Calquence Demonstrates Sustained Survival Benefit for CLL

Updated results from the ELEVATE-TN phase 3 trial showed AstraZeneca’s Calquence (acalabrutinib) maintained a statistically significant progression-free survival (PFS) benefit versus chlorambucil plus obinutuzumab and a safety and tolerability profile consistent with the known profile for Calquence at a median follow up of approximately 5 years in combination and as a monotherapy in chronic lymphocytic leukemia (CLL), the company said in a statement.

Results also showed longer overall survival (OS) for Calquence combined with obinutuzumab compared with chlorambucil combined with obinutuzumab in previously untreated adults with CLL, the company said.

CLL is the most prevalent type of leukemia in adults, with more than 100,000 patients diagnosed globally in 2019, according to the company.

At a median follow-up of 58.2 months, Calquence plus obinutuzumab reduced the risk of disease progression or death by 89%, based on a hazard ratio (HR) of 0.11, 95% confidence interval (CI) 0.07-0.16, and as a monotherapy by 79%, based on a HR of 0.21, 95% CI 0.15-0.30, compared with chlorambucil plus Obinutuzumab, the company said. 

OS data are immature, and medians were not yet reached in any treatment arm, the company said.

The relative risk for death was 45% lower in the Calquence plus obinutuzumab arm, based on an HR of 0.55, 95% CI 0.30-0.99, the company said.

An estimated 90% of patients treated with the Calquence combination were alive at 5 years versus 84% for Calquence alone and 82% for chlorambucil plus obinutuzumab, the company said.

Separately, follow-up data from the ASCEND phase 3 trial showed Calquence demonstrated a sustained PFS benefit at 4 years based on investigator assessment compared with investigator’s choice of rituximab combined with either idelalisib (IdR) or bendamustine (BR) in adults with refractory or relapsed CLL, the company said.

At 42 months, an estimated 62% of patients treated with Calquence were alive and had not progressed by comparison with 19% of patients treated with IdR/BR, the company said.

The median follow-up was 46.5 months for Calquence and 45.3 months for IdR/BR, the company said.

The safety and tolerability of Calquence in the ASCEND and ELEVATE-TN trials were consistent with earlier findings, with no new safety signals identified, the company said.

The results were presented at the 2022 American Society of Clinical Oncology Annual Meeting on June 4, 2022.

“These data from ELEVATE-TN, with nearly 5 years of follow-up, support what I have seen in clinical practice and provide clinicians with further reassurance when prescribing this therapy. Patients with chronic lymphocytic leukemia often remain on therapy for many years, so long-term efficacy and tolerability are critical factors that physicians consider when deciding on a treatment plan,” Jeff P. Sharman, MD, director of research at Willamette Valley Cancer Institute, Medical Director of Hematology Research for the US Oncology Network, and a lead investigator of the ELEVATE-TN trial, said in the statement.

Reference

Calquence plus obinutuzumab demonstrated sustained survival benefit in 1st-line chronic lymphocytic leukaemia with 90% of patients surviving five years in ELEVATE-TN trial. AstraZeneca. News release. June 4, 2022. Accessed June 5, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/calquence-plus-obinutuzumab-demonstrated-sustained-survival-benefit-in-1st-line-chronic-lymphocytic-leukaemia.html