An immune-based cancer therapy being developed by Bristol-Myers Squibb Co. and AbbVie Inc. improved remission rates in patients with a form of blood cancer by about five months, on average, compared with the current standard treatment in late-stage trials, potentially paving the way for U.S. Food and Drug Administration approval.
The drug, elotuzumab, was granted breakthrough therapy designation for multiple myeloma by the agency in May 2014, which could lead to a speedier approval depending on how the agency views the trial results.
The latest results come from a phase 3 study of 646 patients that tested elotuzumab in addition to the current standard of care, a combination of drugs including Celgene Corp.’s blockbuster Revlimid. The study showed a 30 percent reduction in the risk of progression or death when elotuzumab was added to the treatment regimen.
“This study is an innovative approach -– one that combines the precision of a targeted, immune-based therapy with traditional myeloma therapy,” American Society of Clinical Oncology President-Elect Julie M. Vose said in a statement. “The results are very encouraging, giving renewed hope to patients who have relapsed.”
Bristol-Myers, which will take the lead on marketing the drug, declined to comment on its plans for submitting it for FDA approval.
Elotuzumab harnesses the body’s immune system to fight cancer by attaching to a protein found on the surface of myeloma cells as well as to a type of immune cell known as a “natural killer” cell. Researchers believe the drug works both by targeting the myeloma cells directly and also boosting the ability of killer cells to attack the myeloma.
“It was particularly striking that the difference between the elotuzumab and control groups seems to get bigger over time, which really speaks to the power of this immune-based approach,” Sagar Lonial, lead study author and chief medical officer of the Winship Cancer Institute of Emory University, said in a statement.
This is the first phase 3 study to show the benefit of using a targeted immune-based approach to treat multiple myeloma. Immune-based therapies are a hot field in cancer treatment, with Bristol-Myers and rival Merck & Co. both recently introducing products that trigger the body’s immune system to fight tumors. Their drugs, Opdivo and Keytruda, each cost $150,000 a year for patients.
Bristol-Myers shares fell less than 1 percent to $67.19 at 9:30 a.m. in New York after Robyn Karnauskas, a Deutsche Bank AG analyst, questioned whether elotuzumab is as good as Amgen Inc.’s Kyprolis cancer drug.
The Bristol-Myers medication helped patients live without disease progression at a 30 percent better rate than with the standard treatment. That compared with a 50 percent improvement for Kyprolis, Karnauskas wrote in a investor note.
In a separate research note, Seamus Fernandez, an analyst at Leerink Partners, said that while elotuzumab showed “a solid but not striking” survival rate of 4 1/2 months, the results “suggest potential differentiation from AMGN’s Kyprolis over time.”
More than 114,000 people globally are diagnosed with multiple myeloma each year. In the U.S., less than half of patients survive for five years beyond their diagnosis, according to Bristol-Myers.
The drug was studied in patients who had either relapsed or had been unresponsive to therapies besides Revlimid and who had tried anywhere from one to three previous therapies before going on elotuzumab.
A summary of the results was released Wednesday by the American Society of Clinical Oncology and will be presented at the group’s meeting that begins May 29.