Calquence plus obinutuzumab demonstrated sustained survival benefit

Updated results from the ELEVATE-TN Phase III 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 five years in combination and as a monotherapy in chronic lymphocytic leukaemia (CLL).1

Results also showed longer overall survival (OS) for Calquence combined with obinutuzumab compared with chlorambucil combined with obinutuzumab in previously untreated adults with CLL.1 CLL is the most prevalent type of leukaemia in adults, with over 100,000 patients diagnosed globally in 2019.2

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.1 OS data are immature, and medians were not yet reached in any treatment arm.1 The relative risk for death was 45% lower in the Calquence plus obinutuzumab arm (based on a HR of 0.55, 95% CI 0.30-0.99).1 An estimated 90% of patients treated with the Calquence combination were alive at five years versus 84% for Calquence alone and 82% for chlorambucil plus obinutuzumab.1

Separately, follow-up data from the ASCEND Phase III trial showed Calquence demonstrated a sustained PFS benefit at four years based on investigator assessment compared with investigator’s choice of rituximab combined with either idelalisib (IdR) or bendamustine (BR) in adults with relapsed or refractory CLL.3 At 42 months, an estimated 62% of patients treated with Calquence were alive and had not progressed in comparison with 19% of patients treated with IdR/BR.3 The median follow-up was 46.5 months for Calquence and 45.3 months for IdR/BR.3

The safety and tolerability of Calquence in the ELEVATE-TN and ASCEND trials were consistent with earlier findings, with no new safety signals identified.1,3

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: “These data from ELEVATE-TN, with nearly five 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 leukaemia 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. These data show that acalabrutinib combined with obinutuzumab helped previously untreated patients live longer compared with chlorambucil plus obinutuzumab and was generally well-tolerated.”

Anas Younes, Senior Vice President, Haematology R&D, AstraZeneca, said: “We are committed to bringing efficacious and safe treatments to patients with haematological diseases. With chronic lymphocytic leukaemia, these two factors are particularly important due to the chronic nature of the disease and the likelihood of patients having comorbidities. The totality of our longer-term data at ASCO show Calquence’s efficacy benefits and sustained safety profile in key treatment settings, providing more options for patients and their physicians.”

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

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