We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
FDA Accepts Roche's Filing for Lunsumio VELO-Polivy in LBCL
Read MoreHide Full Article
Key Takeaways
Roche's sBLA for Lunsumio VELO plus Polivy in LBCL was accepted by the FDA.
Phase III SUNMO data showed a 59% reduction in progression or death risk versus R-GemOx.
The combo delivered 11.5 months median PFS versus 3.8 months with R-GemOx.
Roche (RHHBY - Free Report) 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).
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.
The FDA has set a target action date of Feb. 9, 2027.
Year to date, shares of RHHBY have lost 1% against the industry’s growth of 3.1%.
Image Source: Zacks Investment Research
More on RHHBY’s Lunsumio and Polivy Combination
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).
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.
The combination's safety profile was consistent with the established safety characteristics of the individual therapies.
Updated results presented recently at the American Society of Clinical Oncology (“ASCO”) Annual Meeting and European Hematology Association (“EHA”) 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.
Patients with relapsed or refractory LBCL represent a population with significant unmet medical needs and urgently require access to effective treatment options.
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.
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.
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.
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.
Roche’s hematology portfolio includes MabThera/Rituxan, Gazyva/Gazyvaro, Polivy, Venclexta/Venclyxto in collaboration with AbbVie, Hemlibra, PiaSky, Lunsumio and Columvi.
RHHBY’s 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.
RHHBY’s Efforts to Diversify Pipeline
Strong growth from key drugs like Ocrevus, Vabysmo, Hemlibra and Phesgo has helped RHHBY offset declining revenues from legacy drugs.
Roche has a strong and diversified pipeline spanning multiple therapeutic modalities.
The FDA recently accepted and granted Priority Review to RHHBY’s 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–III breast cancer. A regulatory decision is expected by Nov. 30, 2026.
A tentative approval of breast cancer candidate giredestrant could serve as a meaningful catalyst for the stock.
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 - Free Report) and Novo Nordisk (NVO - Free Report) .
Roche’s 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.
Eli Lilly currently leads the obesity market with its tirzepatide-based dual GLP-1/GIP receptor agonists, Mounjaro and Zepbound.
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.
Both LLY and NVO generate a major chunk of their total revenues from their respective cardiometabolic drugs.
View the Zacks #1 Rank List
Image: Bigstock
FDA Accepts Roche's Filing for Lunsumio VELO-Polivy in LBCL
Key Takeaways
Roche (RHHBY - Free Report) 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).
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.
The FDA has set a target action date of Feb. 9, 2027.
Year to date, shares of RHHBY have lost 1% against the industry’s growth of 3.1%.
Image Source: Zacks Investment Research
More on RHHBY’s Lunsumio and Polivy Combination
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).
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.
The combination's safety profile was consistent with the established safety characteristics of the individual therapies.
Updated results presented recently at the American Society of Clinical Oncology (“ASCO”) Annual Meeting and European Hematology Association (“EHA”) 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.
Patients with relapsed or refractory LBCL represent a population with significant unmet medical needs and urgently require access to effective treatment options.
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.
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.
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.
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.
Roche’s hematology portfolio includes MabThera/Rituxan, Gazyva/Gazyvaro, Polivy, Venclexta/Venclyxto in collaboration with AbbVie, Hemlibra, PiaSky, Lunsumio and Columvi.
RHHBY’s 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.
RHHBY’s Efforts to Diversify Pipeline
Strong growth from key drugs like Ocrevus, Vabysmo, Hemlibra and Phesgo has helped RHHBY offset declining revenues from legacy drugs.
Roche has a strong and diversified pipeline spanning multiple therapeutic modalities.
The FDA recently accepted and granted Priority Review to RHHBY’s 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–III breast cancer. A regulatory decision is expected by Nov. 30, 2026.
A tentative approval of breast cancer candidate giredestrant could serve as a meaningful catalyst for the stock.
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 - Free Report) and Novo Nordisk (NVO - Free Report) .
Roche’s 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.
Eli Lilly currently leads the obesity market with its tirzepatide-based dual GLP-1/GIP receptor agonists, Mounjaro and Zepbound.
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.
Both LLY and NVO generate a major chunk of their total revenues from their respective cardiometabolic drugs.
RHHBY’s Zacks Rank
Roche currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.