RegulationPriority Review (US), Accelerated Approval (US), Orphan Drug (AU), Paediatric investigation plan (EU), Breakthrough Therapy (US), Orphan Drug (US)

Gene Sequence

Sequence Code 13451140H

Source: *****

Sequence Code 13451157L

Source: *****

146

Clinical Trials associated with Cemiplimab-RWLC

NCT06616584 / Not yet recruitingPhase 2/3IIT

A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.

Start Date11 Jul 2025

Sponsor / Collaborator

SWOG

[+2]

NCT06651593 / Not yet recruitingPhase 2IIT

Phase II Biomarker Study of SAR444881 in Combination With Cemiplimab in Solid Tumors

To study possible biomarkers that may be related to how SAR444881 works (either alone or when combined with cemiplimab) in participants with solid tumors.

Start Date15 Apr 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+2]

NCT06585410 / Not yet recruitingPhase 3

A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)

This study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called programmed cell death-1 (PD-1) on the surface of certain immune cells.
The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.
The study is looking at:
* The side effects cemiplimab might cause
* How well cemiplimab works

Start Date28 Jan 2025

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

100 Clinical Results associated with Cemiplimab-RWLC

100 Translational Medicine associated with Cemiplimab-RWLC

100 Patents (Medical) associated with Cemiplimab-RWLC

401

Literatures (Medical) associated with Cemiplimab-RWLC

31 Dec 2024·OncoImmunology

Overexpression of CCL-20 and CXCL-8 genes enhances tumor escape and resistance to cemiplimab, a programmed cell death protein-1 (PD-1) inhibitor, in patients with locally advanced and metastatic cutaneous squamous cell carcinoma

Article

Author: Nardone, Valerio ; Esposito, Alfonso ; Ciardiello, Davide ; Del Tufo, Sara ; Esposito, Daniela ; Giugliano, Maria Cristina ; Cioli, Eleonora ; Formisano, Luigi ; Ronchi, Andrea ; Troiani, Teresa ; D’Ippolito, Emma ; Zito Marino, Federica ; De Falco, Vincenzo ; Famiglietti, Vincenzo ; Caraglia, Francesco ; Argenziano, Giuseppe ; Napolitano, Rossella ; Napolitano, Stefania ; Bianco, Roberto ; Franco, Renato ; Suarato, Gabriella ; Ciardiello, Fortunato

Cemiplimab has demonstrated relevant clinical activity in cutaneous squamous cell carcinoma (cSCC) but mechanisms of primary and acquired resistance to immunotherapy are still unknown. We collected clinical data from locally advanced and/or metastatic cSSC patients treated with cemiplimab in two Italian University centers. In addition, gene expression analysis by using Nanostring Technologies platform to evaluate 770 cancer- and immune-related genes on 20 tumor tissue samples (9 responders and 11 non-responders to cemiplimab) was performed. We enrolled 81 patients with a median age of 82 years. After 16.4 months of median follow-up, 12- and 24-months PFS were 53% and 42%, respectively; while 12- and 24-months OS were 71% and 61%, respectively. Treatment was well tolerated. Overall response rate (ORR) was 58%, with a disease control rate (DCR) of 77.8%. The difference between genes expressed in responder versus non-responder patient samples was substantial, particularly for genes involved in immune system regulation. Cemiplimab-resistant tumors were associated with over-expression of CCL-20 and CXCL-8. Cemiplimab confirmed efficacy and safety data in real-life cSCC patients. Overexpression of CCL-20 and CXCL-8 could represent biomarkers of lack of response to immunotherapy.

10 Dec 2024·NEUROLOGY

Immune Checkpoint Inhibitor Myopathy

Review

Author: Pinal-Fernandez, Iago ; Liewluck, Teerin ; Beecher, Grayson ; Mammen, Andrew L.

Immune checkpoint inhibitor (ICI) therapy has revolutionized the treatment of several malignancies, with improved survival. These monoclonal antibodies target immune checkpoints, including cytotoxic T-lymphocyte-associated protein 4 (ipilimumab and tremelimumab), programmed death 1 (nivolumab, pembrolizumab, cemiplimab, and dostarlimab), programmed death ligand 1 (atezolizumab, avelumab, and durvalumab), and lymphocyte activation gene 3 (relatlimab), and effectively augment the immune response against tumor cells. Releasing the brakes on the immune system has consequences, however, in the form of immune-related adverse events (irAEs), which may affect any organ. Neurologic irAEs represent 1%-3% of all irAEs, with immune-mediated myopathy (ICI myopathy) being the most common manifestation. Recent large patient series and systematic reviews have established the key features and highlighted new insights into ICI myopathy. ICI myopathy is characterized by an acute or subacute onset of oculobulbar and/or proximal limb weakness, with or without associated respiratory insufficiency and myocarditis. Creatine kinase elevation is common. Oculobulbar presentations with or without respiratory failure may be misattributed to neuromuscular junction disorders, particularly because acetylcholine receptor antibodies are present in up to 40% of patients; however, an electrodiagnostic evidence of a defect of neuromuscular transmission is often absent even in patients with severe weakness, highlighting that the myopathic process is the driving force behind these presentations. Muscle histopathology commonly demonstrates a unique signature of multifocal clusters of necrotic and regenerating fibers, differentiating ICI myopathy from other autoimmune myopathies. Transcriptomic analysis has uncovered distinct subgroups within ICI myopathy, revealing varying degrees of type 1 and type 2 interferon pathway activation alongside notable upregulation of the interleukin (IL)-6 pathway in affected muscle tissue. This discovery presents a promising avenue for intervention through the use of therapies that suppress the interferon pathway and target IL-6 or its receptor. Despite clinical improvements with immunomodulatory therapy, with corticosteroids the mainstay of treatment, mortality remains high, particularly in those with associated myocarditis or respiratory failure requiring intubation, where mortality occurs in up to 50%. ICI withdrawal can lead to cancer progression and death, highlighting a need for improved approaches to ICI rechallenge, performed in limited patients with variable success to date.

01 Dec 2024·INTERNATIONAL IMMUNOPHARMACOLOGY

A comprehensive review of immune checkpoint inhibitors for cancer treatment

Review

Author: Arafat Hossain, Md. ; Arafat Hossain, Md

Immunology-based therapies are emerging as an effective cancer treatment, using the body's immune system to target tumors. Immune checkpoints, which regulate immune responses to prevent tissue damage and autoimmunity, are often exploited by cancer cells to avoid destruction. The discovery of checkpoint proteins like PD-1/PD-L1 and CTLA-4 was pivotal in developing cancer immunotherapy. Immune checkpoint inhibitors (ICIs) have shown great success, with FDA-approved drugs like PD-1 inhibitors (Nivolumab, Pembrolizumab, Cemiplimab), PD-L1 inhibitors (Atezolizumab, Durvalumab, Avelumab), and CTLA-4 inhibitors (Ipilimumab, Tremelimumab), alongside LAG-3 inhibitor Relatlimab. Research continues on new checkpoints like TIM-3, VISTA, B7-H3, BTLA, and TIGIT. Biomarkers like PDL-1 expression, tumor mutation burden, interferon-γ presence, microbiome composition, and extracellular matrix characteristics play a crucial role in predicting responses to immunotherapy with checkpoint inhibitors. Despite their effectiveness, not all patients experience the same level of benefit, and organ-specific immune-related adverse events (irAEs) such as rash or itching, colitis, diarrhea, hyperthyroidism, and hypothyroidism may occur. Given the rapid advancements in this field and the variability in patient outcomes, there is an urgent need for a comprehensive review that consolidates the latest findings on immune checkpoint inhibitors, covering their clinical status, biomarkers, resistance mechanisms, strategies to overcome resistance, and associated adverse effects. This review aims to fill this gap by providing an analysis of the current clinical status of ICIs, emerging biomarkers, mechanisms of resistance, strategies to enhance therapeutic efficacy, and assessment of adverse effects. This review is crucial to furthering our understanding of ICIs and optimizing their application in cancer therapy.

426

News (Medical) associated with Cemiplimab-RWLC

18 Nov 2024

·www.globenewswire.com

Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU)

Nov. 15, 2024 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025. The resubmitted sBLA is supported by data from the multi-trial, LIBERTY-CUPID Phase 3 clinical program (Study A, Study B, and Study C) for Dupixent in CSU. The sBLA adds results from Study C, which was conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Study C, the second LIBERTY-CUPID pivotal trial in biologic-naïve patients, met its primary and key secondary endpoints confirming results seen in the previous Study A. Results showed Dupixent significantly reduced itch and urticaria activity (itch and hives). Safety results in all LIBERTY-CUPID Phase 3 trials were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (≥5%) compared to placebo were injection site reactions and COVID-19 infection. CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria. However, the disease remains uncontrolled despite antihistamine treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life. More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines. The LIBERTY-CUPID Phase 3 study program evaluating Dupixent for CSU consists of Study A, Study B, and Study C. Study A and Study C were conducted in CSU patients who were uncontrolled on standard-of-care antihistamines while Study B was conducted in CSU patients who were uncontrolled on standard-of-care antihistamines and refractory or intolerant to omalizumab. Dupixent has been approved for CSU in Japan and the United Arab Emirates (UAE) and is also under regulatory review in the European Union based on earlier trial readouts. Outside of Japan and the UAE, the safety and efficacy of Dupixent for CSU has not been fully evaluated by any regulatory authority. Dupixent, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are two of the key and central drivers of type 2 inflammation that play a major role in multiple related and often co-morbid diseases. Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, CSU, and chronic obstructive pulmonary disease in different age populations. More than 1,000,000 patients are currently being treated with Dupixent globally.1 Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent, Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug ApprovalPriority Review

14 Nov 2024

·www.globenewswire.com

Sensei Biotherapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights

- SNS-101 Phase 1/2 dose expansion clinical data expected in the first half of 2025 - - Organizational restructuring to focus resources on advancing the clinical development of SNS-101 - - Cash runway extended into the second quarter of 2026 - BOSTON, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the third quarter ended September 30, 2024, and provided corporate updates. “The third quarter of 2024 saw significant progress in advancing patient enrollment in the dose expansion portion of the Phase 1 study for SNS-101 across dose levels and patients with primary and acquired resistance to PD-1 inhibitors. Looking ahead, management has focused its attention on preparing for Phase 2 studies,” said John Celebi, President and Chief Executive Officer. “We believe SNS-101 has disruptive potential for the treatment of a multitude of cancer indications and for this reason we are making the difficult decision to reduce our headcount to focus our resources on advancing the clinical development of SNS-101. We anticipate that these changes will extend our cash runway into the second quarter of 2026. We look forward to sharing a clinical update focused primarily on the activity profile of SNS-101 and additional details about the design of Phase 2 studies. I want to express my gratitude to all our affected employees for the contributions they have made to the Company.” Clinical Highlights and Milestones SNS-101 SNS-101 is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor microenvironment. VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates. Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101 as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) in patients with advanced solid tumors. Patient enrollment is advancing in the dose expansion portion of the Phase 1/2 study, with approximately half of the dose expansion study enrolled. To further the Company’s objective of generating clinical data that informs both the optimal dose and patient population for Phase 2 studies, including comprehensive data from patients with both primary and acquired resistance to PD-1 inhibitors, the Company expects to report clinical data across two dose levels in multiple tumor types in the first half of 2025.Sensei received preliminary guidance from the FDA on the dose optimization strategy for SNS-101. The Company plans to re-engage with the agency following additional data from the dose expansion portion of the Phase 1/2 clinical trial.SNS-101 continues to be well tolerated with a best-in-class pharmacological profile among anti-VISTA antibodies.In November, Sensei presented an overview of SNS-101 at PEGS Europe: Protein and Antibody Engineering Summit.In November, the Company presented data on spatial proteomic profiling of VISTA and PSGL-1 interactions across cancer indications in a poster presentation at the Society of Immunotherapy Cancer (SITC) 39th Annual Meeting. Corporate Updates Sensei is announcing an organizational restructuring to streamline operations and focus resources on advancing the clinical development of SNS-101. The Company will close its research site in Rockville, Maryland and reduce its workforce by approximately 46 percent, with most of the headcount reductions in the Company’s preclinical research and development group. These changes are anticipated to extend cash runway into the second quarter of 2026.In July, the Company announced the appointment of Josiah Craver as Senior Vice President, Finance. In September, Josiah was appointed as the Company’s principal financial officer and principal accounting officer. Third Quarter 2024 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $47.0 million as of September 30, 2024. Sensei expects its current cash balance to fund operations into the second quarter of 2026. Research and Development (R&D) Expenses: R&D expenses were $4.6 million for the quarter ended September 30, 2024, compared to $3.8 million for the quarter ended September 30, 2023. The increase in R&D expenses was primarily attributable to higher expense associated with clinical trials, personnel costs and manufacturing related expense partially offset by lower costs for preclinical research and lower consulting fees. General and Administrative (G&A) Expenses: G&A expenses were $3.2 million for the quarter ended September 30, 2024, compared to $3.9 million for the quarter ended September 30, 2023. The decrease in G&A expense was primarily attributable to decreased costs associated with insurance premiums as well as lower outside services expense, personnel costs and license fees. Net Loss: Net loss was $7.3 million for the quarter ended September 30, 2024, compared to $7.1 million for the quarter ended September 30, 2023. About Sensei BiotherapeuticsSensei Biotherapeutics (Nasdaq: SNSE) is a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients. Through its TMAb™ (Tumor Microenvironment Activated biologics) platform, Sensei develops conditionally active therapeutics designed to disable immunosuppressive signals or activate immunostimulatory signals selectively in the tumor microenvironment to unleash T cells against tumors. Sensei’s lead product candidate is SNS-101, a conditionally active antibody designed to block the V-domain Ig suppressor of T cell activation (VISTA) checkpoint selectively within the low pH tumor microenvironment, where VISTA acts as a suppressor of T cells by binding the receptor PSGL-1. For more information, please visit www.senseibio.com, and follow the company on X @SenseiBio and LinkedIn. Condensed Statements of Operations(Unaudited, in thousands except share and per share data) Three Months Ended September 30, 2024 2023 Operating expenses: Research and development $4,637 $3,818 General and administrative 3,186 3,919 Total operating expenses 7,823 7,737 Loss from operations (7,823) (7,737)Total other income 570 613 Net loss (7,253) (7,124)Net loss attributable to common stockholders (7,253) (7,124)Net loss per share, basic and diluted $(0.29) $(0.28)Weighted-average common shares outstanding, basic and diluted 25,147,999 25,514,115 Selected Condensed Balance Sheet Data (Unaudited, in thousands) September 30, 2024 December 31, 2023 Cash and cash equivalents $19,131 $13,011 Marketable securities 27,870 52,746 Total assets 53,254 74,374 Total liabilities 7,475 9,479 Total stockholders’ equity 45,779 64,895 Cautionary Note Regarding Forward-Looking StatementsAny statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe”, “designed to,” “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Sensei’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of Sensei’s product candidates, the timing of Sensei’s Phase 1/2 clinical trial of SNS-101, including reporting of data therefrom, and its belief that its existing cash and cash equivalents will be sufficient to fund its operations into the second quarter of 2026. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Sensei’s product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Sensei’s product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Sensei’s product candidates; the risk that Sensei’s product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Sensei anticipates; risks associated with Sensei’s dependence on third-party suppliers and manufacturers, including sole source suppliers, over which Sensei may not always have full control; risks regarding the accuracy of Sensei’s estimates of expenses, capital requirements and needs for additional financing; and other risks and uncertainties that are described in Sensei’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on November 14, 2024 and Sensei’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact:Michael BiegaSenior Director, Investor RelationsSensei Biotherapeuticsmbiega@senseibio.com Media Contact: Joyce Allaire LifeSci Advisors Jallaire@lifesciadvisors.com

Phase 1Financial StatementExecutive Change

13 Nov 2024

·www.globenewswire.com

Regeneron to Highlight Pioneering Pipeline Progress Across Multiple Modalities Spanning 10 Types of Blood Cancers and Disorders at ASH

Oral presentation shares head-to-head results for investigational combination pozelimab plus cemdisiran vs. ravulizumab in paroxysmal nocturnal hemoglobinuria Initial results for odronextamab in first-line follicular lymphoma showcase compelling monotherapy potential and progress in the confirmatory trial Additional oral presentations explore odronextamab in areas of high unmet need, including the primary analysis in diffuse large B-cell lymphoma progressing after CAR-T therapy and first results in relapsed/refractory marginal zone lymphoma TARRYTOWN, N.Y., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data from its hematology pipeline will be shared across 23 abstracts at the American Society of Hematology (ASH) 2024 Annual Meeting, taking place from December 7-10 in San Diego, CA. The latest research advances demonstrate the potential of Regeneron’s diverse pipeline, which aims to address unmet needs in ten types of blood cancers and disorders. These innovative and differentiated approaches include CD3 bispecific antibodies, costimulatory bispecific antibodies, and a pioneering combination of a monoclonal antibody and small interfering RNA (siRNA). “Our presentations at ASH demonstrate the progress we are making toward transforming care for a range of blood cancers and disorders where advancements are desperately needed,” said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President and Hematology Clinical Development Unit Head at Regeneron. “These include new head-to-head data exploring a novel combination that aims to maximize disease control in paroxysmal nocturnal hemoglobinuria compared to a standard-of-care treatment, as well as initial results from our confirmatory odronextamab trial in first-line follicular lymphoma. Together, our presentations underscore our commitment to work towards translating scientific breakthroughs to differentiated medicines for hematology patients.” At ASH, abstracts in blood disorders include an oral presentation from an exploratory cohort of a Phase 3 trial investigating a novel combination of pozelimab with cemdisiran compared to ravulizumab in patients with paroxysmal nocturnal hemoglobinuria (PNH) who were naïve to complement inhibition at baseline. Notably, the presentation will detail interim results from patients who were initially randomized to ravulizumab but crossed over to the combination in an open label extension portion of the trial. Progress on the odronextamab development program will be featured in twelve abstracts. Among them are initial results in patients with previously untreated follicular lymphoma (FL) from Part 1 of the Phase 3 OLYMPIA-1 confirmatory trial, which consists of a non-randomized safety run-in (Part 1) followed by a randomized efficacy portion (Part 2) comparing odronextamab monotherapy to rituximab plus standard-of-care chemotherapies. Two oral presentations on the ELM-1 and pivotal ELM-2 trials will feature new analyses in settings with significant unmet needs: one in patients with diffuse large B-cell lymphoma (DLBCL) who progressed after CAR-T therapy and the other in relapsed/refractory (R/R) marginal zone lymphoma (MZL). Other notable abstracts include the latest linvoseltamab efficacy and safety results from the pivotal LINKER-MM1 study in R/R multiple myeloma (MM), preclinical data evaluating a CD38xCD28 costimulatory bispecific antibody in combination with linvoseltamab, and preclinical data on TMPRSS6 inhibition in beta-thalassemia. The full list of Regeneron presentations at ASH includes: Abstract TitleAbstractPresenterSession Date/Time (PT)Odronextamab Efficacy and Safety of Odronextamab Monotherapy in Patients (Pts) with Diffuse Large B-Cell Lymphoma (DLBCL) Progressing after CAR T-Cell Therapy: Primary Analysis from the ELM-1 StudyAbstract #866Oral PresentationSessionMatthew MatasarMonday, December 9, at 2:45-4:15 pmMarriott Marquis San Diego Marina, Pacific Ballroom Salons 15-17Efficacy and Safety of Odronextamab in Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL): Data from the R/R MZL Cohort in the ELM-2 StudyAbstract #862Oral PresentationSessionTae Min KimMonday, December 9, at 2:45-4:15 pmMarriott Marquis San Diego Marina, Marriott Grand Ballroom 11-13Odronextamab Monotherapy in Previously Untreated Patients with High-Risk Follicular Lymphoma (FL): Results of the Safety Lead-in of the Phase 3 OLYMPIA-1 StudyAbstract #4411Poster PresentationSessionElizabeth BremMonday, December 9, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HEfficacy and Safety of Odronextamab in Rare Subtypes of Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma (B-NHL): Data from a Dedicated Cohort of Other B-NHLs in the ELM-2 StudyAbstract #4502Poster PresentationSessionEmmanuel BachyMonday, December 9, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HTreatment Duration and Risk of Fatal Infections in Patients with B-Cell Non-Hodgkin Lymphoma Achieving Complete Response with OdronextamabAbstract #3080Poster PresentationGottfried von KeudelMonday, December 9, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HDynamics of Complete Responses in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma Treated with Odronextamab in the ELM-2 StudyAbstract #4486Poster PresentationSessionSabarish AyyappanMonday, December 9, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HLong-Term Efficacy and Safety of Odronextamab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Pooled Analysis from ELM-1 and ELM-2 StudiesAbstract #3118Poster PresentationSessionJohn N. AllanSunday, December 8, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HEvaluation of CAR-HEMATOTOX Scoring as a Predictor of Infection Risk following Treatment with Odronextamab (a CD20×CD3 Bispecific Antibody) in Relapsed/Refractory Diffuse Large B-Cell LymphomaAbstract #3076Poster PresentationSessionMathew MatasarSunday, December 8, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HEvaluation of Baseline CAR-HEMATOTOX Scores to Predict Increased Severe Infection Risk in Patients with Relapsed/Refractory Follicular Lymphoma Treated with OdronextamabAbstract #1650Poster PresentationSessionMatthew MatasarSaturday, December 7, at 5:30-7:30 pmSan Diego Convention Center, Halls G-HDynamics of Complete Responses in Patients with Relapsed or Refractory Follicular Lymphoma Treated with Odronextamab in the ELM-2 StudyAbstract #1628Poster PresentationSessionStefano LuminariSaturday, December 7, at 5:30-7:30 pmSan Diego Convention Center, Halls G-HTrial in Progress: Odronextamab for the Treatment of Patients with Relapsed/Refractory Mantle Cell Lymphoma following Prior BTK Inhibitor Therapy - A Cohort of the ELM-2 StudyAbstract Publication OnlySrikanth AmbatiN/AMatching-Adjusted Indirect Comparisons (MAICs) of Odronextamab Versus Mosunetuzumab and Epcoritamab for the Treatment of Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL) after Two or More Lines of Systemic TherapyAbstract Publication OnlyDeepa JagadeeshN/ALinvoseltamabLinvoseltamab in Patients with Relapsed/Refractory Multiple Myeloma: Longer Follow-Up and Selected High-Risk Subgroup Analyses of the LINKER-MM1 StudyAbstract #3369Poster PresentationMansi R. ShahSunday, December 8, at 6:00-8:00 pmSan Diego Convention Center, Halls G-HSoluble BCMA Dynamics in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Linvoseltamab in LINKER-MM1Abstract #3310Poster PresentationAnasuya HazraSunday, December 8, at 6:00-8:00 pm San Diego Convention Center, Halls G-HCharacterization of Linvoseltamab’s BCMA Binding Epitope and Efficacy Against BCMA Mutations in Relapsed/Refractory Multiple MyelomaAbstract #3265Poster PresentationKen Lee & Yi ZhouSunday, December 8, at 6:00-8:00 pm San Diego Convention Center, Halls G-HA CD38xCD28 Costimulatory Bispecific Antibody Demonstrates Potent Preclinical Combinatorial Activity with a BCMAxCD3 T Cell-EngagerAbstract #3283Poster PresentationKara Olson & David J. DiLilloSunday, December 8, at 6:00-8:00 pm San Diego Convention Center, Halls G-HReducing Time Toxicity for Anti-B-Cell Maturation Antigen (BCMA) Bispecific Treatment: Evidence from Pivotal Single-Arm Trial Data on Teclistamab, Elranatamab, and Linvoseltamab for Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM)Abstract #2271Poster Presentation SessionSikander AilawadhSaturday, December 7, at 5:30-7:30 pmSan Diego Convention, Halls G-HExposure-Response Analyses of Various Efficacy and Safety Endpoints in Support of Registrational Dose Selection of Linvoseltamab in Patients with Relapsed/Refractory Multiple MyelomaAbstract Publication OnlyOleg MilbergN/AComparative Effectiveness of Linvoseltamab Versus Current Real-World Standard-of-Care Therapies in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma Treated at IMWG SitesAbstract Publication OnlyShaji KumarN/AComparative Effectiveness of Linvoseltamab Versus Current Real-World (RW) Standard-of-Care (SOC) Therapies in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma (RRMM): Key Subgroups AnalysisAbstract Publication OnlyShaji KumarN/AAdditional PresentationsEfficacy and Safety of Pozelimab Plus Cemdisiran vs Ravulizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria who are Naïve to Complement Inhibition* Abstract #306Oral Presentation SessionChristopher PatriquinSaturday, December 7, at 4 – 5:30 pmSan Diego Convention Center, Room 11TMPRSS6 Inhibition Rapidly Reverses Liver Iron Overload and Prevents an Increase of Splenic Pro-Inflammatory Macrophages in a Mouse Model of Beta-Thalassemia Abstract #2473Poster Presentation SessionHeinrich E. LobSunday, December 8, at 6:00-8:00 pm San Diego Convention Center, Halls G-HThe Reality of Beta Thalassemia and Iron Chelation Therapy – A Qualitative Study Unveiling the Patient BurdenAbstract Publication OnlyChris Hartford *Agreement with Alnylam Pharmaceuticals, Inc. Linvoseltamab as well as the combination of pozelimab and cemdisiran are investigational, and the potential uses of odronextamab in R/R MZL and rare subtypes of R/R aggressive B-cell non-Hodgkin lymphoma are also investigational and have not been approved by any regulatory authority. Odronextamab is approved in the European Union as Ordspono™ to treat R/R FL or DLBCL after two or more lines of systemic therapy, but the safety and efficacy of odronextamab have not been fully evaluated by any other regulatory authority. About Regeneron in Hematology At Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite® technologies to develop medicines for patients with diverse blood cancers and rare blood disorders. Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in various combinations and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments. Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling. About Regeneron's VelocImmune® Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's Co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985.They were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo®, Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). About Regeneron  Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.  Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation pozelimab in combination with cemdisiran, odronextamab, linvoseltamab, and the other programs discussed or referenced in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as odronextamab for the treatment of follicular lymphoma in the United States, linvoseltamab for the treatment of relapsed/refractory multiple myeloma in the United States and/or European Union, and the other programs discussed or referenced in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above) and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2023 and its Form 10-Q for the quarterly period ended September 30, 2024. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Contacts:Media RelationsTammy AllenTel: +1 914-306-2698tammy.allen@regeneron.comInvestor RelationsMark HudsonTel: +1 914-847-3482mark.hudson@regeneron.com

Phase 3Clinical ResultDrug ApprovalASHImmunotherapy

100 Deals associated with Cemiplimab-RWLC

External Link

KEGG	Wiki	ATC	Drug Bank
-	Cemiplimab-RWLC	L01XC33	DB14707

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic Carcinoma to the Uterine Cervix	EU	Regeneron Pharmaceuticals, Inc.	17 May 2023
Metastatic Carcinoma to the Uterine Cervix	IS	Regeneron Pharmaceuticals, Inc.	17 May 2023
Metastatic Carcinoma to the Uterine Cervix	LI	Regeneron Pharmaceuticals, Inc.	17 May 2023
Metastatic Carcinoma to the Uterine Cervix	NO	Regeneron Pharmaceuticals, Inc.	17 May 2023
Recurrent Cervical Cancer	EU	Regeneron Pharmaceuticals, Inc.	17 May 2023
Recurrent Cervical Cancer	IS	Regeneron Pharmaceuticals, Inc.	17 May 2023
Recurrent Cervical Cancer	LI	Regeneron Pharmaceuticals, Inc.	17 May 2023
Recurrent Cervical Cancer	NO	Regeneron Pharmaceuticals, Inc.	17 May 2023
Uterine Cervical Cancer	CA	Sanofi-Aventis Canada, Inc.	25 Mar 2022
Advanced Skin Squamous Cell Carcinoma	EU	Regeneron Pharmaceuticals, Inc.	28 Jun 2019
Advanced Skin Squamous Cell Carcinoma	IS	Regeneron Pharmaceuticals, Inc.	28 Jun 2019
Advanced Skin Squamous Cell Carcinoma	LI	Regeneron Pharmaceuticals, Inc.	28 Jun 2019
Advanced Skin Squamous Cell Carcinoma	NO	Regeneron Pharmaceuticals, Inc.	28 Jun 2019
Basal Cell Carcinoma	EU	Regeneron Pharmaceuticals, Inc.	28 Jun 2019
Basal Cell Carcinoma	IS	Regeneron Pharmaceuticals, Inc.	28 Jun 2019
Basal Cell Carcinoma	LI	Regeneron Pharmaceuticals, Inc.	28 Jun 2019
Basal Cell Carcinoma	NO	Regeneron Pharmaceuticals, Inc.	28 Jun 2019
Locally Advanced Lung Non-Small Cell Carcinoma	EU	Regeneron Pharmaceuticals, Inc.	28 Jun 2019
Locally Advanced Lung Non-Small Cell Carcinoma	IS	Regeneron Pharmaceuticals, Inc.	28 Jun 2019
Locally Advanced Lung Non-Small Cell Carcinoma	LI	Regeneron Pharmaceuticals, Inc.	28 Jun 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Non-Small Cell Lung Cancer	Phase 3	-	Regeneron Pharmaceuticals, Inc.	11 Jul 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	US	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	AU	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	CA	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	GE	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	IL	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	MY	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	KR	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	TW	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	TH	Regeneron Pharmaceuticals, Inc.	30 Jun 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05208944 (THIO-101, SITC2024) Manual	Phase 2	Non-Small Cell Lung Cancer	69	THIO 180mg dose +cemiplimab (3rd-line)	ccllfazlhm(ybbdgfifnz) = puzddxtacq prztnmalna (ddhkofinga ) View more	Positive	06 Nov 2024
NCT05259696 (GLIMMER-01, SITC2024) Manual	Phase 1/2	Solid tumor	21	E-602 20 mg/kg + cemiplimab 350 mg	prtlcloxrn(tabduzfpck) = jujoksjwcf diuayrxbwe (cngcqydiwx ) View more	Positive	05 Nov 2024
NCT04646005 (CTgov)	Phase 2	Recurrent Cervical Cancer \| Metastatic Cervical Carcinoma	113	Cemiplimab+ISA 101b	ohsupzqchg(yiwvizxwup) = sytmyxsski ngoswqjope (ocnybdnqwx, gwraomvzfr - rnvmbmdgto) View more	-	19 Sep 2024
NCT04722523 (ESMO2024) Manual	Phase 1	Locally Advanced Head and Neck Squamous Cell Carcinoma Neoadjuvant	30	Cemiplimab + platinum-doublet chemotherapy + cetuximab	iygtrsrhmb(gsklmxatqn) = rzpcmcedxo oxazjaanyh (dckanzooxa ) View more	Positive	14 Sep 2024
ESMO2024	Not Applicable	Cutaneous Squamous Cell Carcinoma	-	Neoadjuvant cemiplimab	ehugjyudjg(bifuvuaomg) = 25% had ≥1 grade 3 or 4 treatment-emergent adverse event (TEAE) rkupbliewu (ekangdcwms )	-	14 Sep 2024
ESMO2024	Not Applicable	Locally Advanced Lung Non-Small Cell Carcinoma	-	Cemiplimab monotherapy	oyojkldjrc(egfjknpzik) = Any-grade treatment-related adverse events (TRAEs) occurred in 98.3% vs 100.0% of pts treated with Cemiplimab monotherapy vs Cemiplimab in combination with chemotherapy xaqdbkroia (eyjkpophwn ) View more	-	14 Sep 2024
ESMO2024	Not Applicable	Locally Advanced Lung Non-Small Cell Carcinoma	-	Cemiplimab in combination with chemotherapy		-	14 Sep 2024
WCLC2024 Manual	Not Applicable	PD-L1 positive Non-Small Cell Lung Cancer PD-L1 High Expression (TPS >= 50%)	102	Cemiplimab alone	qzxqcbsihz(rhiuqoykzw) = khtewehxxa iabazfzsux (phvqdodcba ) View more	Positive	09 Sep 2024
EMPOWER-Lung1 (WCLC2024) Manual	Phase 3	Non-Small Cell Lung Cancer PD-L1 ≥50%	565	Cemiplimab	sclgrkygqr(brjzbsqlss) = jztxmnqpab ezpefbrkio (puocujnltk, 22.1 - 31.9) View more	Positive	09 Sep 2024
EMPOWER-Lung1 (WCLC2024) Manual	Phase 3	Non-Small Cell Lung Cancer PD-L1 ≥50%	565	Chemotherapy	sclgrkygqr(brjzbsqlss) = zmgitikywz ezpefbrkio (puocujnltk, 10.5 - 16.2) View more	Positive	09 Sep 2024
NCT03005782 (Pubmed) Manual	Phase 1	Melanoma Adjuvant	-	Fianlimab 1,600 mg + Cemiplimab 350 mg (anti-PD-1-naïve melanoma)	bmgsysrxji(pdrnznctgf) = vrvurvhfqg segcvfgfzl (egvoanwjzz ) View more	Positive	20 Jun 2024
NCT03005782 (Pubmed) Manual	Phase 1	Melanoma Adjuvant	-	Fianlimab 1,600 mg + Cemiplimab 350 mg (systemic treatment-naïve melanoma)	bmgsysrxji(pdrnznctgf) = oaeqgupnvy segcvfgfzl (egvoanwjzz )	Positive	20 Jun 2024
NCT03194867 (CTgov)	Phase 1/2	Relapse multiple myeloma \| Plasma cell myeloma refractory	109	Isatuximab+CemiplimabQ2W (Phase 1: Isatuximab + CemiplimabQ2W)	bkeobifmeu(wsnjpufeuh) = vgcrnwzvjz uzcypxxnzx (sdtxuicxcs, bhmduinenv - lqiflgqyhi) View more	-	14 Jun 2024
NCT03194867 (CTgov)	Phase 1/2	Relapse multiple myeloma \| Plasma cell myeloma refractory	109	Isatuximab (Phase 2: Isatuximab)	rvnghbtnxz(sqsulgmlzh) = natbtuqjgm doshwpocmy (xzqvmyrxgr, ofrcoxozdo - nogtgvbxoq) View more	-	14 Jun 2024

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