Seven-Year Follow-Up Data from Phase 3 RESONATE-2 Trial Show Long-Term Survival Benefits of Imbruvica Monotherapy in First-Line CLL Treatment
May 22, 2021 03:01
CST Updated
03:01
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
Janssen Pharmaceuticals
Pharmaceutical R&D Developer
May 20, 2021 /BioonBIOON/ -- Janssen Pharmaceuticals, a Johnson & Johnson (JNJ) company, recently announced the targeted anticancer drug Imbruvica (Chinese trade name: Yike®, generic name: ibrutinib) as a first-line monotherapy for chronic lymphocyticLeukemia(CLL) Phase 3 RESONATE-2 (PCYC-1115/1116) Study Efficacy Endpoints: Progression-Free Survival (PFS) and Overall Survival (OS)Up to 7 Years of Follow-UpAs a result, this isLongest Phase 3 Follow-up Data for a BTK Inhibitor to Date, reinforced the long-term survival benefit and established safety of Imbruvica in the treatment of CLL.
Imbruvica (Yike®) is an oral BTK inhibitor., co-developed and commercialized by Johnson & Johnson and AbbVie. InChina, Imbruvica has been approved., Treatment: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL), Waldenström's Macroglobulinemia (WM). For relevant information, please visit the official website of Janssen Pharmaceuticals.
The 7-year results of the RESONATE-2 study further support the long-term benefits of Imbruvica monotherapy in first-line CLL, with the breadth and maturity of the data continuing to grow, reinforcing this standard-of-care therapy and its positive impact on progression-free survival and overall survival.
Chronic lymphocytic leukemia (CLL, Image source: dxline.info)
The RESONATE-2 study evaluated 269 patients with chronic lymphocytic leukemia (CLL) aged ≥65 years without 17p deletion (del17p). These patients were randomized to receive continuous Imbruvica treatment until disease progression or unacceptable toxicity, or chlorambucil for up to 12 cycles.
Over up to 7 years of follow-up, Imbruvica monotherapy demonstrated a sustained PFS benefit,90% Reduction in Disease Progression or Risk(HR=0.160; 95% CI: 0.111-0.230). At 6.5 years, the median PFS in the Imbruvica treatment group had not been reached, with 61% of patients alive and progression-free, compared with 9% in the chlorambucil treatment group. The PFS benefit with Imbruvica treatment was observed across all subgroups, including those with high-risk genomic features such as TP53 mutation, unmutated IGHV, or 11q deletion (HR=0.091; 95% CI: 0.054-0.152).
Additionally, at 6.5 years,78% of patients in the Imbruvica treatment group remained alive.。Over time, the complete response (CR) rate with Imbruvica treatment increased to 34%. During a follow-up period of up to 7 years, nearly half of the patients continued to receive Imbruvica treatment.
Long-term tolerability of Imbruvica monotherapy is favorable, with no new safety signals. The ongoing incidence rate of Grade 3 or higher adverse events remains low:Hypertension(Years 5–6: n=20; Years 6–7: n=15) and atrial fibrillation (Years 5–6: n=7; Years 6–7: n=5). Additionally, no major bleeding events of Grade 3 or higher occurred during Years 5–7. During Years 5–6, adverse events of any grade leading to treatment discontinuation occurred in 3% of patients (n=2); during Years 6–7, no patients in the Imbruvica treatment arm discontinued treatment due to adverse events.
Imbruvica (Yike®, generic name: ibrutinib) is the first globally approved BTK inhibitor, jointly developed and commercialized by Janssen Biotech, Inc., a Johnson & Johnson company, and Pharmacyclics, an AbbVie company. Imbruvica exerts its anticancer effects by blocking BTK, which is required for cancer cell proliferation and metastasis. BTK is a key signaling molecule within the B-cell receptor signaling complex and plays a critical role in the survival and migration of malignant B cells, as well as in various other serious and debilitating diseases. Imbruvica blocks signaling pathways that mediate uncontrolled B-cell proliferation and dissemination, helping to kill and reduce the number of cancer cells and delay cancer progression. InClinical TrialIn the study, monotherapy and combination therapies targeting a broad spectrum of hematologic malignanciesTumorDemonstrated strong therapeutic efficacy.
Since receiving marketing approval in November 2013, Imbruvica has obtained 11 U.S.FDAApproved: Chronic lymphocytic leukemia (CLL) with or without deletion 17p (del17p), small lymphocytic lymphoma (SLL) with or without deletion 17p (del17p), Waldenström's macroglobulinemia (WM), previously treated mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) requiring systemic therapy and having received at least one prior anti-CD20-based therapy, and chronic graft-versus-host disease (cGVHD) after failure of one or more systemic therapies.
in China, Imbruvica (Yike®, ibrutinib) was approved in August 2017 as a monotherapy for the treatment of: (1) patients who have received at least one prior therapyChronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)patients; (2) who have previously received at least one therapyMantle cell lymphoma (MCL)patient. In November 2018, Imbruvica was approved for a new indication: (1) as monotherapy for patients who have previously received at least one prior therapyWaldenström macroglobulinemia (WM)first-line treatment for patients, or for patients unsuitable for chemoimmunotherapy; (2) in combination with rituximab for the treatment of patients with WM. During the 2018 national medical insurance negotiations, Imbruvica was successfully included in the National Reimbursement Drug List following a substantial price reduction.
Currently, AbbVie and Johnson & Johnson are advancing an extensive Imbruvica clinical program.TumorDevelopment projects. According to the annual reports released by both parties, the global sales of Imbruvica reached $9.442 billion in 2020. Analysts predict that Imbruvica's sales will reach $11.9 billion in 2025. (Bioon.com)
Source: Long-Term Data from the Phase 3 RESONATE-2 Study Demonstrate Efficacy and Safety of Single-Agent IMBRUVICA® in Previously Untreated CLL Patients