor activity in such patients. The breakthrough therapy designation provides increased drug development guidance from the FDA and accelerated approval for drugs that treat serious or life-threatening conditions and that provide a substantial improvement over currently available treatments. Tafinlar is already approved for use in certain types of skin cancer.

Clinical Trial to Examine Effectiveness of Lung Cancer Vaccine TG4010 in Select Patients

A new clinical trial will examine the effectiveness of the lung cancer drug TG4010. TG4010 acts like a vaccine: it sensitizes the immune system to MUC1, a protein expressed in high levels on many lung tumor cells, and thus primes the immune system to attack these cancer cells. A previous trial suggested that TG4010 is most likely to be effective in patients with low levels of a certain kind of immune cell called triple-positive activated lymphocytes or TrPAL. In the new trial, patients with advanced non-small cell lung cancer (NSCLC) whose tumors express high levels of MUC1 and who have low levels of TrPAL will receive either TG4010 or a placebo along with their standard treatment.

Novel Immune-Based Cancer Drug Imprime PGG Appears Effective in Certain Lung Cancer 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.

Clinical Trial Continues to Examine Lung Cancer Vaccine

A new phase II/III clinical trial will further investigate the effectiveness of the lung cancer vaccine tergenpumatucel-L (HyperAcute-Lung immunotherapy, or HAL) against non-small cell lung cancer (NSCLC). Patients with advanced NSCLC that has resisted previous treatment will receive either HAL or the chemotherapy drug docetaxel (Taxotere). HAL consists of lung cancer cells that have been modified to prevent them from growing. A mouse gene has been inserted into these cells, causing them to express a molecule on their surface that human immune systems recognize as foreign. When the cells are injected into humans, they provoke a strong immune response, which stimulates the immune system to also attack the patient’s own lung cancer cells. A previous phase I/II trial of HAL had produced promising results.

Rash from Tarceva May Herald Drug Effectiveness

Skin rash is a common side effect of the lung cancer drug erlotinib (Tarceva). However, a clinical trial suggests that this rash can be a good sign and can be used to guide dosing. One hundred twenty-four patients with advanced non-small cell lung cancer (NSCLC) received first-line treatment with Tarceva. The drug dose was gradually increased until patients developed a skin rash or other side effects that prevented further dose increases. Seventy percent of patients developed a skin rash. Patients who developed a skin rash survived longer than those who did not (6.8 months longer on average), even though they did not differ in how much the treatment reduced the growth of their tumors.

Four-Drug Combination Shown to Be Safe and Effective for NSCLC

A combination of the drugs carboplatin (Paraplatin), paclitaxel (Taxol/Abraxane), cetuximab (Erbitux), and bevacizumab (Avastin) has demonstrated effectiveness against non-small cell lung cancer (NSCLC) in a phase II clinical trial. One hundred two patients with advanced non-squamous NSCLC received the four-drug combo as a first-line treatment. Tumors shrank in 56% of patients and stopped growing in an additional 21%. Patients went an average of 7 months without their cancer progressing; the average survival time was 15 months. Four treatment-related deaths occurred, including two due to hemorrhage (heavy bleeding), which can be a rare but serious effect of Avastin treatment. This side effect profile was within the predefined safety margin. A phase III trial further investigating this drug combination for NSCLC is currently enrolling participants.

Exelixis Initiates Randomized Phase II Clinical Trial of Cabozantinib Plus Abiraterone in Chemotherapy-Naive Patients with Metastatic CRPC

“Exelixis, Inc. today announced that it has initiated a phase II clinical trial comparing cabozantinib plus abiraterone and prednisone (abiraterone/prednisone) versus abiraterone/prednisone in patients with castration-resistant prostate cancer (CRPC) who have bone metastases and have not been previously treated with chemotherapy. The primary endpoint for the randomized, open-label trial is radiographic progression-free survival (PFS).”


Clinical Trial Investigates the Use of Electrical Fields to Fight Brain Metastases in Lung Cancer

A new clinical trial will evaluate the safety and effectiveness of NovoTTF therapy to treat non-small cell lung cancer (NSCLC) that has spread to the brain. NovoTTF therapy uses the NovoTTF-100A system, a portable device consisting of an electrical field generator and electrodes that attach to the patient’s scalp. The device produces alternating electrical fields, so-called ‘tumor treating fields’ (TTF), in the brain that are intended to disrupt the process by which tumor cells divide and multiply. NovoTTF therapy is already approved to treat certain kinds of brain cancer that do not respond to other treatments. The new trial will study patients with NSCLC that has spread to the brain and was previously treated with focused, high-powered radiation.

Combination of S-1, Platinol, and Radiation Promising for Lung Cancer

Results from a phase II clinical trial suggest that combining the cancer drug S-1 (Teysuno) with the chemotherapy agent cisplatin (Platinol) and radiation therapy may be effective in non-small cell lung cancer (NSCLC). Patients with inoperable, locally advanced NSCLC were treated with S-1, Platinol, and radiation to the chest region. Tumors shrank at least 30% in 36 out of 41 patients. Although some patients experienced low levels of white blood cells, overall the treatment was well tolerated. S-1 is itself a combination of tegafur (a chemotherapy agent), gimeracil (which boosts tegafur levels in the body), and oteracil (which protects the stomach and gut from tegafur toxicity.