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Sanofi (SNY) Multiple Myeloma Phase III Study Meets Goal
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Sanofi (SNY - Free Report) announced that a phase III study evaluating its anti-CD38 monoclonal antibody, Sarclisa (isatuximab), met its primary endpoint of minimal residual disease (MRD) negativity in transplant-eligible patients with newly diagnosed multiple myeloma.
The HD7 study was conducted by the German-Speaking Myeloma Multicenter Group (GMMG) in Germany and evaluated Sarclisa in combination with standard-of-care treatment, Bristol-Myers’ (BMY - Free Report) multiple myeloma drug, Revlimid (lenalidomide), bortezomib and dexamethasone (Sarclisa-RVd). Data from the study showed that after 18 weeks of induction treatment with Sarclisa-RVd, 50.1% of patients achieved MRD negativity or the absence of myeloma cells in the bone marrow after treatment.
Sanofi claims that this is the first phase III study to meet the primary endpoint of MRD negativity, an important clinical endpoint associated with better patient outcomes, in this patient population.
Sanofi stock has gained 3.7% this year so far compared with an increase of 18.5% for the industry.
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Sarclisa is presently approved in combination with Amgen’s (AMGN - Free Report) Kyprolis (carfilzomib) and dexamethasone (Kd) for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) in the second- to fourth-line setting. It is also approved for use in combination with Bristol-Myers’ another multiple myeloma drug, Pomalyst (pomalidomide) and dexamethasone for treating adults with RRMM having received at least two prior therapies including Revlimid (lenalidomide) and a proteasome inhibitor.
Sarclisa is being evaluated in multiple phase III studies in combination with the current standard treatments across the multiple myeloma segment while also being evaluated for other hematologic malignancies and solid tumors.
Kyprolis is a key drug in Amgen’s oncology portfolio approved for multiple myeloma. The drug generated sales of $293 million in the third quarter of 2021, up 13% year over year. Amgen is evaluating Kyprolis for additional indications. Kyprolis is being investigated for weekly dosing in combinations with lenalidomide and dexamethasone for relapsed multiple myeloma.
Bristol-Myers’ Pomalyst, also a multiple myeloma drug, is performing well and contributing to the top line. Pomalyst generated sales of $851 million in the third quarter of 2021, up 10% year over year.
Bristol-Myers’ Pomalyst is approved to treat adults with multiple myeloma in adults who have earlier received two medicines, including a proteasome inhibitor and lenalidomide, and whose disease became worse during treatment.
A better-ranked stock from the same space is GlaxoSmithKline (GSK - Free Report) , which sports a Zacks Rank #1.
Glaxo’s stock has risen 24.1% this year so far. Estimates for Glaxo’s 2021 earnings have risen 8.9% over the past 60 days while those for 2022 are up 5.5% over the same timeframe.
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Sanofi (SNY) Multiple Myeloma Phase III Study Meets Goal
Sanofi (SNY - Free Report) announced that a phase III study evaluating its anti-CD38 monoclonal antibody, Sarclisa (isatuximab), met its primary endpoint of minimal residual disease (MRD) negativity in transplant-eligible patients with newly diagnosed multiple myeloma.
The HD7 study was conducted by the German-Speaking Myeloma Multicenter Group (GMMG) in Germany and evaluated Sarclisa in combination with standard-of-care treatment, Bristol-Myers’ (BMY - Free Report) multiple myeloma drug, Revlimid (lenalidomide), bortezomib and dexamethasone (Sarclisa-RVd). Data from the study showed that after 18 weeks of induction treatment with Sarclisa-RVd, 50.1% of patients achieved MRD negativity or the absence of myeloma cells in the bone marrow after treatment.
Sanofi claims that this is the first phase III study to meet the primary endpoint of MRD negativity, an important clinical endpoint associated with better patient outcomes, in this patient population.
Sanofi stock has gained 3.7% this year so far compared with an increase of 18.5% for the industry.
Sarclisa is presently approved in combination with Amgen’s (AMGN - Free Report) Kyprolis (carfilzomib) and dexamethasone (Kd) for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) in the second- to fourth-line setting. It is also approved for use in combination with Bristol-Myers’ another multiple myeloma drug, Pomalyst (pomalidomide) and dexamethasone for treating adults with RRMM having received at least two prior therapies including Revlimid (lenalidomide) and a proteasome inhibitor.
Sarclisa is being evaluated in multiple phase III studies in combination with the current standard treatments across the multiple myeloma segment while also being evaluated for other hematologic malignancies and solid tumors.
Kyprolis is a key drug in Amgen’s oncology portfolio approved for multiple myeloma. The drug generated sales of $293 million in the third quarter of 2021, up 13% year over year. Amgen is evaluating Kyprolis for additional indications. Kyprolis is being investigated for weekly dosing in combinations with lenalidomide and dexamethasone for relapsed multiple myeloma.
Bristol-Myers’ Pomalyst, also a multiple myeloma drug, is performing well and contributing to the top line. Pomalyst generated sales of $851 million in the third quarter of 2021, up 10% year over year.
Bristol-Myers’ Pomalyst is approved to treat adults with multiple myeloma in adults who have earlier received two medicines, including a proteasome inhibitor and lenalidomide, and whose disease became worse during treatment.
Sanofi currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked stock from the same space is GlaxoSmithKline (GSK - Free Report) , which sports a Zacks Rank #1.
Glaxo’s stock has risen 24.1% this year so far. Estimates for Glaxo’s 2021 earnings have risen 8.9% over the past 60 days while those for 2022 are up 5.5% over the same timeframe.