Feasibility and Phase 2a Study of Relatlimab and Nivolumab (Opdualag™) in Adolescent and Young Adult Patients Newly Diagnosed With Replication Repair Deficient High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG)

The goal of this study is to further evaluate feasibility and tolerability of Opdualag for patients with replication repair deficient HGG, including DIPG.

Start Date01 Mar 2027

Sponsor / Collaborator

Nationwide Children's Hospital

NCT07459543

/ Not yet recruitingPhase 4

A Phase 4, Single Arm, Open Label Study to Evaluate Safety, Tolerability, and Efficacy of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in Participants With Previously Untreated, Unresectable or Metastatic Melanoma in India.

The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in untreated, unresectable or metastatic melanoma participants in India

Start Date15 Nov 2026

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT06319196

/ RecruitingPhase 2IIT

Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High Risk Melanoma

Clear-Me is a biomarker-driven phase II study that tests whether the combination anti- lymphocyte-activation gene-3 (LAG3)/anti-programmed cell death protein 1(PD-1) inhibition Bristol-Myers Squibb (BMS986213) is superior to anti-PD-1 inhibition in patients with detectable circulating tumor deoxyribonucleic acid (ctDNA) following definitive surgery for high risk melanoma. Patients will be allocated to either Arm A or Arm B via the process of randomization. The randomization process will be stratified according to stage (Stage 2A/2B/3A/3B/3C/3D or 4), to ensure absolute balance between stage groups. The investigators are choosing only 1 stratification factor, disease stage, as the investigators consider stage being the most significant prognosticating variable. Each stage represents a biologically distinct entity with varying recurrence rate outcomes. Block randomization will be performed to ensure equal sample sizes in the combination and monotherapy arms. At least 54 patients will be included in the randomized part of the study. The investigators are expecting approximately 20% of the patients to have detectable ctDNA after definite surgery. Therefore, approximately 270 patients are expected to be enrolled and tested for ctDNA in the entire study.

Start Date27 Aug 2026

Sponsor / Collaborator

University Health Network

100 Clinical Results associated with Nivolumab/Relatlimab

100 Translational Medicine associated with Nivolumab/Relatlimab

100 Patents (Medical) associated with Nivolumab/Relatlimab

Literatures (Medical) associated with Nivolumab/Relatlimab

26 Nov 2025·Cureus Journal of Medical Science

Drug-Induced Bullous Pemphigoid Triggered by Immune Checkpoint Inhibitor Opdualag in an Elderly Patient With Recurrent Metastatic Melanoma: A Case Report and Treatment Course With Dupilumab

Article

Author: Lutwak, Moises ; Kerdel, Francisco ; Lutwak, Daniel ; Moreno, Brian A

Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disorder most commonly affecting elderly individuals and may be triggered by medications, including immune checkpoint inhibitors (ICIs). We present the case of an 81-year-old male with a history of recurrent metastatic melanoma previously treated with nivolumab and relatlimab (Opdualag), who developed a persistent pruritic eruption following initiation of dual PD-1/LAG-3 blockade. Despite discontinuation of immunotherapy six months before dermatologic evaluation and use of multiple topical corticosteroids and oral antihistamines, symptoms persisted. A punch biopsy and direct immunofluorescence demonstrated linear IgG and C3 deposition along the basement membrane zone, consistent with BP. On initial dermatologic examination, urticarial pink plaques involved approximately 50% of the body surface area, with lesions affecting the left medial inferior chest and epigastric region. Treatment with subcutaneous dupilumab was initiated alongside clobetasol 0.05% ointment. At follow-up, the patient reported persistent activity, receiving intramuscular triamcinolone acetonide and adjunctive therapies, including hydroxyzine, hydrocortisone 2.5% cream (for groin), and triamcinolone 0.1% ointment. By the second week of treatment, new plaques continued to appear daily without subjective improvement. Objective scoring with the Bullous Pemphigoid Disease Area Index was not obtained. This case illustrates the diagnostic and therapeutic challenges in managing ICI-induced BP and highlights the early course of dupilumab therapy, which had not yet produced clinical improvement at the time of last follow-up. Continued therapy was planned, and no adverse effects were reported.

01 Oct 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Safety profile of nivolumab-relatlimab in cancer patients: a living pharmacovigilance study of clinical trials and postmarketing data (version 1.0)

Review

Author: Wu, Chengmi ; Zhou, Jingyi ; Wu, Qian ; Jiang, Jie ; Yang, Ziwen ; Zhu, Jianhong ; Li, Sha ; Wu, Junyan

In 2022, the FDA approved nivolumab-relatlimab for the treatment of unresectable or metastatic melanoma. In the present study, we conducted a living pharmacovigilance study, integrating data from clinical trials and the FDA Adverse Event Reporting System (FAERS) database, to assess the safety profile of nivolumab-relatlimab. Treatment related adverse events (TRAEs) in trials of nivolumab-relatlimab available in electronic databases were systematically searched. The outcomes included were all-grade (grades 1-5) and high-grade (grades 3-5) TRAEs, considering both overall and individual aspects. Meta-analysis was conducted to calculate the incidence and risk ratio of TRAEs associated with nivolumab-relatlimab. Certainty of evidence was assessed using the GRADE system. Adverse events reports were extracted from the FAERS database, and a disproportionality analysis was carried out to estimate the safety signals of AEs associated with nivolumab-relatlimab. A total of 12 trials were included, the incidence of all-grade and high-grade TRAEs for nivolumab-relatlimab was 74.11 % and 38.05 %, respectively. Compared with nivolumab monotherapy, therapy with nivolumab-relatlimab was associated with a significantly increased risk of high-grade TRAEs, and some individual specified all-grade TRAEs, including hypothyroidism/thyroiditis, rash, diarrhea/colitis, hepatitis, adrenal insufficiency, hypophysitis, arthralgia and myalgia. Disproportionality analyses of FAERS pharmacovigilance data identified 39 positive signals, with 18 AEs not mentioned in the drug label. Nivolumab-relatlimab showed significantly higher reporting frequencies for 15 AEs than nivolumab monotherapy. Our study provides valuable insights into the potential safety profile of nivolumab-relatlimab, the results of this living study will be updated to incorporate new, robust evidence as it becomes available.

11 Jan 2025·Gastroenterology Report

Single-cell transcriptomic landscape indicates the potential role of immunotherapy in metastatic pancreatic angiosarcoma

Article

Author: Yang, Yizhen ; Chen, Luohai ; Zeng, Zhirong ; Peng, Sui ; Xie, Yubin ; Lin, Xiaoxuan ; Liu, Man ; Chen, Minhu ; Zhang, Ning

Abstract:

Background:

Pancreatic angiosarcoma is a rare and highly aggressive tumor originating from lymphatic or vascular endothelial cells, with poor prognosis and few effective treatments. In this study, we aimed to characterize the tumor ecosystem of metastatic pancreatic angiosarcoma, along with its potential treatment strategies.

Methods:

Single-cell RNA-sequencing and bioinformatics analysis were performed on samples obtained from one patient, including at total of 16,841 cells from pancreatic angiosarcoma liver metastasis and adjacent normal liver tissue.

Results:

Pancreatic angiosarcoma cells exhibited marked upregulation of nuclear factor kappa-B (NF-κB), hypoxia-inducible factor 1 (HIF-1), and myelocytomatosis oncogene (MYC) proto-oncogene signaling pathways, while presenting limited upregulation of actionable therapeutic targets except for cyclin-dependent kinase 4 (CDK4) and epidermal growth factor receptor. Several immune checkpoint genes, including cytotoxic T-lymphocyte-associated protein 4 (CTLA4), lymphocyte-activation gene 3 (LAG3), programmed cell death protein 1 (PDCD1), and cluster of differentiation 86 (CD86), were upregulated in tumor-infiltrating T cells, natural killer (NK) cells, and myeloid cells. Furthermore, intercellular interaction profiling demonstrated enhanced activity of the programmed death-ligand 1 (PD-L1) and CD86 signaling pathways within the tumor microenvironment. The gene-set scores of T/NK-cell exhaustion, regulatory T cell, and macrophage angiogenesis were significantly higher in tumor tissues compared with adjacent normal tissues. However, the phagocytosis scores of macrophages within the tumor-infiltrating region were significantly lower than those in the adjacent normal tissues.

Conclusions:

Our findings outlined an immunosuppressive and angiogenic tumor ecosystem in pancreatic angiosarcoma liver metastasis, suggesting that pancreatic angiosarcoma may be insensitive to most targeted therapies. Conversely, immunotherapies targeting LAG3, PD-L1, and CD86 (e.g. isatuximab, Opdualag, and abatacept) and anti-angiogenic agents may be therapeutically effective and worthy of subsequent exploration.

113

News (Medical) associated with Nivolumab/Relatlimab

08 Jul 2026

·www.biospace.com

Seres Therapeutics Announces Early Clinical Data Showing Potential for SER-155 in Immune Checkpoint Inhibitor-Related Enterocolitis (irEC), a Frequent Adverse Reaction That Forces Many Patients to Halt Cancer Treatment

80% of SER-155 recipients achieved immunosuppressive-free clinical response of diarrhea (a primary symptom of irEC) at Day 15 in the Investigator-Sponsored Trial (IST) conducted by Memorial Sloan Kettering Cancer Center (MSK) SER-155 has potential to treat irEC, a frequent side effect of immune checkpoint inhibitors (ICIs) that often causes halting of cancer treatment, without requiring treatment with systemic immunosuppressive drugs SER-155 was well tolerated, with no drug-related serious adverse events observed Drug pharmacology data provide confirmatory evidence of Seres’ live biotherapeutics operating as designed to repair the mucosal epithelial barrier and reduce gastrointestinal inflammation, which supports possible expansion into multiple other inflammatory and immune diseases Company to host webcast today, July 8, at 8:30 am ET CAMBRIDGE, Mass., July 08, 2026 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (Nasdaq: MCRB), (Seres or the Company), a leading live biotherapeutics company, today announced encouraging top-line results from an IST evaluating SER-155 in patients with irEC. The study (NCT06801067), conducted at MSK, by Principal Investigator David Faleck, M.D., Director of Inflammatory and Immune-Related Bowel Diseases, evaluated SER-155 in 15 patients with moderate-to-severe (Grade 2- 3) irEC, which affects approximately 25% of all immune checkpoint inhibitor (ICI) therapy recipients in the US. Clinical guidelines for these patients stipulate halting of ICI cancer treatment and initiation of systemic immunosuppressive corticosteroids, which are associated with clinically meaningful toxicities and other negative consequences, including: systemic immunosuppression, increased infection risk, metabolic complications, and potential interference with cancer treatment. There remains a significant unmet need for systemic immunosuppressive-free therapeutic approaches that reduce gastrointestinal inflammation and diarrhea and may allow patients who develop irEC to avoid disruption of their life-saving ICI cancer treatment. Participants in the study were on a wide range of ICI types, including PD-1 inhibitors (Keytruda ® , Opdivo ® , Zynz ® ), PD-L1 inhibitors (Imfinzi ® , Bavencio ® ), CTLA-4 inhibitors (Yervoy ® , Imjudo ® ), LAG-3 inhibitor (Opdualag ® ), and combinations thereof. The promising study results support continued development of SER-155 to treat irEC. Topline Clinical Results Day 15 Data Following SER-155 dosing, 12 of 15 participants (80%) achieved an immunosuppressive-free clinical response at Day 15, the primary endpoint, defined as at least a 1-grade improvement in diarrhea symptoms without immunosuppressive therapy (i.e., a corticosteroid and/or biologic immunomodulator drug). Notably, 8 of these 12 responders (67%) achieved greater than or equal to a 2-grade improvement in diarrhea symptoms without immunosuppressive therapy at Day 15. At Day 15, 5 of 15 participants (33%) achieved immunosuppressive-free complete clinical remission, defined as total resolution of diarrhea symptoms to Grade 0, without immunosuppressive therapy. Day 43 Data At Day 43, 5 of 15 participants (33%) maintained immunosuppressive-free clinical response, and, notably, 2 of 15 participants (13%) maintained immunosuppressive-free complete clinical remission. All 12 participants with immunosuppressive-free clinical response at Day 15 had the same, or better, diarrhea grade at Day 43. As noted, 5 maintained immunosuppressive-free clinical response at Day 43. The other 7 were treated with non-systemically acting, gastrointestinal-targeted immunosuppressives after Day 15. Safety SER-155 was generally well tolerated through Day 43, with no safety concerns identified, consistent with the outcome in Seres’ Phase 1b study of SER-155 in participants undergoing allogeneic hematopoietic cell transplantation (allo-HCT). There were no serious adverse events assessed as related to SER-155 and no bloodstream infections reported in the study through Day 43. Two participants experienced 2 non-serious adverse events each, assessed as possibly related to vancomycin and SER-155. All 4 adverse events were moderate in severity and were resolved. Pharmacology SER-155 bacterial strain engraftment (a measure of drug pharmacokinetics and strain growth in the gastrointestinal tract) was robust, with the majority of SER-155 strains observed across the study participants, and with kinetics, magnitude, and durability comparable to that observed in prior Seres clinical studies. Translational biomarkers of gastrointestinal inflammation (fecal calprotectin) and of mucosal epithelial barrier integrity (fecal albumin), which were elevated in participants at baseline, prior to SER-155 dosing, both showed decreases post SER-155 treatment, with statistically significant reductions achieved by Day 43, reflecting improvement in two mechanistically linked dimensions of irEC disease. Data suggest that administration of SER-155 led to improvement in mucosal epithelial barrier integrity, providing support for potential further development in multiple other inflammatory and immune diseases. “We are extremely pleased with the study data from our long-time collaborator, MSK, which highlight SER-155’s potential as a non-immunosuppressive treatment for irEC, which could enable patients to continue their ICI cancer treatment,” said Richard Kender, Executive Chairman and Interim CEO of Seres. “We are engaging with potential partners, including companies with ICI franchises, as we evaluate next steps for the development of SER-155 in irEC. We also continue to engage with potential collaborators and financing partners as we seek funding to advance the Phase 2 study of SER-155 in allo-HCT, and development in our broader pipeline.” Matthew Henn, Ph.D., President and Chief Scientific Officer of Seres added, “These clinical and pharmacological results underscore the potential of SER-155 to address mucosal epithelial barrier dysfunction and gastrointestinal inflammation through disease pathways not targeted by existing therapies. Beyond irEC, we believe these encouraging data support continued development of Seres’ live biotherapeutic platform to target microbe-specific functions linked to multiple inflammatory and immune diseases in addition to irEC, such as ulcerative colitis and Crohn’s disease.” “Patients receiving ICI treatment who develop irEC face significant challenges, as current management often necessitates interruption or discontinuation of checkpoint inhibitor therapy and treatment with systemic immunosuppressives, which are associated with clinically significant side effects,” commented Dr. Faleck. “These results suggest SER-155 may offer a promising, novel approach to managing irEC, with the potential to reduce reliance on systemic immunosuppressive therapies, while also helping patients continue ICI treatment. We look forward to continued development to further understand the role microbiome therapeutics could play in this setting and the broader opportunity to support the growing number of patients receiving checkpoint inhibitors across multiple cancer types. We intend to present the IST results at a future medical conference.” Jonathan Peled, M.D., Ph.D., Bone Marrow Transplant Specialist and Cellular Therapist, MSK, noted, “MSK has partnered with Seres for over a decade, advancing research aimed at improving outcomes for cancer patients. As an investigator in Seres’ Phase 1b study of SER-155 in allo-HCT, I observed the meaningful reduction in bloodstream infections in patients receiving SER-155. I am now further encouraged by the results of SER-155 in patients with irEC.” Webcast Information Seres’ management will host a webcast today, July 8, 2026, at 8:30 a.m. ET. To listen to the audio portion of the webcast, please dial 800-715-9871 (domestic) or 646-307-1963 (international) and reference the conference ID number 3327556. To join the live webcast, please visit the “Events and Presentations” tab within the “Investors and News” section of the Seres website at . A replay will be available on the Seres website after the event and will be archived for at least 21 days. About the Investigator-Sponsored Trial (IST) (NCT06801067) This investigator-sponsored, open-label trial evaluated SER-155 in 15 participants with Grade 2-3 (moderate to severe) irEC who were naïve to immunosuppressive therapy. Participants received microbiome conditioning with oral vancomycin on Days 1 and 2, followed by oral administration of SER-155 (2 capsules per day) for 12 consecutive days. The primary efficacy endpoint was the proportion of participants achieving an immunosuppressive-free clinical response on Day 15, defined as at least a 1-grade improvement in diarrhea symptoms, without the use of immunosuppressive therapy. The study is also evaluating the safety, tolerability, and drug pharmacology of SER-155. The IST is designed to inform if SER-155 may provide an alternate treatment for irEC with the potential to prevent interruption of the patient’s ICI cancer treatment. Participants in the study were on a wide range of ICI types, including PD-1 inhibitors (Keytruda ® , Opdivo ® , Zynyz ® ), PD-L1 inhibitors (Imfinzi ® , Bavencio ® ), CTLA-4 inhibitors (Yervoy ® , Imjudo ® ), LAG-3 inhibitor (Opdualag ® ), and combinations thereof. All ICIs administered include irEC as adverse reactions in their labels. About Immune Checkpoint Inhibitors (ICIs) ICIs have revolutionized cancer treatment across multiple tumor types. ICIs represent one of the largest and fastest-growing segments of the oncology market, with the worldwide market valued at well over $50 billion in 2025. Well known ICI brands include: Keytruda ® , Opdivo ® and Yervoy ® . ICIs work by blocking "checkpoint" proteins—such as PD-1, PD-L1, and CTLA-4—that tumor cells exploit to hide from and inactivate T-cells, effectively turning the immune system's attack mode back on. The amplified immune response can also attack healthy tissue, causing serious immune-related adverse events, such as immune checkpoint inhibitor-related enterocolitis (irEC). About Immune checkpoint inhibitor-related enterocolitis (irEC) IrEC, also called immune-mediated colitis, is among the most frequent and severe immune-related adverse reactions in ICI recipients. irEC can result in diarrhea, gastrointestinal inflammation, abdominal pain, blood in stool, among other symptoms, and may significantly affect quality of life and can progress to serious and life-threatening consequences. irEC has been linked to hospitalizations with longer lengths of stay, higher ICU use, high rehospitalization rates and mortality. Current standard of care for those who suffer from moderate to severe irEC (in the US this approximates 25% of all ICI recipients) requires halting their ICI cancer therapy and initiating a systemic immunosuppressive corticosteroid and/or biologic, further compromising the patient’s immune system. There are numerous toxicities associated with systemic immunosuppressives, and the immunosuppression may negate the anti-cancer effect of the ICI therapy, putting patient cancer outcomes at risk. A significant unmet need remains for systemic immunosuppressive-free therapeutic approaches that reduce gastrointestinal inflammation and diarrhea and may allow patients who develop irEC to avoid disruption of their ICI therapy. About Seres Therapeutics Seres Therapeutics, Inc. (Nasdaq: MCRB) is a clinical-stage biotechnology company developing novel live biotherapeutics, with a focus on therapies designed to allow patients to maintain their cancer therapy when faced with significant side effects, and that treat inflammatory and immune diseases. The Company led the development and FDA approval of VOWST™, the first orally administered microbiome therapeutic, which was subsequently divested to Nestlé Health Science. SER-155, a cultivated multi-strain biotherapeutic, which has received Breakthrough Therapy and Fast Track designations, is being advanced for the prevention of bloodstream infections in patients undergoing allogeneic hematopoietic stem cell transplant (allo-HCT), and is Phase 2 ready, pending receipt of funding. An investigator-sponsored trial of SER-155 in immune checkpoint inhibitor–related enterocolitis (irEC) to further evaluate the potential breadth of the Company’s live biotherapeutic platform is ongoing. The Company is advancing IND-enabling studies for SER-603, which is in development for inflammatory bowel disease. Mechanistically, Seres’ biotherapeutics target the mucosal epithelial barrier-immune interface and are optimized to modulate host function to increase epithelium integrity, induce immune homeostasis, and prevent the colonization and overgrowth of harmful bacteria in the gastrointestinal tract. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements about: SER-155 and its intended uses and benefits in irEC; our clinical development plans for SER-155 and SER-603; potential accessibility for patients; the timing and results of clinical studies and data readouts; current or future product candidates and their potential impacts and outcomes; engagement with potential partners and financing sources; our ability to access capital to advance our programs; our planned strategic focus; the anticipated timing of any of the foregoing; and other statements that are not historical fact. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: (1) our need for additional funding; (2) our ability to continue as a going concern; (3) we have incurred significant losses, are not currently profitable and may never become profitable; (4) our cost reduction actions may not achieve their intended benefits, including an extended cash runway; (5) our limited operating history; (6) we may not be able to realize the anticipated benefits of the VOWST sale, and may face new challenges as a smaller, less diversified company; (7) we have in the past and may in the future receive notice of the failure to satisfy a continued listing rule from The Nasdaq Stock Market LLC; (8) our novel approach to therapeutic intervention; (9) our reliance on third parties to conduct our clinical trials and manufacture our product candidates; (10) our ability to achieve market acceptance necessary for commercial success; (11) the competition we will face; (12) our ability to protect our intellectual property; (13) impact of our recent management transitions and appointments and our ability to retain key personnel; and (14) disruptions at the FDA or other government agencies. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended May 5, 2026, as well as our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Investor and Media Contacts: IR@serestherapeutics.com Carlo Tanzi, Ph.D. Kendall Investor Relations ctanzi@kendallir.com

Clinical ResultPhase 1ImmunotherapyBreakthrough TherapyFast Track

10 Jun 2026

·www.biospace.com

Cytospire Therapeutics Appoints Samit Hirawat, M.D., as Non-Executive Director

Dr Hirawat i s the former CMO and Head of Global Drug Development at Bristol Myers Squibb and former EVP and Head of Oncology Development at Novartis Augments Cytospire’s clinical development experience as Cytospire prepares CYT X300 , its lead pan - gamma delta T cell engager , for clinical trials LONDON, UK – June, 10 2026 – Cytospire Therapeutics Limited (“Cytospire”), a UK based biotech developing differentiated multispecific immune cell engager antibodies designed to enhance and direct the activity of the body’s own immune system, today announces that Samit Hirawat, M.D., has been appointed as a non-executive director to the company’s board of directors. Dr Hirawat, an internationally recognized senior biopharmaceutical executive, has more than 30 years of experience in drug development spanning tenures at large global pharmaceutical and prestigious research organizations. Most recently, Dr Hirawat served as Chief Medical Officer, Executive Vice President, and Head of Global Drug Development at Bristol Myers Squibb, where he oversaw the worldwide clinical development portfolio and advanced multiple transformative therapies across diverse therapeutic areas. This included global approvals for 12 new molecular entities including Breyanzi (lisocabtagene), Abecma (idecabtagene), Opdualag (nivolumab + relatlimab), Augtyro (repotrectinib) and Krezati (adagrasib). Prior to that, he spent more than a decade at Novartis Pharmaceuticals in roles of increasing strategic and operational responsibility, culminating in his position as Executive Vice President and Head of Oncology Development. Dr Hirawat earned his Bachelor of Medicine and Bachelor of Surgery (MBBS) from Sawai Man Singh Medical College in Jaipur, India. He conducted his Internal Medicine residency and Medical Oncology fellowship in New York at North Shore University Hospital. Dr Hirawat has published more than 150 peer-reviewed manuscripts and abstracts across major therapeutic areas. “ Samit is a recognised leader in the field of clinical development and having the ability to access his vast expertise as a member of the Cytospire board will be an invaluable asset as we advance our innovative pipeline of pan-gamma delta T cell engagers ”  said Natalie Mount , Chief Executive Officer of Cytospire .  Peter Goodfellow, Non-Executive Chair of Cytospire added “ Samit is a fantastic addition to the Cytospire Board of Directors. He joins th e company at a particularly exciting time as the lead development programme, CYT X300, is being advanced into clinical trials as a treatment for EGFR-positive solid tumours, such as colorectal, head and neck and non-small cell lung cancers ”. “ I’m delighted to be joining Cytospire’s Board during this pivotal time in the Company’s journey” said Dr Samit Hirawat . “ Cytospire’s pan-gamma delta T cell engager technology has significant differentiation over conventional CD3 T cell engager approaches and huge potential to improve outcomes for patients in multiple cancer indications . I look forward to collaborating with the Cytospire team and contributing my experience to help advance the se important new therapies ”. Cytospire’s pan-gamma delta T cell engagers are uniquely engineered to target all gamma delta T cells rather than only specific subtypes. Through this approach, Cytospire seeks to overcome patient heterogeneity and generate broader, more effective antitumour immune responses through the activation of both tissue/tumour resident and blood resident effector cells. Cytospire recently announced the closing of an oversubscribed £61 million ($83 million) Series A financing supported by a strong syndicate of specialist biotech investors (see press release Cytospire Therapeutics announces Series A financing ). About Cytospire Therapeutics Cytospire is developing an innovative portfolio of differentiated multispecific engager antibodies to enhance and direct the activity of innate and adaptive effector immune cells.  Our core technology allows binding and activation of both tissue/tumour and blood resident gamma delta T cells. This opens a path to safer and more efficacious targeting of well-validated antigens that are intractable to CD3 T cell engagers due to toxicity. There are broad opportunities for Cytospire’s gamma delta T cell engagers in solid and haematological malignancies, as well as in autoimmune disease.  Based in London, UK, Cytospire Therapeutics is backed by a strong syndicate of life science investors including Abingworth, 4BIO Capital, Servier Ventures, British Business Bank, Sound Bioventures, LifeArc Ventures and Criteria Bio Ventures. For more information, visit  Contacts Andrew Fadden, Chief Business Officer contact@cytospiretx.com Frazer Hall, Mark Swallow MEDiSTRAVA cytospire@medistrava.com

Executive Change

18 May 2026

·www.fiercebiotech.com

Analysts ‘shaking heads’ after Regeneron melanoma drug fails to beat Keytruda in phase 3 trial

The failure of Regeneron’s “defining catalyst” of the first half of the year puts fresh pressure on the company, analysts said.\n A phase 3 trial of Regeneron’s LAG-3 inhibitor has missed its primary endpoint, leaving the biopharma reeling from the second failure of a key late-stage program in the past year.The trial assessed fianlimab in combination with Regeneron’s PD-1 inhibitor Libtayo as a first-line treatment for unresectable locally advanced or metastatic melanoma. Progression-free survival (PFS) on the drug combination was statistically no better than on Merck & Co.’s PD-1 inhibitor Keytruda, causing the trial to miss its primary endpoint.Median PFS was numerically longer with the fianlimab combination, at 11.5 months on the high dose, compared with 6.4 months on Keytruda. The statistical miss was driven by a late separation in the PFS curves, BMO Capital Markets analysts said in a note to investors after speaking with Regeneron.“It is clear that while mPFS was improved with high-dose fianlimab combo treatment, separation from monotherapy treatment did not occur until later in the study, leading to the not statistically significant result,” the analysts said. “Somewhat encouragingly, [Regeneron’s investor relations] did note a trend in [overall survival] improvement.” The p value was just the wrong side of statistical significance. But, as the analysts said, “close does not count.” The failure of Regeneron’s “defining catalyst” of the first half of the year puts fresh pressure on the company, according to the analysts, who said they were left “shaking our heads” by the latest flop.Pressure began to ratchet up almost one year ago, when Regeneron and Sanofi reported the failure of one of two phase 3 trials of their IL-33 drug itepekimab in chronic obstructive pulmonary disease. The back-to-back misses for key pipeline projects “amp up the pressure” on the next 12 to 18 months of clinical development at Regeneron, the analysts said.Regeneron has ways to salvage fianlimab. A phase 3 trial comparing the high-dose fianlimab combination to Bristol Myers Squibb’s LAG-3/PD-1 fixed-dose immunotherapy Opdualag is continuing. Regeneron sees showing an overall survival benefit over Opdualag and hitting the primary response rate endpoint of the head-to-head trial as paths back for fianlimab, Evercore ISI analysts said in a note to investors. Yet both BMO and Evercore analysts removed fianlimab from their models in response to the phase 3 flop. It is possible that Regeneron will show fianlimab is noninferior to Opdualag, BMO analysts said, but that is no longer the base-case assumption. BMO and Evercore analysts forecast $1.8 billion and $900 million in risk-adjusted peak sales, respectively, in melanoma before removing fianlimab from their models. With fianlimab now seen as a long shot, BMO analysts said “clean positive readouts” from Regeneron’s Factor XI program will be critical to regaining investor confidence. Regeneron is developing two Factor XI antibodies in a broad program, with initial pivotal data expected in 2027 and a series of readouts in the calendar for the coming years. Phase 3 data on the cemdisiran-pozelimab combination are another catalyst, BMO analysts said. Results from pivotal trials of the combination in geographic atrophy and paroxysmal nocturnal hemoglobinuria are due this year.

100 Deals associated with Nivolumab/Relatlimab

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic melanoma	European Union	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Metastatic melanoma	Iceland	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Metastatic melanoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Metastatic melanoma	Norway	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Unresectable Melanoma	European Union	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Unresectable Melanoma	Iceland	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Unresectable Melanoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Unresectable Melanoma	Norway	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Melanoma	United States	Bristol Myers Squibb Co.	18 Mar 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 3	United States	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Japan	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Argentina	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Australia	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Austria	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Belgium	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Brazil	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Chile	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Colombia	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Denmark	Bristol Myers Squibb Co.	07 Oct 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06101134 (CTgov)	Phase 2	Melanoma \| Metastatic melanoma	100	relatlimab+nivolumab+rHuPH20+relatlimab+nivolumab (Cohort 1: Metastatic Melanoma)	kpfwksnsnr = fqzuaifoem ptycrxbaie (sjjqtquggq, ymvkthenzn - mbvnpijcsx) View more	-	09 Apr 2026
				nivolumab+nivolumab+rHuPH20 (Cohort 2: Resected Melanoma)	kpfwksnsnr = dhhvqjfqru ptycrxbaie (sjjqtquggq, gddbqqngkd - oehvcsqelq) View more
NCT05002569 (RELATIVITY-098, CTgov)	Phase 3	Melanoma \| Metastatic melanoma	1,093	nivolumab+relatlimab (Treatment 1)	qncletwixc(dvrmjjzruu) = lywwcnpcuq cioourdqzm (cgrghmxjrc, fieyvncpnp - vsbpxyezye) View more	-	08 Jan 2026
				nivolumab (Treatment 2)	qncletwixc(dvrmjjzruu) = wlevkcqfgr cioourdqzm (cgrghmxjrc, npzasluhym - zkmujeluio) View more
NCT05002569 (RELATIVITY-098, Company_Website) Manual	Phase 3	Melanoma Adjuvant	-	Opdualag	wqtkqtkvha(pathdjwpqk) = did not meet its primary endpoint. wprzadrvug (ylqbxtitix ) Not Met	Negative	13 Feb 2025
				Opdivo
ESMO2024 Manual	Not Applicable	Melanoma Second line \| First line \| Neoadjuvant	205	Nivolumab/Relatlimab	tgjzhtcrfj(gzgakprlkc) = bfaaduphcr xqonbqxzzl (vxcrozyvjw ) View more	Positive	14 Sep 2024
				Nivolumab/Relatlimab (subsequent line(C2))	tgjzhtcrfj(gzgakprlkc) = vhpapmusqm xqonbqxzzl (vxcrozyvjw ) View more
NEWS Manual	Phase 2/3	Melanoma	714	Opdualag	zekuhkezsr(yzqlouzwna) = pnipojavmv rlcgyyzgdf (glwaaftbur )	Positive	03 Jan 2024
				nivolumab	zekuhkezsr(yzqlouzwna) = xtuyehjiqz rlcgyyzgdf (glwaaftbur )
NCT03662659 (RELATIVITY-060, CTgov)	Phase 2	Gastrooesophageal junction cancer \| Gastroesophageal junction adenocarcinoma	274	BMS986213 (BMS986213 + Chemotherapy)	wjctvsinyl = ycyrikygjt daodritdiz (qutrbtvfgm, omlfqplmct - clcwimxkrs) View more	-	09 May 2022
				Nivolumab (Nivolumab + Chemotherapy)	wjctvsinyl = emlueyajza daodritdiz (qutrbtvfgm, klptloojok - bvddslrnee) View more

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