Latest news with #nivolumab
Medscape
16 hours ago
- Health
- Medscape
Fact or Fiction: Bladder Cancer
Recent advances in immunotherapy, genomic profiling, and bladder-sparing techniques have begun to reshape diagnostic algorithms and treatment strategies across disease stages, from non-muscle-invasive to metastatic bladder cancer. Immunotherapies targeting PD-1 and PD-L1 have shown durable responses in certain subsets of patients, while next-generation sequencing helps guide decisions by identifying actionable mutations and molecular subtypes. Additionally, minimally invasive surgical techniques, improvements in intravesical therapies, and novel surveillance tools such as urinary biomarkers contribute to a more personalized, risk-adapted approach. As the field moves toward more integrated, multidisciplinary care, clinicians and care teams must stay abreast of these innovations to ensure optimal outcomes, improved quality of life, and equitable access to cutting-edge therapies. Checkpoint inhibitors such as atezolizumab, nivolumab, and pembrolizumab have been approved for patients with advanced or metastatic urothelial carcinoma, especially those ineligible for cisplatin-based chemotherapy or with disease progression after platinum therapy. These agents work by targeting PD-1 or PD-L1 pathways to enhance the immune system's ability to fight cancer. In recent years, nivolumab was approved for use in combination with cisplatin and gemcitabine as first-line treatment for unresectable or metastatic urothelial carcinoma, marking a major shift toward integrating immunotherapy earlier in treatment algorithms. Learn more about immunotherapy for bladder cancer. Cigarette smoking is the leading risk factor for bladder cancer, responsible for approximately 50% of all cases. Smokers are twice as likely to develop bladder cancer than nonsmokers. Smoking cessation significantly reduces risk over time, though former smokers remain at elevated risk compared to never-smokers. Occupational exposures, such as to benzidine and beta-naphthylamine, are also important, especially for long-term workers in underregulated environments. However, these exposures account for a smaller percentage of overall cases. Environmental exposures are increasingly being realized as a cause for bladder cancer. Pesticides and contaminated drinking water are concerns. Learn more about bladder cancer etiology. The majority of NMIBC cases are managed conservatively, starting with transurethral resection of bladder tumor (TURBT). At recurrence, however, intravesical therapy with instilled chemotherapy drugs, Bacillus Calmette-Guérin (BCG), and immediate radical cystectomy are options that should be discussed. Radical cystectomy is generally reserved for patients who are unresponsive to or who have high-grade T1 lesions with associated carcinoma in situ, lymphovascular invasion, or variant histology. Bladder preservation is a cornerstone of treatment for low- and intermediate-risk patients with NMIBC, aiming to maintain quality of life while achieving cancer control. Surveillance through periodic cystoscopy and urinary cytology is essential to detect recurrences, which are common. Learn more about treatment for NMIBC. Although several urinary biomarkers (eg, NMP22, UroVysion FISH, Cxbladder, bladder tumor antigen tests) are available, they have not replaced cystoscopy, which remains the cornerstone of surveillance. Cystoscopy provides direct visualization and allows for resection of visible tumors, whereas biomarkers have variable sensitivity and specificity with the potential for false positives. Urinary biomarkers are being incorporated as adjuncts to traditional surveillance, however, as they offer minimal discomfort and invasiveness for patients. Ongoing research is exploring novel biomarker panels and genomic assays to better personalize surveillance regimens and reduce the burden of routine cystoscopy without compromising oncologic safety. Learn more about long-term monitoring for bladder cancer. Neoadjuvant cisplatin-based chemotherapy, typically gemcitabine plus cisplatin (GC) or methotrexate-vinblastine-doxorubicin-cisplatin (MVAC), has been shown to improve overall survival, with some studies finding a 10% benefit in 5-year survival. As a result, neoadjuvant chemotherapy is considered a standard of care for eligible patients with muscle-invasive bladder cancer. For cisplatin-ineligible patients, ongoing trials are evaluating alternative treatment options in the neoadjuvant setting. Molecular subtyping, while there is not yet currently sufficient evidence to be the standard of care, may help to inform treatment decision-making and offer the potential for more targeted therapies. Learn more about neoadjuvant therapy for bladder cancer.
Yahoo
30-06-2025
- Business
- Yahoo
I-Mab Highlights Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025
71% objective response rate (ORR) (12/17) per RECIST v1.1, with a favorable safety profile 83% ORR (10/12) in patients across doses selected for ongoing dose expansion study Responses observed in patients with low PD-L1 and/or CLDN18.2 expression Updated results to be presented at ESMO GI on July 2nd Company to host investor event on July 8th ROCKVILLE, Md., June 26, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the 'Company'), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced publication of ESMO Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) abstract #388MO related to positive data from a Phase 1b study evaluating givastomig in combination with nivolumab and mFOLFOX6 chemotherapy for metastatic gastric cancers. An objective response rate (ORR) of 71% (12/17) was observed across all dose levels with an ORR of 83% (10/12) observed at dose levels selected for the ongoing dose expansion study (8 and 12 mg/kg). Responses were rapid and deepened over time, and were observed in tumors with low levels of PD-L1 expression and/or low levels of Claudin 18.2 (CLDN18.2) expression. There was a favorable safety profile, with low incidence of GI and liver toxicities. I-Mab intends to host a virtual investor event on Tuesday, July 8th (register here) to recap the data being presented at ESMO GI. The abstract is based on the results of the dose escalation part of a Phase 1b study (NCT04900818) evaluating the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig used in combination with nivolumab and mFOLFOX6 as first line therapy (1L) in patients with Claudin 18.2-positive gastric cancers (≥1+ intensity in ≥1% of cells). The primary endpoint is safety. The study only enrolled patients in the U.S. 'We are excited to share positive initial data from the Phase 1b dose escalation study of givastomig in gastric cancers at ESMO GI 2025. Givastomig shows promising activity in the first line setting, with responses that are both rapid onset and durable, deepening over time. This is the first study to evaluate givastomig in combination with immunochemotherapy and we are very pleased by the overall tolerability, consistent pharmacokinetic data and soluble 4-1BB induction. We look forward to sharing the data with the oncology and investment communities at ESMO GI 2025 on July 2nd,' said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. 'Givastomig's strong response data and favorable safety profile are encouraging. I look forward to presenting the data for this novel Claudin 18.2 targeted therapy next week at ESMO GI and discussing with colleagues,' said Samuel J Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital. 'Gastroesophageal cancers continue to be a significant unmet medical need, and novel combination approaches are critical. On behalf of the study team, I am enthusiastic to continue to support the givastomig clinical program.' ESMO GI Presentation Details: Title: Preliminary Safety and Efficacy of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Combination with Nivolumab and mFOLFOX in Metastatic Gastroesophageal Carcinoma (mGEC)Speaker: Samuel J. Klempner, MD, Associate Professor of Medicine, Massachusetts General HospitalPresentation Number: 388MODate and Time: Wednesday, July 2nd at 16:50 CEST (10:50am EST) Givastomig Phase 1b Dose Escalation Data Summary in 1L Gastric Cancers 17 advanced metastatic gastric cancer patients were treated with givastomig across the 5 mg/kg (n=5), 8 mg/kg (n=6), and 12 mg/kg (n=6) dose levels as of the February 28, 2025, data cutoff. All patients were efficacy evaluable Patient Characteristics: The 17 patients enrolled in the study were treatment naïve metastatic gastric, esophageal or gastroesophageal adenocarcinomas Patients were HER2-negative, Claudin 18.2-positive (defined as >1+ intensity in >1% of tumor cells) regardless of PD-L1 expression levels All patients were enrolled at sites within the United States Efficacy Results: Objective Response Rates (ORRs): 71% of patients (12/17) achieved a partial response (PR) per RECIST v1.1 5 mg/kg (2/5) 8 mg/kg (5/6) 12 mg/kg (5/6), with one unconfirmed response as of the data cutoff At the doses selected for dose expansion (8 and 12 mg/kg), 83% (10/12) of patients achieved PRs 80% of patients (4/5) with CLDN18.2 expression below 75% (CLDN-Low) achieved a PR. The CLDN-Low response rate increased to 100% of patients (3/3) in the doses selected for expansion (8 and 12 mg/kg) The disease control rate (DCR) was 100% across the three dose levels Dose-dependent PK was observed, similar to monotherapy PK. Patients also experienced a dose dependent induction of soluble 4-1BB, a positive indicator of T cell activation and engagement ORR: % (n) All(n=17) Cohorts Chosen for expansion(8 and 12 mg/kg)(n=12) PD-L1 Any 71 (12/17) 83 (10/12) ≥5 82 (9/11) 89 (8/9) <5 50 (3/6) 67 (2/3) ≥1 73 (11/15) 82 (9/11) <1 50 (1/2) 100 (1/1) CLDN18.2 ≥75 67 (8/12) 78 (7/9) <75 80 (4/5) 100 (3/3) Durability: 8 of 17 patients remained on study treatment and the longest treatment duration was 11.3 months as of the data cutoff Safety: No dose limiting toxicities (DLT) were observed and a maximum tolerated dose (MTD) was not reached Common treatment related adverse events (TRAEs, ≥10% of patients) were generally Grade 1 or Grade 2 including nausea, vomiting, infusion related reaction, fatigue, decreased appetite, diarrhea, abdominal pain, chills, dyspepsia and gastritis Grade 3 TRAEs attributed to givastomig were rare, with single cases of abdominal pain, ALT/AST increases, gastritis, and infusion related reaction No Grade 4 or Grade 5 TRAEs were reported Virtual Investor Event: Register for the Post-ESMO GI 2025 Investor Event here. A replay of the webinar will be accessible on the News & Events page of the I-Mab website for 90 days. About Givastomig Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line (1L) metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents. An ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment continues to progress ahead of schedule in the second dose expansion cohort (n=20). The study builds on positive Phase 1 monotherapy data. Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio. About I-Mab I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. The Company's differentiated pipeline is led by givastomig, a potential best-in-class, bispecific antibody (Claudin 18.2 x 4-1BB) designed to treat Claudin 18.2-positive gastric cancers. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed for first-line metastatic gastric cancers, with additional potential in other solid tumors. In Phase 1 trials, givastomig was observed to maintain strong tumor-binding and anti-tumor activity, attributable to a potential synergistic effect of proximal interaction with Claudin 18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents. For more information, please visit and follow us on LinkedIn and X. I-Mab Forward-Looking Statements This announcement contains forward-looking statements. These statements are made under the 'safe harbor' provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as 'will', 'expects', 'believes', 'designed to', 'anticipates', 'future', 'intends', 'plans', 'potential', 'estimates', 'confident', and similar terms or the negative thereof. I-Mab may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the Company's pipeline and clinical development of I-Mab's drug candidates, including givastomig; the projected advancement of the Company's portfolio and anticipated milestones and related timing; the Company's expectations regarding the impact of data from ongoing and future clinical trials; the timing and progress of studies and trials (including with respect to patient enrollment); the potential benefits of givastomig; and the availability of data and information from ongoing studies and trials. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; and I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the 'Risk Factors' section in I-Mab's annual report on Form 20-F filed with the SEC on April 3, 2025, as well as the discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the SEC. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. I-Mab Investor & Media Contacts PJ Kelleher LifeSci Advisors +1-617-430-7579 pkelleher@ IR@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Medscape
13-06-2025
- Health
- Medscape
Nivolumab Plus Chemotherapy Improves Survival in Lung Cancer
Adding nivolumab to neoadjuvant chemotherapy significantly improved 5-year overall survival among patients with resectable non-small cell lung cancer (NSCLC), according to findings from a phase 3 trial presented at the recent American Society of Clinical Oncology (ASCO) 2025 annual meeting. The survival benefit was more pronounced in patients who achieved a pathologic complete response or a presurgery clearance of circulating tumor DNA (ctDNA). METHODOLOGY: The phase 3 CheckMate 816 trial has shown that compared with neoadjuvant chemotherapy alone, nivolumab plus chemotherapy improvespathologic complete response rates and event-free survival in patients with stage IB-IIIA resectable NSCLC. Based on these findings, this regimen was approved for this patient population in the US, EU, and other places. compared with neoadjuvant chemotherapy alone, nivolumab plus chemotherapy improvespathologic complete response rates and event-free survival in patients with stage IB-IIIA resectable NSCLC. Based on these findings, this regimen was approved for this patient population in the US, EU, and other places. Researchers are now reporting the final, prespecified analysis of overall survival. In the trial, 358 patients with stage IB-IIIA resectable NSCLC were randomly assigned to receive either nivolumab plus platinum-based chemotherapy or platinum-based chemotherapy alone every 3 weeks for three cycles. Surgery was performed within 6 weeks of completing neoadjuvant treatment. Postoperative adjuvant chemotherapy, radiotherapy, or both were permitted. Primary endpoints were event-free survival and pathologic complete response. Overall survival was the key secondary endpoint. The median follow-up duration was 68.4 months. TAKEAWAY: The 5-year overall survival rate was 65.4% with nivolumab plus chemotherapy vs 55.0% with chemotherapy alone. Nivolumab plus chemotherapy reduced the risk for death by 28% (hazard ratio [HR], 0.72; P = .048). = .048). Among patients who received the combination therapy, the 5-year overall survival rate was 95.3% for those who achieved a pathological complete response vs 55.7% for those who did not. Overall, 24% of patients in the nivolumab group achieved a pathological complete response vs only 2.2% in the chemotherapy group. ctDNA clearance before surgery was a strong prognostic indicator, regardless of treatment. At 5 years, overall survival was 75.0% among patients with ctDNA clearance vs 52.6% in those without (HR for death, 0.38 in the nivolumab group and 0.39 in the chemotherapy-only group). The combination therapy was associated with consistent survival benefits across disease stage and PDL-1 expression levels. The 5-year lung cancer-specific survival rate was 74.9% with nivolumab plus chemotherapy vs 65.1% with chemotherapy alone (HR, 0.65). No new safety concerns emerged, and there were no new deaths related to a trial treatment. IN PRACTICE: 'In this trial, we found that the use of neoadjuvant nivolumab plus chemotherapy resulted in significantly longer overall survival than chemotherapy alone, along with long-term benefit regarding event-free survival,' the authors wrote. 'These findings support the hypothesis that neoadjuvant chemoimmunotherapy can have a profound impact on the course of a patient's life when paired with the curative potential of surgical resection.' SOURCE: This study, led by Patrick M. Forde, MB, BCh, PhD, Trinity St. James's Cancer Institute, Trinity College Dublin, Dublin, Ireland, was published online in The New England Journal of Medicine and presented at ASCO. LIMITATIONS: Although the overall survival with nivolumab plus chemotherapy achieved statistical significance, the margin was narrow. Additionally, several subgroups in the exploratory analyses were too small for adequate statistical comparison, requiring cautious interpretation of these results. Black patients were underrepresented, which may have affected the generalizability of the findings. DISCLOSURES: This study was funded by Bristol Myers Squibb. Five authors declared being employees of Bristol Myers Squibb, with some holding stock or stock options with the company. Several authors declared working as consultants or having other ties with various sources including Bristol Myers Squibb.
Medscape
02-06-2025
- Business
- Medscape
Adjuvant Nivolumab + CRT Improves DFS in HNSCC
Adding nivolumab (Opdivo) to standard-of-care cisplatin radiotherapy (CRT) after surgery for locally advanced head and neck squamous cell carcinoma (HNSCC) in patients at a high risk for relapse reduced the risk for recurrence, as per a phase 3 trial. This new therapeutic option 'improved high-risk locally advanced squamous cell carcinoma of the head and neck,' said study author Jean Bourhis, MD, PhD, during a press conference at American Society of Clinical Oncology (ASCO) 2025. Postoperative nivolumab added to standard-of-care adjuvant CRT 'could be proposed as a new standard treatment for the first time in two decades,' said Bourhis, MD, PhD, of Lausanne University Hospital in Lausanne, Switzerland, while reporting results of NIVOPOSTOP (GORTEC 2018-01) during the press conference. Agreeing with Bourhis' characterization of the therapeutic regimen followed in the new trial, Stuart Wong, MD, said NIVOPOSTOP 'represents a potential new standard,' in his comments as discussant of the results at the meeting's Plenary Session. As immunotherapy for head and neck cancers evolve, so must the approach to managing these patients, said Wong, who is director of the Center for Disease Prevention Research at the Medical College of Wisconsin in Milwaukee. 'In a world where neoadjuvant and adjuvant anti–PD-1 [programmed cell death 1] are options for patient care, a multidisciplinary tumor board discussion is optimal and should include individual patient and social factors, as well as consideration of individual tumor growth dynamic,' Wong said. 'The NIVOPOSTOP study presents a major turning point,' he added. 'However, we face many steep obstacles ahead of us, foremost among these the completion of ongoing studies.' Study Design and Results The study enrolled 680 patients aged 75 years or younger with HNSCC who had complete macroscopic surgical resection of stage III or IV cancer. Half the patients were either smokers or heavy smokers, and the most common tumor site was the oral cavity. About 80% of patients had either stage IVA or IVB disease. After surgical resection, patients were randomized to one of the two regimens. The treatment group received one dose of 240 mg nivolumab, followed by a dose of 360 mg nivolumab every 3 weeks plus standard-of-care 100 mg/m2 cisplatin every 3 weeks and 66 grays (Gy) of intensity-modulated RT (IMRT), followed by six doses of 480 mg nivolumab over 4 weeks. The control group received 100 mg/m2 cisplatin every 3 weeks and IMRT 66 Gy. The rate of 3-year disease-free survival in the nivolumab plus CRT group was 63.1% vs 52.5% in the control group ( P = .034), representing a 24% improvement, Bourhis said. The nivolumab plus CRT group also had a 37% reduced risk for cumulative incidence of locoregional relapses alone at 3 years, he added. Compliance rates were similar between both groups. For example, RT compliance rates over 55 days were 95% for nivolumab plus CRT and 97% for CRT. The proportion of patients experiencing more serious side effects in the 100 days following treatment was higher in the nivolumab plus CRT group than in the control group (13.1% vs 5.6%). The most common grade 4 adverse events in both groups were neutropenia and lymphocytopenia. Most treatment-related adverse events were less serious grade 1 or 2 events and were related to chemoradiotherapy in both groups. The nivolumab group had 'a slight increase' in renal toxicity (24% vs 15%) and 'a more pronounced increase' in thyroid disorders (20% vs 2%), Bourhis said. Evidence Is Growing NIVOPOSTOP adds to a body of evidence supporting the use of adjuvant immunotherapy in difficult-to-treat disease, Glenn Hanna, MD, director of the Center for Cancer Therapeutic Innovation at Dana-Farber Cancer Institute in Boston, said at the press conference. He cited results from the KEYNOTE-689 trial, reported in April at American Association for Cancer Research Annual Meeting 2025, in which patients with HNSCC were given perioperative neoadjuvant pembrolizumab followed by adjuvant pembrolizumab. 'It brings us into a space where we were with kidney cancers and with melanoma, to say what is the right sequence of immunotherapy?' Hanna said. He noted that NIVOPOSTOP and KEYNOTE-689 both reported similar outcomes. 'So do you give the immunotherapy first, or do we wait and do it in the adjuvant setting?' he said. Based on Bourhis' research, 'they are comparable.' He added, 'I think now immunotherapy will be here and present for our head and neck patients undergoing cancer resection.' NIVOPOSTOP received support from Bristol Myers Squibb and GORTEC. Bourhis reported having financial relationships with AstraZeneca, Bristol Myers Squibb, Merck Serono, and Merck Sharpe and Dohme. Hanna reported having relationships with Actuate Therapeutics, Bicara Therapeutics, Boxer Capital, Bristol Myers Squibb, Coherus BioSciences, Elevar Therapeutics, Genentech, Greywolf Therapeutics, ImmunityBio, InhibRx, KSQ Therapeutics, Kura Oncology, Merck, Naveris, Nextech Invest, PDS Biotechnology, Regeneron, Remix Therapeutics, Replimune, Secura Bio, and Surface Oncology. Wong reported receiving research funding from Hookipa Pharma, Merck, and Novartis.
Yahoo
01-06-2025
- Business
- Yahoo
Replimune Presents New Analyses from the IGNYTE Study of RP1 plus Nivolumab in Anti-PD1 Failed Melanoma at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
- RP1 plus nivolumab generated robust responses in both injected and non-injected lesions - - Deep/visceral injections, including into the liver and lung, resulted in numerically higher rates of response compared to superficial injections only and were generally well tolerated - WOBURN, Mass., June 01, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented two posters highlighting data updates for RP1 (vusolimogene oderparepvec) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago. 'The new analyses we presented from the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD-1 failed melanoma confirms our belief in the systemic activity of the combination, and also shows robust responses in injected liver and lung lesions with an acceptable safety profile,' said Kostas Xynos, M.D., Chief Medical Officer of Replimune. 'Additional data also presented at the meeting shows that RP1 can be handled safely with no additional biosafety protocols required confirming that standard disinfection procedures are sufficient for clean up.' Key findings are outlined below. Poster Presentation: Response analysis for injected and non-injected lesions and the safety and efficacy of superficial and deep RP1 injection in the registrational cohort of anti-PD-1-failed melanoma patients of the IGNYTE trial (Track: Melanoma/Skin Cancers; June 1, 2025, 9:00 am – 12:00 pm CDT; Location: Hall A, Board 20; Abstract: 9537) The poster included an analysis from the IGNYTE clinical trial of RP1 plus nivolumab in the cohort of anti-PD-1 failed melanoma patients (n=140). In the trial, the objective response rate (ORR) was 32.9% using RECIST 1.1. The complete response rate was 15.0% and landmark overall survival (OS) rates at 1, 2, and 3 years were 75.3%, 63.3%, and 54.8% respectively. Median OS has not been reached. Patients experienced numerically higher objective response rates after receiving deep injections (± superficial) compared with superficial injections only. Deep responses were observed in injected and non-injected lesions. The ORR by injection type using RECIST 1.1 was 29.8% when only superficial lesions were injected, 42.9% for deep/visceral plus superficial injections injected, and 40.9% when only deep/visceral lesions were injected. There was a ≥30% reduction in 93.6% (73/78) of injected lesions and 79.0% (94/119) of non-injected lesions. The kinetics of response were similar in injected vs non-injected lesions. Of the non-injected visceral organ lesions in responding patients, 96.2% (50/52) showed reduction from baseline, with 65.4% reduced by ≥30%. RP1 injections directly into the lung and liver were generally well tolerated and resulted in few organ-specific adverse events that were easily managed. Liver and lung injections had a tolerable safety profile. No bleeding events were reported after liver injection. Lung injections were associated with low rates of pneumothorax events, which were typically of low grade and manageable. Overall, these data support the safety and efficacy of deep/visceral injections and demonstrate the development of a robust systemic anti-tumor response following treatment with RP1 plus nivolumab. Poster Presentation: Biosafety analysis from the skin cancer cohorts in the IGNYTE clinical trial of RP1 (Track: Melanoma/Skin Cancers; June 1, 2025, 9:00 am – 12:00 pm CDT; Location: Hall A, Board 17; Abstract: 9534) RP1 was assessed in various samples taken from patients. This demonstrated that RP1 DNA is primarily detected at the injection site, consistent with RP1 replication in the tumor, and much more rarely on dressings, in blood, on mucous membranes or in urine. In all cases, live RP1 was only rarely if ever detected, demonstrating that while residual RP1 DNA may be present, this does not indicate the presence of live RP1 There were no systemic herpetic infections in patients or reports of HSV-1 infections in contacts. RP1 is completely neutralized using standard disinfectants within 30 seconds of contact, confirming that standard disinfection procedures are sufficient for RP1 clean-up. Collectively these data demonstrate that the likelihood of transmission of RP1 to patients' contacts or into the external environment is minimal, with no transmission having been reported to date. Both posters will be available on the Company website under Events and Presentations. About RP1RP1 is Replimune's lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP-R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. About RP2RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP-R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP-R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity. About ReplimuneReplimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune's proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit Forward Looking StatementsThis press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the regulatory review process and timing of potential product approval, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as 'could,' 'expects,' 'intends,' 'may,' 'plans,' 'potential,' 'should,' 'will,' 'would,' or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues and the Russian-Ukrainian and Israel-Hamas political and military conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Investor InquiriesChris BrinzeyICR Media InquiriesArleen GoldenbergReplimune917.548.1582 media@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
