Lunsumio Gets FDA Accelerated Approval as Third Line Treatment for Follicular Lymphoma

The US Food and Drug Administration (FDA) granted Roche’s Lunsumio (mosunetuzumab) an accelerated approval near the end of 2022 for the treatment of adult patients with relapsed or refractory follicular lymphoma.

Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody, the first in its class to be FDA approved for follicular lymphoma. It was approved in the EU for the same indication in June last year.

The bispecific antibody is indicated for patients who have received two or more prior lines of systemic therapy. Lunsumio was granted accelerated approval based on response rate from the pivotal Phase II GO29781 study.

Roche noted that the drug is an accessible, off-the-shelf treatment option. Lunsumio is administered as an intravenous infusion and can be given in an outpatient setting. It is administered for a fixed duration, allowing for time off the treatment.

Lunsumio will be taking on Novartis’ CD19-directed T cell immunotherapy Kymriah and gene therapies from Bristol Myers Squibb (Breyanzi) and Gilead (Yescarta). Its greater accessibility gives it an edge over the gene therapies, which are more complex and expensive to develop and can lead to patients often waiting several weeks for an infusion.

Related: Rigel’s Rezlidhia (olutasidenib) Gets FDA Approval for Relapsed or Refractory AML

Follicular lymphoma is a slow-growing form of non-Hodgkin lymphoma, but tumors can become more aggressive over time. It is the second most common type of lymphoma, and 13,000 new cases are diagnosed each year in the US.

“Despite treatment advances, follicular lymphoma remains incurable and relapse is common, with outcomes worsening following each consecutive treatment,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development in a news release. “Lunsumio represents our first approved T-cell engaging bispecific antibody and builds on our legacy of more than 20 years of innovation in blood cancer.”

The FDA approval was based on positive results from the GO29781 study of Lunsumio in individuals with heavily pre-treated follicular lymphoma, including those who were at high risk of disease progression or whose disease was refractory to prior therapies.

Results from the study showed high and durable response rates. An objective response — the combination of complete response rate and partial response rate with respect to tumor shrinkage — was seen in 80 percent of patients treated with Lunsumio. The responses were sustained for at least 18 months in the majority of patients. A complete response (CR) was achieved in 60 percent of patients.

The median duration of response among those who responded was almost two years (22.8 months).

The most common adverse event (AE) among 218 patients with haematologic malignancies who received Lunsumio was cytokine release syndrome (CRS; 38 percent of patients), which can be severe and life-threatening. The median duration of CRS events was three days. Other common AEs included fatigue, rash, pyrexia and headache.

Lunsumio will be subject to a confirmatory Phase III trial as it was approved under the FDA’s accelerated approval pathway.

Roche said the drug will become available in the “coming weeks” and is expected to cost around $180,000 for a treatment course consisting of eight cycles, the company told Reuters.

The company has another bispecific from the same class, glofitamab, which has demonstrated promising results in diffuse large B-cell lymphoma (DLBCL), the most common form of lymphoma. According to analysts at Jefferies, the two drugs could reach $2 billion in sales despite entering a crowded lymphoma market.

Cell therapies remain the most popular type of treatment being researched and developed for blood cancers. However, GlobalData has warned that the blood cancer market won’t be sustainable with an oversaturated cell therapy pipeline. According to the data and analytics company, there are currently over 800 products under development for just five major blood cancers, warning that if even if they all get the regulatory pass, the market won’t be able to sustain so many products.