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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Calquence (acalabrutinib) (BTK inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Calquence approved in China for chronic lymphocytic leukaemia
Published date:
09/04/2023
Excerpt:
AstraZeneca’s Calquence (acalabrutinib), a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been approved in China for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy.
Title:
acalabrutinib (Calquence) is accepted for restricted use within NHSScotland
Published date:
03/05/2021
Excerpt:
acalabrutinib (Calquence) is accepted for restricted use within NHSScotland....as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Source:
Title:
Calquence approved in Japan for the treatment of relapsed or refractory chronic lymphocytic leukaemia
Published date:
01/25/2021
Excerpt:
AstraZeneca’s Calquence (acalabrutinib), a next-generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been approved in Japan for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma [SLL]).
Source:
Published date:
11/05/2020
Excerpt:
Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Source:
Excerpt:
CALQUENCE is a kinase inhibitor indicated for the treatment of adult patients with:...Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Source:
Title:
Chemotherapy-free treatment option to be offered to patients with England’s most common leukaemia
Published date:
03/18/2021
Excerpt:
Acalabrutinib, taken as a twice daily tablet, is recommended as an option for adults with untreated chronic lymphocytic leukaemia (CLL)...NICE has recommended the use of acalabrutinib, as a monotherapy option for adults with...no 17p deletion or TP53 mutation...
Source:
Published date:
11/06/2019
Excerpt:
Acalabrutinib, ibrutinib, venetoclax + rituximab (VenR), duvelisib, and idelalisib + rituximab (IdR) are included as options for patients with relapsed or refractory disease, regardless of patient's age and comorbities
Source:
Title:
Acalabrutinib ± Obinutuzumab vs Obinutuzumab + Chlorambucil in TreatmentNaïve Chronic Lymphocytic Leukemia: ELEVATE-TN 4-Year Follow-up
Published date:
08/09/2021
Excerpt:
A 4-year update analysis from the phase 3 ELEVATE-TN study was performed to assess long-term efficacy and safety of acalabrutinib (A) ± obinutuzumab (O)...Median PFS was significantly longer for A-containing arms...A+O vs O+Clb: HR 0.10 (95% CI: 0.07, 0.17)...A vs O+Clb: HR 0.19 (95% CI: 0.13, 0.28)...A ± O demonstrates durable disease control, tolerability, and flexibility to tailor treatment as a monotherapy or
combination therapy in TN CLL patients.
Trial ID:
Source:
Title:
Calquence met primary efficacy endpoint in head-to-head trial against ibrutinib in chronic lymphocytic leukaemia
Published date:
01/25/2021
Excerpt:
Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival (PFS) for adults with previously treated, high-risk chronic lymphocytic leukaemia (CLL) compared to ibrutinib.
Trial ID:
Source:
Title:
ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
Published date:
05/27/2020
Excerpt:
After a median follow-up of 16.1 months (range, 0.03-22.4 months), median PFS was significantly longer with acalabrutinib monotherapy (PFS not reached) compared with investigator’s choice (16.5 months [95% CI, 14.0 to 17.1 months]; hazard ratio, 0.31 [95% CI, 0.20 to 0.49]; P < .0001). Estimated 12-month PFS was 88% (95% CI, 81% to 92%) for acalabrutinib and 68% (95% CI, 59% to 75%) for investigator’s choice.
DOI:
10.1200/JCO.19.03355
Trial ID:
Source:
Title:
Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial
Published date:
04/18/2020
Excerpt:
We compare the efficacy of acalabrutinib with or without obinutuzumab against chlorambucil with obinutuzumab in patients with treatment-naive chronic lymphocytic leukaemia....At median follow-up of 28·3 months (IQR 25·6-33·1), median progression-free survival was longer with acalabrutinib-obinutuzumab and acalabrutinib monotherapy,…
DOI:
10.1016/S0140-6736(20)30262-2
Trial ID:
Source:
Title:
Calquence granted US Breakthrough Therapy Designation for chronic lymphocytic leukaemia
Published date:
08/14/2019
Excerpt:
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia (CLL)...The FDA granted the BTD based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials.
Source:
Title:
ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL)
Excerpt:
Acalabrutinib + O and acalabrutinib monotherapy significantly improved PFS vs O + Clb, with tolerable safety in pts with TN CLL.
DOI:
10.1182/blood-2019-128404
Trial ID:
