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Zacks Investment Research <\/p>\nRoche RHHBY announced that the FDA has accepted its supplemental biologics license application (sBLA) seeking approval of Lunsumio VELO (mosunetuzumab), as a subcutaneous formulation, in combination with Polivy (polatuzumab vedotin) for adults with relapsed or refractory large B-cell lymphoma (LBCL).<\/p>\n
The targeted population comprises adult patients with relapsed or refractory LBCL, including diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy.<\/p>\n
The FDA has set a target action date of Feb. 9, 2027.<\/p>\n
Year to date, shares of RHHBY have lost 1% against the industry\u2019s growth of 3.1%.<\/p>\n
Zacks Investment Research <\/p>\n
Image Source: Zacks Investment Research<\/p>\n
More on RHHBY\u2019s Lunsumio and Polivy Combination <\/p>\n
The sBLA was accepted based on data from the phase III SUNMO study. At a median follow-up of 23.2 months, the combination of Lunsumio VELO and Polivy reduced the risk of disease progression or death (PFS) by 59% compared to MabThera\/Rituxan (rituximab), gemcitabine and oxaliplatin (R-GemOx).<\/p>\n
The combination of Lunsumio VELO and Polivy also showed a three-times longer median PFS at 11.5 months compared to 3.8 months observed with R-GemOx.<\/p>\n
The combination’s safety profile was consistent with the established safety characteristics of the individual therapies.<\/p>\n
Updated results presented recently at the American Society of Clinical Oncology (\u201cASCO\u201d) Annual Meeting and European Hematology Association (\u201cEHA\u201d) Congress showed that the Lunsumio VELO and Polivy combination continued to demonstrate clinical benefit in PFS with longer follow-up, particularly among patients receiving second-line treatment, while maintaining a consistent safety profile with no new safety concerns identified.<\/p>\n
Patients with relapsed or refractory LBCL represent a population with significant unmet medical needs and urgently require access to effective treatment options.<\/p>\n
A potential approval will make this Lunsumio-Polivy combination an important chemotherapy-free treatment option that can be administered in an outpatient setting, potentially improving clinical outcomes.<\/p>\n
Please note that Lunsumio is currently approved as a fixed-duration monotherapy for the treatment of adult patients with third-line or later relapsed or refractory follicular lymphoma (FL) in both intravenous and subcutaneous (Lunsumio VELO) formulations.<\/p>\n
Roche is advancing a broad global clinical development program for Lunsumio, evaluating its potential use earlier in the treatment paradigm and in combination with other therapies. This includes the phase III CELESTIMO and MorningLyte studies in second-line or later and frontline FL, respectively.<\/p>\n
Story Continues <\/p>\n
Polivy, a first-in-class antibody-drug conjugate targeted against CD79b, is approved globally in combination with MabThera\/Rituxan plus cyclophosphamide, doxorubicin and prednisone for previously untreated DLBCL, as well as in combination with bendamustine and MabThera\/Rituxan for relapsed or refractory DLBCL.<\/p>\n
Roche\u2019s hematology portfolio includes MabThera\/Rituxan, Gazyva\/Gazyvaro, Polivy, Venclexta\/Venclyxto in collaboration with AbbVie, Hemlibra, PiaSky, Lunsumio and Columvi.<\/p>\n
RHHBY\u2019s pipeline of investigational hematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and off-the-shelf allogeneic CAR T-cell therapies.<\/p>\n
RHHBY\u2019s Efforts to Diversify Pipeline <\/p>\n
Strong growth from key drugs like Ocrevus, Vabysmo, Hemlibra and Phesgo has helped RHHBY offset declining revenues from legacy drugs.<\/p>\n
Roche has a strong and diversified pipeline spanning multiple therapeutic modalities.<\/p>\n
The FDA recently accepted and granted Priority Review to RHHBY\u2019s new drug application for giredestrant, an investigational oral selective estrogen receptor degrader (SERD), for the adjuvant treatment of adults with ER-positive, HER2-negative stage I\u2013III breast cancer. A regulatory decision is expected by Nov. 30, 2026.<\/p>\n
A tentative approval of breast cancer candidate giredestrant could serve as a meaningful catalyst for the stock.<\/p>\n
While Roche is making efforts to further diversify its broad portfolio, the company remains a late entrant into the highly competitive obesity market, which is currently dominated by other large-cap pharma players, such as Eli Lilly LLY and Novo Nordisk NVO.<\/p>\n
Roche\u2019s obesity assets include enicepatide (CT-388) and petrelintide. Roche is rapidly advancing its obesity pipeline, with both enicepatide and petrelintide progressing into phase III studies.<\/p>\n
Eli Lilly currently leads the obesity market with its tirzepatide-based dual GLP-1\/GIP receptor agonists, Mounjaro and Zepbound.<\/p>\n
Arch rival Novo Nordisk commands a strong position with its semaglutide-based GLP-1 therapies, Ozempic and Wegovy, used in type II diabetes and obesity.<\/p>\n
Both LLY and NVO generate a major chunk of their total revenues from their respective cardiometabolic drugs.<\/p>\n
RHHBY\u2019s Zacks Rank <\/p>\n
Roche currently carries a Zacks Rank #2 (Buy). You can see the complete list of today\u2019s Zacks #1 Rank (Strong Buy) stocks here.<\/p>\n
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report<\/a><\/p>\n Roche Holding AG (RHHBY) : Free Stock Analysis Report<\/a><\/p>\n Novo Nordisk A\/S (NVO) : Free Stock Analysis Report<\/a><\/p>\n Eli Lilly and Company (LLY) : Free Stock Analysis Report<\/a><\/p>\n This article originally published on Zacks Investment Research (zacks.com).<\/a><\/p>\n