Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX? (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Wh
RARITAN, N.J.,?June 12, 2021?/PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 MAIA (NCT02252172) study showing the addition of DARZALEX??(daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over lenalidomide and dexamethasone (Rd) alone in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression.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 #LB1901).
The prespecified interim analysis for OS found that after a median follow-up of nearly five years (56.2 months), a 32 percent reduction in the risk of death was observed in the D-Rd treatment arm vs. Rd arm.1?Median OS was not reached in either arm [hazard ratio (HR): 0.68, 95 percent confidence interval (CI), 0.53-0.86;?p=0.0013].1?Median progression-free survival (PFS) was not reached after nearly five years and the PFS benefit observed with D-Rd was maintained, with a 47 percent reduction in risk of disease progression or death [HR: 0.53; 95 percent CI, 0.43-0.66;?p<0.0001].1?These data are expected to form the basis of future regulatory submissions.
"The treatment of multiple myeloma becomes more complex with each relapse. Therefore, it is critical to achieve deep treatment responses and improved survival with frontline therapy," said?Thierry Facon, M.D.*, Professor of Haematology at Lille University Hospital,?Lille, France?and study investigator. "These results strongly support the use of daratumumab, lenalidomide and dexamethasone?as a new standard of care to extend survival and improve clinical outcomes in transplant ineligible patients with newly diagnosed multiple myeloma."
All patients enrolled in the MAIA study (n=737) were diagnosed with NDMM, were ineligible for high-dose chemotherapy and ASCT, and received 28-day cycles of D-Rd (n=368) or Rd (n=369). Patients were treated until disease progression or unacceptable toxicity.1?The median age of patients was 73 years (range, 45-90 years). Median PFS was not reached with D-Rd vs. 34.4 months with Rd [HR, 0.53; 95 percent CI, 0.43-0.66;?p<0.0001]. Of the 186 patients in the Rd arm who received subsequent therapy, 46 percent received DARZALEX?.
Additional New Findings from the MAIA Longer-Term Follow-Up Analysis:
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting?sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at?www.janssen.com. Follow us at?@JanssenUS?and?@JanssenGlobal. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. *Dr. Facon has served as a consultant to Janssen; he has not been paid for any media work. Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding DARZALEX?FASPRO?. 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 Forward-Looking 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. ___________________________
1?Facon T et al. ?Overall Survival Results With Daratumumab, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Transplant-ineligible Newly Diagnosed Multiple Myeloma: Phase 3 MAIA Study. Abstract #LB1901. Presented at 2021 European Hematology Association Virtual Congress.
2?DARZALEX??Prescribing Information,?March 2021.
3?Data on File. Janssen Biotech, Inc.
4?Moreau P, Attal M, Hulin C, et al. Phase 3 randomized study of daratumumab (DARA) + bortezomib/thalidomide/dexamethasone (D-VTd) vs VTd in transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM): CASSIOPEIA Part 1 results. Presented at Annual Meeting of the American Society of Clinical Oncology (ASCO),?Chicago, IL, USA, 31 May ??4 June 2019: abstract 8003.
5Janssen Research & Development, LLC. A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at:?https://clinicaltrials.gov/ct2/show/NCT02076009?term=mmy3003&rank=1?Identifier: NCT02136134.
6?Janssen Research & Development, LLC. Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at:?https://clinicaltrials.gov/ct2/show/NCT02136134?term=mmy3004&rank=1?Identifier: NCT02076009.
7?Janssen Research & Development, LLC. A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma (Cassiopeia). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at:?https://clinicaltrials.gov/ct2/show/NCT02541383?term=mmy3006?Identifier: NCT02541383.
8?Janssen Research & Development, LLC. A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at:?https://clinicaltrials.gov/ct2/show/NCT02195479?term=mmy3007&rank=1?Identifier: NCT02195479.
9?Janssen Research & Development, LLC. Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at:?https://clinicaltrials.gov/ct2/show/NCT02252172?term=mmy3008&rank=1?Identifier: NCT02252172.
10?Janssen Research & Development, LLC. A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at:?https://clinicaltrials.gov/ct2/show/NCT03217812?term=MMY3011&rank=1?Identifier: NCT03217812.
11?European Myeloma Network. Compare Progression Free Survival Btw Daratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at:?https://clinicaltrials.gov/ct2/show/NCT03180736?term=MMY3013&rank=2?Identifier: NCT03180736.
12?Amgen. Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. (CANDOR). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at:?https://clinicaltrials.gov/ct2/show/NCT03158688?term=NCT03158688&rank=1?Identifier: NCT03158688.
13?Kumar, SK et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan; 26(1):149-57.
14?American Cancer Society. "What Is Multiple Myeloma?" Available at:?http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed?May 2021.
15?American Cancer Society. "Key Statistics About Multiple Myeloma." Available at:?https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html. Accessed?May 2021. Media contacts:
Michelle Larkin
Phone: +1 610-304-5842 Satu Glawe
Phone: +49 172-294-6264 Investor Relations:
Jennifer McIntyre
Phone: +1 732-524-3922 U.S. Medical Inquiries:
+1 800-526-7736 SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson
- Estimated five-year OS rate of 66 percent with D-Rd vs. 53 percent with Rd [HR: 0.68; 95 percent CI, 0.53-0.86;?p=0.0013].1
- Estimated five-year PFS rate of 53 percent with D-Rd vs. 29 percent with Rd [HR: 0.53; 95 percent CI, 0.43-0.66;?p<0.0001].1
- Median time to next treatment was not reached with D-Rd vs. 42.4 months with Rd [HR: 0.47; 95 percent CI, 0.37-0.59;?p<0.0001].1
- Updated overall response rate (ORR) of 93 percent with D-Rd vs. 82 percent with Rd.1
- In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
- In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
- In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
- In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
- In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
- In combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
- As monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting?sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at?www.janssen.com. Follow us at?@JanssenUS?and?@JanssenGlobal. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. *Dr. Facon has served as a consultant to Janssen; he has not been paid for any media work. Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding DARZALEX?FASPRO?. 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 Forward-Looking 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. ___________________________
1?Facon T et al. ?Overall Survival Results With Daratumumab, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Transplant-ineligible Newly Diagnosed Multiple Myeloma: Phase 3 MAIA Study. Abstract #LB1901. Presented at 2021 European Hematology Association Virtual Congress.
2?DARZALEX??Prescribing Information,?March 2021.
3?Data on File. Janssen Biotech, Inc.
4?Moreau P, Attal M, Hulin C, et al. Phase 3 randomized study of daratumumab (DARA) + bortezomib/thalidomide/dexamethasone (D-VTd) vs VTd in transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM): CASSIOPEIA Part 1 results. Presented at Annual Meeting of the American Society of Clinical Oncology (ASCO),?Chicago, IL, USA, 31 May ??4 June 2019: abstract 8003.
5Janssen Research & Development, LLC. A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at:?https://clinicaltrials.gov/ct2/show/NCT02076009?term=mmy3003&rank=1?Identifier: NCT02136134.
6?Janssen Research & Development, LLC. Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at:?https://clinicaltrials.gov/ct2/show/NCT02136134?term=mmy3004&rank=1?Identifier: NCT02076009.
7?Janssen Research & Development, LLC. A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma (Cassiopeia). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at:?https://clinicaltrials.gov/ct2/show/NCT02541383?term=mmy3006?Identifier: NCT02541383.
8?Janssen Research & Development, LLC. A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at:?https://clinicaltrials.gov/ct2/show/NCT02195479?term=mmy3007&rank=1?Identifier: NCT02195479.
9?Janssen Research & Development, LLC. Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at:?https://clinicaltrials.gov/ct2/show/NCT02252172?term=mmy3008&rank=1?Identifier: NCT02252172.
10?Janssen Research & Development, LLC. A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at:?https://clinicaltrials.gov/ct2/show/NCT03217812?term=MMY3011&rank=1?Identifier: NCT03217812.
11?European Myeloma Network. Compare Progression Free Survival Btw Daratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at:?https://clinicaltrials.gov/ct2/show/NCT03180736?term=MMY3013&rank=2?Identifier: NCT03180736.
12?Amgen. Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. (CANDOR). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at:?https://clinicaltrials.gov/ct2/show/NCT03158688?term=NCT03158688&rank=1?Identifier: NCT03158688.
13?Kumar, SK et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan; 26(1):149-57.
14?American Cancer Society. "What Is Multiple Myeloma?" Available at:?http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed?May 2021.
15?American Cancer Society. "Key Statistics About Multiple Myeloma." Available at:?https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html. Accessed?May 2021. Media contacts:
Michelle Larkin
Phone: +1 610-304-5842 Satu Glawe
Phone: +49 172-294-6264 Investor Relations:
Jennifer McIntyre
Phone: +1 732-524-3922 U.S. Medical Inquiries:
+1 800-526-7736 SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson