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.
An early clinical trial of the drug MK-3475 in non-small cell lung cancer (NSCLC) has yielded promising results. MK-3475 targets PD-1, a protein on the surface of immune cells. Another protein, PD-L1, is present on many tumor cells and can bind to PD-1, which deactivates immune cells. MK-3475 blocks PD-1, allowing the immune cells to keep attacking cancer cells. Patients with advanced NSCLC who had failed at least two other treatments were given MK-3475. Tumors shrank in 24% of the patients overall. However, tumor shrinkage occurred in 67% of patients with high levels of PD-L1 on their tumors, compared to only 9% of others. PD-L1 levels may therefore help predict which patients will likely respond to MK-3475.
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.
A new study has dashed hopes that high doses of interferon given early on would be enough to curb melanoma. In a phase II clinical trial of about 200 people with melanomas that had not begun to spread, researchers treated half with high-dose interferon every day for a month and the other half with the same high-dose interferon regimen followed by 48 weeks of “maintenance” doses of this immune response-boosting protein. Maintenance doses are typically about 50% lower and are given three times a week instead of daily. The researchers found that the latter group did better, living longer without recurrence as well as surviving longer overall. The latter year-long interferon treatment is standard in the US and Australia, while lower doses of interferon are more commonly used in Europe, says an accompanying editorial.
The makers of the cancer drug bavituximab are initiating the SUNRISE trial, a phase III clinical trial investigating the efficacy of the drug against non-small cell lung cancer (NSCLC). Patients with advanced non-squamous NSCLC whose cancer has progressed after first-line treatment will receive either bavituximab plus docetaxel (Taxotere) or Taxotere by itself. Bavituximab inhibits phosphatidylserine, a protein found on the surface of tumors and tumor-associated cells that acts to suppress the body’s immune reponse. By blocking phosphatidylserine’s action, bavituximab allows the immune system to continue attacking the cancer. To find out more, patients can go to www.sunrisetrial.com.
Surgeons may be able to see—and remove—skin cancers completely, thanks to a new compound that tags tumors. Called BLZ-100, the experimental compound combines a fluorescent dye with a protein fragment that binds cancer cells. A phase I clinical trial of intravenously injected BLZ-100 will soon be underway in Australia, enrolling up to 30 people with basal cell carcinomas, squamous cell carcinomas, or melanomas that lack the dark pigment melanin, making them hard to diagnose. In addition, U.S. clinical trials are expected for other kinds of tumors by the end of 2014.
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.
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.