AstraZeneca Reports Positive Results in Cancer Drug Clinical Trial

AstraZeneca recently announced that its cancer drug, Calquence elicited positive responses in a Phase 2 clinical trial of mantle cell lymphoma patients. 

The Phase 2 trial, ACE-LY-004, uncovered that patients treated with acalabrutinib, branded as Calquence, remained progression-free for an average of 22 months.

Additionally, median survival was not yet reached at three years of follow-up. And at a 38-month follow-up, 24 patients remained on treatment, while 31 patients continued to be followed for survival. 

The safety and tolerability profile of Calquence was promising, with only 14 patients discontinuing their treatment due to adverse events. 

“Mantle cell lymphoma is an aggressive, difficult-to-treat blood cancer that is typically diagnosed at an advanced stage and often becomes resistant to treatment,” Michael L. Wang, MD, principal investigator of the ACE-LY-004 trial, said in the announcement. 

“This data shows that patients treated with acalabrutinib experienced deep responses over time, while the safety profile remained largely the same, including low rates of Grade 3/4 events, cardiac events and bleeding events, which are important in this patient population,” continued Wang, who also serves as a professor at the University of Texas MD Anderson Cancer Center. 

Notably, the adverse events patients reported were minor and included headache (38 percent), fatigue (30 percent), cough (23 percent), and myalgia (22 percent). 

Additionally, just 16 patients experienced cardiac adverse events, but 11 of these patients had prior cardiac risk factors.

“These results add to the mounting evidence that Calquence can provide sustained responses in patients over more than three years,” said Jose Baselga, executive vice president of oncology research and development at AstraZeneca.

“Calquence is an important chemo-free treatment option for relapsed or refractory mantle cell lymphoma and is rapidly being embraced across the clinical and patient community,” Baselga concluded. 

Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma that accounts for nearly six percent of all non-Hodgkin lymphoma cases, AstraZeneca stated. It mainly affects males 60 years of age and older. 

Calquence is a Bruton’s tyrosine kinase (BTK) inhibitor originally used to treat adults with mantle cell lymphoma who have received at least one prior treatment. 

But as part of its extensive clinical development program, AstraZeneca and Acerta Pharm are currently evaluating Calquence in over 20 company-sponsored clinical trials.

Specifically, the drug is being developed for the treatment of chronic lymphocytic leukemia, mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, and other hematologic malignancies, the company said. 

In mid-June, Calquence showed long-term efficacy and tolerability for patients with chronic lymphocytic leukemia in two clinical trials. 

In the first trial, patients treated with 200 milligrams of Calquence once daily saw an overall response rate of 97 percent. And in patients with high-risk disease characteristics, there was a 100 percent overall response rate.

Eighty-six percent of patients receiving Calquence in 1-st-line monotherapy stayed on treatment for over four years following the conclusion of the trial. 

In the second trial, patients were treated with 100 milligrams of Calquence and 82 percent of these patients remained alive and saw no disease profession at 18 months.

Throughout the pandemic, pharmaceutical companies have worked to develop drugs and vaccines to help combat the virus.

In June, AstraZeneca announced that Calquence reduced inflammation and improved clinical outcomes in 19 patients with severe COVID-19. At the time, Calquence was one of the most promising potential COVID-19 drugs.

Although the initial data was encouraging, AstraZeneca announced in November that Calquence did not meet the primary endpoint of keeping patients alive and free of respiratory failure in the Phase 2 CALAVI trial.