T-VEC Keeps Shrinking Melanomas

An experimental vaccine that is injected into melanomas can shrink them for an average of 8 months, according to findings presented at the American Society of Clinical Oncology’s 2013 meeting. Called talimogene laherparepvec (T-VEC), this immunotherapy consists of a virus engineered to carry human genes for granulocyte macrophage colony-stimulating growth factor (GM-CSF). Once inside a tumor, T-VEC kills tumor cells both by bursting them and by boosting the immune response against them. In a phase III clinical trial, melanomas shrank in 16% of those injected with T-VEC (48 out of 295) compared to just 2% of those treated directly with GM-CSF (30 out of 141). Moreover, melanomas disappeared completely in more than 10% of those treated with T-VEC. Doctors caution that because T-VEC is injected into melanomas, this treatment is only practical for people with accessible tumors.


Gene Expression Pattern Predicts Risk in Early Lung Cancer

In a past clinical trial, researchers identified a collection of 15 genes whose expression pattern predicted the relative risk of death in people with early-stage non-small cell lung cancer (NSCLC). Now, a new study has confirmed these findings in a larger, independent group of patients. Early-stage NSCLC patients who were classified into high- or low-risk groups based on testing the expression of the 15 genes differed significantly in their overall 5-year survival. These gene expression patterns may therefore help distinguish patients at higher risk who would benefit from adjuvant chemotherapy (chemotherapy given after tumor removal surgery), from lower-risk patients who could avoid the side effects of chemotherapy. Indeed, the Pervenio test, which looks at the expression of 14 genes, is already used to identify the patient who may benefit from aduvant chemotherapy.


New Immunotherapy May Turn IL-12 On and Off in Melanomas

Doctors may someday be able to adjust interleukin-12 (IL-12) levels in melanomas at will, according to results of an ongoing clinical trial presented at Melanoma Bridge 2013 Conference in Naples, Italy. IL-12 is an immune system protein that can shrink melanomas, but also has nasty side effects. The experimental immunotherapy entails injecting tumors with a virus that does not cause diseas, and that has been engineered to produce the IL-12 when people take a drug called veledimex. In the phase I/II trial of 21 people with melanomas that had been injected with this engineered virus, IL-12 production turned on when they took veledimex and turned off when they stopped. Depending on the dose, veledimex increased IL-12 production by 1,000 to 100,000 times.


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.


FDA OKs Trial of Stem Cell Therapy for Melanoma

A promising stem cell-based immunotherapy against melanomas has been fast-tracked by the U.S. Food and Drug Administration (FDA), based on previous clinical trials showing that it may double 5-year survival rates to about 50%. The upcoming phase III clinical trial will accept 250 people with melanomas that have spread; enrollment is expected to begin in early 2014. This experimental immunotherapy uses a mixture of a person’s own cells: cancer stem cells from his or her tumor, which are thought to be behind the spread of tumors, and immune system cells from the blood, which learn to recognize the cancer stem cells. These cancer stem cells are inactivated to keep them from forming new tumors,  then the mixture is injected back into the patient. The reintroduced immune system cells then focus an attack on the cancer stem cells that remain in the tumor, which helps keep them from spreading.


FDA Mulls Change in Cancer Drug Approval Process

Modern cancer research indicates that cancers driven by genetic mutations in the same chemical pathway (a group of proteins in a cell that work together) may be more closely related, even if they occur in different parts of the body, than two cancers driven by different mutations that occur in the same organ. Current U.S. Food and Drug Administration (FDA) standards, however, still use the traditional anatomical location-based categories when approving cancer drugs (eg, lung cancer vs pancreatic cancer). As a result, a drug that is approved for treating a specific cancer caused by a given mutation must undergo new clinical trials to get approved for treating a cancer driven by the same mutation in another body part. However, the FDA’s ‘cancer czar’ recently floated an unofficial proposal for approving cancer drugs based on the chemical pathways they target. Such a change could greatly streamline cancer drug development.


FDA Mulls Change in Cancer Drug Approval Process

Modern cancer research indicates that cancers driven by genetic mutations in the same chemical pathway (a group of proteins in a cell that work together) may be more closely related, even if they occur in different parts of the body, than two cancers driven by different mutations that occur in the same organ. Current U.S. Food and Drug Administration (FDA) standards, however, still use the traditional anatomical location-based categories when approving cancer drugs (eg, lung cancer vs pancreatic cancer). As a result, a drug that is approved for treating a specific cancer caused by a given mutation must undergo new clinical trials to get approved for treating a cancer driven by the same mutation in another body part. However, the FDA’s ‘cancer czar’ recently floated an unofficial proposal for approving cancer drugs based on the chemical pathways they target. Such a change could greatly streamline cancer drug development.


FDA Mulls Change in Cancer Drug Approval Process

Modern cancer research indicates that cancers driven by genetic mutations in the same chemical pathway (a group of proteins in a cell that work together) may be more closely related, even if they occur in different parts of the body, than two cancers driven by different mutations that occur in the same organ. Current U.S. Food and Drug Administration (FDA) standards, however, still use the traditional anatomical location-based categories when approving cancer drugs (eg, lung cancer vs pancreatic cancer). As a result, a drug that is approved for treating a specific cancer caused by a given mutation must undergo new clinical trials to get approved for treating a cancer driven by the same mutation in another body part. However, the FDA’s ‘cancer czar’ recently floated an unofficial proposal for approving cancer drugs based on the chemical pathways they target. Such a change could greatly streamline cancer drug development.


Combo Chemotherapy Bests Single Drug Against Melanoma

Two chemotherapy drugs may be better than one against melanoma, according to results from an ongoing clinical trial that were presented at the 2013 meeting of the  International Society for Melanoma Research. The drugs were dacarbazine, which is U.S. Food and Drug Administration (FDA)-approved for melanoma, and paclitaxel, which is FDA-approved for breast, lung, and pancreatic cancers. In a phase III trial of 529 melanoma patients, the drug combination kept tumors from growing two times longer than dacarbazine alone (4.8 vs 2.5 months, respectively). The subgroups that did best included men and people with melanomas that had spread to the liver or brain. This is particularly encouraging for the latter group because they have the worst prognosis.