Tadeusz Robak, MD, PhD, professor of hematology, Medical University of Lodz, chief, Department of Hematology, Copernicus Memorial Hospital, Lodz, Poland, discusses subsequent treatment after discontinuation of ibrutinib (Imbruvica) on the phase 3 RESONATE-2 trial (NCT01722487) in patients with chronic lymphocytic leukemia (CLL).

Of the patients enrolled on RESONATE-2, which examined ibrutinib vs chlorambucil in patients aged 65 years and older with CLL or small lymphocytic leukemia, 19 discontinued ibrutinib and were given subsequent therapy, according to Roback. Various chemoimmunotherapy regimens, such as fludarabine plus cyclophosphamide and rituximab (Rituxan), bendamustine plus rituximab, or chlorambucil and rituximab, were given to 9 patients. Additionally, 2 patients received subsequent treatment with only chemotherapy, and 7 patients were given novel agents, including venetoclax (Venclexta) alone or in combination with rituximab, Roback explains.

Notably, very few patients on the trial received subsequent treatment after ibrutinib discontinuation; immediate treatment is not necessary until disease progression, Roback adds. Notably, patients with CLL still experienced good remissions without progression and did not require further treatment, despite discontinuing treatment with ibrutinib, Roback concludes.

Videos

Tadeusz Robak, MD, PhD, discusses subsequent treatment after discontinuation of ibrutinib on the phase 3 RESONATE-2 trial in patients with chronic lymphocytic leukemia.

Dr. Roback on Subsequent Treatment Following Ibrutinib Discontinuation in CLL 

Tadeusz Robak, MD, PhD, professor of hematology, Medical University of Lodz, chief, Department of Hematology, Copernicus Memorial Hospital, Lodz, Poland, discusses the inclusion criteria of the the phase 3 RESONATE-2 trial (NCT01722487) in chronic lymphocytic leukemia (CLL).

With up to 7 years of follow-up, findings from the RESONATE-2 trial demonstrated sustained progression-free survival and overall survival benefit with frontline, single-agent ibrutinib (Imbruvica) vs chlorambucil in patients with CLL. 

This study enrolled patients with previously untreated CLL, Robak explains. Major inclusion criteria stated that patients had to be at least 65 years of age, Robak explains. Patients were randomized 1:1 to receive ibrutinib vs chlorambucil.

Moreover, patients with 17p deletions were excluded from the study. At the time the study was planned, chlorambucil was a standard frontline therapy for patients with CLL, Robak explains. However, it was known that chlorambucil was was not an acceptable therapy for patients who harbored 17p deletions, Robak concludes.

Tadeusz Robak, MD, PhD, discusses the inclusion criteria of the the phase 3 RESONATE-2 trial in chronic lymphocytic leukemia. 


 Dr. Robak on the Inclusion Criteria of the RESONATE-2 Trial in CLL 

Tadeusz Robak, MD, PhD, professor of hematology, Medical University of Lodz, chief, Department of Hematology, Copernicus Memorial Hospital, Lodz, Poland, discusses the results of the 7-year follow-up analysis of the phase 3 RESONATE-2 trial (NCT01722487) in chronic lymphocytic leukemia (CLL).

During the 2021 International Workshop on CLL, updated long-term findings from RESONATE-2 were presented in a virtual poster. The results showed that at a median follow-up of up to 7 years, the median progression-free survival (PFS) was not reached with ibrutinib (Imbruvica) compared with 15 months with chlorambucil (HR, 0.160; 95% CI, 0.111-0.230). Moreover, 61% of patients who received ibrutinib vs 9% of patients who received chlorambucil were estimated to be progression free and alive at 6.5 years, Robak says. 

Additionally, the PFS advantage with ibrutinib vs chlorambucil was observed irrespective of age, Rai status at baseline, ECOG performance status at baseline, size of bulky disease, presence or absence of high-risk features like 

 mutations, 11q deletions, and/or unmutated 

, and ß2-microglobulin level at baseline, Robak concludes.

Tadeusz Robak, MD, PhD, discusses the results of the 7-year follow-up analysis of the phase 3 RESONATE-2 trial in chronic lymphocytic leukemia.



Tadeusz Robak, MD, PhD

Articles

Dr. Roback on Subsequent Treatment Following Ibrutinib Discontinuation in CLL

Dr. Robak on the Inclusion Criteria of the RESONATE-2 Trial in CLL

Dr. Robak on the Results of the 7-Year Follow-Up of RESONATE-2 in CLL