We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
TSVT, BMY Discontinue Enrollment in Late-stage Abecma Study
Read MoreHide Full Article
2seventy bio, Inc. (TSVT - Free Report) announced that it will discontinue enrollment in its ongoing phase III KarMMa-9 study.
The study is evaluating Abecma (idecabtagene vicleucel; ide-cel) with Revlimid (lenalidomide) maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma (NDMM) who have a suboptimal response to autologous stem cell transplant.
Shares of TSVT were down 9.4% on the news.
Year to date, TSVT’s shares have gained 1.2% against the industry’s decline of 3.5%.
Image Source: Zacks Investment Research
2seventy and Bristol Myers Squibb (BMY - Free Report) are collaborating for the development of Abecma. The KarMMa-9 study is being conducted by BMY.
TSVT, BMY Stop Enrollment in KarMMa-9 Study
Abecma is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T-cell immunotherapy.
The decision to discontinue enrollment in the KarMMa-9 study was taken by TSVT and BMY following a rigorous review of the business case for the KarMMa-9 study given the evolving landscape in NDMM treatments.
KarMMa-9 was designed based on positive data from cohort 2c of the KarMMa-2 trial, which demonstrated a favorable benefit/risk profile for Abecma in a similar patient population.
However, the NDMM treatment landscape has evolved significantly since then with the increasing use of quadruplet therapy induction, the incorporation of more aggressive consolidation therapies and the ongoing optimization of maintenance therapy regimens.
Consequently, there are considerably fewer eligible patients for Abecma in this setting than when the study was first designed.
In April 2024, the FDA approved Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 study.
TSVT added that Abecma continues to show encouraging signs of growth with an expanded label in the third line setting with a differentiated safety profile. TSVT anticipates that the discontinuation of the late-stage study will save more than $80 million in near-term expenditures and accelerate its path to breakeven in 2025.
2seventy bio and BMY share equal profits and losses related to the development, manufacturing and commercialization of Abecma in the United States.
BMY assumes the sole responsibility for Abecma drug product manufacturing and commercialization outside the United States.
TSVT Provides Guidance for Abecma
TSVT expects Abecma’s revenues to grow 30% sequentially in the United States during the third quarter. Revenues in the second quarter were $54 million.
TSVT Restructures Business
Earlier in 2024, TSVT sold all of the assets related to its oncology and autoimmune cell therapy programs to Regeneron Pharmaceuticals (REGN - Free Report) . REGN made an upfront payment of $5 million for the sale.
In June 2024, TSVT announced the completion of an asset purchase agreement with Novo Nordisk (NVO - Free Report) .
Under the terms of the agreement, NVO acquired TSVT’s gene therapy products for the treatment, diagnosis and prevention of hemophilia for an upfront consideration of $38 million, plus up to an additional $2 million that will be held back for 12 months and may be used to settle certain indemnification claims.
Image: Bigstock
TSVT, BMY Discontinue Enrollment in Late-stage Abecma Study
2seventy bio, Inc. (TSVT - Free Report) announced that it will discontinue enrollment in its ongoing phase III KarMMa-9 study.
The study is evaluating Abecma (idecabtagene vicleucel; ide-cel) with Revlimid (lenalidomide) maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma (NDMM) who have a suboptimal response to autologous stem cell transplant.
Shares of TSVT were down 9.4% on the news.
Year to date, TSVT’s shares have gained 1.2% against the industry’s decline of 3.5%.
Image Source: Zacks Investment Research
2seventy and Bristol Myers Squibb (BMY - Free Report) are collaborating for the development of Abecma. The KarMMa-9 study is being conducted by BMY.
TSVT, BMY Stop Enrollment in KarMMa-9 Study
Abecma is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T-cell immunotherapy.
The decision to discontinue enrollment in the KarMMa-9 study was taken by TSVT and BMY following a rigorous review of the business case for the KarMMa-9 study given the evolving landscape in NDMM treatments.
KarMMa-9 was designed based on positive data from cohort 2c of the KarMMa-2 trial, which demonstrated a favorable benefit/risk profile for Abecma in a similar patient population.
However, the NDMM treatment landscape has evolved significantly since then with the increasing use of quadruplet therapy induction, the incorporation of more aggressive consolidation therapies and the ongoing optimization of maintenance therapy regimens.
Consequently, there are considerably fewer eligible patients for Abecma in this setting than when the study was first designed.
In April 2024, the FDA approved Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 study.
TSVT added that Abecma continues to show encouraging signs of growth with an expanded label in the third line setting with a differentiated safety profile. TSVT anticipates that the discontinuation of the late-stage study will save more than $80 million in near-term expenditures and accelerate its path to breakeven in 2025.
2seventy bio and BMY share equal profits and losses related to the development, manufacturing and commercialization of Abecma in the United States.
BMY assumes the sole responsibility for Abecma drug product manufacturing and commercialization outside the United States.
TSVT Provides Guidance for Abecma
TSVT expects Abecma’s revenues to grow 30% sequentially in the United States during the third quarter. Revenues in the second quarter were $54 million.
TSVT Restructures Business
Earlier in 2024, TSVT sold all of the assets related to its oncology and autoimmune cell therapy programs to Regeneron Pharmaceuticals (REGN - Free Report) . REGN made an upfront payment of $5 million for the sale.
In June 2024, TSVT announced the completion of an asset purchase agreement with Novo Nordisk (NVO - Free Report) .
Under the terms of the agreement, NVO acquired TSVT’s gene therapy products for the treatment, diagnosis and prevention of hemophilia for an upfront consideration of $38 million, plus up to an additional $2 million that will be held back for 12 months and may be used to settle certain indemnification claims.
TSVT is solely banking on Abecma for growth.
TSVT’s Zacks Rank
2seventy bio currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.