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Melanoma clinical trials show important promise

Dennis Thompson
Health Day Reporter

Monday, June 2, 2014 (HealthDay News)-Relatively new drugs appear to be effective in increasing the survival rate of patients fighting advanced patients melanomaThe most deadly form of Skin cancerAccording to a pair of preliminary studies.

The drug Yervoy (ipilimumab) “releases the brakes on the immune system” and improves the body’s ability to target and attack. melanomaSaid Dr. Philip Friedlander, an assistant professor of dermatology at Mount Sinai School of Medicine in New York City.

Two trials report that Yervoy can dramatically extend the survival of stage 3 and stage 4 patients melanomaAdd months and years to their lives, on their own, and in combination with others cancer medicine.

“This is a big step forward,” Friedlander said of the drug, which was approved by the Food and Drug Administration in 2011. “This is a new immune approach that uses your immune system to fight. cancer

The results of both trials will be presented at the American Clinical Society on Monday. OncologyAnnual meeting in Chicago. Therefore, the data and conclusions should be considered preliminary until published in a peer-reviewed medical journal.

5-year survival rate for stage 4 individuals melanomacancer It has spread to other parts of the body-it’s now 15 to 20 percent, according to Americans. cancer society.

Yervoy works by blocking a receptor called CTLA-4, which normally inactivates the body’s lymphocytes, the white blood cells that form the forefront of the immune system’s response. By blocking CTLA-4, the drug unleashes and attacks the immune system cancer cell.

In one of these trials, doctors announced that they extended the median survival of 53 patients with inoperable advanced melanoma by about three and a half years, said Dr. Mario Sznol, a medical professor who is the author of the study. .. Oncology At the Yale School of Medicine. They did this by combining Yervoy with another immune system drug called nivolumab.

The researchers reported that the combination therapy nearly doubled the overall survival seen in previous studies of either drug alone.

Nivolumab, not yet approved by the FDA, works by disarmament tumorDefending against attacks from the immune system, Sznol said.

“You’re actually hitting two molecules that control immune activation in different places,” Sznol said. “There are multiple ways in which lymphocytes are suppressed. Perhaps two of these mechanisms give better results than just one.”

Sznol said he “has never seen” the results of using the two. Drug Combine.

“If we look at all 53 patients we have treated, we have a one-year survival rate of 85% and a two-year overall survival rate of 79%,” he said. “Because it’s a small study, it’s difficult to compare between studies, but no matter how we choose patients, we’ve never seen a study with a 2-year survival rate close to 79%.”

Dr. Ren Lichtenfeld, Deputy Chief Medical Officer of the United States, is even more striking given that many patients have already been treated three times for melanoma. cancer society.

“Many of these patients had pretreatment before taking this drug, which means that their previous treatment had failed,” said Lichtenfeld. “When you see such a result, you certainly stand up and pay attention.”

According to Sznol, Phase 3 of the combination therapy, the final trial, has been completed and is expected to produce results within a year.

A second clinical trial of 951 patients also reported strong results for Yervoy. In patients who underwent surgery for high-risk stage 3 melanoma, this drug was found to reduce cancer recurrence by about 25% compared to placebo or dummy drugs.

The drug was given four times every three weeks and treatment was continued at three-month intervals for up to three years. The 3-year recurrence-free survival rate was 46.5% in the Yervoy group, compared with 34.8% in the placebo group.

However, both studies have reported serious side effects. In the second clinical trial, five treatment-related deaths occurred, and about half of the patients discontinued treatment due to side effects such as skin. rash And colon inflammation, Thyroid And Pituitary gland..

Side effects were even more pronounced in combination therapy trials. “When we give two Drug Together, we see a higher incidence of side effects, “Sznol said.

However, he argued that the benefits of survival and the high cost of Yervoy outweigh the risks. “I am very confident with the oncologists and their ability to manage the side effects of treatment,” says Sznol. “If later studies prove to be effective enough, the risk / benefit ratio is worth it.”



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Pharmaceutical company Bristol Myers Squibb has priced Yervoy at $ 30,000 per injection. This means that it costs $ 120,000 to treat the entire four-dose course.

“Whatever the cost, this kind of effectiveness could be a less costly but more cost-effective treatment than a much less effective one,” Sznol said.

Bristol Myers Squibb helped fund both studies, researchers report.

In the third clinical trial presented at the conference, another new Immunotherapy A drug called MK-3475 also had a significant life-prolonging effect on patients with advanced melanoma.

MK-3475 targets the same receptor as nivolumab, one of the drugs used in the combination therapy trial.

More than 400 patients participated in this phase I trial. This is an early effort in the approval process. The 1-year survival rate was 74% for patients who had not previously been treated with Yervoy and 65% for patients who were previously treated with Yervoy for melanoma.

The FDA has granted MK-3475 a priority review designation. This means that the FDA wants to speed up application review. This trial was funded by the pharmaceutical company Merck.

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References

Source: Philip Friedlander, MD, Ph.D. , Director of the Melanoma Oncology Program, and Associate Professor of Dermatology at Mount Sinai School of Medicine in New York City. Mario Snol, MD, Professor, Oncology, Yale School of Medicine, New Haven, Connecticut. Len Lichtenfeld, MD, MACP, Deputy Chief Medical Officer, American Cancer Society; June 2, 2014, Presentation Summary, Annual Meeting of the American Society of Clinical Oncology

Melanoma clinical trials show important promise

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