Genentech's Lunsumio and Polivy Combination Significantly Prolongs Remission for People With Relapsed or Refractory Large B-cell Lymphoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented today results from the Phase III SUNMO [ NCT05171647 ] study showing Lunsumio ® (mosunetuzumab-axgb) administered subcutaneously in combination with Polivy ® (polatuzumab vedotin-piiq) demonstrated a clinically meaningful and statistically significant improvement in its primary endpoints of progression-free survival (PFS) and objective response rate (ORR) compared to Rituxan ® (rituximab), gemcitabine and oxaliplatin (R-GemOx), in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for transplant. Primary analysis data were featured at the 18 th International Conference on Malignant Lymphoma as a late-breaking oral presentation.
Results from the SUNMO study will be submitted to global health authorities, including the U.S. Food and Drug Administration (FDA). The National Comprehensive Cancer Network ® (NCCN ®) has recently added Lunsumio and Polivy to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) as a category 2A recommendation for the treatment of people with second-line (2L) diffuse large B-cell lymphoma (DLBCL) who are not intended to proceed to transplant. †
'Lunsumio and Polivy represent the first combination of a bispecific antibody and antibody-drug conjugate, which could avoid chemotherapy and potentially provide an alternative option for some patients with relapsed or refractory LBCL,' said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. 'We are also encouraged by the favorable safety profile and potential for outpatient use of this regimen, which may suit diverse patient and healthcare system needs.'
At a median follow-up of 23.2 months, the Lunsumio and Polivy combination demonstrated a 59% reduction in risk of disease progression or death compared to R-GemOx (hazard ratio [HR] 0.41, 95% confidence interval [CI]: 0.28–0.61; p<0.0001). Median PFS was three times longer with Lunsumio and Polivy at 11.5 months (95% CI: 5.6-17.6), compared to 3.8 months for R-GemOx (95% CI: 2.9-4.1) and 12-month PFS was more than doubled at 48.5% (95% CI: 39.6-57.4) vs.17.8% (95% CI: 5.4-30.3), respectively. This PFS benefit was consistent across subgroups, including in high-risk patients with primary refractory disease (HR 0.46, 95% CI: 0.29–0.72). At the interim analysis, overall survival (OS) data were not yet mature. OS numerically favored the Lunsumio and Polivy combination with a median of 18.7 months (95% CI: 14.1–not evaluable [NE]) compared to 13.6 months for R-GemOx (95% CI: 9.9–NE; HR 0.80; 95% CI: 0.54 - 1.20).
'There remains a clear need for effective and well-tolerated treatments for people with this difficult-to-treat disease,' said Jason Westin, professor of lymphoma and director of lymphoma clinical research, The University of Texas, MD Anderson Cancer Center. 'If approved, this off-the-shelf treatment combination of mosunetuzumab-axgb and polatuzumab vedotin-piiq could be administered over a fixed period of time, without mandatory hospitalization or traditional chemotherapy, which could provide a meaningful option for patients with relapsed or refractory LBCL.'
In the Lunsumio and Polivy arm, 30% more patients achieved an objective response (70.3%, 95% CI: 61.9-77.8) compared to R-GemOx (40.0%; 95% CI: 28.5-52.4), and the complete response rate was doubled at 51.4% (95% CI: 42.8-60.0) versus 24.3% (95% CI: 14.8-36.0). Nearly 75% of patients with a complete response were still in remission after one year (72.6%; 95% CI: 61.4-83.8) compared to 44.1% for R-GemOx (95% CI: 13.2-74.9).
The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines, potentially allowing use across outpatient and community settings. The incidence of cytokine release syndrome (CRS) events in the Lunsumio plus Polivy arm was low, occurring in one in four patients, with less than 5% of patients experiencing Grade 2 or 3 CRS events. No immune effector cell-associated neurotoxicity syndrome events were reported. Rates of Grade 3–4 (58.5% vs. 57.8%) and Grade 5 (5.2% vs. 6.3%) adverse events (AEs) were similar between the combination and R-GemOx, with fewer AEs leading to treatment discontinuation in the Lunsumio and Polivy arm (2.2% vs. 4.7%).
High-dose chemotherapy followed by stem-cell transplant has traditionally been the standard 2L treatment for people with R/R LBCL. While 2L therapies have advanced, DLBCL can progress rapidly and many people are not candidates for, cannot tolerate, or do not have access to latest therapies. There is an urgent need for treatments that are rapidly available upon a diagnosis of relapse, that can manage the disease and improve long-term outcomes.
Genentech's lymphoma portfolio is one of the broadest in the industry, providing a unique and much-needed opportunity to combine regimens with different and complementary mechanisms of action. We are exploring our CD20xCD3 bispecifics, Lunsumio and Columvi ® (glofitamab-gxbm), alongside Polivy to move one step closer towards our goal of improving the lives of as many patients with lymphomas as possible. This includes the Phase III STARGLO study [ NCT04408638 ] evaluating the efficacy and safety of Columvi in combination with GemOx versus R-GemOx alone in patients with R/R DLBCL who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy.
Lunsumio is already approved for people with R/R follicular lymphoma after two or more lines of therapy in more than 60 countries worldwide. Polivy in combination with R-CHP is approved for people with previously untreated diffuse large B-cell lymphoma (DLBCL) in more than 100 countries worldwide and in combination with bendamustine and Rituxan for R/R DLBCL in more than 90 countries worldwide.
†NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way
About the SUNMO study
The SUNMO [ NCT05171647 ] study is an international, multi-center, randomized Phase III trial evaluating the efficacy and safety of subcutaneously administered Lunsmio ® (mosunetuzumab-axgb) in combination with intravenous Polivy ® (polatuzumab vedotin-piiq) compared to Rituxan ® (rituximab), gemcitabine and oxaliplatin (R-GemOx), in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for autologous stem cell transplant. Outcome measures include progression-free survival and objective response rate (dual primary endpoints), overall survival, duration of objective response, complete response rate, duration of complete response, safety and tolerability, and patient-reported outcomes.
About Lunsumio ® (mosunetuzumab-axgb)
Lunsumio 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's 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 lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, and other indications.
About Polivy ® (polatuzumab vedotin-piiq)
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed 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 those expressing 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.
About large B-cell lymphoma (LBCL)
Large B-cell lymphomas (LBCL), composed predominantly of diffuse large B-cell lymphoma (DLBCL), are the most common type of non-Hodgkin lymphoma (NHL) that affect B-cell lymphocytes, a type of white blood cells. DLBCL is the most common form of aggressive NHL and makes up about 80% of LBCLs. While it can arise in lymph nodes, it can also occur in organs outside of the lymphatic system. Approximately 160,000 people worldwide are diagnosed with DLBCL each year, with comparable incidence rates across regions. Medical practices, including pathological classification, diagnosis, staging, initial treatment and relapse management, are similarly approached worldwide. While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes.
Lunsumio U.S. Indication
Lunsumio (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.
It is not known if Lunsumio is safe and effective in children.
The conditional approval of Lunsumio is based on response rate. There are ongoing studies to establish how well the drug works.
What is the most important information I should know about Lunsumio?
Lunsumio may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Lunsumio 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 on a 'step-up dosing schedule.'
The step-up dosing schedule is when you receive smaller 'step-up' doses of Lunsumio on Day 1 and Day 8 of your first cycle of treatment
You will receive a higher dose of Lunsumio on Day 15 of your first cycle of treatment
If your dose of Lunsumio is delayed for any reason, you may need to repeat the step-up dosing schedule
Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS
Your healthcare provider will check you for CRS during treatment with Lunsumio 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, if you have severe side effects.
What are the possible side effects of Lunsumio?
Lunsumio may cause serious side effects, including:
neurologic problems. Lunsumio can cause serious and life-threatening neurological problems. Your healthcare provider will check you for neurologic problems during treatment with Lunsumio. 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, 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 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, 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 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. Your health care 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 and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with Lunsumio. Lunsumio can cause the following low blood cell counts:
low white blood cell counts (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 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:
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 if you develop severe side effects.
The most common side effects of Lunsumio include: tiredness, rash, fever, and headache.
The most common severe abnormal blood test results with Lunsumio include: decreased phosphate, increased glucose, and increased uric acid levels.
Before receiving Lunsumio, 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 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
Females who are able to become pregnant:
your healthcare provider should do a pregnancy test before you start treatment with Lunsumio
you should use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of Lunsumio
are breastfeeding or plan to breastfeed. It is not known if Lunsumio passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of Lunsumio
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?
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 the possible side effects of Lunsumio. Talk to your healthcare provider for more information about the benefits and risks of Lunsumio.
You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. 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 or visit https://www.Lunsumio.com.
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 http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see the full Prescribing Information and visit https://www.Polivy.com for additional Important Safety Information.
About Columvi® (glofitamab-gxbm)
Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Genentech's broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development program that also includes Lunsumio® (mosunetuzumab-axgb), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Genentech is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma and mantle cell lymphoma.
Columvi U.S. Indication
Columvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer.
It is not known if Columvi is safe and effective in children.
The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works.
What is the most important information I should know about Columvi?
Columvi can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death.
Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including:
fever of 100.4°F (38°C) or higher
chills or shaking
fast or irregular heartbeat
dizziness or light-headedness
trouble breathing
shortness of breath
Due to the risk of CRS, you will receive Columvi on a 'step-up dosing schedule'.
A single dose of a medicine called obinutuzumab will be given to you on the first day of your first treatment cycle (Day 1 of Cycle 1).
You will start the Columvi step-up dosing schedule a week after the obinutuzumab dose. The step-up dosing schedule is when you receive smaller 'step-up' doses of Columvi on Day 8 and Day 15 of Cycle 1. This is to help reduce your risk of CRS. You should be hospitalized during your infusion and for 24 hours after receiving the first step-up dose on Day 8. You should be hospitalized during your infusion and for 24 hours after receiving the second step-up dose on Day 15 if you experienced CRS during the first step-up dose.
You will receive your first full dose of Columvi a week after the second step-up dose (this will be Day 1 of Cycle 2).
If your dose of Columvi is delayed for any reason, you may need to repeat the 'step-up dosing schedule'.
If you had more than mild CRS with your previous dose of Columvi, you should be hospitalized during and for 24 hours after receiving your next dose of Columvi.
Before each dose of Columvi, you will receive medicines to help reduce your risk of CRS and infusion-related reactions.
Your healthcare provider will monitor you for CRS during treatment with Columvi 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 Columvi if you have severe side effects.
Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Columvi Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away.
What are the possible side effects of Columvi?
Columvi may cause serious side effects, including:
Cytokine Release Syndrome.
Neurologic problems. Columvi can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with Columvi. 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, including:
headache
confusion and disorientation
difficulty paying attention or understanding things
trouble speaking
sleepiness
memory problems
numbness, tingling, or weakness of the hands or feet
dizziness
shaking (tremors)
Serious Infections. Columvi can cause serious infections that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your healthcare provider right away if you develop any signs of an infection, including: fever, chills, weakness, cough, shortness of breath, or sore throat.
Growth in your tumor or worsening of tumor related problems (tumor flare). Tell your healthcare provider if you get any of these signs or symptoms of tumor flare:
tender or swollen lymph nodes
pain or swelling at the site of the tumor
chest pain
cough
trouble breathing
The most common side effects of Columvi include: CRS, muscle and bone pain, rash, and tiredness.
The most common severe abnormal lab test results with Columvi include: decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting).
Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects.
Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you:
have an infection
have kidney problems
are pregnant or plan to become pregnant. Columvi may harm your unborn baby
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with Columvi.
You should use effective birth control (contraception) during treatment and for 1 month after your last dose of Columvi. Talk to your healthcare provider about what birth control method is right for you during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Columvi.
are breastfeeding or plan to breastfeed. Columvi may pass into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of Columvi.
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 Columvi?
Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems.
These are not all the possible side effects of Columvi. Talk to your health care provider for more information about the benefits and risks of Columvi.
You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. 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 Columvi full Prescribing Information and Medication Guide or visit https://www.Columvi.com.
About Genentech in hematology
For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we're investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Genentech Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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Also on display at #SNMMI25, as part of GE HealthCare's comprehensive portfolio of theranostics-enabling solutions for clinical and operational excellence, are the following innovations: MINItrace Magni, iii GE HealthCare's newest cyclotron technology, designed with a small footprint (about the size of a commercial refrigerator) and the goal of providing an easy-to-site, easy-to-install solution for the reliable, in-house production of commercial PET tracers and radiometals, including Gallium-68, used in diagnostic imaging to support personalized care plans. Adoption of such easy-to-site, easy-to-install technology may help enhance the capabilities of the healthcare system but also grant clinicians the ability to offer a variety of tracers to their patients and encourage the practice of precision care locally, helping fuel inhouse Theranostics capabilities. Omni Legend is a performance-focused PET/CT designed to evolve and help meet growing healthcare system demands by enabling clinicians to reduce dose by up to 40% iv while maintaining exceptional image quality. Supportive of the diagnostic portion of theranostics, the system continues to gain in popularity, representing the company's fastest-ever-selling PET/CT. v StarGuide is a digital SPECT/CT with a 12 CZT detector design that delivers high-quality 3D images and short scan times. Optimized for certain theranostic procedures, the system is designed to help clinicians pinpoint the size, shape, and position of lesions and monitor therapy with exceptional precision. Its flexibility in patient scanning and workflow efficiencies also support high patient throughput and help reduce complexity. For oncology patients, especially those in pain, short scans can help enhance comfort and overall experience. Aurora is an advanced dual-head SPECT/CT designed with excellent diagnostic capabilities vi and streamline workflows, offering clinicians excellent image quality and operational efficiency. Its CT has a 40 mm detector – twice the detector coverage compared to CTs of other hybrid systems vii – with the ability to reduce the dose up to 82%, viii support accurate quantitation, and help clinicians make the personalized care decisions that are at the heart of theranostics. Theranostics Pathway Manager Tile is an easy-to-use application, available on GE HealthCare's Command Center software, that is designed to simplify the time-consuming task of coordinating the theranostics care pathway. It does so by tracking patient readiness for therapy, eliminating the need for manual data gathering across disparate systems (e.g., labs, scheduling, ordering, spreadsheets), and providing a unified, up-to-date view of each patient's treatment journey. Oregon Health & Science University will be an early adopter. 'Every day counts when it comes to cancer care. The latest theranostics solutions will help our care teams more quickly and easily keep tabs on patient readiness and reduce patient coordination time—freeing up more time for clinicians to focus on direct patient care,' says Erik Mittra, M.D., Ph.D., professor of diagnostic radiology in the at Oregon Health & Science University. Altogether, GE HealthCare has the unique ability to provide solutions along every step of the theranostics care pathway. Our integrated portfolio of solutions provides clinicians with the isotopes, imaging, informatics, and molecular imaging agents necessary for the practice and advancement of precision care. For more information on GE HealthCare's innovative portfolio of theranostics-enabling solutions, please visit SNMMI show attendees are also encouraged stop by the company's booth (#638 and #1023) at New Orleans Ernest N. Morial Convention Center in New Orleans, Louisiana from June 21-24. About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient's journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits. GE HealthCare is proud to be among 2025 Fortune World's Most Admired Companies™. Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website for more information. i LesionID Pro with automated zero-click pre-processing is 510(k)-pending with the U.S. FDA. Not CE Marked and not licensed in accordance with Canadian law. Not available for sale in the United States, Europe, Canada, or any other region. ii Cancer. World Health Organization. Published February 3, 2022. Accessed March 2, 2023. iii Technology in development that represents ongoing research and development efforts. These technologies are not products and may never become products. Not CE marked. iv Omni Legend 21cm as compared to Discovery MI Gen1 20cm. As demonstrated in phantom testing. v Based on orders data of GE HealthCare PET/CT systems since 2010. vi Compared to NM/CT 870 DR. vii As compared to NM/CT 870 DR with Optima 540 CT. viii a ASiR-V reduces dose by 50% to 82% relative to FBP at the same image quality (Image quality as defined by low contrast detectability). viii b In clinical practice, the use of ASiR‐V may reduce CT patient dose depending on the clinical task, patient size, anatomical location, and clinical practice. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task. Low Contrast Detectability (LCD), Image Noise, Spatial Resolution and Artifact were assessed using reference factory protocols comparing ASiR‐V and FBP. The LCD was measured using 0.625 mm slices and tested for both head and body modes using the MITA CT IQ Phantom (CCT183, The Phantom Laboratory), using a model observer method.

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20 hours ago

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CCS Presents Four Peer-Reviewed Posters at American Diabetes Association's 85th Scientific Sessions

CHICAGO--(BUSINESS WIRE)-- CCS, a leading provider of clinical solutions and home-delivered medical supplies for those living with chronic conditions, will present four peer-reviewed posters at the American Diabetes Association's (ADA) 85th Scientific Sessions, which will take place June 20–23 in Chicago. These latest poster presentations illustrate CCS's focus on delivering evidence-based approaches to diabetes care management that ensure patients have the education and coaching they need to thrive and cost-effectively stay adherent while managing their chronic condition. "At CCS, we meet patients where they are — with empathy, education, and evidence-based support..." Share The ADA Scientific Sessions is a globally recognized conference dedicated to advancing the field of diabetes. This annual meeting serves as a critical forum for presenting cutting-edge research, innovation, and new evidence-based approaches to diabetes prevention, management, and care. Presentation Highlights from CCS at the ADA Scientific Sessions CCS's clinical strategy and innovation vice president, Coni Dennis, DNP, RN, and NE-BC, will present findings for all four accepted poster presentations at the ADA's 85th Scientific Sessions, and she shared this insight leading into the event: 'At CCS, we meet patients where they are — with empathy, education, and evidence-based support. These poster presentations reflect our commitment to improving health outcomes for people with diabetes by combining data-driven clinical insight with hands-on, compassionate care.' All poster presentations will take place at the conference on Sunday, June 22, from 12:30–1:30 p.m. CT in West Hall F1. The following are the four specific posters that CCS will be presenting: Presentation Title: Evaluating the Impact of Multichannel Diabetes Care Coaching and Education in Patients New to Continuous Glucose Monitoring Abstract Number: 534 Summary: This study, part of an ongoing randomized control trial (RCT), evaluated whether adults with diabetes newly starting a continuous glucose monitor (CGM) achieve better outcomes when they receive diabetes self-management education and support (DSMES) from a certified diabetes care and education specialist (CDCES), compared to using a CGM alone. Presentation Title: Examining the Impact of Continuous Glucose Monitoring Sourcing in Medicaid Patients — Adherence, Healthcare Costs, and Utilization Abstract Number: 1046 Summary: This study compared healthcare costs and utilization among Medicaid beneficiaries who received CGM supplies through a pharmacy or a durable medical equipment provider. Presentation Title: Healthcare Costs and Utilization Among Patients Eligible for Continuous Glucose Monitors — A Comparison of Users and Nonusers Abstract Number: 1049 Summary: This retrospective cohort study used claims data to compare glycemic control, healthcare utilization, and total cost of care over 12 months among individuals on bolus insulin who used CGMs versus those who did not. It also assessed the incidence of hypoglycemia and diabetic ketoacidosis (DKA). Presentation Title: Evaluating an Evidence-Based Quality Improvement Initiative for Food Insecurity Screening and Referral in Adults with Diabetes Initiating Continuous Glucose Monitor Therapy Abstract Number: 1143 Summary: This study assessed food insecurity (FI) among adults with diabetes initiating CGM therapy, comparing rates to national averages and examining glycemic outcomes between food-insecure and food-secure individuals. These posters will be made available on the American Diabetes Association's website after August 25. About CCS CCS is the strategic partner addressing America's most pressing healthcare challenges through intelligent chronic care management, tackling the $412 billion annual diabetes burden and chronic conditions affecting over 133 million Americans. At the core of CCS's differentiated model is LivingConnected®, a human-led, digitally enabled clinical solution. PropheSee™ — an AI-powered predictive model that identifies nonadherence risk and delivers personalized interventions — is an integral part of this solution, creating a first-of-its-kind platform to improve adherence, enhance clinical outcomes, and help prevent costly hospitalizations. By combining data-driven insights with three decades of industry relationships, CCS is the smart choice for health plans, providers, employers, and manufacturers who believe that value-based care starts by keeping patients healthy and delivers benefits like lower cost of care, improved HEDIS scores, and alleviating provider burnout. CCS's approach extends clinical reach while supporting over 200,000 people nationwide with home-delivered medical supplies and pharmaceuticals annually. Recognized as a Great Place to Work® and with numerous peer-reviewed publications validating our care management approach, CCS is more than a trusted supplier — we're a partner in transforming chronic care delivery. To learn more about how CCS is addressing today's healthcare challenges, visit or connect with us on LinkedIn.

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20 hours ago

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OrsoBio to Present Preclinical Data on Mitochondrial Protonophore Portfolio in Models of Obesity at the American Diabetes Association's 85th Scientific Sessions

MENLO PARK, Calif.--(BUSINESS WIRE)--OrsoBio, Inc. ('OrsoBio' or 'the Company'), a clinical-stage biopharmaceutical company developing treatments for obesity and obesity-associated disorders, today announced new preclinical data being presented at the 85th Scientific Sessions of the American Diabetes Association (ADA) being held June 20-23, 2025, in Chicago, Ill. The Company will present three abstracts highlighting the efficacy of its mitochondrial protonophores to induce weight loss and provide glycemic benefits while preserving lean mass in diet-induced obese (DIO) mice. The studies demonstrate the potential of TLC-6740 and TLC-1180—as monotherapy and in combination with the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide—for both the induction and maintenance of weight loss following incretin treatment. 'The mechanism of our mitochondrial protonophores to increase energy expenditure complements that of incretins to enhance and sustain weight loss and provide additive metabolic benefits,' said Mani Subramanian, MD, PhD, Chief Executive Officer of OrsoBio. 'These preclinical findings mark an important step in fulfilling our mission to develop innovative, effective, oral therapies for obesity that preserve muscle and support cardiometabolic health.' OrsoBio is advancing a pipeline of novel therapies targeting obesity through mechanistically distinct and complementary approaches. The Company's lead candidates include TLC-6740 and TLC-1180, both mitochondrial protonophores that promote weight loss by increasing energy expenditure. In addition, OrsoBio is developing TLC-3595, a selective inhibitor of acetyl-CoA carboxylase 2 (ACC2), designed to enhance fat oxidation. "GLP-1 receptor agonists have transformed obesity treatment but are limited by gastrointestinal side effects and loss of muscle mass,' said Rob Myers, MD, Chief Medical Officer of OrsoBio. 'Our preclinical data show that our mitochondrial protonophores drive sustained, fat-selective weight loss and metabolic benefits when combined with or sequenced after GLP-1 receptor agonists. These findings support our ongoing Phase 1b study of TLC-6740 in combination with tirzepatide (NCT05822544)." Poster information: Sequential Combination of the Mitochondrial Protonophore TLC-6740 With Semaglutide Normalizes Body Weight and Preserves Lean Mass in DIO Mice Abstract #1687-P Poster Session: Monday, June 23, 2025 (12:30 - 1:30 p.m. CT) This preclinical study assessed TLC-6740 alone, in combination with low-dose semaglutide (sequential combination), and as maintenance therapy following semaglutide discontinuation in DIO mice. The sequential combination of TLC-6740 with low-dose semaglutide produced superior body weight and fat mass loss, and improved glycemic parameters compared with TLC-6740 alone and high-dose semaglutide. Initiating TLC-6740 after semaglutide discontinuation maintained body weight and fat mass loss, and glycemic benefits. These findings support evaluation of TLC-6740 in combination with incretins in people living with obesity; a 24-week combination study of TLC-6740 with tirzepatide is ongoing (NCT05822544). De Novo or Sequential Combination of the Mitochondrial Protonophore TLC-1180 With Semaglutide Improves Weight Loss and Preserves Lean Mass in DIO Mice Abstract #1694-P Poster Session: Monday, June 23, 2025 (12:30 - 1:30 p.m. CT) This preclinical study evaluated the effects of TLC-1180 alone, in combination with semaglutide, and as a maintenance treatment following semaglutide discontinuation in DIO mice. As monotherapy, TLC-1180 demonstrated body weight and fat mass loss and preserved lean mass. Body weight and fat mass loss were amplified, and lean mass was preserved with TLC-1180 in combination with semaglutide. These benefits persisted when TLC-1180 was used as a maintenance treatment after semaglutide discontinuation. These data highlight the potential of TLC-1180 as monotherapy, in combination with incretins, or as maintenance therapy post incretin discontinuation in people living with obesity. Novel Combination of a Mitochondrial Protonophore and an Acetyl-CoA Carboxylase 2 (ACC2) Inhibitor Causes Weight Loss and Preserves Lean Mass in Obese Mice Abstract #1686-P Poster Session: Monday, June 23, 2025 (12:30 - 1:30 p.m. CT) This preclinical study evaluated the effects of the mitochondrial protonophore, TLC-1180, and the ACC2 inhibitor, TLC-3595—as monotherapy and in combination—and semaglutide in DIO mice. TLC-3595 dose dependently reduced body weight, fat mass, and liver biochemistry while preserving lean mass in DIO mice. A combination of TLC-3595 with TLC-1180 had similar weight loss efficacy to semaglutide, but preserved lean mass. Taken together, these data suggest that the novel, all-oral, non-incretin combination of TLC-3595 and TLC-1180 may cause similar weight loss to incretins and may afford additional advantages, including improved weight loss quality and/or tolerability (e.g., reduced incidence of gastrointestinal adverse events). About TLC-6740 TLC-6740 is a novel, oral, liver-targeted mitochondrial protonophore in development for the treatment of obesity and obesity-associated diseases, including diabetes and MASH. Based on active hepatic uptake and mitochondrial protonophore activity, TLC-6740 increases energy expenditure in hepatocytes, and is expected to have broad, systemic metabolic and cardiovascular benefits, including weight loss, improved insulin sensitivity, and as a treatment for MASH, and dyslipidemia. TLC-6740 is currently being evaluated in a Phase 1b clinical trial, as monotherapy and in combination with tirzepatide, in patients living with obesity (NCT05822544). About TLC-1180 TLC-1180 is a novel, potent, long-acting mitochondrial protonophore that has been shown to increase energy expenditure in mice with diet-induced obesity (DIO). In preclinical studies of DIO mice, TLC-1180 induced weight loss, improved glucose control, and enhanced the efficacy of GLP-1 receptor agonists, both as a single agent and in combination with incretins. TLC-1180 is currently completing IND-enabling studies and a first-in-human study is expected to initiate in 2025. About TLC-3595 TLC-3595 is a novel and selective ACC2 inhibitor designed to treat obesity and type 2 diabetes by increasing fatty acid oxidation (FAO), reducing ectopic lipid accumulation, and improving insulin sensitivity in skeletal muscle and liver. The compound may also have potential as a treatment for other conditions characterized by impaired FAO, including heart failure with preserved ejection fraction (HFpEF) and metabolic dysfunction-associated steatohepatitis (MASH). About OrsoBio, Inc. OrsoBio, Inc. is a privately held, clinical-stage biopharmaceutical company dedicated to developing therapies to treat obesity and obesity-associated disorders, including type 2 diabetes, MASH, and severe dyslipidemias. OrsoBio currently has four programs in clinical and preclinical development with first-in-class compounds that address central pathways in energy metabolism. For more information, please visit