Genentech’s Lunsumio VELO™ Now Available Subcutaneously for Relapsed or Refractory Follicular Lymphoma

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lunsumio VELO™ (mosunetuzumab-axgb), a novel subcutaneous formulation, to treat adult patients with relapsed or refractory follicular lymphoma (FL) who have undergone two or more prior lines of systemic therapy. This approval, based on data from the Phase I/II GO29781 study, marks a significant advancement in managing this often chronic condition, offering a drastically reduced administration time and greater flexibility for patients.

Follicular lymphoma, the most common indolent form of non-Hodgkin lymphoma, typically requires lifelong management, often involving cycles of remission and relapse. As the disease progresses, it becomes increasingly challenging to treat, making innovative therapeutic approaches crucial. Lunsumio VELO promises to revolutionize patient care by transforming the administration process from a lengthy 2-4 hour intravenous infusion to a near-instantaneous, approximately one-minute subcutaneous injection.

“Reducing the burden of care for individuals with follicular lymphoma is of paramount importance, especially given its chronic nature,” stated Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “This FDA approval means treatment can now be administered in about a minute, significantly cutting down clinic time and better aligning care with patients’ personal needs and preferences.”

Beyond the convenience of a shorter administration, Lunsumio VELO offers a fixed-duration treatment schedule, potentially as short as six months. This contrasts with traditional “treat-to-progression” models that can require indefinite therapy. This approach not only eases the patient’s logistical burden but also allows for a more predictable treatment journey, potentially minimizing long-term exposure and associated side effects.

Dr. Ian Flinn, M.D., Ph.D., of Tennessee Oncology and One Oncology, highlighted the broader implications of this approval. “This represents a significant stride in expanding access to effective follicular lymphoma treatments. Lunsumio VELO, with its manageable cytokine release syndrome profile and expedited administration, empowers oncologists to deliver advanced care within community practice settings, bringing cutting-edge therapies closer to patients.”

The FDA’s decision is underpinned by compelling data from the GO29781 study, which demonstrated robust efficacy in patients with third-line or later (3L+) FL. The study reported an objective response rate (ORR) of 75% and a complete response rate (CR) of 59%. The median duration of response was notably 22.4 months, suggesting durable benefits. Common adverse reactions included injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain, and diarrhea. Importantly, the incidence of CRS was 30%, with most events being low-grade and resolving rapidly, indicating a manageable safety profile.

This subcutaneous formulation builds on the success of the intravenous Lunsumio, which was the first bispecific antibody approved for 3L+ FL. Genentech, a member of the Roche Group, is actively pursuing further advancements in its bispecific antibody program. Ongoing Phase III trials are evaluating Lunsumio and Lunsumio VELO in earlier lines of therapy, including the SUNMO study investigating Lunsumio VELO in combination with Polivy® (polatuzumab vedotin-piiq) for second-line or later large B-cell lymphoma, and the MorningLyte study exploring Lunsumio VELO alongside lenalidomide in previously untreated FL.

For patients requiring access support, Genentech offers assistance programs through Genentech Access Solutions.

**About the GO29781 Study**
The Phase I/II GO29781 study (NCT02500407) is a multicenter, open-label trial evaluating the safety, efficacy, and pharmacokinetics of mosunetuzumab-axgb, administered both intravenously and subcutaneously, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

**About Follicular Lymphoma (FL)**
Follicular lymphoma (FL) is an indolent form of non-Hodgkin lymphoma, accounting for approximately 20% of all cases. While generally responsive to treatment, it is characterized by relapse and remission cycles, with subsequent lines of therapy often proving less effective. Early progression is associated with a poorer long-term prognosis. In the United States, an estimated 13,000 new FL cases are diagnosed annually, with over 110,000 diagnoses worldwide each year.

**About Lunsumio VELO™ (mosunetuzumab-axgb)**
Lunsumio VELO™ is a subcutaneous formulation of mosunetuzumab-axgb, a bispecific antibody designed to target CD20 on B cells and CD3 on T cells. This dual targeting mechanism activates T cells to eliminate CD20-positive B cells. Lunsumio VELO is under investigation as a monotherapy and in combination regimens for various B-cell non-Hodgkin lymphomas.

**Lunsumio and Lunsumio VELO U.S. Indication**
LUNSUMIO and LUNSUMIO VELO are indicated for the treatment of adult patients with follicular lymphoma whose cancer has returned or did not respond to previous treatment after two or more lines of systemic therapy. Efficacy is based on response rate, with ongoing studies to confirm clinical benefit.

**Important Safety Information**
Lunsumio and Lunsumio VELO carry a risk of Cytokine Release Syndrome (CRS), a serious and potentially life-threatening side effect. Symptoms include fever, chills, low blood pressure, rapid heartbeat, fatigue, difficulty breathing, headache, confusion, anxiety, dizziness, nausea, and vomiting. Due to this risk, a step-up dosing schedule is employed, and patients are closely monitored. Medical attention is required immediately if CRS symptoms occur.

Other serious side effects include neurologic problems, severe infections, Hemophagocytic lymphohistiocytosis (HLH), and low blood cell counts (lymphopenia, neutropenia, anemia, thrombocytopenia). Tumor flare, a worsening of tumor-related symptoms, can also occur. Healthcare providers may adjust or discontinue treatment based on the severity of side effects.

Common side effects for Lunsumio include CRS, fatigue, rash, headache, fever, muscle pain, cough, itching, and peripheral neuropathy. For Lunsumio VELO, common side effects include injection site reactions, fatigue, rash, CRS, COVID-19, musculoskeletal pain, and diarrhea.

Patients should inform their healthcare provider of all medical conditions, including infections, pregnancy status, and breastfeeding plans. Effective contraception is recommended for females of childbearing potential during and after treatment.

**About Polivy® (polatuzumab vedotin-piiq)**
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). CD79b is a protein expressed on the surface of B cells, making it a target for therapies treating certain types of non-Hodgkin lymphoma. Polivy binds to cancer cells and delivers an anti-cancer agent to destroy them.

**Polivy U.S. Indication**
Polivy is indicated for the treatment of adults with diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) in combination with other therapies, and for DLBCL in adults who have progressed after at least two prior therapies, in combination with bendamustine and a rituximab product.

**Important Safety Information for Polivy**
Serious side effects of Polivy can include peripheral neuropathy, infusion-related reactions, low blood cell counts, infections, rare but serious brain infections, tumor lysis syndrome, and potential liver toxicity. Common side effects include peripheral neuropathy, nausea, fatigue, diarrhea, constipation, hair loss, and stomatitis. Polivy may lower blood cell counts and increase uric acid levels.

Patients should consult their healthcare provider if they are pregnant, planning to become pregnant, or breastfeeding, as Polivy may harm an unborn baby and requires effective contraception.

**About Genentech in Hematology**
Genentech has a long-standing commitment to developing innovative treatments for blood cancers, with over two decades of experience in hematology research and development.

**About Genentech**
Genentech is a leading biotechnology company dedicated to discovering, developing, manufacturing, and commercializing medicines for serious and life-threatening conditions. As a member of the Roche Group, Genentech is headquartered in South San Francisco, California.