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Bristol Myers (BMY) Announces CAR T Cell Therapy Breyanzi Data
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Bristol Myers Squibb (BMY - Free Report) announced primary analysis results from two studies — TRANSCEND FL and TRANSCEND NHL 001 — on CAR T cell therapy, Breyanzi.
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells.
Breyanzi is approved by the FDA for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal LBCL and follicular lymphoma grade 3B, who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy, or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age or relapsed or refractory disease after two or more lines of systemic therapy.
TRANSCEND F is an open-label, global, multicenter, phase II, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary outcome measure is the overall response rate. Secondary outcome measures include complete response rate, duration of response and progression-free survival.
Results showed that 97% of patients with relapsed or refractory follicular lymphoma treated with Breyanzi achieved a response, with 94% achieving a complete response and 81.9% of responders in ongoing response at 12 months.
TRANSCEND NHL 001 is an open-label, multicenter, pivotal, phase I, single-arm, seamless-design study to determine the safety, pharmacokinetics and antitumor activity of Breyanzi in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma Grade 3B and mantle cell lymphoma. The primary outcome measures are treatment-related adverse events, dose-limiting toxicities and the overall response rate. Secondary outcome measures include complete response rate, duration of response and progression-free survival.
Results showed that 86.5% of patients in the relapsed or refractory mantle cell lymphoma cohort achieved a response. Approximately 74.3% achieved a complete response.
Per the management, these results underscore Breyanzi’s potential best-in-class and best-in-disease profile for a CD19-directed CAR T cell therapy in lymphomas.
The results of these studies will be discussed with health authorities.
Bristol Myers shares have lost 8.1% in the year so far compared with the industry's decline of 6.2%.
Image Source: Zacks Investment Research
Earlier in the year, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Breyanzi for the treatment of adult patients with DLBCL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B (FL3B) who relapsed within 12 months from completion of or are refractory to first-line chemoimmunotherapy.
Approval of new drugs and label expansion of existing ones will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as one of its prime drugs, Revlimid, is facing generic competition.
While sales of the immuno-oncology drug Opdivo, approved for multiple cancer indications, maintain momentum, one of the other top drugs, Eliquis, is also now facing generic erosion in Canada and the U.K.; hence, sales of the drug declined in international markets in the first quarter.
The approval of drugs like Opdualag, Breyanzi and Sotyktu has added a new stream of revenues to the company’s top line.
While the CAR T space has potential, competition is stiff from Gilead’s (GILD - Free Report) Yescarta and Novartis’ (NVS - Free Report) Kymriah, among others.
Gilead’s Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy and adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL (not otherwise specified) primary mediastinal large B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Novartis’ Kymriah is approved for the treatment of relapsed or refractory (r/r) pediatric and young adult (up to and including 25 years of age) acute lymphoblastic leukemia, r/r adult DLBCL and r/r adult follicular lymphoma.
Image: Shutterstock
Bristol Myers (BMY) Announces CAR T Cell Therapy Breyanzi Data
Bristol Myers Squibb (BMY - Free Report) announced primary analysis results from two studies — TRANSCEND FL and TRANSCEND NHL 001 — on CAR T cell therapy, Breyanzi.
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells.
Breyanzi is approved by the FDA for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal LBCL and follicular lymphoma grade 3B, who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy, or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age or relapsed or refractory disease after two or more lines of systemic therapy.
TRANSCEND F is an open-label, global, multicenter, phase II, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary outcome measure is the overall response rate. Secondary outcome measures include complete response rate, duration of response and progression-free survival.
Results showed that 97% of patients with relapsed or refractory follicular lymphoma treated with Breyanzi achieved a response, with 94% achieving a complete response and 81.9% of responders in ongoing response at 12 months.
TRANSCEND NHL 001 is an open-label, multicenter, pivotal, phase I, single-arm, seamless-design study to determine the safety, pharmacokinetics and antitumor activity of Breyanzi in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma Grade 3B and mantle cell lymphoma. The primary outcome measures are treatment-related adverse events, dose-limiting toxicities and the overall response rate. Secondary outcome measures include complete response rate, duration of response and progression-free survival.
Results showed that 86.5% of patients in the relapsed or refractory mantle cell lymphoma cohort achieved a response. Approximately 74.3% achieved a complete response.
Per the management, these results underscore Breyanzi’s potential best-in-class and best-in-disease profile for a CD19-directed CAR T cell therapy in lymphomas.
The results of these studies will be discussed with health authorities.
Bristol Myers shares have lost 8.1% in the year so far compared with the industry's decline of 6.2%.
Image Source: Zacks Investment Research
Earlier in the year, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Breyanzi for the treatment of adult patients with DLBCL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B (FL3B) who relapsed within 12 months from completion of or are refractory to first-line chemoimmunotherapy.
Approval of new drugs and label expansion of existing ones will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as one of its prime drugs, Revlimid, is facing generic competition.
While sales of the immuno-oncology drug Opdivo, approved for multiple cancer indications, maintain momentum, one of the other top drugs, Eliquis, is also now facing generic erosion in Canada and the U.K.; hence, sales of the drug declined in international markets in the first quarter.
The approval of drugs like Opdualag, Breyanzi and Sotyktu has added a new stream of revenues to the company’s top line.
While the CAR T space has potential, competition is stiff from Gilead’s (GILD - Free Report) Yescarta and Novartis’ (NVS - Free Report) Kymriah, among others.
Gilead’s Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy and adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL (not otherwise specified) primary mediastinal large B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Novartis’ Kymriah is approved for the treatment of relapsed or refractory (r/r) pediatric and young adult (up to and including 25 years of age) acute lymphoblastic leukemia, r/r adult DLBCL and r/r adult follicular lymphoma.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.