Key Takeaways Regeneron won EC nod to expand Libtayo as adjuvant therapy for high-risk CSCC after surgery and radiation.FDA approved Eylea HD for RVO with dosing up to every eight weeks after an initial monthly period.The agency also cleared a monthly option of Eylea HD across wAMD, DME, DR and RVO for select patients.Regeneron Pharmaceuticals, Inc. (REGN) announced that the European Commission (EC) has approved label expansion of its PD-1 inhibitor Libtayo (cemiplimab).The EC approved Libtayo as an adjuvan ...

Approval based on results of landmark Phase 3 C-POST trial that show Libtayo is first immunotherapy to significantly improve disease-free survival in CSCC in the adjuvant setting, reducing the risk of recurrence or death by 68% (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001) Libtayo is the current standard of care in advanced CSCC in Europe, and this approval has the potential to change the treatment paradigm for patients in an earlier setting TARRYTOWN, N.Y., Nov. 19, 2025 (GLOBE NEWSW ...

Core Insights - Sensei Biotherapeutics announced results from the dose expansion portion of its Phase 1/2 trial for solnerstotug, a monoclonal antibody targeting VISTA, at the ESMO Congress 2025 [1][2] Study Design and Patient Population - The Phase 1 dose expansion is a multi-center, open-label study evaluating solnerstotug as monotherapy and in combination with Libtayo, enrolling 44 patients with "hot" tumor types and 20 patients with "cold" tumor types [2] - Among the "hot tumor" patients, 41 had previously received PD-(L)1 therapy and progressed, indicating a challenging prognosis for these patients [3][4] Efficacy Results - In the higher 15 mg/kg dose cohort, the overall 6-month progression-free survival (PFS) rate was 50% among PD-(L)1 resistant patients, which is significantly higher than historical benchmarks [6][7] - Six clinical responses were observed at the 15 mg/kg dose, including five in patients with PD-(L)1 resistant tumors, while no responses were noted at the 3 mg/kg dose [5][6] Safety Profile - Solnerstotug was well tolerated, with only six mild (Grade 1) cytokine release syndrome (CRS) events reported, all manageable [8][9] - The safety profile remains consistent with prior data and compares favorably to other checkpoint inhibitor combinations [8] Future Development Plans - Sensei plans to initiate two Phase 2 studies in 2026, subject to FDA feedback and capital raising, focusing on NSCLC and Merkel Cell Carcinoma [11][12] - The first trial will be a randomized study comparing solnerstotug plus a PD-(L)1 inhibitor against chemotherapy in patients who failed anti-PD-(L)1 treatment [11] - The second trial will be a single-arm study in PD-(L)1 resistant Merkel Cell Carcinoma patients, with potential for accelerated approval [12] Unique Mechanism of Action - The combination of solnerstotug and cemiplimab may demonstrate a unique pattern of delayed, durable responses, indicating a complementary mechanism to PD-(L)1 therapies [10][9]

Core Opinion - Regeneron Pharmaceuticals received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for Libtayo as an adjuvant treatment for adult patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation [1][2] Clinical Trial Results - The Phase 3 C-POST trial demonstrated that Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo, with a hazard ratio of 0.32 and a p-value of less than 0.0001 [1][2] - In the trial, locoregional or distant recurrence rates were lower in the Libtayo group (4% vs. 17% for locoregional and 5% vs. 13% for distant recurrence) compared to placebo [2] Safety Profile - The safety profile of Libtayo in this trial was consistent with its known safety profile in advanced cancers, with adverse events occurring in 91% of patients receiving Libtayo and 89% in the placebo group [3] - Grade ≥3 adverse events were reported in 24% of the Libtayo group compared to 14% in the placebo group, with hypertension being the only grade ≥3 adverse event occurring in more than 2% of patients in the Libtayo arm [3] Trial Design - The C-POST trial was a randomized, placebo-controlled, double-blind, multicenter global study involving 415 patients at high risk of CSCC recurrence [4][5] - Participants received either Libtayo or placebo for up to 48 weeks, with specific dosing regimens outlined [5] About CSCC - Cutaneous squamous cell carcinoma (CSCC) is a common type of non-melanoma skin cancer, with a projected 40% increase in incidence in the EU by 2040 [6] Regeneron's Commitment to Cancer Treatment - Regeneron aims to develop transformative medicines for cancer, leveraging scientific innovation and a deep understanding of biology and genetics [7][8] - The company has a robust pipeline focused on various solid tumors and blood cancers, with Libtayo being a key asset [8][27]

Core Insights - Regeneron Pharmaceuticals announced new data from the Phase 3 C-POST trial for Libtayo (cemiplimab), focusing on a patient-centric every 6-week dosing regimen for high-risk cutaneous squamous cell carcinoma (CSCC) [1][2] Group 1: Clinical Data and Trial Results - The C-POST trial data will be presented at the ESMO 2025 Meeting, highlighting the efficacy and safety of Libtayo as an adjuvant treatment for CSCC [1][2] - Patients in the trial initially received 350 mg of Libtayo every 3 weeks for 12 weeks, with most switching to every 6-week dosing thereafter, while the safety profile remained consistent with previous findings [2] Group 2: Regulatory and Approval Status - The new data supports the FDA approval of Libtayo as the first immunotherapy for adjuvant treatment of adult patients with high-risk CSCC following surgery and radiation [2] Group 3: Company Overview and Pipeline - Regeneron is focused on developing therapies for over 30 types of solid tumors and blood cancers, with nearly half of its pipeline dedicated to oncology assets [6][26] - Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint, approved in over 30 countries for various indications, including advanced CSCC and non-small cell lung cancer [8][9]

Core Insights - Immuneering Corporation (IMRX) has entered into a clinical supply agreement with Eli Lilly (LLY) for the KRAS G12C inhibitor, olomorasib (LY3537982) [1] - The agreement supports a planned phase II study evaluating Immuneering's atebimetinib (IMM-1-104) in combination with olomorasib for treating advanced KRAS G12C-mutant non-small cell lung cancer (NSCLC) [2] - Immuneering's shares rose by 21.7% following the announcement, and the stock has increased by 170.5% year-to-date compared to the industry's 4.1% rise [2][3] Agreement Details - The combination of atebimetinib and olomorasib is expected to provide a vertical blockade of the RAS-MAPK pathway, with preclinical data showing enhanced tumor regression and prolonged survival compared to monotherapy [5] - This is Immuneering's second collaboration announcement in 2025, following a similar agreement with Regeneron Pharmaceuticals to evaluate atebimetinib with Libtayo for advanced NSCLC [6][7] - In both agreements, Immuneering retains full worldwide development and commercialization rights to atebimetinib [8] Ongoing Studies - Immuneering is advancing atebimetinib in other cancer studies, including a phase IIa study in combination with modified gemcitabine/nab-paclitaxel for first-line pancreatic cancer [9] - Preliminary data from this study indicated a 94% overall survival and 72% progression-free survival at six months, with updated data expected later in Q3 2025 [10] - The company plans to initiate a pivotal study for atebimetinib in combination with modified gemcitabine/nab-paclitaxel in 2026, pending regulatory feedback [11]

Core Insights - Sensei Biotherapeutics, Inc. announced the presentation of clinical data from the Phase 1/2 trial of solnerstotug, both alone and in combination with Libtayo, at the ESMO Congress 2025 in Berlin [1] Company Overview - Sensei Biotherapeutics is a clinical stage biotechnology company focused on developing next-generation therapeutics for cancer patients [2] - The company utilizes its TMAb™ platform to create conditionally active therapeutics that target immunosuppressive signals in the tumor microenvironment [2] - Solnerstotug is the lead product candidate, designed to block the VISTA checkpoint selectively in low pH tumor environments, enhancing T cell activation [2]

Core Insights - Libtayo (cemiplimab) has shown a 68% reduction in the risk of disease recurrence or death in high-risk cutaneous squamous cell carcinoma (CSCC) patients after surgery, with significant reductions in locoregional (80%) and distant recurrence (65%) compared to placebo [1][5][6] - The Phase 3 C-POST trial results were presented at the 2025 ASCO Annual Meeting and published in the New England Journal of Medicine, establishing Libtayo as the first immunotherapy to demonstrate a statistically significant benefit in the adjuvant setting for high-risk CSCC [2][4] - Regulatory applications for Libtayo have been submitted in the United States and European Union for the treatment of adjuvant CSCC [1][7] Group 1: Trial Results - The C-POST trial was a randomized, placebo-controlled, double-blind study involving 415 patients, with 209 receiving Libtayo and 206 receiving placebo [9][10] - The median duration of follow-up was 24 months, with updated overall survival (OS) data suggesting an emerging benefit for Libtayo (HR: 0.78; 95% CI: 0.39-1.56) [3] - Disease-free survival (DFS) at two years was 87% for Libtayo versus 64% for placebo, with median DFS not reached for Libtayo-treated patients [5] Group 2: Safety and Efficacy - Safety assessments indicated that adverse events (AEs) of any grade occurred in 91% of patients in the Libtayo arm, with grade ≥3 AEs occurring in 24% [6] - The most common AEs in the Libtayo arm included fatigue, pruritus, rash, diarrhea, and hypothyroidism, with treatment discontinuations due to AEs at 10% for Libtayo compared to 2% for placebo [6] - An exploratory analysis showed that Libtayo reduced the risk of disease recurrence or death by 72% in tumors with PD-L1 ≥1% and by 68% in tumors with PD-L1 <1% [4] Group 3: Industry Context - The results from the C-POST trial highlight the critical unmet need for systemic therapies in high-risk CSCC, as surgery and radiotherapy remain the primary treatments [2] - Libtayo's promising results position it as a potential new standard of care in the adjuvant setting for high-risk CSCC patients [4] - Regeneron is actively working with global regulatory authorities to expedite the availability of Libtayo for patients [4]

Core Insights - Sensei Biotherapeutics reported favorable clinical data for its lead product candidate, solnerstotug, in patients with PD-(L)1-resistant cancers, indicating a potential breakthrough in treatment options for this challenging patient population [2][3] - The company has completed enrollment for its dose expansion cohort and expects to present full data by the end of 2025 [1][6] - Sensei's cash position is strong, with a runway expected to last into the second quarter of 2026 [5] Clinical Development - Solnerstotug is designed to target the immune checkpoint VISTA, which is associated with poor survival rates in various cancers [3] - The ongoing Phase 1/2 clinical trial is evaluating solnerstotug both as a monotherapy and in combination with Regeneron's PD-1 inhibitor, Libtayo [4] - Preliminary data from the trial shows response rates nearly three times higher than historical expectations for PD-(L)1-resistant patients [2][6] Financial Performance - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $34.3 million, down from $41.3 million at the end of 2024 [5] - Research and Development (R&D) expenses decreased to $3.7 million in Q1 2025 from $4.9 million in Q1 2024, primarily due to lower personnel and facility costs [7] - General and Administrative (G&A) expenses also saw a decrease, totaling $3.5 million in Q1 2025 compared to $3.8 million in Q1 2024 [8] Operational Highlights - The company has completed enrollment of 63 patients in the dose expansion stage, including 10 patients with microsatellite stable colorectal cancer (MSS CRC) and 53 patients with PD-(L)1-resistant "hot" tumors [6] - Sensei participated in various conferences to discuss its clinical progress and strategic direction, enhancing its visibility in the oncology sector [6]

Core Insights - Immuneering Corporation reported positive data from its ongoing Phase 2a trial of IMM-1-104, showing encouraging responses in pancreatic cancer treatment [1][3] - The company has extended its cash runway into 2026, ensuring sufficient funding for ongoing operations [1][8] - Dr. Igor Matushansky has been appointed as Chief Medical Officer to lead clinical efforts, particularly for the upcoming Phase 3 trial in first-line pancreatic cancer [1][5] Clinical Developments - The Phase 2a trial of IMM-1-104 has shown exceptional efficacy, with a third-line monotherapy patient achieving over 13 months of progression-free survival and a first-line combination therapy patient achieving a complete response [3][5] - A clinical trial supply agreement has been established with Regeneron Pharmaceuticals to evaluate IMM-1-104 in combination with Libtayo® for non-small cell lung cancer [1][4] Financial Performance - As of March 31, 2025, the company reported cash and cash equivalents of $35.9 million, a slight decrease from $36.1 million at the end of 2024 [11] - Research and Development (R&D) expenses for Q1 2025 were $11.5 million, up from $11.2 million in Q1 2024, primarily due to increased clinical costs [11] - The net loss for Q1 2025 was $15.0 million, or $0.42 per share, compared to a net loss of $14.3 million, or $0.49 per share, in Q1 2024 [11][16]