Roche
RHHBY
announced that the FDA approved intravenously-administered Lunsumio (mosunetuzumab) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have been treated with two or more lines of systemic therapy. Lunsumio has been approved by the regulatory agency under the accelerated pathway.
Following approval, Lunsumio is the first CD20xCD3 T cell engaging bispecific antibody approved in the United States for the treatment of FL. The medication was approved for a similar indication in the European Union earlier this June.
The FDA’s approval is based on positive data from the phase II GO29781 study, which evaluated the safety and efficacy of Lunsumio in patients with heavily pre-treated R/R FL. Data from the study showed high and durable response rates in study participants following treatment with Lunsumio. An objective response was observed in 80% of study participants who received Lunsumio, with 60% of participants achieving complete remission.
An off-the-shelf cancer immunotherapy, Lunsumio will help treat patients who do not respond to multiple lines of treatment and help them achieve disease remission. A commercial launch for the therapy is expected in the coming weeks.
Shares of Roche have declined 23.5% this year against the
industry
’s 12.2% increase.
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FL is the most common slow-growing form of non-Hodgkin’s lymphoma. Per management estimates, more than 100,000 people across the globe are diagnosed with FL. There are very limited treatment options for FL patients, especially those who relapse.
Lunsumio was developed by Genentech, a member of the Roche Group. The antibody is also being evaluated in late-stage studies for treating early-line NHL.
Lunsumio has been developed by Roche in collaboration with
Biogen
BIIB
. Earlier this February, Biogen exercised an option to participate in the development and commercialization of Lunsumio. Following the exercise of this option, Biogen will share profits and losses of Lunsumio in the United States in the low to mid-30% range and also be eligible to receive royalties in the low-single-digit range in ex-U.S. markets. In return for receiving this right, Biogen made a one-time payment of $30 million to Roche and also paid a portion of the development expenses incurred by Roche on Lunsumio in 2021.
Like Roche, many companies like
AbbVie
ABBV
and
Regeneron
REGN
are also developing their respective CD20xCD3 bispecific antibodies targeting NHL indications.
AbbVie is developing epcoritamab, its own CD20xCD3 T cell engaging bispecific antibody, in collaboration with Genmab for treating adult patients with R/R diffuse large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. Last month, Genmab and Roche announced that the FDA accepted the company’s regulatory filing seeking approval for epcoritamab in R/R LBCL. A decision is expected before May 2023-end.
Regeneron is currently evaluating its own CD20xCD3 antibody odronextamab in patients with FL indication. Earlier this month, Regeneron announced topline data from a pivotal phase II study, which evaluated odronextamab in heavily pre-treated R/R FL patients. Data from the study showed an 82% response rate in patients, including 75% of participants achieving a complete response. Based on this data, Regeneron will make a regulatory submission to the FDA next year.
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold).You can see
the complete list of today’s Zacks #1 Rank stocks here
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