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Johnson & Johnson : New Phase 3 Study Results Show IMBRUVICA - Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia

06/14/2021 | 08:26am EDT

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced primary results from the pivotal Phase 3 GLOW study (NCT03462719) evaluating fixed-duration IMBRUVICA plus venetoclax (I+V) compared to chlorambucil plus obinutuzumab (Clb+O) for first-line treatment of elderly or unfit patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixedduration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duration of remission and significantly improved depth of remission. 1 With I+V, undetectable minimal residual disease (uMRD) in peripheral blood (PB) was sustained by 85 percent of patients one year after end of treatment. 1 The safety and tolerability profile of I+V was consistent with CLL treatment in an older population with comorbidities.1 These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefing and will be presented as a late-breaking abstract during the EHA Virtual Congress (Abstract #LB1902).

'In the GLOW study, two very active blood cancer treatments are combined to create a complementary therapeutic regimen with the hope that deep responses might enable treatment-free remission for patients,' said Arnon Kater(+) , M.D., Ph.D., deputy head of hematology, University of Amsterdam Faculty of Medicine, the Netherlands and principal study investigator. 'The data from GLOW showed that IMBRUVICA in an oral, once-daily fixed-duration combination with venetoclax outperformed a standard chemoimmunotherapy regimen for older or unfit patients, providing the first comparative evidence that this approach has the potential to improve depth of response and, therefore, extends time to progression versus standard therapy.' The GLOW study evaluated the efficacy and safety of first-line fixed-duration I+V versus Clb+O in elderly patients with CLL/SLL, or patients ages 18-64 with a cumulative illness rating scale (CIRS) score of greater than six or creatinine clearance less than 70 mL/min. 1 The CIRS score measures comorbidity, or concurrent non-CLL illness, in patients across multiple body systems. 2 GLOW excluded patients with del(17p) or known TP53 mutations. Randomization to fixed-duration I+V or a standard six 28-day cycle of Clb+O was stratified by immunoglobulin heavy chain variable region gene (IgHV) mutational status and del(11q) status. 1 Patients in the I+V arm received three months of IMBRUVICA lead-in therapy followed by 12 months of combination I+V therapy, and all patients stopped therapy regardless of MRD status.1 In the study, 106 patients received I+V and 105 received Clb+O (n=211; median age, 71 years). 1 At a median follow-up of 27.7 months, independent review committee (IRC)-assessed PFS for fixed-duration I+V was superior to Clb+O [Hazard Ratio (HR) 0.216; 95 percent confidence interval [CI], 0.131-0.357; p < 0.0001] and the improvement in PFS favoring I+V was consistent across predefined subgroups, including older patients and patients with higher comorbidity scores. 1 Median PFS was not reached for I+V and 21.0 months for Clb+O (95 percent CI, 16.6-24.7). 1 At three months after the end of treatment (EOT+3), the rate of uMRD was significantly higher for I+V versus Clb+O in bone marrow (51.9 percent vs. 17.1 percent, respectively; p < 0.0001) and peripheral blood (54.7 percent vs. 39.0 percent, respectively; p < 0.0001). 1 Complete response (CR) rates (including CR with incomplete hematologic recovery) by IRC assessment were also significantly higher for fixed-duration I+V versus Clb+O (38.7 percent vs. 11.4 percent; p < 0.0001).1 Responses to fixed-duration I+V were sustained after EOT; 84.5 percent (49/58) of patients maintained peripheral blood uMRD from EOT+3 to the assessment 12 months after EOT (EOT+12). 1 Thereby, with a median follow-up of 27.7 months, time to next anti-cancer therapy was extended with I+V vs. Clb+O [HR, 0.143; 95 percent CI, 0.05-0.41]. 1 The most common Grade 3 or higher treatment-emergent adverse events (TEAEs) for fixedduration I+V were neutropenia/neutrophil count decrease (34.9 percent), infections (17 percent), and diarrhea (10.4 percent) and neutropenia/neutrophil count decrease (49.5 percent), thrombocytopenia (20 percent), and infections (11.4 percent) for Clb+O.1 Deaths during treatment occurred in seven patients on fixed-duration I+V and two patients on Clb+O.1 At time of analysis, overall survival was immature; there were eleven deaths in the fixed-duration I+V arm and twelve in the Clb+O arm.1


IMBRUVICA (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. The BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiply and spread. By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs. 4,5,6 IMBRUVICA is approved in more than 100 countries, and, to date, is the only BTK inhibitor that has been used to treat more than 230,000 patients worldwide. IMBRUVICA was first approved by the U.S. Food and Drug Administration (FDA) in November 2013, and today is indicated for adult patients in six disease areas, including five hematologic cancers - adults with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) with or without 17p deletion (del17p), adults with Waldenstrom's macroglobulinemia (WM), adult patients with previously treated mantle cell lymphoma (MCL), adult patients with previously treated marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy - and adult patients with previously treated chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.

Cautions Concerning Forward-Looking Statements This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMBRUVICA (ibrutinib). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., or any of the other Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned 'Cautionary Note Regarding ForwardLooking Statements' and 'Item 1A. Risk Factors,' and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.


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