Navigation Links
Investigational drug may increase survival for some patients with advanced melanoma

An experimental drug aimed at restoring the immune system's ability to spot and attack cancer halted cancer progression or shrank tumors in patients with advanced melanoma, according to a multisite, early-phase clinical trial at Johns Hopkins Kimmel Cancer Center and 11 other institutions. All patients had experienced disease progression despite prior systemic therapies, and most had received two or more prior treatments.

Patients who showed responses to the drug, nivolumab (anti-PD-1; BMS-936558; MDX-1106; ONO-4538), survived for an average 16.8 months following initiation of treatment. Overall, 62 percent of patients (66 of 107) were alive one year following treatment initiation, and 43 percent (46 of 107) were alive two years later. Average survival among 33 patients (31 percent) whose tumors shrank significantly was two years. The drug is now being tested in three larger, phase III trials in melanoma, which generally compare a new therapy with a standard one currently in use.

Results of the study are published online March 3 in the Journal of Clinical Oncology.

"The results seen here are remarkable for these patients with treatment-resistant, advanced metastatic melanoma, who had limited life expectancies when they joined the trial," says study lead-author Suzanne Topalian, M.D., professor of surgery and oncology, and director of the melanoma program at Johns Hopkins.

The immune-based therapy aims not to kill cancer cells directly, but to block a pathway that shields tumor cells from immune system components that are potentially able and poised to fight cancer. The pathway includes two proteins called programmed death-1 (PD-1), expressed on the surface of immune cells, and programmed death ligand-1 (PD-L1), expressed on cancer cells. When PD-1 and PD-L1 join together, they form a biochemical shield protecting tumor cells from being destroyed by the immune system. Another protein involved in the pathway, that is expressed by some tumors and by cells in the immune system, is programmed death ligand𔃀 (PD-L2), which was discovered by Johns Hopkins investigators in 2001.

One hundred seven people with advanced melanoma were given the medication, which is administered intravenously in an outpatient clinic every two weeks. Results suggest that some patients can safely remain on the treatment for up to two years. Participants received doses of 0.1, 0.3, 1, 3, or 10 mg/kg in 12 or fewer eight-week cycles of treatment. Investigators observed responses at all doses, though the highest response rate was in seven of 17 (41 percent) patients receiving 3 mg/kg, the dose now being tested in phase III trials. Participants given that amount survived an average 20.3 months following treatment initiation.

Drug-related adverse events occurred in 84 percent of patients; 22 percent had serious side effects. Among the most common serious side effects were lymphopenia (low levels of infection-fighting white blood cells circulating in the blood); diarrhea; fatigue; and endocrine disorders. Each affected 1-3 percent of participants. There were no drug-related deaths in patients with melanoma receiving nivolumab.

Several companies also are investigating anti-PD1 agents or anti-PD-L1 agents in the treatment of cancers, including melanoma.

Ultimately, investigators envision boosting the effectiveness of the therapy by combining it with other anticancer agents, including cancer vaccines, other immunotherapies, or drugs that block enzymes called kinases, the researchers say.

Contact: Vanessa Wasta
Johns Hopkins Medicine

Related medicine news :

1. Investigational drug effective in treating iron deficiency in kidney disease patients on dialysis
2. Investigational Drug Effective in Treating Iron Deficiency in Chronic Kidney Disease Patients on Dialysis: Study
3. NIH launches trial of investigational genital herpes vaccine
4. Investigational PARP inhibitor promising in BRCA-related cancers
5. Targeted investigational therapy potential to overcome crizotinib resistance in lung cancers
6. Investigational malaria vaccine found safe and protective
7. Method patent issued for investigational new class of pain medication
8. Investigational agent targets gene signaling pathways to improve response for patients with CLL
9. Despite recession, childrens health spending increased between 2009-2012, says new report
10. Death of partner associated with increased risk of heart attack, stroke
11. Frequent school moves can increase the risk of psychotic symptoms in early adolescence
Post Your Comments:
(Date:11/26/2015)... (PRWEB) , ... November 26, 2015 , ... ... a real-time eReferral system for diagnostic imaging in the Waterloo region. Using the ... and Nuclear Medicine tests directly from their electronic medical record (EMR) without the ...
(Date:11/26/2015)... ... November 26, 2015 , ... WorldCare International, Inc., the ... 61st annual Employee Benefits Conference. The Employee Benefits Conference was hosted by the ... Wednesday, November 11th, 2015. The conference was held at the Hawaii Convention Center ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... all, Water For Empowerment ™ attracts volunteers together who want to combine ... empowering women as key stakeholders in the process. The non-profit launched its first ...
(Date:11/25/2015)... ... ... Dr. John Pierce, Medical Director at the Ageless Forever clinic in Las ... Pro laser therapy cap. FDA cleared for safety and efficacy, the Capillus272 offers men ... surgery, prescription pills, or topical foams. , “Capillus272™ Pro is a home-use device ...
(Date:11/25/2015)... ... November 25, 2015 , ... Lakeview Health, ... country to celebrate their sobriety and show through pictures what a positive difference ... photos this Thanksgiving with the hashtag #FacesOfGratitude on their Facebook, Twitter, and Instagram ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... DUBLIN , Nov. 25, 2015 /PRNewswire/ ... announced the addition of the "Global ... to their offering. --> ... "Global Brain Monitoring Devices Market 2015-2019" ... Research and Markets ( ) ...
(Date:11/25/2015)...  The American Academy of Pediatrics (AAP), American ... March of Dimes cheered today,s signature into law ... of 2015 (S.799), which takes much-needed strides ... to drugs, such as opioids, and to improve ... organizations have worked together leading advocacy efforts for ...
(Date:11/25/2015)... Nov. 25, 2015 On Tuesday, November ... bellwether trial against Wright Medical Technology, Inc. for ... Conserve metal-on-metal hip implant device, awarded $11 million ... two week trial and three days of deliberations, ... device was defectively designed and unreasonably dangerous, and ...
Breaking Medicine Technology: