{"id":52320,"date":"2022-12-23T04:02:08","date_gmt":"2022-12-23T03:02:08","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fda-approves-genentechs-lunsumio-a-first-in-class-bispecific-antibody-to-treat-people-with-relapsed-or-refractory-follicular-lymphoma\/"},"modified":"2022-12-23T04:02:08","modified_gmt":"2022-12-23T03:02:08","slug":"fda-approves-genentechs-lunsumio-a-first-in-class-bispecific-antibody-to-treat-people-with-relapsed-or-refractory-follicular-lymphoma","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fda-approves-genentechs-lunsumio-a-first-in-class-bispecific-antibody-to-treat-people-with-relapsed-or-refractory-follicular-lymphoma\/","title":{"rendered":"FDA Approves Genentech\u2019s Lunsumio, a First-in-Class Bispecific Antibody, to Treat People With Relapsed or Refractory Follicular Lymphoma"},"content":{"rendered":"
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\n\u2013 With Lunsumio, people with heavily pretreated follicular lymphoma (FL) may experience remission with a chemotherapy-free, fixed-duration treatment that can be accessed in an outpatient setting \u2013<\/i>\n<\/p>\n

\n\u2013 Results from the pivotal Phase II GO29781 study demonstrated that 80% of patients who received at least two prior therapies achieved durable response rates, with 60% experiencing complete remission \u2013<\/i>\n<\/p>\n

\n\u2013 Discovered and developed by Genentech scientists, Lunsumio is now the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA to treat the most common slow-growing form of non-Hodgkin\u2019s lymphoma, FL \u2013<\/i>\n<\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Lunsumio\u00ae<\/sup> (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or refractory (R\/R) follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Lunsumio, a CD20xCD3 T-cell engaging bispecific antibody, represents a new class of fixed-duration cancer immunotherapy, which is off-the-shelf and readily available, so that patients do not have to wait to start treatment. Lunsumio will be available in the United States in the coming weeks.\n<\/p>\n

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\n\u201cThis approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,\u201d said Elizabeth Budde, M.D., Ph.D., hematologic oncologist and associate professor, City of Hope Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, and Lunsumio clinical trial investigator. \u201cAs a first-in-class T-cell engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio\u2019s high response rates and fixed-duration could change the way advanced follicular lymphoma is treated.\u201d\n<\/p>\n

\n\u201cDespite treatment advances, follicular lymphoma remains incurable and relapse is common, with outcomes worsening following each consecutive treatment,\u201d said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. \u201cLunsumio represents our first approved T-cell engaging bispecific antibody and builds on our legacy of more than 20 years of innovation in blood cancer.\u201d\n<\/p>\n

\nThe FDA approval is based on positive results from the Phase II GO29781 study of Lunsumio in people with heavily pretreated FL, 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 was seen in 80% (72\/90 [95% confidence interval (CI): 70-88]) of patients treated with Lunsumio, with a majority maintaining responses for at least 18 months (57% [95% CI: 44-70]). The objective response rate is the combination of complete response (CR) rate (a disappearance of all signs and symptoms of cancer) and partial response rate (a decrease in the amount of cancer in the body). The median duration of response among those who responded was almost 2 years (22.8 months [95% CI: 10-not reached]). A CR was achieved in 60% of patients (54\/90 [95% CI: 49-70]). \u00a0Among 218 patients with hematologic malignancies who received Lunsumio at the recommended dose, the most common adverse event (AE) was cytokine release syndrome (CRS; 39%), which can be severe and life-threatening. The median duration of CRS events was 3 days (range: 1-29). Other common AEs (\u226520%) included fatigue, rash, pyrexia and headache.\n<\/p>\n

\nLunsumio is administered as an intravenous infusion for a fixed-duration, which allows for time off therapy, and can be infused in an outpatient setting. Hospitalization may be needed to manage select AEs, should be considered for subsequent infusions following a Grade 2 CRS event, and is recommended for subsequent infusions following a Grade 3 CRS event.\n<\/p>\n

\n\u201cThis additional treatment option is good news for people whose blood cancer has not responded to multiple lines of treatment because it can become more difficult to treat each time it returns,\u201d said Dr. Lee Greenberger, chief scientific officer of the Leukemia & Lymphoma Society. \u201cThis bispecific antibody is an off-the-shelf, accessible treatment option that has the potential to help those with relapsed or refractory follicular lymphoma achieve remission.\u201d\n<\/p>\n

\nLunsumio was developed based on Genentech\u2019s broad expertise in creating bispecific antibodies. Lunsumio is designed to address the diverse needs of people with blood cancer, physicians and practice settings, and is part of the company\u2019s robust bispecific antibody clinical program in lymphoma. Lunsumio is being further investigated as a subcutaneous formulation (i.e., administered under the skin) and in Phase III studies that will expand the understanding of its impact in earlier lines of treatment in people with non-Hodgkin\u2019s lymphoma.\n<\/p>\n

\nGenentech is committed to helping people access the medicines they are prescribed and will be offering comprehensive services for people prescribed Lunsumio to help minimize barriers to access and reimbursement. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at 866-4ACCESS\/866-422-2377 or www.Genentech-Access.com<\/a>.\n<\/p>\n

\nAbout the GO29781 Study<\/b>\n<\/p>\n

\nThe GO29781 study [NCT02500407<\/a>] is a Phase II, multicenter, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio\u00ae<\/sup> (mosunetuzumab-axgb) in people with relapsed or refractory B-cell non-Hodgkin\u2019s lymphoma. Outcome measures include complete response rate (best response) by independent review facility (primary endpoint), objective response rate, duration of response, progression-free survival, safety and tolerability (secondary endpoints).\n<\/p>\n

\nAbout Follicular Lymphoma<\/b>\n<\/p>\n

\nFollicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin\u2019s lymphoma, accounting for about one in five cases. It typically responds well to treatment but is often characterized by periods of remission and relapse. The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis. It is estimated that, in the United States, approximately 13,000 new cases of FL will be diagnosed in 2022 and more than 100,000 people are diagnosed with FL each year worldwide.\n<\/p>\n

\nAbout Lunsumio\u00ae<\/sup> (mosunetuzumab-axgb)<\/b>\n<\/p>\n

\nLunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient\u2019s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development program for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin\u2019s lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers.\n<\/p>\n

\nLunsumio U.S. Indication<\/b>\n<\/p>\n

\nLUNSUMIO (mosunetuzumab-axgb) is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments for their cancer.\n<\/p>\n

\nIt is not known if LUNSUMIO is safe and effective in children.\n<\/p>\n

\nThe conditional approval of LUNSUMIO is based on response rate. There are ongoing studies to establish how well the drug works.\n<\/p>\n

\nWhat is the most important information I should know about LUNSUMIO?<\/b>\n<\/p>\n

\nLUNSUMIO may cause Cytokine Release Syndrome (CRS), <\/b>a serious side effect that is common during treatment with LUNSUMIO and can also be severe or life-threatening.\n<\/p>\n

\nGet medical help right away if you develop any signs or symptoms of CRS at any time, including:<\/b>\n<\/p>\n