On May 20, 2025 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) discussed the supplemental Biologics License Application (sBLA) for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant (ASCT) (Press release, Genentech, MAY 20, 2025, View Source [SID1234653262]).

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"Columvi in combination with GemOx demonstrated a 41% reduction in risk of death in a Phase III, randomized, multiregional clinical trial, supporting its recent approval by the European Commission and inclusion in the U.S. National Comprehensive Cancer Network treatment guidelines as a category 1 preferred regimen," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We believe the STARGLO results are applicable to U.S. patients, with the global study population closely mirroring the real-world clinical profile of DLBCL patients in the U.S., and we will continue working with the FDA on the regulatory path forward."

Today’s discussion focused on the applicability of the Phase III STARGLO results to the U.S. patient population, with Committee members citing that further data are needed. The STARGLO study was a multiregional clinical trial (MRCT) that enrolled 274 patients globally across 62 sites in 13 countries, including the U.S., Australia, and multiple European countries, with the majority of patients (52%) enrolling outside of Asia.

The clinical and disease characteristics of the overall population enrolled in this multiregional clinical trial are representative of U.S. patients with this disease today. On that basis the STARGLO results are applicable to U.S. patients. Based on extensive guidelines and real-world clinical practice, there are no biological or clinical differences for DLBCL management worldwide. There is a broad and robust clinical development program of Columvi, indicating that region and/or race are not relevant determinants of outcomes to treatment.

"Many of the patients with DLBCL who I see in my clinic are similar to the patients reflected in this study, making the glofitamab-GemOx regimen an important potential treatment option," said Krish Patel, M.D., Director of Lymphoma Research, Sarah Cannon Research Institute. "These patients need more effective, readily available treatment options and the compelling results from STARGLO deliver on this need."

A statistically significant 41% reduction in the risk of death (hazard ratio [HR]=0.59, 95% confidence interval [CI]: 0.40–0.89, p=0.011) was observed in patients treated with Columvi in combination with GemOx versus Rituxan (rituximab) plus GemOx (R-GemOx). The Columvi combination also met its key secondary endpoints, with a 63% reduction in risk of disease worsening or death (progression-free survival, PFS) compared to R-GemOx (HR=0.37; 95% CI: 0.25–0.55, p<0.0001). Median overall survival was 25.5 months for people treated with the Columvi combination, nearly double what was seen for people treated with R-GemOx at 12.9 months (HR=0.62, 95% CI: 0.43-0.88) in a follow-up analysis. Safety of the combination was consistent with the known safety profiles of the individual medicines. Patients received a higher median number of cycles of the Columvi combination (11 versus 4), due to disease progression in the R-GemOx arm. A higher rate of adverse events (AEs) was observed with the Columvi regimen. One of the most common AEs was cytokine release syndrome, which was generally low grade (Any Grade: 44.2%, Grade 1: 31.4%, Grade 2: 10.5%, Grade 3: 2.3%) and occurred primarily in Cycle 1. Two-year follow-up data from STARGLO will be presented at the upcoming 61st American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 30 – June 3, 2025.

For people with DLBCL who have R/R disease, therapy options that can provide durable remissions are limited. In the U.S., approximately 75% of patients with R/R DLBCL are not candidates for, cannot tolerate, or do not have access to latest treatments. New treatments that can be initiated in community practices, where the majority of patients are treated, and have the potential to provide rapid disease control with durable remissions, could meaningfully address the needs of patients with this aggressive and life-threatening form of lymphoma.

Based on the STARGLO data, this Columvi combination is approved in more than 30 countries, including the EU, for people with R/R DLBCL who are ineligible for ASCT. Columvi in combination with GemOx was recently added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as an NCCN category 1 preferred recommendation for the treatment of people with second-line DLBCL who are not intended to proceed to transplant.† Columvi monotherapy has been approved for use in R/R DLBCL after two or more prior lines of therapy in more than 60 countries worldwide, including the U.S. STARGLO is intended as a confirmatory study to convert the accelerated approval of Columvi in the U.S. to full approval.

The ODAC provides the FDA with independent opinions and review of safety and efficacy data from outside medical experts, though the recommendations are not binding. The FDA’s evaluation of this Columvi combination for R/R DLBCL is ongoing and a decision on approval is expected by July 20, 2025.

†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 STARGLO Study

The STARGLO study [GO41944; NCT04408638] is a Phase III, multicenter, open-label, randomized study evaluating the efficacy and safety of Columvi (glofitamab-gxbm) in combination with gemcitabine plus oxaliplatin (GemOx) versus Rituxan (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumor effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability.

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, 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 (DLBCL) and mantle cell lymphoma.

As part of Genentech’s efforts to elevate treatment standards in the earlier stages of DLBCL, where there is the best opportunity to improve long-term outcomes and prevent relapse, Columvi is also being investigated in combination with other medicines in previously untreated DLBCL in the Phase III SKYGLO study [GO44145; NCT06047080].

About Diffuse Large B-Cell Lymphoma

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.

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

On May 20, 2025 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported scientific evidence from the Phase 1 APOLLO study demonstrating that lymphodepletion improves the expansion and persistence of MAR-T cells (Press release, Marker Therapeutics, MAY 20, 2025, View Source [SID1234653247]).

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The Company’s Phase 1 APOLLO study is investigating MT-601, a MAR-T cell product, in patients with lymphoma who have relapsed after anti-CD19 chimeric antigen receptor (CAR)-T cell therapy or for whom anti-CD19 CAR-T cell therapy is not an option. In December, the Company provided an update on the progress and clinical observations from the study, with a data cutoff date of September 10, 2024 (Press Release, December 19, 2024). This update included clinical data from 9 patients from 5 clinical sites in the United States. Infusion of MT-601 was well tolerated in all study participants with no dose limiting toxicities (DLTs), including immune-effector cell associated neurotoxicity syndrome (ICANS). Objective responses were achieved in 7 out of 9 patients (78%), with 4 patients demonstrating complete response (CR; 44.4%) as early as 4 weeks after infusion of MT-601.

The Company previously reported that study participants showed early objective responses with and without lymphodepletion. Today, Marker provides data demonstrating preliminary evidence that lymphodepletion supports the expansion and persistence of MT-601 in vivo. Using T Cell Receptor (TCR) sequencing as an immunomonitoring strategy, the Company has evidence suggesting that MT-601 MAR-T cell clones in the drug product expanded and persisted at significantly higher levels in patients receiving lymphodepletion compared to patients who did not undergo the conditioning regimen. Preliminary results from this observation have been posted on the Investor Relations section of the Marker website.

The Company believes that the enhanced in vivo expansion and persistence of MT-601 may positively influence the clinical anti-tumor activity of MT-601 in the ongoing APOLLO study. Similar correlations have been observed when using lymphodepletion with other T cell therapies, including CAR-T and tumor infiltrating lymphocyte (TIL) products. While these prior studies have shown that T cell therapies can be effective with and without lymphodepletion, the use of lymphodepletion was associated with improved clinical outcomes and an enhanced expansion and persistence of T cells (Rosenberg SA, J Natl Cancer Inst, 1994; Ramos CA et al, J Clin Oncol, 2020; Turtle CJ et al, Sci Transl Med, 2016).

"We are excited to see these results from our immunomonitoring study," said Juan Vera, M.D., President and CEO of Marker Therapeutics. "Our preliminary data clearly suggests that lymphodepletion increases the expansion and persistence of MT-601 in patients. This is the first time we have obtained this evidence in vivo and it provides a clear direction for our MAR-T cell studies going forward."

Dr. Vera continued, "Comparative data from previous studies suggest that incorporating lymphodepletion in our MAR-T cell trials may enhance clinical outcomes by boosting T cell expansion and anti-tumor activity. Consistent with this, our immunomonitoring data indicates that lymphodepletion leads to a more robust antigen-specific T cell response. Importantly, despite the incorporation of lymphodepletion, MT-601 continues to demonstrate an excellent safety profile."

Driven by encouraging early clinical data and a shifting competitive landscape, the Company reported a marked increase in patient enrollment. In the first five months of 2025 alone, the Company enrolled and successfully manufactured product for more patients than in the entire year of 2024. This upward trend reflects growing momentum and is expected to meaningfully expand the magnitude of the clinical data set, which the Company plans to present later this year.

"We believe the incorporation of lymphodepletion was the right strategic decision as demonstrated by our immunomonitoring data. The incorporation of lymphodepletion has led to increased T cell expansion and persistence, which we believe has the potential to further enhance the clinical outcomes we are seeing. We are now enrolling at an increased pace and are well-positioned to generate meaningful data, which we expect to share by the end of this summer," concluded Dr. Vera.

About MT-601

The Company’s lead product, MT-601, is a multi-antigen recognizing (MAR) T cell product that utilizes a non-genetically modified approach that specifically targets six different tumor antigens upregulated in lymphoma cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGEA-4). Marker is currently investigating MT-601 in the Company-sponsored Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of patients with lymphoma who have relapsed after or are not candidates for anti-CD19 CAR-T cell therapies.

About APOLLO

The APOLLO trial (clinicaltrials.gov Identifier: NCT05798897) is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with relapsed or refractory lymphoma who have either failed anti-CD19 chimeric antigen receptor (CAR) T cell therapy or are not candidates for anti-CD19 CAR-T cell therapy. The primary objective of this exploratory Phase 1 clinical trial is to evaluate the optimum dose, safety, and preliminary efficacy of MT-601 in participants with various lymphoma subtypes. Under the APOLLO trial, it is anticipated that nine clinical sites across the United States will cumulatively enroll up to approximately 30 participants during the dose escalation phase.

About MAR-T cells

The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, MAR-T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since MAR-T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell approaches and may provide patients with meaningful clinical benefits.

On May 20, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported a collaboration to develop a companion diagnostic (CDx) test with Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers (Press release, Tempus, MAY 20, 2025, View Source [SID1234653263]). Tempus completed confirmatory testing in Verastem’s Phase 2 RAMP-201 clinical trial, which evaluated the combination of avutometinib and defactinib to treat recurrent low-grade serous ovarian cancer (LGSOC) and was the basis of the recent U.S. Food and Drug Administration’s (FDA) accelerated approval of the combination in KRAS-mutated recurrent LGSOC.

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LGSOC is a rare form of ovarian cancer that disproportionately affects younger women, is highly recurrent and has a poor response rate to chemotherapy. It accounts for approximately 6% to 10% of serous ovarian cancers1. Tempus’ FDA-approved xT CDx assay is being leveraged as an investigational assay in Verastem’s global Phase 3 RAMP-301 clinical trial. The investigational assay prospectively assesses KRAS status in patients with recurrent LGSOC to group patients into KRAS-mutation or KRAS-wild type cohorts for analysis in the primary and secondary endpoints of the study.

"We look forward to continuing to work with Verastem to pursue an unmet need for patients with LGSOC, who, until now, had very few treatment options," said Mike Yasiejko, Executive Vice President and General Manager, Genomics, at Tempus. "Our xT CDx assay is uniquely positioned to support this work."

"Collaborating with Tempus to evaluate KRAS mutation status using the xT assay was an important component of the RAMP-201 clinical trial. Continuing our collaboration to fully develop a CDx assay is part of our post-marketing commitment to the FDA for our recent accelerated approval of avutometinib plus defactinib and is a critical step in bringing targeted therapies to patients with recurrent KRAS-mutant LGSOC," said John Hayslip, MD, Chief Medical Officer of Verastem Oncology.

xT CDx is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for use in the detection of substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status, using DNA isolated from Formalin-Fixed Paraffin Embedded (FFPE) tumor tissue specimens, and DNA isolated from matched normal blood or saliva specimens, from previously diagnosed cancer patients with solid malignant neoplasms. The test is intended as a CDx to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling. Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product. xT CDx is a single-site assay performed at Tempus AI, Inc., Chicago, IL. For the complete xT CDx label, including companion diagnostic indications and important risk information, please visit Tempus’ document library here.

On May 20, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on the development of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that members of management will participate in the following upcoming investor events (Press release, Mersana Therapeutics, MAY 20, 2025, View Source [SID1234653248]):

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TD Cowen 6th Annual Oncology Innovation Summit
Format: Fireside chat
Date/Time: Tuesday, May 27, 2025, at 2:00 p.m. Eastern Time

Goldman Sachs 46th Annual Global Healthcare Conference
Format: Presentation
Date/Time: Monday, June 9, 2025, at 2:00 p.m. Eastern Time

Live webcasts of these events will be available on the Investors & Media section of Mersana’s website at www.mersana.com. Archived replays will be available for approximately 90 days following the events.

On May 20, 2025 KaliVir Immunotherapeutics, Inc., a clinical-stage biotechnology company developing cutting-edge, multi-mechanistic oncolytic immunotherapy programs, reported the successful completion of the first cohort in its STEALTH-001 study, a Phase 1/1b clinical trial of VET3-TGI for patients with incurable, advanced solid tumors (Press release, KaliVir Immunotherapeutics, MAY 20, 2025, View Source [SID1234653264]).

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VET3-TGI is a novel oncolytic immunotherapy designed to target and selectively kill tumor cells while also expressing an immuno-stimulatory transgene payload consisting of interleukin-12 and a TGFbeta inhibitor. The Data Safety Committee, charged with monitoring the safety and overall risk-benefit of treatment on the STEALTH-001 (NCT06444815) clinical study, convened following dosing of the first cohort in the dose-escalation portion of the study, and approved continuation of dosing for the next intratumoral (IT) and intravenous (IV) infusion cohorts.

"The safety profile demonstrated in our initial first-in- human cohort is critical as it opens up expanded dosing in both the study’s IV infusion and IT injection arms which will continue in parallel on study STEALTH-001. We are excited to assess not only the safety of VET3-TGI but further investigate both proof of concept and anti-tumor activity moving forward," said James Burke, M.D., Chief Medical Officer of KaliVir Immunotherapeutics.

The STEALTH-001 trial is a dose escalation and expansion study evaluating VET3-TGI administered through direct IT injection and IV infusion. The trial is evaluating VET3-TGI as a monotherapy and in combination with a checkpoint inhibitor in patients with pathologically confirmed, advanced, unresectable or metastatic solid tumors. The study continues to progress as planned through its dose escalation phase.

"Completing this first cohort reinforces our commitment to advancing our VET platform and its potential to address significant unmet needs in oncology," said Helena Chaye, Ph.D., CEO of KaliVir Immunotherapeutics. "We remain focused on our mission to develop novel oncolytic virus candidates with the potential to transform the treatment landscape for patients with advanced cancer."