In a recent press release, biopharmaceutical company AstraZeneca announced that its drug CALQUENCE (acalabrutinib) met both its primary and secondary endpoints in the Phase 3 ELEVATE-RR clinical trial. These endpoints included progression-free survival rates, safety, and tolerability. CALQUENCE was being evaluated for patients with chronic lymphocytic leukemia (CLL) who have been previously treated. Ultimately, ELEVATE-RR compared CALQUENCE to ibrutinib, also used to treat this patient population.
CALQUENCE, approved to treat CLL, mantle cell lymphoma, and small lymphocytic lymphoma, is a selective BTK inhibitor. Since B-cells can play a role in the multiplication and proliferation of cancer cells, CALQUENCE inhibits BTK signaling.
Overall, ELEVATE-RR is the first Phase 3 clinical trial to compare two Bruton’s tyrosine kinase (BTK) inhibitors. During the trial, patients received either 100mg CALQUENCE 2x daily or 420mg ibrutinib 1x daily. The patients participated until they reached either a level of drug toxicity, or their CLL progressed. Overall, CALQUENCE was found to be effective in halting disease progression. Unlike ibrutinib, CALQUENCE also saw a lower rate of atrial fibrillation, a potentially dangerous irregular heartbeat.
During the trial, researchers determined that this therapy was relatively safe and well-tolerated. The orally administered therapy should not be administered to patients who are pregnant. Some side effects and adverse reactions include:
- Serious bacterial, viral, or fungal infections
- Skin cancer
- Anemia (low red blood cell count)
- Bruising and bleeding
- Neutropenia (low white blood cell count)
- Thrombocytopenia (low platelet count)
- Muscle pain and weakness
While adverse reactions occurred in both groups, CALQUENCE had a slightly lower rate of negative reactions.
Chronic Lymphocytic Leukemia (CLL)
There is no clear cause of chronic lymphocytic leukemia (CLL), a blood and bone marrow cancer. However, doctors do know that genetic mutations occur in the DNA of blood-producing cells, leading to the development of abnormal lymphocytes. As these multiply, the lymphocytes crowd out healthy cells. CLL is the 2nd most common form of leukemia in adult patients. In many cases, symptoms do not appear until later stages of the cancer. Symptoms include:
- Abdominal pain
- Spleen enlargement
- Swollen, but painless, lymph nodes
- Night sweats
- Unintended weight loss
- Frequent infections
- Easy bruising and bleeding