On December 22, 2025 Ipsen (Euronext: IPN; ADR: IPSEY) reported an exclusive licensing agreement for global rights outside of Greater China, for SIM0613, an antibody-drug conjugate (ADC) with best-in-class potential. Targeting the LRRC15 protein, SIM0613 is designed for enhanced tumor penetration and differentiated anti-tumor activity in solid tumors with the highest unmet needs.

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"Today’s announcement underscores our bold vision to lead innovation and shape the future of oncology," said Christelle Huguet, PhD EVP and Head of Research & Development, Ipsen. "By advancing first- and best-in-class therapies early, we maximize the potential to transform patient outcomes globally. The addition of the SIM0613 ADC is testament to this ambition—pioneering science that opens new possibilities for those who need it most and builds on Ipsen’s rapidly evolving research and early development portfolio, with over 20 programs added since 2020."

"SIM0613 is developed via Simcere Zaiming’s proprietary antibody-drug conjugate platform," said Renhong Tang, PhD, CEO of Simcere Zaiming. "We are excited to partner with Ipsen on this novel drug candidate and look forward to working together to advance the clinical development of SIM0613. "

Under the terms of the agreement, Simcere Zaiming is eligible to receive up to $1.06B comprising upfront, development, regulatory and commercial milestone payments, and tiered royalties on sales, contingent upon successful development and regulatory approvals. Ipsen will have manufacturing rights, following the tech transfer process and will assume responsibility for all activities outside Greater China including Phase I preparation activities and submission of the Investigational New Drug and Clinical Trial applications.

About SIM0613
SIM0613 targets the leucine-rich repeat-containing 15 (LRRC15), a protein highly expressed on varies tumor types and cancer-associated fibroblasts but with limited expression on normal cells. Upon binding to the LRRC15 protein, SIM0613 is internalized where the cytotoxic payload is released, killing the cancer cell and therefore sparing healthy cells. SIM0613 is specifically engineered for deep tumor and cancer-associated fibroblast penetration, resulting in robust tumor regressions in multiple in vivo preclinical models.

(Press release, Ipsen, DEC 22, 2025, View Source [SID1234661579])

On December 22, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported additional updates on FLAMINGO-01 and the Company’s corporate strategy.

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Corporate Strategy

The Company recently attended a Noble Capital conference on December 3, 2025, where further details of the Company’s FLAMINGO-01 clinical strategy, financing strategy, and partnering strategy were discussed in a fireside chat with the Noble analyst. The video is now available on the Company’s website at the bottom of the Welcome page: View Source

Below are highlights from the discussion with additional information:

Clinical strategy – The FLAMINGO-01 clinical strategy continues to evolve with various options to further reduce risk and increase the chances of marketing approval supported by the current financing strategy that is supporting the current burn rate, the increasing interest from investigators and patients, cost reduction activities, and continued interest to add additional sites and countries to the study.

Approximately 140 sites are actively enrolling patients, and there are plans to activate an additional 10 already approved sites in 2026 and additional EU countries.

Quality improvement and cost reduction may be realized by moving more clinical trial operations internally and ending the use of a CRO for the US operations and global management.

The study has transitioned from strong interest from principal investigators to patient driven interest, including the formation of wait lists at certain sites.

The Company has entered into discussions with leading clinical sites in the United Kingdom and Canada regarding joining the study, which would require regulatory approval in each country, independent from the FDA and EMA regulatory approval that the Company has already received.

Financing strategy – The ATM financing is being used judiciously and efficiently to keep up with the burn rate in 2025, potentially exceeding the burn rate by year end. This ATM strategy reduces the likelihood of the Company doing a near term financing, increasing the chances for non-dilutive strategic partnerships at any time before or after an interim analysis.

The Company’s annual burn rate was approximately $7 million in 2024 and 2023. The income statements for these periods have been reported as losses of $16 million and $9 million respectively, but the cash flow used for operations is much lower at $7 million due to the non-cash stock and options expenses added to the income statements.

For the first three quarters of 2025, the burn rate is approximately $7 million, representing a gradual increase in burn rate over 2024, but not a substantial increase due to the Company’s lean structure and ongoing cost saving initiatives. In addition, a large part of the clinical expenses is from the upfront costs and the first 6 months of monthly vaccinations or Primary Immunization Series, after which the cost per patient should be lower when boosters are given once every 6 months.

Partnering strategy – The Company continues to attend partnering conferences.

Large pharma dominates the breast cancer drug market, including acquiring or partnering with smaller biotechs who have promising new breast cancer drugs.

We believe patent filings for treating non-HLA-A*02 patients with GLSI-100 will strengthen the patent portfolio for GLSI-100, in addition to the biologics data exclusivity available to GLSI-100 in the US.

FLAMINGO-01 Data Safety Monitoring Board (DSMB) & Steering Committee

The FLAMINGO-01 DSMB met twice in 2025, most recently in December 2025, and recommended to continue the study as is without modification. The Steering Committee also met at SABCS 2025 and discussed the clinical strategy, endorsing the planned modifications to FLAMINGO-01. The planned modifications subject to regulatory approval include:

increasing the size of the study, which would increase the power of the study thus decreasing the risk by designing the study to assume more recurrences even though fewer recurrences may be anticipated and observed,

doubling or quadrupling the enrollment rate, which will increase the patient years in the study more rapidly thus proportionately increase the event rate, which may shorten the time to reach an interim analysis or milestone,

continuing to enroll past the interim analyses so that the current momentum at the clinical sites continues,

using the interim analysis to potentially resize the study or to change the subsequent interim analysis, to change the number of events triggering an analysis, or to change the timing of the study based on recommendations by an independent committee, and

using a recently manufactured GP2 commercial drug product lot in FLAMINGO-01

CEO Snehal Patel commented, "We are looking forward to continuing our financing strategy and implementing the planned Phase III trial derisking modifications, pending regulatory approvals. The discussions with clinicians at SABCS 2025 were encouraging, as the study has become more widely recognized by the breast cancer community, leading to patient and investigator driven interest to expand FLAMINGO-01 into the United Kingdom and Canada. The potential for GLSI-100 to save lives by preventing metastatic breast cancer recurrences and thus reduce overall healthcare costs was also highlighted at the Noble conference. The open label data of FLAMINGO-01 in the non-HLA-A*02 arm has helped to increase the probability of success, while potentially doubling the market for GLSI-100, and will continue to be analyzed as we may provide updates or publications at any time."

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 600 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, DEC 22, 2025, View Source [SID1234661578])

On December 22, 2025 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported updates on zugocaptagene geleucel (zugo-cel), formerly known as CTX112, its investigational allogeneic CAR T targeting CD19, in development for autoimmune disease and hematologic malignancies.

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"Preliminary data from zugo-cel in patients with rheumatologic autoimmune diseases have been encouraging, and the therapy has been well tolerated to date. We have also initiated an additional Phase 1 basket study in immune thrombocytopenia purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA), two autoimmune hematologic diseases," said Naimish Patel, M.D., Chief Medical Officer of CRISPR Therapeutics. "In hematologic malignancies, clinical experience to date supports continued advancement of the program. Together with our recently established collaboration with Lilly to evaluate zugo-cel with pirtobrutinib in aggressive B-cell lymphomas, these developments reflect the breadth of opportunity for zugo-cel. We look forward to sharing additional data at future scientific meetings."

Autoimmune Disease

Zugo-cel, targeting CD19, is in an ongoing Phase 1 basket trial in autoimmune rheumatologic diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and inflammatory myositis. Patients in the study may have active SLE (with or without renal involvement), SSc, or idiopathic inflammatory myopathy (IIM) despite the use of standard therapies.

Preliminary clinical data from the Phase 1 study has been encouraging, and zugo-cel has been well tolerated to date.

As of the data cut-off on December 17, 2025, four patients (2 SLE and 2 immune-mediated necrotizing myopathy (IMNM) with interstitial lung disease) have been treated at a dose of 100 million cells and followed for at least 28 days post-infusion:

Zugo-cel cell expansion is comparable to that observed at the same dose in patients in the ongoing B-cell lymphomas trial.
Rapid and deep B-cell depletion in the periphery was observed within the first 1-2 days and maintained over the first month of treatment, with repopulating B-cells demonstrating a shift toward an unswitched, naïve repertoire.
All patients demonstrated significant clinical improvement at the Day 28 assessment.
The first patient with SLE, refractory to 9 prior therapies with a baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 8, has maintained drug-free DORIS clinical remission through Month 6 following CAR T therapy.
Treatment has been well-tolerated, with no high-grade cytokine release syndrome (CRS) or immune-effector cell-associated neurotoxicity syndrome (ICANS) observed.
Clinical trials in autoimmune disease remain ongoing across indications. The Company expects to provide additional updates in the second half of 2026. In addition, a Phase 1 clinical trial for zugo-cel has been initiated in ITP and wAIHA.

Immuno-Oncology

Positive clinical data generated to date support the advancement of zugo-cel into the Phase 2 portion of the ongoing Phase 1/2 trial in patients with (R/R) CD19-positive B-cell malignancies. Eligible disease subtypes include large B-cell lymphoma (LBCL), follicular lymphoma (FL) grade 1-3a, marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL).

Zugo-cel was administered after a standard course of lymphodepletion with fludarabine and cyclophosphamide. A total of 39 patients have been treated across all 4 dose levels. The recommended Phase 2 dose (RP2D) was recently endorsed at the 600 million cell dose for the large B-cell lymphoma (LBCL) cohort.

As of the data cut-off of November 20, 2025, 10 patients with R/R LBCL have been treated at the RP2D of 600 million cell dose and have had at least one month of follow-up, with the following observations:

An overall response rate (ORR) of 90% (9/10) and a complete response rate (CRR) of 70% (7/10) were observed, including a complete response (CR) in a patient who relapsed following autologous CAR T cell therapy.
Among patients who have completed 12-months of follow-up, 67% (2/3) remained in CR at the 12-month evaluation.
Peak mean CAR T cell expansion of approximately 1,700 cells/µL was observed at the RP2D, representing approximately a four-fold higher expansion compared with patients receiving 300 million cells.
Rates of Grade 3 CRS, ICANS and serious infections were 17%, 17%, and 8%, respectively, among all LBCL patients treated at the RP2D (n=12).
No Grade 3 ICANS or CRS has been observed at the 100 million cell dose, which is the dose currently being studied in the autoimmune basket trials.
The Phase 1/2 clinical trial in R/R B-cell malignancies is ongoing. The Company expects to provide additional updates in the second half of 2026. CRISPR Therapeutics has also established a new collaboration and clinical supply agreement with Lilly to evaluate zugo-cel together with pirtobrutinib in aggressive B-cell lymphomas, further expanding the program’s development in oncology.

About Zugocaptagene Geleucel (zugo-cel; formerly CTX112)
Zugocaptagene geleucel (zugo-cel) is a wholly-owned, allogeneic chimeric antigen receptor (CAR) T cell therapy product candidate targeting Cluster of Differentiation 19 (CD19), in development for both autoimmune and immuno-oncology indications. Zugo-cel is an off-the-shelf allogeneic CAR T that utilizes CRISPR Cas9 for targeted gene knockout and CAR insertion for immune evasion and enhanced T effector cell potency. Zugo-cel is given following a standard lymphodepletion regimen without the need for HLA matching. Zugo-cel is being investigated in ongoing clinical trials in adult patients with systemic lupus erythematosus, systemic sclerosis, and inflammatory myositis and in adult patients with relapsed or refractory B-cell malignancies.

(Press release, CRISPR Therapeutics, DEC 22, 2025, View Source [SID1234661577])

On December 22, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported it will be commencing a pivotal Phase III registrational trial of its 64Cu-SARTATE diagnostic agent in patients with neuroendocrine tumours (NETs). This follows a successful End of Phase meeting with the United States (US) Food and Drug Administration (FDA), in which all key components of the proposed trial design were agreed upon with the Agency. Recruitment into the trial is expected to commence in 2026.

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The trial will be a multi-centre, single arm, non-randomised, open-label Phase III diagnostic clinical trial of 64Cu-SARTATE Positron Emission Tomography (PET) in approximately 70 participants. As a pivotal trial, the final study results are intended to support an application to the US FDA for approval of 64Cu-SARTATE as a new diagnostic imaging agent in NETs.

The aim of this registrational trial is to investigate the ability of 64Cu-SARTATE PET/computed tomography (CT) to detect NETs, building on compelling preclinical and clinical trial data generated to date, including the first-in-human CL01 trial1 and the Phase II DISCO trial (NCT04438304)2-3. The DISCO trial findings were recently accepted for presentation at the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium, which will be held January 8-10, 2026 (San Francisco, CA)4.

In the DISCO trial, 64Cu-SARTATE was found to be safe and well tolerated with lesion detection substantially higher than that of the current standard-of-care (SOC), 68Ga-DOTATATE. 64Cu-SARTATE also showed enhanced lesion detection in the liver, the most common metastatic site for patients with gastroenteropancreatic (GEP)-NETs. Hepatic metastatic burden is clinically important as it is strongly associated with patient outcomes and significantly influences clinical management of the disease5. The enhanced diagnostic capabilities of 64Cu-SARTATE offer significant potential to transform and advance both the detection and management of patients with NETs, paving the way for improved patient outcomes and more effective treatment pathways.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are very excited to progress to a Phase III trial in the NETs indication and are thankful for the time and valuable guidance the FDA has provided on our 64Cu-SARTATE agent during the End of Phase meeting. This will be our third registrational trial, highlighting Clarity’s strong commitment to advancing our pipeline in areas of high unmet medical need with our next-generation Targeted Copper Theranostic products.

"Our team and collaborators are determined to progress 64Cu-SARTATE through this registrational trial and towards commercialisation as we continue building on excellent preclinical and clinical data clearly illustrating the advantages of this product over SOC agents. Time and time again we have shown our commitment to the highest standards of scientific and clinical research, putting ourselves head-to-head against the current SOC to clearly emphasise the benefits and enhanced diagnostic performance of our products, something that very few radiopharmaceutical companies do.

"We would like to thank everyone who contributed to progressing 64Cu-SARTATE to this exciting stage, from our patients who participate in our clinical trials and their families, to our incredible team, investigators and collaborators who work tirelessly towards our mutual goal of improving treatment outcomes for people with cancer. We also thank the FDA for their collaborative approach to our interactions, which we have now experienced for many years. We believe that better diagnostic tools will help clinicians determine the best course of treatment for their patients. With 64Cu-SARTATE we are getting closer to achieving this goal, and we look forward to commencing recruitment into this pivotal trial next year."

About SARTATE
SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2), such as NETs. Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu-SARTATE) or copper-67 (67Cu) for therapy (67Cu-SARTATE).

Disclaimer
64Cu-SARTATE is an unregistered product. The safety and efficacy of 64Cu-SARTATE have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration. There is no guarantee that this product will become commercially available.

About NETs
NETs, also known as well-differentiated neuroendocrine neoplasms or carcinoids, represent a heterogeneous group of malignant transformations of cells of the diffuse neuroendocrine system6. They most commonly occur in the gastrointestinal tract (48%), lung (25%), and pancreas (9%), but may also originate in other areas, including the breast, prostate, thymus and skin7. NETs can either be benign or malignant, as well as non-functional and functional8. NETs traditionally have been considered uncommon; however, the incidence has been increasing as a worldwide phenomenon9.

Overall, it is estimated that approximately 200,000 people are living with NETs in the US10-11. Patients with NETs present with subtle clinical symptoms, which can lead to a delay in diagnosis of more than 4 years12. As such, about 30-75% of NETs patients have distant metastases at the time of diagnosis13. A 10-year relative survival rate for patients with metastatic GEP-NETs is 3–36%.

(Press release, Clarity Pharmaceuticals, DEC 22, 2025, View Source [SID1234661567])

On December 21, 2025 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO (mosunetuzumab-axgb), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. Based on the study results, Lunsumio VELO is approved under accelerated approval. Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial.

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"Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences."

Lunsumio VELO reduces administration time with an approximately one-minute injection, compared with a 2-4 hour intravenous (IV) infusion. Like Lunsumio administered intravenously, Lunsumio VELO can be administered outpatient and is a fixed-duration treatment given for a defined period, which could be as short as six months. By contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.

"This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma," said Dr. Ian Flinn, M.D., Ph.D., Tennessee Oncology and One Oncology. "With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings."

The FDA approval is supported by the primary analysis of the GO29781 study that evaluated Lunsumio VELO in patients with third-line or later (3L+) FL. Results showed the objective response rate and complete response rate in patients treated with Lunsumio VELO were 75% (95% confidence interval [CI]: 64–83%) and 59% (95% CI: 48–69%), respectively. The median duration of response was 22.4 months (95% CI: 16.8–22.8). The most common adverse reactions (≥20%) were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain and diarrhea. The CRS rate was 30% and events were mostly low grade (Grade 1–2, 28%; Grade 3, 2.1%), occurred during Cycle 1, and all resolved after a median duration of two days (range: 1–15). CRS can be severe and life-threatening.

Lunsumio IV was the first bispecific antibody approved for 3L+ FL. Long-term data from the SC and IV arms of the GO29781 study were presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

These data have been submitted to other healthcare authorities around the world. Recently, the European Commission granted conditional marketing authorization of Lunsumio SC for the treatment of adult patients with R/R FL after two or more lines of systemic therapy.

Genentech continues to advance its bispecific antibody program in lymphoma, with ongoing Phase III studies evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment. This includes the SUNMO study investigating Lunsumio VELO in combination with Polivy (polatuzumab vedotin-piiq) in second-line or later large B-cell lymphoma , and the MorningLyte study investigating Lunsumio VELO in combination with lenalidomide in previously untreated FL.

Genentech is committed to helping patients get the medicine their doctor prescribed. 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 View Source

About the GO29781 Study

The GO29781 [NCT02500407] study is a Phase I/II, multicenter, open-label, dose-escalation and expansion study evaluating the safety, efficacy, and pharmacokinetics of mosunetuzumab-axgb administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The efficacy of Lunsumio VELO was established on the basis of objective response rate and duration of response.

About Follicular Lymphoma (FL)

Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin 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 2025 and more than 110,000 people are diagnosed with FL each year worldwide.

About Lunsumio VELO (mosunetuzumab-axgb)

Lunsumio VELO is a subcutaneous formulation of mosunetuzumab-axgb, a 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’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. Lunsumio VELO is being investigated as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, large B-cell lymphoma, and other indications.

Lunsumio and Lunsumio VELO U.S. Indication

LUNSUMIO (mosunetuzumab-axgb) or LUNSUMIO VELO 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.

It is not known if LUNSUMIO or LUNSUMIO VELO is safe and effective in children.

The conditional approval for this use is based on response rate. There are ongoing studies to establish how well the drug works.

Important Safety Information

What is the most important information I should know about LUNSUMIO or LUNSUMIO VELO?

LUNSUMIO or LUNSUMIO VELO can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO or LUNSUMIO VELO, and can also be severe or life-threatening.

Get medical help right away if you develop any signs or symptoms of CRS at any time, including:

fever of 100.4°F (38°C) or higher
chills
low blood pressure
fast or irregular heartbeat
tiredness or weakness
difficulty breathing
headache
confusion
feeling anxious
dizziness or light-headedness
nausea
vomiting
Due to the risk of CRS, you will receive LUNSUMIO or LUNSUMIO VELO on a "step-up dosing schedule."

The step-up dosing schedule is when you receive smaller "step-up" doses before receiving higher doses of LUNSUMIO or LUNSUMIO VELO during your first cycle of treatment
If your dose of LUNSUMIO or LUNSUMIO VELO is delayed for any reason, you may need to repeat the "step-up dosing schedule"
You may receive medicines to help reduce your risk of CRS before your dose
Your healthcare provider will check you for CRS during treatment with LUNSUMIO or LUNSUMIO VELO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with LUNSUMIO or LUNSUMIO VELO, if you have severe side effects.

What are the possible side effects of LUNSUMIO or LUNSUMIO VELO?

LUNSUMIO or LUNSUMIO VELO can cause serious side effects, including:

Neurologic problems. LUNSUMIO or LUNSUMIO VELO can cause serious and life-threatening neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO or LUNSUMIO VELO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with LUNSUMIO or LUNSUMIO VELO, including:
headache
numbness and tingling of the arms, legs, hands, or feet
dizziness
confusion and disorientation
difficulty paying attention or understanding things
forgetting things or forgetting who or where you are
trouble speaking, reading or writing
sleepiness or trouble sleeping
tremors
loss of consciousness
seizures
muscle problems or muscle weakness
loss of balance or trouble walking
tiredness
Serious infections. LUNSUMIO or LUNSUMIO VELO can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with LUNSUMIO or LUNSUMIO VELO, including:
fever of 100.4°F (38°C) or higher
cough
chest pain
tiredness
shortness of breath
painful rash
sore throat
pain during urination
feeling weak or generally unwell
Hemophagocytic lymphohistiocytosis (HLH). LUNSUMIO or LUNSUMIO VELO can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with LUNSUMIO or LUNSUMIO VELO. Your healthcare provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include:
fever
enlarged spleen
easy bruising
low blood cell counts
liver problems
Low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO or LUNSUMIO VELO and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO or LUNSUMIO VELO. LUNSUMIO or LUNSUMIO VELO can cause the following low blood cell counts:
low white blood cell counts (lymphopenia [for LUNSUMIO VELO only] and neutropenia). Low white blood cells can increase your risk for infection
low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath
low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems
Growth in your tumor or worsening of tumor-related problems (tumor flare). LUNSUMIO or LUNSUMIO VELO can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with LUNSUMIO or LUNSUMIO VELO:
chest pain
cough
trouble breathing
tender or swollen lymph nodes
pain or swelling at the site of the tumor
Your healthcare provider may temporarily stop or permanently stop treatment with LUNSUMIO or LUNSUMIO VELO if you develop severe side effects.

The most common side effects of LUNSUMIO include: CRS, tiredness, rash, headache, fever, muscle pain, cough, itching, and numbness, tingling, or pain in the hands or feet (nerve damage).

The most common side effects of LUNSUMIO VELO include: injection site reactions, tiredness, rash, CRS, COVID-19, muscle and joint pain, and diarrhea.

The most common severe abnormal blood test results with LUNSUMIO include: decreased phosphate, increased glucose, and increased uric acid levels.

The most common severe abnormal blood test results with LUNSUMIO VELO include: decreased white blood cell counts and increased uric acid levels.

Before receiving LUNSUMIO or LUNSUMIO VELO, tell your healthcare provider about all of your medical conditions, including if you:

have ever had an infusion reaction after receiving LUNSUMIO
have an infection or have had an infection in the past which lasted a long time or keeps coming back
have or have had Epstein-Barr Virus
are pregnant or plan to become pregnant. LUNSUMIO or LUNSUMIO VELO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LUNSUMIO or LUNSUMIO VELO
Females who are able to become pregnant:

your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO or LUNSUMIO VELO
use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO
are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO or LUNSUMIO VELO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while receiving LUNSUMIO or LUNSUMIO VELO?

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

These are not all of the possible side effects of LUNSUMIO or LUNSUMIO VELO. Talk to your healthcare provider for more information about the benefits and risks of LUNSUMIO or LUNSUMIO VELO.

You may report side effects to the FDA at (800) FDA-1088 or View Source You may also report side effects to Genentech at (888) 835-2555.

Please see Important Safety Information, including Serious Side Effects, as well as the LUNSUMIO full Prescribing Information and Medication Guide and LUNSUMIO VELO full Prescribing Information and Medication Guide and on View Source

About Polivy (polatuzumab vedotin-piiq)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Pfizer ADC technology and is currently being investigated for the treatment of several types of NHL.

Polivy U.S. Indication
Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL).

Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies.

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.

Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy
Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections
Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication
Side effects seen most often

The most common side effects during treatment were

Nerve problems in arms and legs
Nausea
Tiredness or lack of energy
Diarrhea
Constipation
Hair loss
Redness and sores of the lining of the mouth, lips, throat, and digestive tract
Polivy may lower your red or white blood cell counts and increase uric acid levels.

Polivy may not be for everyone. Talk to your doctor if you are

Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby
Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment
Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose
These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment.

You may report side effects to the FDA at (800) FDA-1088 or View Source You may also report side effects to Genentech at (888) 835-2555.

Please see the full Prescribing Information and visit View Source for additional Important Safety Information.

(Press release, Genentech, DEC 21, 2025, View Source [SID1234661584])