NEW YORK, Dec 9 (Reuters) - Cephalon Inc’s experimental cancer drug Treanda was significantly more effective than a common chemotherapy agent in helping patients with chronic lymphocytic leukemia (CLL) who had not received prior treatment achieve remission, according to a late-stage study.
Treanda, also known as bendamustine, was tested against chlorambucil in the pivotal study, which the company has included in its submission to U.S. health regulators seeking approval of the drug for treating CLL.
The overall remission rate — the primary goal of the 305-patient study — was 68 percent with Treanda compared with 39 percent in patients who received chlorambucil, according to data presented on Sunday at the American Society of Hematology annual meeting in Atlanta. The results were deemed to be highly statistically significant, researchers said.
Overall remission rate was defined as complete response, nodular partial response confirmed after eight weeks, and progression-free survival.
Complete response was seen in 30 percent of the Treanda group compared to just 2 percent in the chlorambucil group, researchers said.
“On the basis of these positive results, bendamustine could be an important first-line chemotherapy option for patients with CLL,” Dr. Wolfgang Knauf, the study’s lead investigator, said in a statement.
The U.S. Food and Drug Administration earlier this month told Cephalon CEPH.O it would review Treanda for CLL on a priority basis, effectively cutting in half the time for an approval decision to about six months.
CLL is a slowly progressing cancer of the blood and bone marrow with an estimated 15,000 new cases in the United States each year, according to the National Cancer Institute.
The company is also testing Treanda, which is administered intravenously, for non-Hodgkin’s lymphoma and other cancers.
While there was no difference seen in overall survival, researchers found Treanda to be significantly more effective than chlorambucil in helping CLL patients achieve remission.
Median progression free survival — the time before the disease progresses — and duration of remission were significantly longer with Treanda, researchers said.
Median progression free survival with Treanda was 21.7 months compared to 9.3 months with the control group, while median duration of remission was 18.9 months with the Cephalon drug versus 6.1 months with the other chemotherapy drug.
Toxicity of Treanda was manageable and did not impair quality of life when compared with chlorambucil, researchers said.
The most common serious side effect seen with the Cephalon drug was low white blood cell count with fever and pneumonia. (Reporting by Bill Berkrot, editing by Maureen Bavdek)