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RHHBY's Lunsumio Combo Meets Goal in 2L Follicular Lymphoma Study
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Key Takeaways
Roche's phase III CELESTIMO study met its primary endpoint in second-line or later follicular lymphoma.
Roche's Lunsumio-Revlimid delivered a significant PFS improvement versus rituximab plus Revlimid.
Roche plans to submit CELESTIMO data to health authorities and present it at a medical conference.
Roche (RHHBY - Free Report) announced that the phase III CELESTIMO study, evaluating Lunsumio (mosunetuzumab) in combination with Revlimid (lenalidomide) versus MabThera/Rituxan (rituximab) plus Revlimid for treating people with relapsed or refractory (R/R) follicular lymphoma (FL) who received at least one prior line of treatment, has met its primary endpoint.
More on RHHBY’s CELESTIMO Study Data
Data from the CELESTIMO study showed that treatment with the Lunsumio regimen led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus MabThera/Rituxan plus Revlimid. Overall survival data were immature at the time of the interim analysis.
The safety profile of Lunsumio plus Revlimid was consistent with the known safety profiles of the individual medicines, with no new safety signals reported.
Data from the CELESTIMO study is likely to support the potential use of Lunsumio plus Revlimid earlier in the treatment of FL. Per management, the regimen may offer an effective treatment option with outpatient administration and a simple dosing schedule.
CELESTIMO is a confirmatory study required to convert Lunsumio monotherapy’s accelerated approval/conditional marketing authorization for third-line or later FL into full approval. The study is also intended to support an indication for Lunsumio in second-line or later FL.
Roche plans to submit the data from the CELESTIMO study to health authorities and present the same at an upcoming medical conference.
RHHBY’s Price Performance
Year to date, shares of Roche have risen 9.1% compared with the industry’s rise of 12.9%.
Image Source: Zacks Investment Research
Roche’s Recent Developments With Lunsumio
Lunsumio is currently approved as a fixed-duration monotherapy for the treatment of adult patients with third-line or later relapsed or refractory FL in both intravenous and subcutaneous (Lunsumio VELO) formulations.
In June 2026, the FDA accepted Roche’s supplemental biologics license application 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, including diffuse large B-cell lymphoma, after at least one prior line of systemic therapy.
A decision from the FDA is expected on Feb. 9, 2027.
The sBLA was accepted based on data from the phase III SUNMO study.
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.
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. Besides the CELESTIMO study, the phase III MorningLyte study is evaluating Lunsumio plus Revlimid in first-line FL.
Over the past 60 days, estimates for Amarin’s 2026 loss per share have narrowed from 65 cents to 39 cents. During the same time, estimates for 2027 loss per share have narrowed from 51 cents to 50 cents. AMRN shares have lost 0.8% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, delivering an average surprise of 62.27%.
Over the past 60 days, estimates for Arcutis Biotherapeutics’ 2026 earnings have increased from 16 cents per share to 40 cents. Earnings estimates for 2027 have increased from 96 cents per share to $1.14 during the same time. ARQT’s shares have declined 10% year to date.
Arcutis Biotherapeutics’ earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, delivering an average surprise of 41.39%.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 5.5% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
View the Zacks #1 Rank List
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RHHBY's Lunsumio Combo Meets Goal in 2L Follicular Lymphoma Study
Key Takeaways
Roche (RHHBY - Free Report) announced that the phase III CELESTIMO study, evaluating Lunsumio (mosunetuzumab) in combination with Revlimid (lenalidomide) versus MabThera/Rituxan (rituximab) plus Revlimid for treating people with relapsed or refractory (R/R) follicular lymphoma (FL) who received at least one prior line of treatment, has met its primary endpoint.
More on RHHBY’s CELESTIMO Study Data
Data from the CELESTIMO study showed that treatment with the Lunsumio regimen led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus MabThera/Rituxan plus Revlimid. Overall survival data were immature at the time of the interim analysis.
The safety profile of Lunsumio plus Revlimid was consistent with the known safety profiles of the individual medicines, with no new safety signals reported.
Data from the CELESTIMO study is likely to support the potential use of Lunsumio plus Revlimid earlier in the treatment of FL. Per management, the regimen may offer an effective treatment option with outpatient administration and a simple dosing schedule.
CELESTIMO is a confirmatory study required to convert Lunsumio monotherapy’s accelerated approval/conditional marketing authorization for third-line or later FL into full approval. The study is also intended to support an indication for Lunsumio in second-line or later FL.
Roche plans to submit the data from the CELESTIMO study to health authorities and present the same at an upcoming medical conference.
RHHBY’s Price Performance
Year to date, shares of Roche have risen 9.1% compared with the industry’s rise of 12.9%.
Image Source: Zacks Investment Research
Roche’s Recent Developments With Lunsumio
Lunsumio is currently approved as a fixed-duration monotherapy for the treatment of adult patients with third-line or later relapsed or refractory FL in both intravenous and subcutaneous (Lunsumio VELO) formulations.
In June 2026, the FDA accepted Roche’s supplemental biologics license application 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, including diffuse large B-cell lymphoma, after at least one prior line of systemic therapy.
A decision from the FDA is expected on Feb. 9, 2027.
The sBLA was accepted based on data from the phase III SUNMO study.
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.
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. Besides the CELESTIMO study, the phase III MorningLyte study is evaluating Lunsumio plus Revlimid in first-line FL.
RHHBY Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Amarin (AMRN - Free Report) , Arcutis Biotherapeutics (ARQT - Free Report) and Repligen (RGEN - Free Report) , each currently holding a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Amarin’s 2026 loss per share have narrowed from 65 cents to 39 cents. During the same time, estimates for 2027 loss per share have narrowed from 51 cents to 50 cents. AMRN shares have lost 0.8% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, delivering an average surprise of 62.27%.
Over the past 60 days, estimates for Arcutis Biotherapeutics’ 2026 earnings have increased from 16 cents per share to 40 cents. Earnings estimates for 2027 have increased from 96 cents per share to $1.14 during the same time. ARQT’s shares have declined 10% year to date.
Arcutis Biotherapeutics’ earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, delivering an average surprise of 41.39%.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 5.5% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.