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  • Results from Imbruvica RESONATE-2 study provide up...

Results from Imbruvica RESONATE-2 study provide up to seven years of progression-free and overall survival data in first-line chronic lymphocytic leukemia. AbbVie

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Published:9th Jun 2021
AbbVie announced extended long-term data from the Phase III RESONATE-2 study (PCYC-1115/1116) evaluating single-agent Imbruvica (ibrutinib) versus chlorambucil with up to seven years of follow-up in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

These data were presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #7523). Additionally, new data will be presented during the European Hematology Association (EHA) Virtual Congress from June 9-17, including findings from the inform CLL real-world prospective observational registry assessing how real-world treatment patterns align with National Comprehensive Cancer Network (NCCN)-recommended regimens for CLL/SLL. The RESONATE-2 study evaluated 269 patients 65 years or older with previously untreated CLL/SLL, without 17p deletion, who received continuous single-agent Imbruvica until progression or chlorambucil up to 12 cycles. With up to seven years of follow-up, progression-free survival (PFS) benefit with single-agent Imbruvica was sustained (Hazard Ratio [HR] 0.160 [95 percent Confidence Interval (CI): 0.111–0.230]). At 6.5 years of follow-up, median PFS in the Imbruvica treatment arm was not reached: the PFS rate for patients treated with single-agent Imbruvica was 61 percent compared with only nine percent in patients treated with chlorambucil. Additionally, at 6.5 years, the Imbruvica treatment arm showed an overall survival (OS) rate of 78 percent; OS was not captured for the chlorambucil treatment arm for patients with disease progression after a median of five years of follow-up. In this latest follow-up, the overall response rate (ORR) was 92 percent. With up to seven years of follow-up, the complete response (CR)/complete response increase (CRi) rate increased over time to 34 percent; median duration of response (range, <0.1 to 83) and cr (range,><0.1 to 79 months) were not reached. with up to seven years of follow-up, nearly half of patients remained on long-term continuous treatment with imbruvica. imbruvica was well tolerated as a long-term treatment and rates of discontinuation due to aes remained low, with 23 percent of patients in the imbruvica arm discontinuing treatment due to aes as the primary reason. ongoing rates of grade 3 or higher aes of interest remained low for hypertension (five-to-six-year interval: n="20;" six-to-seven-year interval: n="15)" and atrial fibrillation (five-to-six-year interval: n="7;" six-to-seven-year interval: n="5)." across full follow-up, 31 patients had dose reductions due to any-grade aes. of the patients who had a dose reduction, 71 percent had resolution or improvement of the ae. the pivotal phase iii resonate-2 study served as the basis for the fda approval of imbruvica as a single-agent in first-line treatment for cll sll in 2016, following initial approval for relapsed refractory (r r) patients in 2014 based on the resonate study. see-barr p., et al. "up to 7 years of follow-up in the resonate-2 study of first-line ibrutinib treatment for patients with chronic lymphocytic leukemia". 2021 american society of clinical oncology annual meeting. june 4-8, 2021.></0.1></0.1>

Condition: CLL/SLL
Type: drug

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