Chronic lymphocytic leukemia (CLL) is a type of cancer that starts from lymphocytes in the bone marrow.
A combination of two targeted agents - one approved by the Food and
Drug Administration and one undergoing testing - has demonstrated safety
as well as encouraging signs of effectiveness in a phase 1 clinical
trial in patients with relapsed or hard-to-treat chronic lymphocytic
leukemia (CLL) or mantle cell lymphoma (MCL).
‘A combination of two targeted agents has demonstrated safety as well as encouraging signs of effectiveness in a phase 1 clinical trial in patients with relapsed or hard-to-treat chronic lymphocytic leukemia (CLL).’
Institute researchers will report the findings at the 58th annual
meeting of the American Society of Hematology (ASH).
The combination of the approved drug ibrutinib and the novel agent
TGR-1202 is being tested in patients to determine if the two agents can
be safely given at the same time and whether they lead to more durable
remissions in CLL and MCL compared to ibrutinib alone.
which targets the cell protein BTK, often reduces the amount of cancer
in patients with relapsed or drug-resistant CLL or MCL, it rarely
eliminates the cancer or generates long-lasting results in MCL or
high-risk forms of CLL. By pairing it with TGR-1202, which blocks the
P13K-delta protein, researchers hope to disable two key parts of cancer
cells' growth circuitry.
As of late July, 2016, investigators had treated 28 patients - 17 with
CLL, 11 with MCL - with the tandem therapy. The regimen was shown to be
safe, with an 800 mg dose of TGR-1202 found to be suitable for further
"The efficacy of the combination looks promising as well," said
Dana-Farber's Matthew Davids, principal investigator of the
investigator-initiated trial. "We have already seen a complete response - no evidence of cancer - in
one patient with CLL, and several other patients are approaching
complete response," Davids added.
Another potential benefit of the two-drug combination is that it
could offer greater flexibility in treatment, Davids remarked. Patients
who need to discontinue one of the drugs because of temporary
complications could continue with the other and resume the two-drug
regimen when the complications subside.
While enrollment of patients with CLL in the trial is complete,
openings remain for patients with MCL, and the study is open at several
sites across the country through the Blood Cancer Research Partnership, a
Dana-Farber-led hematologic malignancies research consortium funded
through the Leukemia & Lymphoma Society.