Not Enough Cancer Patients Enroll in Clinical Trials

Around 10% of mid- and late-stage clinical trials of cancer treatments end prematurely because not enough patients enroll, a recent analysis shows. This lack of participants slows the development of new cancer medications and wastes considerable amounts of money invested in these trials. The authors of the analysis hope to focus attention on possible reasons why too few patients enroll in clinical trials. Doctors may not always encourage their patients enough to participate, and some insurance plans do not cover the costs associated with clinical trials. Patients may also hesitate because they fear receiving only a placebo instead of treatment. However, in modern clinical trials, new cancer drugs are tested against the current standard therapy, so that all participants receive treatment.


Not Enough Cancer Patients Enroll in Clinical Trials

Around 10% of mid- and late-stage clinical trials of cancer treatments end prematurely because not enough patients enroll, a recent analysis shows. This lack of participants slows the development of new cancer medications and wastes considerable amounts of money invested in these trials. The authors of the analysis hope to focus attention on possible reasons why too few patients enroll in clinical trials. Doctors may not always encourage their patients enough to participate, and some insurance plans do not cover the costs associated with clinical trials. Patients may also hesitate because they fear receiving only a placebo instead of treatment. However, in modern clinical trials, new cancer drugs are tested against the current standard therapy, so that all participants receive treatment.


Lung Cancer Drug Disappoints in 2 Late-Stage Trials

In a recent phase III clinical trial, the cancer drug dacomitinib was no more effective than a placebo at prolonging survival for patients with advanced non-small cell lung cancer (NSCLC) for whom standard therapy had failed. Like the targeted drugs erlotinib (Tarceva) and gefitinib (Iressa), dacomitinib blocks the protein EGFR, but it also inhibits a number of similar, related proteins. Another trial compared dacomitinib to Tarceva in NSCLC patients who had previously received at least one EGFR inhibitor. Dacomitinib did not increase time without cancer worsening compared to Tarceva. Results from a third phase III trial, which compares dacomitinib to Iressa in NSCLC patients with EGFR mutations, are expected next year.


Interim Results from Lung Cancer Clinical Trial of Tivantinib Remain Ambiguous

An ongoing clinical trial is evaluating the effects of cancer drug tivantinib in non-small cell lung cancer (NSCLC). The trial studies patients with advanced non-squamous NSCLC who do not have any mutations in the EGFR gene. Patients receive erlotinib (Tarceva) either by itself or in combination with tivantinib. Enrollment in the trial was stopped because rates of interstitial lung disease (ILD), which can cause lung scarring, may be higher in patients receiving tivantinib. (No such increased levels of ILD were seen in a different trial using tivantinib.) For the patients already enrolled, overall survival, time without cancer worsening, and percentage of patients experiencing tumor shrinkage all seem increased in tivantinib-treated patients. However, it is not yet clear whether these effects are indeed caused by tivantinib or are due to chance.


New Trial Combines Two Immunotherapies Against Melanoma (Yervoy & Prophage)

Will the FDA-approved immune system booster Yervoy (ipilimumab) work better when combined with an experimental melanoma vaccine? Researchers are about to find out ─ the combination will be tested in a phase II clinical trial of up to 25 people. Ipilimumab doesn’t work on its own in about 70% of people with melanomas. The vaccine, called Prophage, could sharpen immune system attacks because it’s made from people’s own tumors.


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.


Xalkori More Effective than Chemotherapy as Second-Line Treatment in ALK+ Lung Cancer

The ALK inhibitor crizotinib (Xalkori) has shown effectiveness in patients with non-small cell lung cancer (NSCLC) who have changes in the ALK gene that make the gene overactive (so-called ‘ALK-positive’ patients). A recent clinical trial compared Xalkori to chemotherapy as a second-line treatment in these patients. Over 300 patients with ALK-positive advanced NSCLC who had undergone one previous round of chemotherapy were treated either with Xalkori or one of the chemotherapy drugs pemetrexed (Alimta) or docetaxel (Taxotere). Tumors shrank in 65% of Xalkori-treated patients, compared to 20% of those receiving chemotherapy. The Xalkori-treated patients also went longer without their cancer worsening, experienced fewer symptoms, and reported higher quality of life.


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.


Biomarker May Predict Best Response to Lung Cancer Drug MK-3475

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.