CONTEXT: Report of new data to be presented by Abbvie at the European Hematology Association (EHA) Virtual Congress derived from the informCLLTM registry assessing how real-word treatment patterns align with National Comprehensive Cancer Network (NCCN) recommended regimens for chronic lymphocytic leukaemia / small lymphocytic leukaemia (CLL/SLL). This data was also presented at ASCO 2021
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1. “The pivotal Phase 3 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.2. (Abstract EP635) Real-World Application of NCCN Clinical Practice Guidelines (NCCN Guidelines®) for CLL/SLL from the informCLL Prospective Observational Registry. Results from the informCLL™ real-world registry assessing treatment alignment with NCCN Guidelines® will be presented as a poster during the EHA Virtual Congress on June 11th.”
2. “NORTH CHICAGO, Ill., June 4, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV), today announced extended long-term data from the Phase 3 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).1 These data will be presented on June 4th during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #7523).”
3. “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.1 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]).1 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.1 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.1 In this latest follow-up, the overall response rate (ORR) was 92 percent.1. 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.1 With up to seven years of follow-up, nearly half of patients remained on long-term continuous treatment with IMBRUVICA.1. 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.1 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).1 Across full follow-up, 31 patients had dose reductions due to any-grade AEs.1 Of the patients who had a dose reduction, 71 percent had resolution or improvement of the AE.1. “With long-term safety and efficacy data for IMBRUVICA in CLL, these latest data from the RESONATE-2 study further reinforce IMBRUVICA as a standard of care that can help patients live longer without chemotherapy,” said Danelle James, M.D., M.A.S., Imbruvica Global Development Lead, Pharmacyclics LLC, an AbbVie company.”
4. “For this analysis, NCCN Guidelines® for CLL/SLL V.2.2017 were used given 74 percent enrollment in 2017.3. The latest analysis showed that a third of high-risk patients with 17p deletion/TP53 mutation, who typically have poor outcomes after chemoimmunotherapy (CIT), did not receive NCCN®-recommended regimens.3 Most patients without 17p deletion/TP53 mutation received recommended therapy across age/comorbidity groups.3 Despite guideline recommendations for prognostic testing, the majority of patients in the registry were not tested for both 17p deletion/TP53 mutation and therefore may have received suboptimal treatment with CIT.3 These results underscore the importance of prognostic marker testing and appropriate selection of therapies based on NCCN Guidelines® recommendations, especially in the community setting.3. IMBRUVICA (ibrutinib) is a once-daily, first-in-class BTK inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics, LLC, an AbbVie Company, and Janssen Biotech, Inc. (Janssen).”
5. “BTK signaling is needed by specific cancer cells to multiply and spread.4,5 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.6. Since its launch in 2013, IMBRUVICA® has received 11 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; Waldenström macroglobulinemia; previously-treated patients with mantle cell lymphoma (MCL)*; previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy* – and previously-treated patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.7. IMBRUVICA® is now approved in 101 countries and has been used to treat more than 230,000 patients worldwide across its approved indications.”