A SWOG trial shows bor­tez­o­mib, lena­lido­mide, and dexa­meth­a­sone delays recurrence and lengthens life for myeloma patients, indicating a possible new standard of care

Portland, OR (Press Release) – The addi­tion of bor­tez­o­mib to a standard two‐drug regi­men for myeloma patients sig­nif­i­cantly lengthened the time before their cancer returned, and sig­nif­i­cantly lengthened their lives, according to new clin­i­cal trial results announced today.

The ran­dom­ized, phase III trial, conducted by SWOG, a publicly funded inter­na­tional cancer clin­i­cal trials network, compared the effectiveness of two drug regi­mens in patients undergoing their first round of treat­ment for myeloma, a type of bone marrow cancer. One regi­men used in the study was lena­lido­mide with dexa­meth­a­sone, a standard first-line treat­ment for myeloma patients. The other drug regi­men also in­cluded bor­tez­o­mib, a second-line drug typically given to myeloma patients whose cancer progresses after initial ther­apy.

SWOG researchers found that the addi­tion of bor­tez­o­mib earlier made a dif­fer­ence for myeloma patients, giving them about another year of remission and another year of life compared to the standard two-drug regime.

Patients receiving bor­tez­o­mib, along with lena­lido­mide and dexa­meth­a­sone, in their first six months of treat­ment had a median remission time of 43 months compared to a median remission of 30 months for patients who received lena­lido­mide and dexa­meth­a­sone alone. Researchers also found that patients who received bor­tez­o­mib lived a median of 75 months, or about six years, after their initial treat­ment. Patients who received the standard two-drug treat­ment lived a median of 64 months, or about five years, after initial treat­ment.

"Our results are clear," said study principal investigator Brian G.M. Durie, M.D., a physician at Cedars-Sinai Outpatient Cancer Center in Los Angeles and chairman of the board at the Inter­na­tional Myeloma Foun­da­tion. "Using bor­tez­o­mib in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone in front-line treat­ment -- hitting the disease early and hard -- makes a meaningful dif­fer­ence for myeloma patients. Our results rep­re­sent a poten­tial new standard of care."

Results of the SWOG study, S0777, were presented this morning at the 57th Annual Meeting of the American Society of Hematology (ASH) held in Orlando, Florida.

Researchers enrolled 474 eli­gible adult patients in S0777 between February 2008 and February 2012 at 139 institutions throughout the NCI's National Cancer Trials Network, which in­cludes SWOG, the Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, and NRG Oncology.

Patients ranged in age from 28 to 87, had active myeloma, and had not had a stem-cell trans­plant or any prior treat­ment for their disease. Patients were ran­dom­ized into two groups. One group received the standard two-drug treat­ment for six cycles over six months. The other group received a three-drug com­bi­na­tion that in­cluded bor­tez­o­mib, a pro­te­a­some inhibitor marketed as Velcade by Millennium Pharma­ceu­ticals. These patients received the triple com­bi­na­tion ther­apy for eight cycles over six months.

Despite the in­­creased remission and longevity, the three-drug com­bi­na­tion did have a drawback: Patients who received bor­tez­o­mib were much more likely to ex­peri­ence sensory neu­rop­athy, or tingling, pain, numb­ness or weakness in their hands and feet.

For more study details, see the ASH abstract at https://ash.confex.com/ash/2015/webprogram/Paper79014.html

According to National Cancer Institute (NCI) statistics, in 2015 an esti­mated 26,850 new cases of myeloma will be diag­nosed and 11,240 people will die of the disease.

The NCI provided pri­mary grant funding for S0777 and was the sponsor of the study. Millennium Phar­ma­ceuticals, Inc., The Takeda Oncology Company, and Celgene Corpo­ra­tion provided the study drugs under their re­spec­tive­ Cooperative Research and Development Agreements with the NCI.

A national team of SWOG researchers led S0777. Along with Durie, they in­clude: Antje Hoering, Ph.D, of Cancer Research And Biostatistics; S. Vincent Rajkumar, M.D., of Mayo Clinic; Muneer H. Abidi, M.D., of Spectrum Health and Michigan State University; Joshua Epstein, DS.c, of University of Arkansas for Medical Sciences; Stephen P. Kahanic, M.D., of Souixland Regional Cancer Center; Mohan C. Thakuri, M.D., of Southeast Clinical Oncology Research Consortium NCORP; Frederic J. Reu, M.D., of Cleveland Clinic; Christopher M. Reynolds, M.D., of Michigan Cancer Research Consortium NCORP; Rachael Sexton, M.S., of Cancer Research And Biostatistics; Robert Z. Orlowski, M.D., Ph.D, of MD Anderson Cancer Center; Bart Barlogie, M.D., Ph.D, of University of Arkansas for Medical Sciences; and Angela Dispenzieri, M.D., of Mayo Clinic.

SWOG is a publicly funded world­wide network of researchers that design and conduct cancer clin­i­cal trials. The group's goal is to change medical practice so it im­proves the lives of people with cancer. The approx­i­mately 6,000 physician-researchers in the network practice at more than 950 institutions nationwide and in six other countries. SWOG is part of the NCI's National Clinical Trials Network and is sup­ported primarily through NCI research funding. Learn more at swog.org.

Source: SWOG.