On December 8, 2025 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported positive new data from its pipeline of allogeneic T-cell immunotherapies at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

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Orca-Q with and Without the Use of GvHD Prophylaxis

A subset of the multi-center Phase 1 clinical trial evaluated Orca-Q, Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), myelofibrosis (MF), myelodysplastic syndrome (MDS) and mixed phenotype acute leukemia (MPAL) with HLA-matched related and unrelated donors. New data evaluating Orca-Q with and without the use of pharmacological graft versus host disease (GvHD) prophylaxis showed encouraging outcomes including rapid neutrophil recovery and low rates of acute and chronic GvHD, relapse and non-relapse mortality (NRM).

"Controlling alloreactivity and reducing GvHD following a conventional stem cell transplant typically requires multi-agent immunosuppression. However, this can impair immune reconstitution and increase the risk of organ toxicity, infection and relapse," said presenting author Samer Srour, M.D., Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center. "In these new findings, Orca-Q demonstrated encouraging outcomes even without the use of any pharmacological GvHD prophylaxis. While ongoing enrollment is important to further validate these results, the data suggest that Orca-Q may be able to control alloreactivity and potentially offer a platform to improve transplant outcomes through controlling GvHD and infection and reducing non-relapse mortality without increasing the risk of relapse."

Patients on Arm A received Orca-Q and single-agent tacrolimus (tac, n=18) while patients on Arm C received Orca-Q and no immune suppression (n=26). Median time to neutrophil engraftment was 15 days for patients who received tac and 11 days for patients who did not. Orca-Q was well-tolerated with 94% overall survival (OS) at one year for patients with tac and 87% for patients without tac. At one year, GvHD-and-relapse-free survival (GRFS) was 77% with tac and 79% without tac, and NRM was 6% and 0% with tac and without tac, respectively. Relapse-free survival (RFS) at one year was 88% with tac and 87% without tac. At Day 180, moderate-to-severe chronic GvHD was 12% with tac and 0% without tac. Grade 3-4 acute GvHD was 8% and 6% with and without tac, respectively.

Importantly, Orca-Q patients treated without GvHD prophylaxis demonstrated more rapid immune reconstitution and improved control of infections. Specifically, BMT CTN Grade 2+ infections at one year were 33% with tac and 17% without tac.

Orca-T and CAR-T Combination Treatment Versus Autologous CAR-T

A second oral presentation compared the results from two separate Phase 1 trials in adults with high-risk relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL). The first trial evaluated OrCAR-T (n=16), a treatment that combines Orca-T and allogeneic CD19/CD22 CAR-T cells, and the second trial evaluated an autologous CD19/22 (n=17). At 18 months, progression-free survival (PFS) and OS were 100% and 100% with OrCAR-T, and 38.5% and 77% in the autologous cohort. Toxicities were mild across both cohorts, with no grade 3-4 CAR-related toxicities reported. At a median follow-up of 2.5 years, there were no relapses or patient deaths with OrCAR-T and seven deaths with autologous, six from refractory B-ALL.

"Among adults with B-ALL, CAR-T therapy is often followed by a consolidative allogeneic transplant to achieve long-term remission," said Lori Muffly, M.D., associate professor in the Division of Blood and Marrow Transplantation-Cellular Therapies at Stanford Health Care. "Emerging data showing improved progression-free survival in patients with a prior transplant has prompted interest in exploring whether combining a high-precision allogeneic therapy like Orca-T with CAR-T cells could provide a feasible, all-in-one treatment. While these findings are early, they suggest this approach has the potential to benefit patients across a range of hematologic diseases."

"Our team is encouraged by these new findings from our broader pipeline programs, including results that highlight the potential to eliminate the need for GvHD prophylaxis while preserving immune reconstitution with Orca-Q," said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. "The durability of Orca-T when combined with CAR-T therapy exemplifies how our high-precision approach may be applied to expand treatment options both within and beyond hematologic malignancies. Overall, these results reinforce our continued focus on advancing our pipeline to bring this high- precision platform to more patients who could potentially benefit."

About Orca-Q

Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy under evaluation in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.

(Press release, Orca Bio, DEC 8, 2025, View Source [SID1234661299])

On December 8, 2025 Qihan Biotech, a clinical-stage biotechnology company developing off-the-shelf cell therapies for autoimmune diseases and cancer, including allogeneic CAR-T and in vivo CAR-T therapies, reported an oral and several poster presentations at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The data included encouraging clinical results with the company’s allogeneic CAR-T program and foundational preclinical work supporting its emerging in vivo CAR-T program.

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Qihan’s oral presentation highlighted clinical data from 20 patients enrolled in three investigator-initiated trials evaluating QT-019B in multiple autoimmune diseases. Treatment was well tolerated, with no events exceeding Grade 1 CRS and no reported ICANS or serious infections.

Across multiple severe autoimmune indications, QT-019B demonstrated clinical benefit in patients dosed at therapeutically relevant levels (n=19), with one subtherapeutic-dose patient excluded from the efficacy summary.

SLE-ITP (n=6): 5 complete responses (CR) with normalized platelet counts and 1 partial response (PR)
APS-associated ITP (n=5): 4 CR with normalized platelet counts
AIHA (n=3): 2 CR with normalized hemoglobin
SLE (n=2): 1 DORIS remission and 1 SRI-4 response at Month 2
Neurological autoimmune diseases (NMOSD and MS; n=3): 2 EDSS stabilization; 1 too soon to assess
Pharmacokinetic and pharmacodynamic readouts reinforce the potential of Qihan’s immune-privileged platform to deliver durable, systemic immune reset.

Robust expansion of allogeneic CAR-T cells observed in 17 of 19 patients treated at therapeutic dose levels
Deep and sustained depletion of pathogenic autoantibodies, consistent with the intended immune-reset mechanism
In MS, early CSF analyses showed rapid and durable clearance of oligoclonal bands (OCB) and kappa free light chains (kFLC)
Qihan’s QT-019B program is supported by IND clearance for rSLE from both the US FDA and the China NMPA. The FDA has also granted Fast Track Designation for the SLE-ITP indication. Phase 1 enrollment is actively underway.

Qihan’s unique "immune-privileged" platform – built on the company’s world-leading capabilities in multiplexable gene editing and deep understanding of transplantation immunology – enables creation of next-generation cells capable of evading immune attack. The platform is uniquely designed to address the biological and translational barriers that have limited progress across the CAR-T field. A primary barrier is immune rejection, where host T and NK cells rapidly eliminate donor cells, limiting expansion and persistence, and preventing cells from surviving long enough to achieve durable clinical benefit. Another major challenge is the need for lymphodepletion, which is associated with organ damage and broad toxicities. Qihan is developing the next generation product QT-019C, which aims to overcome both immune rejection and the dependence on lymphodepletion. Across its oral and poster sessions, the company has demonstrated scientific rigor, clinical relevance, and platform scalability that collectively address these critical obstacles.

"Autologous therapies have shown what cell therapy can achieve, but they are not scalable for autoimmune disease. Efforts to develop off-the-shelf allogeneic approaches have been challenging due to immune rejection, limited expansion and persistence, and the need for lymphodepletion. Our data show a different path," said Luhan Yang, Ph.D., Chief Executive Officer of Qihan Biotech. "Our first-generation program demonstrates strong safety, robust in vivo expansion, meaningful efficacy, and evidence of immune reset. Our next-generation product, which is now in human testing in an IIT, goes further. By driving deeper hypoimmunity and enhanced expansion and persistence, it provides the possibility to eliminate lymphodepletion. We believe we are overcoming the key barriers that have constrained the field and opening the door to broadly accessible, off-the-shelf cell therapies."

Details of the oral and posters being presented are as follows:

Designing immune-evasive UCAR-T cells to overcome allogeneic barriers and advance off-the-shelf immunotherapy
Publication Number: 1045 (Oral Session)
Session Title: 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Refining CAR-T Cells and Engineered HSPCs; New Approaches to HSPC mobilization
Session Date & Time: December 8, 2025, at 4:30PM – 4:45 PM EST

Engineering Quiescent Viral Entry Pathways for in Vivo CAR-T Generation via Binder-Fusogen Combinatorics
Publication Number: 2404
Session Title: 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Poster I
Session Date & Time: December 6, 2025, at 5:30PM – 7:30 PM EST

Cytokine receptor armored CAR-T cells enable robust T cell expansion and function in the absence of lymphodepletion
Publication Number: 4104
Session Title: 702. CAR-T Cell Therapies: Basic and Translational: Poster II
Session Date & Time: December 7, 2025, at 6:00PM – 8:00 PM EST

Enhanced vsvg variants for binder‑dependent and high‑specificity transduction of primary T cells
Publication Number: 4181
Session Title: 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Poster II
Session Date & Time: December 7, 2025, at 6:00PM – 8:00 PM EST

Rapid normalization of platelet counts in patients with refractory thrombocytopenia associated with systemic lupus erythematosus (SLE) following treatment with allogeneic dual-target CD19/BCMA CAR T-cell therapy (QT-019B)
Publication Number: 3031
Session Title: 311. Disorders of Platelet Number or Function: Clinical and Epidemiological: Poster II
Session Date & Time: December 7, 2025, at 6:00PM – 8:00 PM EST

Allogeneic Dual-Target CD19/BCMA CAR T-Cell Therapy (QT-019B) for Refractory Autoimmune Hemolytic Anemia
Publication Number: 5922
Session Title: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III
Session Date & Time: December 8, 2025, at 6:00PM – 8:00 PM EST

About QT-019B
QT-019B is Qihan Biotech’s first-generation allogeneic CAR-T therapy designed to treat severe autoimmune diseases. Engineered using Qihan’s immune-privileged platform, QT-019B incorporates multiplex gene edits to enhance expansion, persistence, and resistance to immune rejection. QT-019B has demonstrated encouraging safety and clinical activity in multiple investigator-initiated trials and has been cleared by US FDA and China NMPA for further clinical development. QT-019B has received FDA Fast Track Designation for SLE-ITP.

QT-019B has been evaluated in the following autoimmune diseases:
SLE: Systemic Lupus Erythematosus
SLE-ITP: Systemic Lupus Erythematosus–associated Immune Thrombocytopenia
APS-ITP: Antiphospholipid Syndrome–associated Immune Thrombocytopenia
AIHA: Autoimmune Hemolytic Anemia
MS: Multiple Sclerosis
NMOSD: Neuromyelitis Optica Spectrum Disorder

(Press release, Qihan Biotech, DEC 8, 2025, View Source [SID1234661298])

On December 8, 2025 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported new data highlighting the potential of Lunsumio (mosunetuzumab-axgb) in earlier treatment lines for people living with different types of lymphoma, presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, December 6-9, 2025 in Orlando, Florida.

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"These data underscore the potential of Lunsumio to support more people living with lymphoma, building on the clinical benefit observed in later-stage follicular lymphoma," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "Moreover, the combinatorial potential of Lunsumio is evident in the two-drug regimens presented, which may enable outpatient treatment while preserving deep and durable efficacy."

Preliminary data support the potential for Lunsumio in combination with lenalidomide in relapsed or refractory (R/R) follicular lymphoma (FL)

First data from the single-arm extension of the Phase III CELESTIMO study, in 54 patients, demonstrated promising efficacy with this two-drug regimen in people with second-line or later (2L+) FL, including a complete response (CR) rate of 87.0% (95% confidence interval [CI]: 75.1–94.6). Cytokine release syndrome (CRS) events were reported in 27.8% of patients, and were predominantly low grade (Grade (Gr) 1: 22.2%; Gr 2: 3.7%; Gr 3: 1.9%), with all CRS events resolved. Neutropenia occurred in 40.7% of patients, and infections occurred in 57.4% of patients. These results indicate the potential of this combination to deliver meaningful outcomes earlier in the disease course. Primary analysis of the pivotal Phase III CELESTIMO study is anticipated in 2026.

Subcutaneous (SC) Lunsumio plus Polivy (polatuzumab vedotin-piiq) data demonstrate meaningful improvements for people with R/R large B-cell lymphoma (LBCL)

Long term follow-up data from the Phase Ib/II GO40516 study demonstrated sustained improvements in patients treated with investigational SC Lunsumio in combination with Polivy compared to those treated with Rituxan (rituximab) and Polivy in people with 2L+ LBCL. The overall response rate (ORR) was 77.5% (95% CI: 61.6–89.2) vs 50.0% (95% CI: 33.8–66.2) and median progression-free survival was 25.4 (95% CI: 9.2– not evaluable ) vs 6.4 months (95% CI:4.7–18.6). No new safety signals were identified. Adverse events (AE) included neutrophil count decreased/neutropenia (40%), febrile neutropenia (2.5%), infections (45%), and peripheral neuropathy (10%). Patient-reported outcomes from the Phase III SUNMO study investigating the same combination, demonstrated benefits across multiple aspects of health-related quality of life measures in comparison to Rituxan with gemcitabine and oxaliplatin particularly in maintaining or improving physical functioning, fatigue, lymphoma symptoms and peripheral neuropathy.

Results from these studies highlight the potential of this outpatient combination to prolong remission and improve outcomes for people living with this aggressive disease, without the need for conventional chemotherapy.

Long-term follow-up data show sustained responses with fixed-duration investigational SC Lunsumio and intravenous (IV) in third line or later (3L+) FL

Five-year follow-up data from the pivotal Phase II GO29781 study, the longest reported follow-up for a CD20xCD3 bispecific in R/R FL, showed durable remissions with IV Lunsumio, with a 5-year overall survival rate of 78.5% (95% CI: 69.6–87.4) and 54-month duration of CR rate (DOCR) of 52.0% (95% CI: 36.1-67.9). Furthermore, three-year follow-up data demonstrated durable responses with investigational SC Lunsumio with an ORR of 74.5%, CR rate of 62.8%, and 30-month DOCR of 53.0% (95% CI: 38.7-67.4). No new safety signals were observed in either study.

Lunsumio monotherapy is approved in over 60 countries for people with FL who have received at least two prior systemic therapies, with ongoing discussions with additional health authorities worldwide. SC Lunsumio was recently approved by the European Commission for FL after two or more lines of systemic therapy. A decision from the US Food and Drug Administration is expected soon.

Lunsumio, along with Columvi (glofitamab-gxbm), is part of Genentech’s industry-leading CD20xCD3 bispecific antibody portfolio. Continuing to explore new formulations and combinations of these medicines across different disease areas and lines of treatment is part of Genentech’s commitment to improve the patient experience and provide more choice to suit diverse patient and healthcare system needs.

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 diffuse large B-cell lymphoma (DLBCL)

Diffuse large B-cell lymphoma (DLBCL) is an aggressive (fast-growing) blood cancer and is the most common form of non-Hodgkin’s lymphoma in the U.S. 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.

About follicular lymphoma (FL)

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 more than 110,000 people are diagnosed with FL each year worldwide.

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 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 or visit View Source

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.

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 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 Columvi full Prescribing Information and Medication Guide or visit View Source

(Press release, Genentech, DEC 8, 2025, View Source [SID1234661297])

On December 8, 2025 Daiichi Sankyo (TSE: 4568) reported it will present new breast cancer clinical research across its DXd antibody drug conjugate (ADC) portfolio from more than 30 abstracts at the 2025 San Antonio Breast Cancer Symposium (#SABCS25), which include four rapid fire mini-oral sessions and other presentations from five landmark trials of ENHERTU (trastuzumab deruxtecan) and DATROWAY (datopotamab deruxtecan) across a broad spectrum of breast cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Four rapid fire mini-oral sessions will feature ENHERTU data in the curative-intent and metastatic settings of HER2 positive breast cancer, including two presentations from the DESTINY-Breast11 phase 3 trial highlighting patient reported outcomes (RF6-06) and further safety analyses (RF6-02) of ENHERTU followed by paclitaxel, trastuzumab and pertuzumab (THP) compared to dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP) in the neoadjuvant setting (before surgery) in patients with high-risk, locally advanced HER2 positive early-stage breast cancer. Additional efficacy and safety data (RF6-01) from the DESTINY-Breast05 phase 3 trial comparing ENHERTU to trastuzumab emtansine (T-DM1) as a post-neoadjuvant (after surgery) therapy in patients with high-risk HER2 positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes also will be highlighted.

The fourth rapid fire presentation will feature patient reported outcomes (RF6-07) from the ENHERTU plus pertuzumab arm of the DESTINY-Breast09 phase 3 trial as a first-line treatment of HER2 positive metastatic breast cancer. Interim results from DESTINY-Breast09 were recently published in The New England Journal of Medicine, marking the eighth pivotal trial of ENHERTU to be published in the prestigious journal.

Additional updates from two other landmark breast cancer trials include poster presentations featuring the final analysis and five-year follow-up of efficacy and safety data (PS5-01-30) from the DESTINY-Breast03 phase 3 trial comparing ENHERTU versus T-DM1 as a second-line treatment of HER2 positive metastatic breast cancer, and further safety analysis (PS5-03-05) from the TROPION-Breast02 phase 3 trial of DATROWAY, the first trial ever to demonstrate a significant improvement in overall survival compared to chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy is not an option.

"Our latest research across these five landmark trials demonstrate how the DXd antibody drug conjugate portfolio of Daiichi Sankyo continues to potentially transform standards of care for patients with breast cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "We remain committed to following the science and collaborating with the breast cancer community to create innovative medicines that advance the treatment of breast cancer."

Additional data from the DESTINY clinical trial program to be highlighted in poster presentations at SABCS include an exploratory post-hoc subgroup analysis by hormone receptor status from the DESTINY-Breast12 phase 3b/4 trial (PS5-01-27) of ENHERTU in patients with HER2 positive metastatic breast cancer and brain metastases; the final results from the ENHERTU monotherapy and ENHERTU plus pertuzumab arms of the DESTINY-Breast07 phase 1b/2 trial (PS5-01-14) in patients with previously untreated HER2 positive metastatic breast cancer; and, initial characteristics of first enrolled patients from the DESTINY Breast Respond HER2 Low Europe non-interventional study (PS5-08-14) of ENHERTU in HER2 low metastatic breast cancer.

Collaborations Supporting Innovation in Breast Cancer Research
Additional data presented at SABCS include results from four externally sponsored trials across the DXd ADC pipeline of Daiichi Sankyo. Two spotlight poster presentations will report interim results from the HALLOW prospective observational trial (PD13-11) evaluating the efficacy and safety of ENHERTU in patients with HER2 low (IHC 1+ or 2+/ISH-) metastatic breast cancer with and without active brain metastases in Japan, and a post-hoc pooled efficacy analysis (PD13-10) from the TUXEDO-3 phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with HER2 positive metastatic breast cancer and active brain metastases or leptomeningeal disease previously treated with ENHERTU. Results from cohorts 1 and cohorts 2 of the TUXEDO-3 trial were recently published in The Lancet Oncology and results from cohort 3 were published in Nature Medicine.

Two poster presentations will report on the intracranial and/or extracranial activity of ENHERTU and DATROWAY. A translational ctDNA analysis of intracranial and extracranial activity (PS2-08-20) of ENHERTU from the DEBBRAH phase 2 trial in patients with HER2 positive and HER2 low breast cancer with leptomeningeal disease will be highlighted, as well as results of intracranial activity (PS1-09-02) of DATROWAY from the DATO-BASE phase 2 trial in patients with HER2 negative breast cancer with leptomeningeal disease.

Trials-in-Progress Across Breast Cancer Portfolio of Daiichi Sankyo
Several trials-in-progress poster presentations at SABCS further highlight research underway to address a broad spectrum of unmet needs for patients with breast cancer.

Additional externally sponsored trials for ENHERTU and DATROWAY include the PONTIAC phase 2 trial (PS5-07-15) evaluating ENHERTU versus CDK4/6 inhibitor-based endocrine therapy as a first-line treatment of non-luminal HR positive, HER2 low and HER2 ultralow advanced breast cancer; a phase 1b trial (PS5-09-22) evaluating ENHERTU in combination with valemetostat, an EZH1/2 inhibitor, in patients with HER2 low, HER2 ultralow and HER2 null metastatic breast cancer; and the TROPION-Breast06 phase 3b trial (PS5-07-21) of DATROWAY in patients with HR positive, HER2 IHC 0 inoperable or metastatic breast cancer refractory to endocrine therapy.

Three additional trials-in-progress from the HERTHENA clinical development program of patritumab deruxtecan (HER3-DXd) also will be highlighted. These include the HERTHENA-Breast04 phase 3 trial (PS5-07-22) evaluating patritumab deruxtecan versus physician’s choice of treatment in patients with HR positive, HER2 negative unresectable locally advanced or metastatic breast cancer; the HERTHENA-Breast03 phase 2 trial (PS5-12-21) evaluating neoadjuvant patritumab deruxtecan plus pembrolizumab before or after pembrolizumab plus chemotherapy in patients with high-risk early-stage TNBC or HR low positive/HER2 negative breast cancer; and, the HERTHENA-Breast01 phase 1b/2 trial (PS5-12-23) evaluating patritumab deruxtecan in combination with HER2 targeted agents in patients with HER2 positive unresectable locally advanced or metastatic breast cancer.

Science & Technology Day
Daiichi Sankyo will hold its annual Science & Technology Day for investors on Monday, December 15, 2025, from 5:30 to 7:30 pm ET / Tuesday, December 16, 2025, from 7:30 – 9:30 am JST. Executives from Daiichi Sankyo will provide an update on R&D, business and manufacturing developments across the portfolio.

Daiichi Sankyo Presentation Highlights at SABCS

Presentation Title

Author

Abstract

Presentation (CST)

ENHERTU (trastuzumab deruxtecan; T-DXd)

Patient-reported outcomes in DESTINY-Breast11: neoadjuvant treatment with trastuzumab deruxtecan (T-DXd) alone or followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in high-risk, HER2+ early-stage breast cancer

S. Modi

RF6-06

Rapid Fire 6
Mini-Oral Session
Wednesday, December 10
1:00 – 2:00 pm

DESTINY-Breast11 safety: neoadjuvant trastuzumab deruxtecan (T-DXd) alone or followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in high-risk, HER2+ early-stage breast cancer

G. Curigliano

RF6-02

Rapid Fire 6
Mini-Oral Session
Wednesday, December 10
1:00 – 2:00 pm

Additional efficacy and safety from the DESTINY-Breast05 study of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T‑DM1) in patients with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary early breast cancer with residual invasive disease after neoadjuvant therapy

S. Loibl

RF6-01

Rapid Fire 6
Mini-Oral Session
Wednesday, December 10
1:00 – 2:00 pm

Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for first-line treatment of patients with HER2 positive (HER2+) advanced/metastatic breast cancer: patient-reported outcomes from the DESTINY-Breast09 study

M. Rimawi

RF6-07

Rapid Fire 6
Mini-Oral Session
Wednesday, December 10
1:00 – 2:00 pm

Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer: final analysis from DESTINY-Breast03

S. Im

PS5-01-30

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

Trastuzumab deruxtecan (T-DXd) monotherapy and T-DXd + pertuzumab in patients with previously untreated HER2+ unresectable/metastatic breast cancer: final results from DESTINY-Breast07

F. Andre

PS5-01-14

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

Outcomes by hormone receptor status in patients with HER2+ advanced/metastatic breast cancer with brain metastases treated with trastuzumab deruxtecan (T-DXd): a post-hoc subgroup analysis of DESTINY-Breast12

H. Wildiers

PS5-01-27

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

DESTINY-Breast Respond HER2 low Europe: description of first enrolled patients in the non-interventional study of T-DXd in HER2 low metastatic breast cancer

V. Guarneri

PS5-08-14

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

Interim analysis results for the effectiveness and safety of trastuzumab deruxtecan in patients with HER2 low breast cancer and brain metastases: the HALLOW study

N. Niikura

PD13-11

Poster Spotlight 13
Friday, December 12
7:00 – 8:30 am

Translational analysis of cerebrospinal fluid and plasma circulating tumor DNA from breast cancer patients with leptomeningeal disease treated with trastuzumab deruxtecan (T-DXd) in the DEBBRAH trial

A. Fitzpatrick

PS2-08-20

Poster Session 2
Wednesday, December 10
5:00 – 6:30 pm

Trials-in-Progress

A randomized phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) versus CDK4/6 inhibitor-based endocrine therapy as first-line therapy of hormone receptor-positive and HER2 low/ultralow advanced breast cancer patients classified as non-luminal subtype according to gene expression profiling: the PONTIAC study

J. Cortes

PS5-07-15

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

Phase 1b study of EZH1/2 inhibitor valemetostat in combination with trastuzumab deruxtecan in subjects with HER2 low/ultralow/null metastatic breast cancer

S. Damodaran

PS5-09-22

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

DATROWAY (datopotamab deruxtecan; Dato-DXd)

First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy was not an option: additional safety analyses from the TROPION-Breast02 study

T. Traina

PS5-03-05

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

Intracranial activity of datopotamab deruxtecan (Dato-DXd) for patients with HER2 negative breast cancer and leptomeningeal disease: results from cohort C of the DATO-Base phase 2 trial

P. Tarantino

PS1-09-02

Poster Session 1
Wednesday, December 10
12:30 – 2:00 pm

Trials-in-Progress

TROPION-Breast06: multicenter, multinational, open-label, single-arm, phase 3b study of datopotamab deruxtecan (Dato-DXd) in patients with locally advanced inoperable or metastatic HR+/HER2 IHC 0 breast cancer refractory to endocrine therapy

K. Jhaveri

PS5-07-21

Poster Session 5
Friday, December 12
12:30 – 2:30 pm

Patritumab Deruxtecan (HER3-DXd)

Outcome of patritumab deruxtecan (HER3-DXd) in patients with HER2 positive metastatic breast cancer and CNS involvement previously treated with T-DXd: a subanalysis of TUXEDO-3

R. Bartsch

PD13-10

Poster Spotlight 13
Friday, December 12
7:00 – 8:30 am

Trials-in-Progress

HERTHENA-Breast04: a phase 3, randomized, open-label study evaluating the efficacy and safety of patritumab deruxtecan (HER3-DXd) versus treatment of physician’s choice in hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) unresectable locally advanced or metastatic breast cancer

B. Pistilli

PS5-07-22

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

HERTHENA-Breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan (HER3-DXd) + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2− breast cancer

J. O’Shaughnessy

PS5-12-21

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

HERTHENA-Breast01: a phase 1b/2, multicenter, open-label, dose-finding study to evaluate the safety and antitumor activity of patritumab deruxtecan (HER3-DXd) in HER2+ unresectable locally advanced or metastatic breast cancer

S. Tolaney

PS5-12-23

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

(Press release, Daiichi Sankyo, DEC 8, 2025, https://www.businesswire.com/news/home/20251208780034/en/Daiichi-Sankyo-Showcases-Strength-of-Industry-Leading-ADC-Portfolio-with-Latest-Research-Updates-from-Five-Landmark-Breast-Cancer-Trials-at-SABCS [SID1234661296])

On December 8, 2025 BostonGene, developer of the leading AI foundation model for cancer and the immune system, reported seven abstracts have been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS) 2025, taking place from December 9–12, 2025, in San Antonio, Texas. The research, conducted in collaboration with leading cancer centers, demonstrates the power of the BostonGene platform to uncover complex breast cancer tumor biology and drive informed, personalized treatment strategies. BostonGene will exhibit at booth #1352.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Poster spotlight discussions:

Poster spotlight number: PD7-03
Title: Circulating immune correlates of pathological response to neoadjuvant pembrolizumab plus chemotherapy in high-risk, early-stage triple-negative breast cancer
Date & time: December 11, 2025; 7:36 AM – 7:39 AM
Presenter: Clinton Yam, MD, MS, The University of Texas MD Anderson Cancer Center

Using BostonGene’s multi-parameter immune phenotyping platform and immunotype signature scores, clinicians at MD Anderson profiled peripheral blood from patients with triple-negative breast cancer (TNBC) undergoing the KEYNOTE-522 regimen. This study showed immune cells in the blood were significantly associated with improved response to KEYNOTE-522. Identified through BostonGene’s natively omnimodal AI model, these immune signatures show promise as minimally invasive biomarkers to identify patients most likely to respond to immune-based neoadjuvant approaches, supporting patient stratification and optimization of therapy in TNBC.

Research done in collaboration with MD Anderson Cancer Center

Poster spotlight number: PD7-09
Title: Feasibility of a machine learning (ML)-based peripheral blood immunoprofiling platform to stratify patients (pts) with early-stage triple-negative breast cancer
Date & time: December 11, 2025; 8:06 AM – 8:09 AM
Presenter: Chiara Corti, MD, Dana-Farber Cancer Institute

BostonGene’s machine learning-based immune phenotyping platform was used to examine blood samples of early-stage triple-negative breast cancer (TNBC). BostonGene’s platform assessed how immune profiles differed between chemotherapy alone and chemotherapy plus immunotherapy, and how they evolved during treatment. Immunotype distribution varied significantly by therapy type and showed dynamic changes, particularly in patients receiving chemo-immunotherapy. These findings support the feasibility of capturing immune dynamics in peripheral blood as a minimally invasive approach to refine patient stratification, improve trial design and inform treatment optimization in early-stage TNBC.

Research done in collaboration with Brigham and Women’s Hospital

Poster presentations:

Presentation number: PS1-09-12
Title: TROP2 expression and therapeutic opportunities in inflammatory breast cancer
Date & time: December 10, 2025; 12:30 PM – 2:00 PM
Presenter: Shayla Murray, MD Anderson Cancer Center

Collaborative research utilizing BostonGene’s foundation AI platform revealed that TROP2 RNA expression alone does not predict antibody-drug conjugate response in inflammatory breast cancers, underscoring the limitations of single-marker approaches. These findings demonstrate the necessity of BostonGene’s AI-driven omnimodal analysis built to uncover complex tumor biology and optimize clinical trial design for next-generation precision oncology therapies.

Research done in collaboration with MD Anderson Cancer Center

Presentation number: PS2-10-30
Title: Tumor-associated macrophage (TAMs) and cancer-associated fibroblasts (CAFs) profiles in invasive lobular carcinoma (ILC) vs no special type (NST)
Date & time: December 10, 2025; 5:00 PM – 6:30 PM
Presenter: Jason Mouabbi, MD, MD Anderson Cancer Center

BostonGene performed a large-scale analysis of 617 ILC and NST breast cancers, leveraging its AI-driven KassandraTM algorithm to deconvolve hundreds of cell subtypes and activation states from RNA data within the tumor microenvironment (TME). Similar to NST, ILC samples harbored immunosuppressive, stroma-rich TMEs dominated by FAP⁺ myofibroblastic CAFs and M1/M2 TAMs, identifying previously unknown opportunities for targeted therapeutics and novel immune strategies in this often understudied cancer.

Research done in collaboration with MD Anderson Cancer Center

Presentation number: PS2-10-16
Title: Distinct immune landscapes in inflammatory and metaplastic breast cancer: Insights from transcriptomic profiling
Date & time: December 10, 2025; 5:00 PM – 6:30 PM
Presenter: Elyse R. Lopez, MD Anderson Cancer Center

BostonGene’s multimodal model, which integrates genomic, transcriptomic, and immunologic data, was used to analyze 444 invasive, inflammatory and metaplastic breast cancer samples. The analysis revealed distinct clinically relevant immune landscapes in both cancers, illustrating BostonGene’s ability to deliver reliable insights for treatment decision-making and optimal trial design.

Research done in collaboration with MD Anderson Cancer Center

Presentation number: PS2-09-24
Title: Aurora kinase A (AURKA) A new druggable target in ER+ inflammatory breast cancer
Date & time: Wednesday, December 10, 2025; 5:00 PM – 6:30 PM
Presenter: Tanu Sharma, PhD, MD Anderson Cancer Center

Researchers at MD Anderson applied BostonGene’s comprehensive pipeline to analyze RNA and DNA samples from ER+ inflammatory breast cancer (IBC) tumors, revealing amplified expression of AURKA in IBC tumors and the potential for synthetic lethality, where therapeutic targeting of AURKA alongside another target could lead to cell death. These findings demonstrate BostonGene’s capability in integrating genomic and transcriptomic data with clinical outcomes to generate biologically grounded, actionable insights.

Research done in collaboration with MD Anderson Cancer Center

Presentation number: PS4-01-10
Title: Characterizing CCR7 gene amplification and protein expression in inflammatory and non-inflammatory breast cancer
Date & time: Thursday, December 11, 2025: 5:00 PM – 6:30 PM
Presenter: Surbhi Shivhare, PhD, MD Anderson Cancer Center

BostonGene, in collaboration with MD Anderson, applied its multimodal model to examine both CCR7 copy number alterations and gene expression in inflammatory breast cancer. This comprehensive study uncovered discordance across CCR7 copy numbers and RNA levels and pointed to the potential impact of membranous CCR7 protein toward disease status. Highlighting BostonGene’s target discovery applications, this study identified CCR7 as a promising therapeutic target for aggressive breast cancer.

Research done in collaboration with MD Anderson Cancer Center

(Press release, BostonGene, DEC 8, 2025, View Source [SID1234661295])