On October 17, 2025 Novartis reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Scemblix (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) in all lines of treatment.

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"For people living with CML, long-term therapy can be physically and emotionally demanding, and many face challenges in reaching treatment milestones without compromising quality of life," said David FitzGerald, Member of the CML Advocates Network. "The availability of more treatment options earlier in the care pathway is a welcome development that brings forward additional possibilities for patients and their healthcare teams to choose approaches that best support both clinical goals and patient well-being."

The positive CHMP opinion is based on data from the Phase III ASC4FIRST trial, which compared Scemblix with investigators’ choice of tyrosine kinase inhibitor (TKI) treatment in patients with newly diagnosed Ph+ CML-CP1,2. In the trial, Scemblix demonstrated superior major molecular response (MMR) rates when compared against all TKIs (imatinib, nilotinib, dasatinib and bosutinib) and also when compared against imatinib alone1,2. Patients treated with Scemblix also required fewer dose reductions and experienced half the rate of adverse events leading to discontinuation1,2.

"To give patients newly diagnosed with CML the best chance to reach key efficacy milestones while maintaining quality of life, it is critical to intervene early with a more selective treatment that combines superior efficacy with tolerability," said Professor Andreas Hochhaus, Head of the Department of Hematology and Medical Oncology at Jena University Hospital, Germany. "If approved, Scemblix could provide patients with a well-tolerated option that may deliver faster, deeper and longer-lasting molecular response with fewer treatment discontinuations due to adverse events, compared with available first-line treatments — potentially paving the way for more patients to reach treatment-free remission."

Scemblix is approved in earlier lines in more than 20 countries, including the US, Japan and China5,6. Scemblix is recommended for the treatment of patients with newly diagnosed Ph+ CML-CP by the 2025 European LeukemiaNet recommendations for the management of CML and by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines)7,8. Since 2021, Scemblix has been a standard of care (SoC) in more than 80 countries for patients previously treated with two or more TKIs5,6,9.

"People newly diagnosed with CML need treatments that deliver both better efficacy and excellent tolerability to achieve early, deep molecular response, which is critical to achieve long-term outcomes like treatment-free remission," said Patrick Horber, M.D., President, International, Novartis. "Scemblix is the only treatment that has demonstrated superior efficacy and tolerability compared to current first-line treatments. Today’s positive CHMP opinion marks a major milestone in our 25-year journey to improve CML care and could help establish a new standard of care in Europe."

Following the CHMP’s recommendation to approve Scemblix for the treatment of adults with Ph+ CML-CP in all lines of treatment, the European Commission (EC) will make a final decision within two months.

About ASC4FIRST
ASC4FIRST (NCT04971226) is a Phase III, head-to-head, multi-center, open-label, randomized study of oral Scemblix 80 mg QD vs. investigator-selected first- or second-generation TKIs (imatinib, nilotinib, dasatinib or bosutinib) in 405 adult patients with newly diagnosed Ph+ CML-CP10. The trial met both primary endpoints with Scemblix demonstrating superior MMR rates at week 48 vs. investigator-selected SoC TKIs (67.7% vs. 49.0%) and imatinib alone (69.3% vs. 40.2%)1,10. Additionally, Scemblix showed a numerical improvement versus the 2G TKI stratum (66% vs. 57.8%)1,10. At week 96, Scemblix demonstrated sustained superior MMR vs. all investigator-selected TKIs (74.1% vs. 52%) and vs. imatinib alone (76.2% vs. 47.1%)2.47.1%), meeting both ASC4FIRST key secondary endpoints2.

About Scemblix (asciminib)
Scemblix is the first CML treatment that works by Specifically Targeting the ABL Myristoyl Pocket (referred to as a STAMP inhibitor in scientific literature)11-13. Other currently approved CML treatments are TKIs that target the ATP-binding site (ATP-competitive)13.

Scemblix is approved to treat newly diagnosed adults with Ph+ CML-CP in more than 20 countries, including the US, Japan and China4,5. It is also approved in more than 80 countries, including the EU, to treat those with Ph+ CML-CP who have previously been treated with two or more TKIs 5,6,7. In some countries, including the US, Scemblix is also approved in patients with Ph+ CML-CP with the T315I mutation5-7.

Scemblix has been studied across multiple treatment lines for Ph+ CML-CP, both as a monotherapy and as a combination therapy.

(Press release, Novartis, OCT 17, 2025, View Source [SID1234656735])

On October 17, 2025 Multitude Therapeutics, Inc., a clinical-stage company focused on the development of antibody-drug-conjugate (ADC) drugs, reported initial data from its ongoing phase I/II open-label, multicenter dose escalation and expansion study evaluating AMT-116, a CD44v9-directed ADC, in patients with EGFR wild-type NSCLC and other advanced solid tumors. The data are being presented on October 17th at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting being held in Berlin, Germany.

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Phase I/II clinical trials are being conducted across Australia, US and China. This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase II Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-116, in patients with advanced solid tumors. The Phase Ia portion will determine the recommended doses for expansion, and the Phase Ib/II portion will focus on further characterizing safety and efficacy in select tumor types.

As of July 17th, 2025, safety data are available for 164 patients who have received AMT-116 once every two weeks (Q2W) at doses ranging from 1.5 to 5.0 mg/kg. Primary tumor types are NSCLC, NPC (nasopharyngeal carcinoma), anal carcinoma and salivary gland cancer. In heavily pretreated EGFR Wild-type NSCLC patients, with prior lines of therapy ranging from 1-5, promising efficacy was observed regardless CD44v9 expression status. The overall response rate (ORR) was 40% (6/15), and the disease control rate (DCR) was 93% (14/15), in EGFR Wild-type NSCLC at dose levels >3 mg/kg. Among five EGFR Wild-type NSCLC patients at 5.0 mg/kg, ORR was 80% (4/5) and DCR was 100% (5/5). Preliminary antitumor activity was also observed in patients with NPC, anal carcinoma and salivary gland cancer at >3mg/kg, with ORRs of 50% (3/6), 60% (3/5) and 33% (2/6), respectively. Antitumor activity was observed across patients with varying levels of CD44v9 expression. The safety profile of AMT-116 was consistent with that of other Topoisomerase I inhibitor-based ADCs, with manageable hematologic toxicities as the most common treatment-related adverse events. Only low-grade and infrequent mucosal and skin toxicities were observed, demonstrating a favorable tolerability profile.

"We are excited by the impressive and durable efficacy shown in the early results of AMT-116, especially in unselected heavily pretreated EGFR Wild-type NSCLC and several other advanced solid tumors. The efficacies of AMT-116 observed so far are consistent with its broad tumor expression profile observed in preclinical studies, while the greatly reduced mucosal and skin toxicities reflect the desired outcome of a carefully selected linker-payload platform aimed at mitigating potential on-target toxicities from normal tissue expression. With these encouraging results, we are further expanding the clinically efficacious dose levels of 4 mg/kg Q2W and 5 mg/kg Q2W cohorts in select tumor types to explore the full potential of this novel ADC for greater patient benefit in NSCLC and beyond," said Dr. Shu-Hui Liu, co-founder and CSO of Multitude Therapeutics.

Mini Oral Presentation Details:

Title: Updated ongoing Phase I/II clinical trial results of AMT-116, a first-in-class anti-CD44v9 antibody-drug conjugate (ADC), in patients with advanced solid tumors
Mini Oral Session Title: Developmental therapeutics
Date and Time: October 17th – 04:05 PM
Location: Heidelberg Auditorium – Hall 6.2
Presentation number: 922MO

About AMT-116
AMT-116, a CD44v9 ADC, is composed of a proprietary antibody with high CD44v9 binding affinity, a hydrolysable linker, and a belotecan derivative payload (a novel and clinically validated topoisomerase-1 inhibitor, named KL610023, collaborating with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK)). CD44v9 is involved in broad biological pathways and has an implicated role in cancer stem cells. The target is a highly abundant protein and is overexpressed broadly in solid tumors with a restrictive normal tissue expression. AMT-116 has a drug-to-antibody ratio of 7-8. AMT-116 is being evaluated in a phase I/II study in patients with EGFR Wild-type NSCLC and other advanced solid tumors. Additional information on the Australia/US Phase I (NCT05725291) and China Phase I/II (NCT06782334) trials can be found at clinicaltrials.gov.

(Press release, Multitude Therapeutics, OCT 17, 2025, View Source;302587390.html [SID1234656752])

On October 17, 2025 Novartis reported results from the five-year analysis of the pivotal Phase III NATALEE trial of Kisqali (ribociclib) that demonstrated a sustained benefit at a median of two years after a three-year treatment with Kisqali (median follow-up: 58.4 months). Results showed a 28.4% reduction in risk of recurrence (HR=0.716; 95% CI 0.618-0.829; nominal p-value <0.0001) in the broadest population of patients with high-risk stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) treated with Kisqali plus endocrine therapy (ET) compared to ET alone1.

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The five-year invasive disease-free survival (iDFS) rates were 85.5% in the Kisqali plus ET arm versus 81.0% in the ET alone arm, representing a clinically meaningful 4.5% improvement1. These late-breaking results will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

"For the thousands of people diagnosed with early breast cancer each year, the fear of recurrence, often as incurable advanced disease, weighs heavily on patients and their families," said Dr. John Crown, Consultant Medical Oncologist at St. Vincent’s University Hospital, Dublin, and NATALEE investigator. "These five-year results show that the benefit of ribociclib persists well beyond the completion of treatment, offering these at-risk patients a greater chance of living breast cancer-free."

As follow-up continued, the confidence intervals (CIs) became narrower1. This pattern held across clinically relevant subgroups, reinforcing the robustness of the observed iDFS benefit1.

"These data reinforce the potential of Kisqali to significantly reduce the long-term risk of breast cancer recurrence, extending well beyond the three-year treatment period. This provides physicians and patients with greater confidence in long-term disease management. Kisqali is redefining the standard of care in adjuvant therapy, including in patients with node-negative disease," said Dushen Chetty, Global Head of Oncology and Hematology Development at Novartis, Ad Interim. "The consistency of the benefit observed across both advanced and early breast cancer settings, together with Kisqali’s established safety profile, underscores its position as the CDK4/6 inhibitor with the most comprehensive Phase III evidence base for improving patient outcomes."

Overall survival (OS) continues to show an encouraging trend, with further improvement in the hazard ratio (HR) to 0.800 and narrowing CI (95% CI: 0.637-1.003; one-sided nominal p-value 0.026) compared to the final iDFS analysis (OS HR = 0.892 (0.661-1.203)), demonstrating a 20% reduction in the risk of death compared to ET alone1. The NATALEE trial will continue follow-up to ensure sufficient data is collected for OS and other long-term endpoints.

iDFS results across pre-specified subgroups1:

Subgroups Hazard ratio 95% CI Absolute risk reduction at 5 years
Overall population 0.716 0.618-0.829 4.5%
Stage II 0.660 0.493-0.884 3.7%
Stage III 0.730 0.615-0.865 5.6%
Node-negative (N0) 0.606 0.372-0.986 5.7%
Node-positive (N1-3) 0.737 0.631-0.860 4.4%
With a median of around two years after all patients completed Kisqali treatment, long-term safety shows no new safety signals1. Overall, rates of secondary primary malignancies (SPMs) were 2.7% (Kisqali plus ET) and 3.0% (ET alone), while SPMs leading to deaths were reported in one patient in each group1.

Kisqali remains the only CDK4/6 inhibitor to demonstrate statistically significant OS benefits across three randomized controlled trials in advanced breast cancer (MONALEESA-2, MONALEESA-3, and MONALEESA-7)2-12.

*OS data remain immature at the five-year NATALEE analysis

About NATALEE
NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali with ET as an adjuvant treatment versus ET alone in the broadest range of patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO13,14. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable13,14. The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria13,14. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial13,14.

About Kisqali (ribociclib)
Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor, helping slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, enable cancer cells to grow and divide quickly. Targeting CDK4/6 with enhanced precision plays a role in tumor control.

Kisqali has been approved as a treatment for breast cancer by regulatory authorities in more than 100 countries worldwide, including the U.S. FDA and the European Commission15,16. In the US, Kisqali is indicated in combination with an AI as an adjuvant treatment for adults with HR+/HER2- stage II and III early breast cancer at high risk of recurrence, as well as for the treatment of adults with HR+/HER2- advanced or MBC as initial ET; Kisqali is also approved in the metastatic indication in combination with fulvestrant as initial ET or following disease progression on ET15. In the EU, Kisqali is approved in combination with an AI for the adjuvant treatment of patients with HR+/HER2- early breast cancer at high risk of recurrence; and for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression16. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist15,16.

In EBC, Kisqali is the only CDK4/6 inhibitor recommended by the NCCN Guidelines for breast cancer as Category 1 preferred for both all node-positive disease as well as for patients with no nodal involvement with high-risk disease characteristics, such as tumor size >5 cm, or for tumors sized 2-5 cm, either Grade 2 with high genomic risk/Ki-67 ≥20% or Grade 317. Kisqali approvals in EBC from regulatory authorities worldwide are ongoing, including recent approval from China’s National Medical Products Administration18. In MBC, Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials2-12. The NCCN Guidelines also recommend Kisqali as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of people living with HR+/HER2- MBC when combined with an AI, making Kisqali the preferred first-line treatment of choice for US prescribers in HR+/HER2- MBC17.

In addition, Kisqali has achieved the highest score (A) on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for EBC19; and has the highest rating of any CDK4/6 inhibitor on the ESMO (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale, achieving a score of four out of five for first-line pre-menopausal patients with HR+/HER2- advanced breast cancer20. Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line21.

Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals.

(Press release, Novartis, OCT 17, 2025, View Source [SID1234656736])

On October 17, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation & immunology (I&I), reported the first disclosure of interim data from the ongoing Phase 2 trial of its lead program, invikafusp alfa, during a late-breaking oral session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Annual Meeting, taking place October 17-21, 2025, in Berlin, Germany.

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These highly anticipated results continue to validate Marengo’s first-in-class precision T cell activation platform – a novel approach aimed at fully addressing the significant unmet need for both PD-1 resistant and refractory patients, as well as those for whom PD-1 therapy is not currently indicated.

"The compelling single-agent activity and tumor regression we’re observing across multiple tumor types, particularly in PD-1-resistant tumors, underscore the potential of invikafusp alfa as a new pan-tumor backbone immunotherapy," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo Therapeutics. "By selectively activating Vβ6/Vβ10 T-cell subsets, we are unlocking distinct immune biology that can reprogram the tumor microenvironment and reinvigorate anti-tumor T cell responses in patient populations who have exhausted current immunotherapies."

As of the July 29, 2025 data cutoff, 55 patients with advanced solid tumors harboring high mutational burden (TMB-H or MSI-H/dMMR) were enrolled across 21 histologies; 44 were efficacy-evaluable. Additional outcomes from the Phase 2 study are outlined below.

Tumor shrinkage: 52% of patients experienced target-lesion regression.
In the TMB-H patients, there was a 20.5% overall response rate (ORR) (9/44) and a 79.5% disease control rate (DCR) (35/44) across six tumor types, including colorectal, gastric, lung, breast, GEJ, and head and neck cancers.
In the MSI-H/dMMR patients, there was a 30% ORR (3/10) and 70% DCR (7/10).
Clinical efficacy was observed in PD-1-resistant/refractory tumors and PD-1 naive tumors where PD-1 was not approved as standard of care, confirming PD-1-independent activity.
The safety profile was consistent with selective T cell activation mechanism of action, and treatment-related AEs were transient and manageable with supportive care.
Building on these clinical data, Marengo is advancing a post-PD-1, biomarker-enriched strategy for invikafusp alfa – continuing the Phase 2 monotherapy expansion in TMB-H or MSI-H/dMMR solid tumors to further characterize the depth and durability of responses across priority indications. In parallel, Marengo is pursuing ongoing regulatory interactions, including recently securing U.S. FDA Fast Track designation in TMB-H mCRC.

To reach broader, frontline populations beyond biomarker TMB-H in large indications, the company is also progressing a Phase 2 combination with Trodelvy (TROP2-directed ADC) in TNBC and HR+/HER2– breast cancer to evaluate synergy in ADC and IO settings.

Invikafusp alfa is a first-in-class, bispecific dual T-cell agonist designed to selectively activate and expand Vβ6/Vβ10 T-cell subsets, which represent ~10% of tumor-infiltrating lymphocytes (TILs). Marengo’s lead asset was designed to restore and amplify anti-tumor immunity in patients who have progressed on or are insensitive to prior immune checkpoint blockade, and it has demonstrated rapid progress to date. Phase 1/2 results of the STARt-001 clinical trial evaluating invikafusp alfa in antigen-rich solid tumors were first presented at SITC (Free SITC Whitepaper) 2024, followed by disclosure of the recommended Phase 2 dose (RP2D) selection rationale and early clinical activity at AACR (Free AACR Whitepaper) 2025.

(Press release, Marengo Therapeutics, OCT 17, 2025, View Source;resistant-solid-tumors-as-a-late-breaking-oral-presentation-at-esmo-2025-302587142.html [SID1234656753])

On October 17, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical-stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported results from the dose expansion portion of its Phase 1/2 trial evaluating solnerstotug (formerly SNS-101), a conditionally active monoclonal antibody targeting VISTA (V-domain Ig suppressor of T cell activation). The data will be shared today during a mini oral session at the ESMO (Free ESMO Whitepaper) Congress 2025.

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The Phase 1 dose expansion is a multi-center, open-label study evaluating solnerstotug as monotherapy and in combination with Libtayo (cemiplimab), Regeneron’s PD-1 inhibitor. The study enrolled patients with a basket of "hot" tumor types (that typically respond to immunotherapy) (n=44), of whom 41 had previously received and progressed on PD-(L)1 therapy, as well as patients with "cold" tumor types (that typically exhibit primary resistance to immunotherapy) (n=20).

Patients who progress following treatment with PD-(L)1 inhibitors ("secondary resistance") face a particularly poor prognosis, as resistance to immune checkpoint blockade is a significant challenge in oncology. For patients who develop secondary resistance, the likelihood of benefiting from a rechallenge with the same therapy is estimated to be 5% or less.1

Currently, treatment options for PD-(L)1 resistant tumors are limited, with many patients receiving chemotherapy, experimental therapies in clinical trials, or palliative care in the absence of effective alternatives. While historical benchmarks in this setting are limited, docetaxel, which is widely used in the 2nd line post-PD-(L)1 setting for Non-Small Cell Lung Cancer (NSCLC), typically has a 6-month PFS of 10-20% in similar patient populations.2 To date, immune checkpoint inhibitor (ICI) combination therapies have not been approved in this setting.

Emerging Clinical Signal and Favorable Tolerability Profile

As of the September 8, 2025, data cutoff, 35 efficacy-evaluable "hot tumor" patients had received cemiplimab with either 15 mg/kg (n=19) or 3 mg/kg dose (n=16) of solnerstotug. Six clinical responses, including five in patients with PD-(L)1 resistant tumors, occurred at the higher 15 mg/kg solnerstotug dose, and no objective responses were observed at the 3 mg/kg dose.

Among 41 "hot tumor" patients that received and progressed on a prior PD-(L)1 therapy, the overall 6-month PFS rate was 37%, which compares favorably with historical benchmarks in this setting. At 15 mg/kg, 6-month PFS reached 50% among PD-(L)1 resistant patients, surpassing rates historically seen in this treatment-refractory population. At 3 mg/kg, 6-month PFS was 24% among PD-(L)1 resistant patients.

Solnerstotug was well tolerated at both 3 mg/kg and 15 mg/kg doses in combination with cemiplimab:

Only six mild (Grade 1) CRS events were observed across all patients in Phase 1 (n=98), all manageable.
No new safety signals were identified across dose expansion (n=64).
The safety profile remains consistent with prior data and compares favorably to other checkpoint inhibitor combinations in this population.

"We believe solnerstotug’s emerging dose-dependent activity in refractory ‘hot’ tumors, combined with a favorable tolerability profile, support its advancement into Phase 2 studies," said Ron Weitzman, M.D., Chief Medical Officer of Sensei Biotherapeutics. "The data suggest that selective blockade of VISTA within the tumor microenvironment may help re-engage exhausted T cells, even after PD-1 failure, a goal long considered out of reach."

In addition to the "hot" tumor cohorts, 20 patients with Microsatellite Stable Colorectal (MSS CRC) "cold" tumors were treated with either solnerstotug as monotherapy or in combination with cemiplimab (350 mg). No responses were observed and the safety profile was consistent with previously reported data.

Durable Disease Control in "Hot" Tumors Followed by Late Onset Responses

Four out of six responders demonstrated prolonged disease control, followed by a late onset response (occurring between 18 and 54 weeks). PD-(L)1 therapies typically have a time to response of 2–3 months, indicating that the combination of solnerstotug plus cemiplimab has a unique and differentiated pattern of activity.

At the 15 mg/kg dose of solnerstotug, notable responses included:

A Merkel Cell Carcinoma (MCC) patient with a durable complete response at week 18 and a duration of response of 54+ weeks
A Microsatellite Instability-High Colorectal Cancer (MSI-H CRC) patient with a partial response (PR) at week 36 and a 33+ week duration
An NSCLC patient with a tumor proportion score less than 5% that was PD-1 naïve had a PR at week 54 and duration of response of 15+ weeks
An Esophageal Cancer patient with a PR at Week 24 and a duration of response of 6 weeks

"This pattern of delayed, durable responses is unusual among immunotherapies," said Kyriakos Papadopoulos, M.D., Co-Director of Clinical Research at START, San Antonio. "It may indicate that solnerstotug acts through a mechanism that is complementary to PD-(L)1 in resistant tumors."

Next Steps: Planned Phase 2 Studies to Evaluate Efficacy in a Commercially Attractive Indication and Potentially Pursue Accelerated Approval in a PD-1 Resistant Population

Sensei is planning two Phase 2 studies to begin in 2026, subject to FDA feedback and the Company’s ability to raise sufficient capital. The first is expected to be a randomized trial in 2nd line NSCLC where patients have received and failed anti-PD-(L)1 treatment. Patients would be randomized to receive either the combination of solnerstotug + a PD-(L)1 inhibitor or chemotherapy.

The second trial is expected to be a single arm study in PD-(L)1 resistant MCC patients where there is limited therapeutic optionality and potential for accelerated approval, subject to FDA feedback.

"We’re pleased by the emerging signs of dose-related activity, durability, and a favorable safety profile—key characteristics of a potentially differentiated immunotherapy," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "These results provide a foundation for our planned Phase 2 development program as we work to better define solnerstotug’s role in treating challenging patient populations."

(Press release, Sensei Biotherapeutics, OCT 17, 2025, View Source/news-releases/news-release-details/sensei-biotherapeutics-reports-new-clinical-results-highlighting" target="_blank" title="View Source/news-releases/news-release-details/sensei-biotherapeutics-reports-new-clinical-results-highlighting" rel="nofollow">View Source [SID1234656737])

Investor Webcast Information

Sensei will host an investor webcast on October 20th at 8:00 AM ET, featuring company leadership and Kyriakos Papadopoulos, MD, Co-Director of Clinical Research at START, San Antonio.

Register for the event here. A replay will be available after the webcast on the Investor Relations page of Sensei’s website: View Source