A041202: trial | Bending the Curve: Trial by Trial

A041202

Ibrutinib regimens versus chemoimmunotherapy in older patients with untreated CLL

Population

Untreated CLL, age 65 years or older

Design

Phase 3 trial; patients aged 65 or older with untreated CLL randomly assigned to bendamustine-rituximab, ibrutinib, or ibrutinib plus rituximab. Primary endpoint PFS. The data and safety monitoring board released the data after the protocol-specified efficacy threshold was met.

Primary endpoint

PFS

Arms

Bendamustine-rituximab (control, n = 183): Bendamustine plus rituximab
Ibrutinib (experimental, n = 182): Ibrutinib alone
Ibrutinib-rituximab (experimental, n = 182): Ibrutinib plus rituximab

People

Woyach JA, senior author Byrd JC

PFSHR 0.39 (95% CI 0.26–0.58)Δ 24-month PFS+13 pointsPFSHR 0.38 (95% CI 0.25–0.59)Δ 24-month PFS+14 pointsPFSHR 1.00 (95% CI 0.62–1.62)

Show the numbers

Results reported for A041202
Endpoint	Analysis	Ibrutinib / Ibrutinib-rituximab	Bendamustine-rituximab	Effect
PFSRandomly assigned patients (n=547); the abstract does not state the analysis population	primaryWoyach 2018	87% at 2 y	74% at 2 y	HR 0.39 (95% CI 0.26–0.58)P<0.001PFS at 2 years. Median PFS was reached only with bendamustine-rituximab. Overall survival: no significant difference among the three groups at a median follow-up of 38 months (abstract gives no values).
PFSRandomly assigned patients (n=547); the abstract does not state the analysis population	primaryWoyach 2018	88% at 2 y	74% at 2 y	HR 0.38 (95% CI 0.25–0.59)P<0.001PFS at 2 years.
PFSRandomly assigned patients (n=547); the abstract does not state the analysis population	primaryWoyach 2018	87% at 2 y	—	HR 1.00 (95% CI 0.62–1.62)P=0.49Hazard ratio compares ibrutinib-rituximab with ibrutinib alone (no significant difference); direction of the ratio as stated in the abstract.

Results reported for A041202
Endpoint	Analysis	Ibrutinib / Ibrutinib-rituximab	Bendamustine-rituximab	Effect
PFSRandomly assigned patients (n=547); the abstract does not state the analysis population	primaryWoyach 2018	87% at 2 y	74% at 2 y	HR 0.39 (95% CI 0.26–0.58)P<0.001PFS at 2 years. Median PFS was reached only with bendamustine-rituximab. Overall survival: no significant difference among the three groups at a median follow-up of 38 months (abstract gives no values).
PFSRandomly assigned patients (n=547); the abstract does not state the analysis population	primaryWoyach 2018	88% at 2 y	74% at 2 y	HR 0.38 (95% CI 0.25–0.59)P<0.001PFS at 2 years.
PFSRandomly assigned patients (n=547); the abstract does not state the analysis population	primaryWoyach 2018	87% at 2 y	—	HR 1.00 (95% CI 0.62–1.62)P=0.49Hazard ratio compares ibrutinib-rituximab with ibrutinib alone (no significant difference); direction of the ratio as stated in the abstract.

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
PFS	0.39	0.26–0.58
PFS	0.38	0.25–0.59
PFS	1	0.62–1.62

Appears in

2015 Ibrutinib as first-line therapy: RESONATE-2, A041202, E1912

Sources

Woyach JA, Ruppert AS, Heerema NA, Zhao W, Booth AM, Ding W, et al. Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL. N Engl J Med. 2018;379(26):2517-2528.
PubMed DOI