Janssen's Innovative Targeted Therapy DARZALEX® Approved in China for Combination Regimens in Relapsed or Refractory Multiple Myeloma
Apr 29, 2021 17:10
CST Updated
17:10
Xian Janssen
Pharmaceutical R&D and Manufacturer
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
On April 29, 2021, Xian Janssen Pharmaceutical Ltd., Johnson & Johnson’s pharmaceutical subsidiary in China, announced that its innovative targeted therapy, Darzalex® (daratumumab injection; English brand name: DARZALEX®; English generic name: daratumumab), had been approved by the National Medical Products Administration (NMPA). The approval is for use in combination with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy. In July 2019, Darzalex®, as the first fully human monoclonal antibody targeting CD38 approved in China, was authorized for monotherapy in adult patients with relapsed and refractory multiple myeloma who had previously received treatments including proteasome inhibitors and immunomodulatory agents and demonstrated disease progression during their last therapy. Last October, this new indication for Darzalex® was again granted “Priority Review” status by the NMPA. The approval of this indication will further address unmet medical needs in the treatment of relapsed or refractory multiple myeloma in China, providing more innovative options for patients at earlier stages of treatment. Clinical studies have shown that daratumumab-based combination regimens can reduce the risk of death and prolong progression-free survival in patients with relapsed or refractory multiple myeloma.
Multiple myeloma is an incurable hematologic malignancy, with its incidence now ranking second among hematologic cancers in China. Professor Wu Depei, Chairman of the Chinese Society of Hematology and Executive Deputy Director of the National Clinical Research Center for Hematologic Diseases, pointed out: “Although the disease trajectory varies among patients with multiple myeloma, relapse is inevitable, and treatment response and survival prognosis decline with each subsequent relapse. Despite significant advances in the treatment of multiple myeloma in recent years, many patients still face the challenge of relapsed or refractory disease, creating an urgent need for novel therapeutic options. Early intervention is particularly critical for patients experiencing their first relapse.”
Zhaoke® is the first fully human monoclonal antibody approved in China that targets CD38. It features a unique innovative mechanism of action, specifically binding to CD38, a key immunotherapeutic target on the surface of myeloma cells, and induces myeloma cell death through multiple mechanisms, achieving rapid response.
Professor Wang Jianxiang, Deputy Director of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, further pointed out: “For patients with relapsed multiple myeloma, our primary treatment goal is to achieve deeper and more durable remission, thereby prolonging progression-free survival as much as possible. Patients who have received at least one prior line of therapy urgently need access to more innovative treatments to obtain significant clinical benefits, thus helping to extend life and improve quality of life.”
The approval of the new indication for ZHAOKE® is based on data from a Phase III clinical study in China (LEPUS) and two multinational Phase III clinical studies (POLLUX and CASTOR). The studies demonstrated that, for patients with relapsed or refractory multiple myeloma, combination therapy regimens based on ZHAOKE® can reduce the risk of death and prolong progression-free survival.
1) At a median follow-up of 8.2 months, results from the LEPUS study demonstrated that daratumumab in combination with bortezomib and dexamethasone, compared with bortezomib and dexamethasone alone, significantly prolonged median progression-free survival (not reached vs. 6.3 months) and reduced the risk of disease progression or death by 72% (HR [95% CI]: 0.28 [0.17, 0.47]; p < 0.00001).
2) At a median follow-up of 55 months, the POLLUX study demonstrated that daratumumab in combination with lenalidomide and dexamethasone significantly prolonged median progression-free survival compared with lenalidomide and dexamethasone alone (45 months vs. 17.5 months), reducing the risk of disease progression or death by 56% (HR [95% CI]: 0.44 [0.35, 0.54]; p < 0.0001).
3) At a median follow-up of 50 months, the CASTOR study demonstrated that daratumumab in combination with bortezomib and dexamethasone significantly prolonged median progression-free survival compared with bortezomib and dexamethasone alone (16.7 months vs. 7.1 months), reducing the risk of disease progression or death by 69% (HR [95% CI]: 0.31 [0.24, 0.39]; p < 0.0001).
4) In clinical studies of daratumumab combination therapy, the most common adverse reactions (≥20%) included upper respiratory tract infections, infectious pneumonia, neutropenia, thrombocytopenia, anemia, peripheral sensory neuropathy, cough, dyspnea, diarrhea, constipation, nausea, back pain, fatigue, peripheral edema, fever, and infusion-related reactions.
Dr. Li Zili, Vice President of Global R&D at Janssen Pharmaceuticals and Head of the Asia-Pacific R&D Center, stated, “We are pleased to see that our efficiently advancing R&D process can rapidly benefit patients at earlier stages of disease, thereby improving patient outcomes and extending progression-free survival. The approval of this new indication underscores Janssen’s commitment to patients in China. We remain dedicated to improving the diagnosis and treatment landscape for multiple myeloma and delivering innovative solutions to patients at all stages of the disease.”
Ms. Zheng Lei, President of Xian Janssen Pharmaceutical Ltd., stated, “Xian Janssen is committed to creating a future free from multiple myeloma. As a significant achievement of Janssen’s years of deep engagement in the field of multiple myeloma, our innovative solutions are poised to further improve the quality of life for patients in China and bring new hope to those with relapsed or refractory disease. As we continue to expand our R&D pipeline in multiple myeloma, Xian Janssen will also maintain collaboration with the government, healthcare institutions, and other stakeholders to enhance access to innovative medicines, striving tirelessly to improve the lives of more patients in China.”
ZHAOKE® is another innovative solution from Xian Janssen for the treatment of multiple myeloma. Previously, VELCADE® (bortezomib injection) was approved in 2005 for the treatment of multiple myeloma and was included in the National Reimbursement Drug List in 2017.
Multiple myeloma is an incurable hematologic malignancy, with its incidence now ranking second among hematologic cancers in China. Professor Wu Depei, Chairman of the Chinese Society of Hematology and Executive Deputy Director of the National Clinical Research Center for Hematologic Diseases, pointed out: “Although the disease trajectory varies among patients with multiple myeloma, relapse is inevitable, and treatment response and survival prognosis decline with each subsequent relapse. Despite significant advances in the treatment of multiple myeloma in recent years, many patients still face the challenge of relapsed or refractory disease, creating an urgent need for novel therapeutic options. Early intervention is particularly critical for patients experiencing their first relapse.”
Zhaoke® is the first fully human monoclonal antibody approved in China that targets CD38. It features a unique innovative mechanism of action, specifically binding to CD38, a key immunotherapeutic target on the surface of myeloma cells, and induces myeloma cell death through multiple mechanisms, achieving rapid response.
Professor Wang Jianxiang, Deputy Director of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, further pointed out: “For patients with relapsed multiple myeloma, our primary treatment goal is to achieve deeper and more durable remission, thereby prolonging progression-free survival as much as possible. Patients who have received at least one prior line of therapy urgently need access to more innovative treatments to obtain significant clinical benefits, thus helping to extend life and improve quality of life.”
The approval of the new indication for ZHAOKE® is based on data from a Phase III clinical study in China (LEPUS) and two multinational Phase III clinical studies (POLLUX and CASTOR). The studies demonstrated that, for patients with relapsed or refractory multiple myeloma, combination therapy regimens based on ZHAOKE® can reduce the risk of death and prolong progression-free survival.
1) At a median follow-up of 8.2 months, results from the LEPUS study demonstrated that daratumumab in combination with bortezomib and dexamethasone, compared with bortezomib and dexamethasone alone, significantly prolonged median progression-free survival (not reached vs. 6.3 months) and reduced the risk of disease progression or death by 72% (HR [95% CI]: 0.28 [0.17, 0.47]; p < 0.00001).
2) At a median follow-up of 55 months, the POLLUX study demonstrated that daratumumab in combination with lenalidomide and dexamethasone significantly prolonged median progression-free survival compared with lenalidomide and dexamethasone alone (45 months vs. 17.5 months), reducing the risk of disease progression or death by 56% (HR [95% CI]: 0.44 [0.35, 0.54]; p < 0.0001).
3) At a median follow-up of 50 months, the CASTOR study demonstrated that daratumumab in combination with bortezomib and dexamethasone significantly prolonged median progression-free survival compared with bortezomib and dexamethasone alone (16.7 months vs. 7.1 months), reducing the risk of disease progression or death by 69% (HR [95% CI]: 0.31 [0.24, 0.39]; p < 0.0001).
4) In clinical studies of daratumumab combination therapy, the most common adverse reactions (≥20%) included upper respiratory tract infections, infectious pneumonia, neutropenia, thrombocytopenia, anemia, peripheral sensory neuropathy, cough, dyspnea, diarrhea, constipation, nausea, back pain, fatigue, peripheral edema, fever, and infusion-related reactions.
Dr. Li Zili, Vice President of Global R&D at Janssen Pharmaceuticals and Head of the Asia-Pacific R&D Center, stated, “We are pleased to see that our efficiently advancing R&D process can rapidly benefit patients at earlier stages of disease, thereby improving patient outcomes and extending progression-free survival. The approval of this new indication underscores Janssen’s commitment to patients in China. We remain dedicated to improving the diagnosis and treatment landscape for multiple myeloma and delivering innovative solutions to patients at all stages of the disease.”
Ms. Zheng Lei, President of Xian Janssen Pharmaceutical Ltd., stated, “Xian Janssen is committed to creating a future free from multiple myeloma. As a significant achievement of Janssen’s years of deep engagement in the field of multiple myeloma, our innovative solutions are poised to further improve the quality of life for patients in China and bring new hope to those with relapsed or refractory disease. As we continue to expand our R&D pipeline in multiple myeloma, Xian Janssen will also maintain collaboration with the government, healthcare institutions, and other stakeholders to enhance access to innovative medicines, striving tirelessly to improve the lives of more patients in China.”
ZHAOKE® is another innovative solution from Xian Janssen for the treatment of multiple myeloma. Previously, VELCADE® (bortezomib injection) was approved in 2005 for the treatment of multiple myeloma and was included in the National Reimbursement Drug List in 2017.