- In the U.S., Bayer has filed for relapsed indolent B-cell non-Hodgkin’s Lymphoma (iNHL)
- In the EU, Bayer has filed for relapsed marginal zone lymphoma (MZL), a subtype of iNHL, and the filing has been accepted
WHIPPANY, NJ, USA I June 21, 2021 I Bayer today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of the investigational combination of the cancer treatments Aliqopa® (copanlisib) and rituximab. The U.S. submission is for the treatment of patients with relapsed indolent B-cell non-Hodgkin’s Lymphoma (iNHL) and is outside of the FDA accelerated approved indication for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. In the EU, Bayer has filed for the treatment of relapsed marginal zone lymphoma (MZL), a subtype of iNHL, and the filing has been accepted. The submissions are supported by positive results from the Phase III trial CHRONOS-3, which were presented in April at the American Association for Cancer Research (AACR) Annual Meeting 2021, and simultaneously published in The Lancet Oncology.1 Indolent NHL consists of the following subtypes: FL, MZL, small lymphocytic lymphoma (SLL) and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM).
“The U.S. and EU submissions of the novel combination of Aliqopa and rituximab bring us forward in advancing new treatment approaches and addressing unmet needs of patients with different types of relapsed iNHL,” said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer. “We are excited about the potential of this investigational combination therapy based on the findings from CHRONOS-3 and we look forward to working with global regulatory authorities.”
The FDA has granted Orphan Drug Designations (ODD) for Aliqopa in chronic lymphocytic leukemia (CLL)/SLL and LPL/WM, and has previously granted an ODD for Aliqopa in FL and MZL. Additionally, Aliqopa was granted Breakthrough Therapy Designation for relapsed MZL in patients who have received at least two prior therapies. Bayer has also previously received an ODD for MZL in the EU.
In 2017, Aliqopa was approved for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies based on the results of a single-arm, multi-center, Phase II clinical trial (CHRONOS-1).2 Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.
CHRONOS-3 is a Phase III randomized, double-blind, placebo-controlled trial with the objective to evaluate whether Aliqopa in combination with rituximab is superior to placebo plus rituximab in extending progression-free survival (PFS) in patients with relapsed iNHL following at least one prior rituximab-containing therapy. Histological subtypes included in the trial were FL, SLL, LPL/WM, and MZL. Patients who had a progression-free and treatment-free interval of at least 12 months after completion of the last rituximab-containing regimen or patients unwilling/unfit or for who chemotherapy was contraindicated by reason of age, co-morbidities and/or residual toxicity were included (NCT02367040). The study enrolled 458 participants.3
About Aliqopa® (copanlisib) Injection2
Aliqopa (copanlisib) is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Aliqopa is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3K-α and PI3K-δ isoforms expressed in malignant B cells. Aliqopa has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines. Aliqopa inhibits several key cell-signaling pathways, including B-cell receptor signaling, CXCR12 mediated chemotaxis of malignant B cells, and NFκB signaling in lymphoma cell lines.
The clinical development program for Aliqopa also includes the Phase III study CHRONOS-4, evaluating Aliqopa in combination with standard immunochemotherapy in relapsed iNHL. More information about this trial can be found at www.clinicaltrials.gov.
For important risk and use information about Aliqopa, please see the full Prescribing Information.
About non-Hodgkin’s Lymphoma
Non-Hodgkin’s Lymphoma (NHL) comprises a highly heterogeneous group of chronic diseases with poor prognosis. NHL is the most common hematologic malignancy and the eleventh most common cancer worldwide, with nearly 510,000 new cases diagnosed in 2018. It accounted for nearly 249,000 deaths worldwide in 2018.4,5
Indolent NHL consists of multiple subtypes, including follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM). While the disease is typically slowly growing, it can become more aggressive over time. Despite treatment advances, there remains a need for improved treatment options for the relapsed or refractory stage of the disease. After response to initial therapy, response rates and duration of response decline with subsequent lines of therapy, underscoring the need for patients whose disease has already progressed.
About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.
References
- Matasar, M., et. al. Copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (CHRONOS-3): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncology. 2021. DOI: https://doi.org/10.1016/S1470-2045(21)00145-5.
- Aliqopa (copanlisib) for injection [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; November 2020.
- ClinicalTrials.gov. Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin’s Lymphoma (iNHL) (CHRONOS-3). https://clinicaltrials.gov/ct2/show/NCT02367040. Last Accessed: May 2021.
- World Cancer Research Fund. Worldwide cancer data: Global cancer statistics for the most common cancers. https://www.wcrf.org/dietandcancer/cancer-trends/worldwide-cancer-data. Last Accessed: May 2021
- Bray, F., Ferlay, J., Soerjomataram, I., Siegel, R.L., Torre, L.A. and Jemal, A. (2018), Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 68: 394-424. https://doi.org/10.3322/caac.21492
SOURCE: Bayer
Post Views: 562
- In the U.S., Bayer has filed for relapsed indolent B-cell non-Hodgkin’s Lymphoma (iNHL)
- In the EU, Bayer has filed for relapsed marginal zone lymphoma (MZL), a subtype of iNHL, and the filing has been accepted
WHIPPANY, NJ, USA I June 21, 2021 I Bayer today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of the investigational combination of the cancer treatments Aliqopa® (copanlisib) and rituximab. The U.S. submission is for the treatment of patients with relapsed indolent B-cell non-Hodgkin’s Lymphoma (iNHL) and is outside of the FDA accelerated approved indication for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. In the EU, Bayer has filed for the treatment of relapsed marginal zone lymphoma (MZL), a subtype of iNHL, and the filing has been accepted. The submissions are supported by positive results from the Phase III trial CHRONOS-3, which were presented in April at the American Association for Cancer Research (AACR) Annual Meeting 2021, and simultaneously published in The Lancet Oncology.1 Indolent NHL consists of the following subtypes: FL, MZL, small lymphocytic lymphoma (SLL) and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM).
“The U.S. and EU submissions of the novel combination of Aliqopa and rituximab bring us forward in advancing new treatment approaches and addressing unmet needs of patients with different types of relapsed iNHL,” said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer. “We are excited about the potential of this investigational combination therapy based on the findings from CHRONOS-3 and we look forward to working with global regulatory authorities.”
The FDA has granted Orphan Drug Designations (ODD) for Aliqopa in chronic lymphocytic leukemia (CLL)/SLL and LPL/WM, and has previously granted an ODD for Aliqopa in FL and MZL. Additionally, Aliqopa was granted Breakthrough Therapy Designation for relapsed MZL in patients who have received at least two prior therapies. Bayer has also previously received an ODD for MZL in the EU.
In 2017, Aliqopa was approved for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies based on the results of a single-arm, multi-center, Phase II clinical trial (CHRONOS-1).2 Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.
CHRONOS-3 is a Phase III randomized, double-blind, placebo-controlled trial with the objective to evaluate whether Aliqopa in combination with rituximab is superior to placebo plus rituximab in extending progression-free survival (PFS) in patients with relapsed iNHL following at least one prior rituximab-containing therapy. Histological subtypes included in the trial were FL, SLL, LPL/WM, and MZL. Patients who had a progression-free and treatment-free interval of at least 12 months after completion of the last rituximab-containing regimen or patients unwilling/unfit or for who chemotherapy was contraindicated by reason of age, co-morbidities and/or residual toxicity were included (NCT02367040). The study enrolled 458 participants.3
About Aliqopa® (copanlisib) Injection2
Aliqopa (copanlisib) is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Aliqopa is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3K-α and PI3K-δ isoforms expressed in malignant B cells. Aliqopa has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines. Aliqopa inhibits several key cell-signaling pathways, including B-cell receptor signaling, CXCR12 mediated chemotaxis of malignant B cells, and NFκB signaling in lymphoma cell lines.
The clinical development program for Aliqopa also includes the Phase III study CHRONOS-4, evaluating Aliqopa in combination with standard immunochemotherapy in relapsed iNHL. More information about this trial can be found at www.clinicaltrials.gov.
For important risk and use information about Aliqopa, please see the full Prescribing Information.
About non-Hodgkin’s Lymphoma
Non-Hodgkin’s Lymphoma (NHL) comprises a highly heterogeneous group of chronic diseases with poor prognosis. NHL is the most common hematologic malignancy and the eleventh most common cancer worldwide, with nearly 510,000 new cases diagnosed in 2018. It accounted for nearly 249,000 deaths worldwide in 2018.4,5
Indolent NHL consists of multiple subtypes, including follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM). While the disease is typically slowly growing, it can become more aggressive over time. Despite treatment advances, there remains a need for improved treatment options for the relapsed or refractory stage of the disease. After response to initial therapy, response rates and duration of response decline with subsequent lines of therapy, underscoring the need for patients whose disease has already progressed.
About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.
References
- Matasar, M., et. al. Copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (CHRONOS-3): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncology. 2021. DOI: https://doi.org/10.1016/S1470-2045(21)00145-5.
- Aliqopa (copanlisib) for injection [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; November 2020.
- ClinicalTrials.gov. Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin’s Lymphoma (iNHL) (CHRONOS-3). https://clinicaltrials.gov/ct2/show/NCT02367040. Last Accessed: May 2021.
- World Cancer Research Fund. Worldwide cancer data: Global cancer statistics for the most common cancers. https://www.wcrf.org/dietandcancer/cancer-trends/worldwide-cancer-data. Last Accessed: May 2021
- Bray, F., Ferlay, J., Soerjomataram, I., Siegel, R.L., Torre, L.A. and Jemal, A. (2018), Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 68: 394-424. https://doi.org/10.3322/caac.21492
SOURCE: Bayer
Post Views: 562
