Core Insights - Immutep Limited is focusing on changing the treatment paradigm for first-line non-small cell lung cancer (1L NSCLC) through innovative immunotherapy approaches [1][5]. Clinical Trial Results - The INSIGHT-003 trial demonstrated strong objective response rates (ORR) and disease control rates (DCR) for the combination of eftilagimod alfa (efti) with KEYTRUDA (pembrolizumab) and chemotherapy in patients with advanced or metastatic non-squamous 1L NSCLC [2][5]. - The ORR for patients with low and no PD-L1 expression (TPS <50%) reached 61.7%, significantly higher than the historical control of 40.8% [3][5]. - The combination therapy showed high ORR and DCR across all PD-L1 expression levels, with specific rates of 54.5% (no PD-L1), 68.0% (low PD-L1), and 75.0% (high PD-L1) [4]. Safety and Efficacy - The combination of efti with KEYTRUDA and chemotherapy has a favorable safety profile and has shown promising clinical responses, particularly in patients with low or absent PD-L1 expression [3][5]. - Efti is expected to set a new standard of care for 1L NSCLC patients, supported by data from multiple clinical trials, including the pivotal TACTI-004 Phase III trial [5][8]. Future Developments - The TACTI-004 Phase III trial is a global study enrolling approximately 756 patients with advanced/metastatic 1L NSCLC, evaluating the same immunotherapy/chemotherapy combination used in INSIGHT-003 [5][6]. - Efti is under evaluation for various solid tumors, including head and neck squamous cell carcinoma and breast cancer, and has received Fast Track designation from the FDA for first-line treatments [8]. Company Overview - Immutep is a late-stage biotechnology company specializing in novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in Lymphocyte Activation Gene-3 (LAG-3) [9].

Core Insights - Astellas Pharma and Pfizer announced positive results from the Phase 3 EV-303 clinical trial for PADCEV in combination with KEYTRUDA, showing significant improvements in event-free survival (EFS) and overall survival (OS) for muscle-invasive bladder cancer (MIBC) patients who are ineligible for cisplatin-based chemotherapy [1][2][3] Group 1: Clinical Trial Results - The EV-303 trial demonstrated a 60% reduction in the risk of tumor recurrence, progression, or death for patients treated with PADCEV plus KEYTRUDA compared to surgery alone, with a Hazard Ratio (HR) of 0.40 [2] - The estimated median EFS has not yet been reached for the combination arm, while it was 15.7 months for the surgery alone arm [2] - An estimated 74.7% of patients treated with the combination were event-free at two years, compared to 39.4% for surgery only [2] - The OS results showed a 50% reduction in the risk of death for the combination treatment, with an HR of 0.50 [3] - The estimated median OS has not yet been reached for the combination arm, while it was 41.7 months for the surgery arm [3] - An estimated 79.7% of patients were alive at two years in the combination group, compared to 63.1% for surgery alone [3] Group 2: Safety and Efficacy - The safety profile of the combination treatment was consistent with previous reports, with common adverse events including pruritus, alopecia, diarrhea, fatigue, and anemia [5] - Grade 3 adverse events occurred in 71.3% of patients treated with the combination, compared to 45.9% for surgery alone [5] - The pathologic complete response (pCR) rate was 57.1% for the combination treatment versus 8.6% for surgery only, indicating a significant difference [6] Group 3: Implications for Treatment - The results from the EV-303 trial may redefine the standard of care for MIBC patients who are cisplatin-ineligible, offering a new systemic treatment approach that improves survival [7][8] - The trial's findings will be discussed with global health authorities for potential regulatory filings, indicating a pathway for future approval [10] - The combination of PADCEV and KEYTRUDA is currently not approved for neoadjuvant and adjuvant treatment in this patient population, but the results suggest a transformative potential [10][9]

Core Insights - The combination of KEYTRUDA and LENVIMA shows a durable 5-year survival benefit compared to chemotherapy for patients with advanced endometrial carcinoma [1] Group 1 - KEYTRUDA plus LENVIMA demonstrates significant efficacy in improving survival rates for patients suffering from advanced endometrial carcinoma [1] - The study highlights the long-term benefits of this combination therapy over traditional chemotherapy options [1]

Translational data validate mechanism of first-in-concept extracellular-cleaving ADC micvotabart pelidotin (MICVO) MICVO combats solid tumors through three-pronged mechanism of action: direct tumor cell killing, bystander effect, and immunogenic cell death Findings demonstrate MICVO’s effects on tumor microenvironment remodeling and immune activation Translational data to be presented in two posters at ESMO 2025 and six posters at AACR-NCI-EORTC BOSTON, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. ...

Confirmation of 30mg efti as optimal biological dose relevant for Immutep’s oncology pipeline and potential future Biological License Applications (BLA)Registrational TACTI-004 (KEYNOTE-F91) Phase III trial in first line non-small cell lung cancer now in process of opening clinical sites in the United States SYDNEY, AUSTRALIA, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, t ...

Global Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount needed to conduct the futility analysisOver 100 clinical sites across 24 countries now activated and open for recruitment Futility analysis remains on track for completion in the first quarter of CY2026 SYDNEY, AUSTRALIA, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and ...

Core Insights - Merck is set to present new research at the ESMO Congress 2025, showcasing over 100 abstracts across more than 20 cancer types, highlighting its commitment to advancing cancer treatment outcomes [1][2]. Group 1: Existing Medicines - Key data on existing medicines in Merck's portfolio will be presented, including findings for KEYTRUDA, LENVIMA, WELIREG, and KEYTRUDA QLEX [2][3]. - Research on KEYTRUDA's impact in bladder, ovarian, and lung cancers will be featured in three Presidential Symposium presentations [2]. Group 2: Investigational Candidates - New data for investigational antibody-drug conjugates (ADCs) will be presented, including raludotatug deruxtecan and ifinatamab deruxtecan, both discovered by Daiichi Sankyo [4]. - Research on sacituzumab tirumotecan, a TROP2-directed ADC, will be shared in four presentations focusing on lung, breast, cervical, and prostate cancers [4]. Group 3: Key Studies - First-time data from the Phase 3 KEYNOTE-905/EV-303 study evaluating KEYTRUDA plus Padcev for muscle-invasive bladder cancer will be presented [6]. - Five-year exploratory follow-up data from the Phase 3 KEYNOTE-775/Study 309 trial evaluating KEYTRUDA plus LENVIMA for advanced endometrial cancer will be showcased [6]. - Ten-year follow-up data from trials evaluating KEYTRUDA monotherapy for metastatic non-small cell lung cancer (NSCLC) will be presented [6]. Group 4: Clinical Research Program - Merck has the largest immuno-oncology clinical research program in the industry, with over 1,600 trials studying KEYTRUDA across various cancers and treatment settings [8].

Core Insights - Astellas Pharma is set to present significant clinical data at the ESMO congress, showcasing advancements in its oncology programs, particularly in muscle-invasive bladder cancer and hormone-sensitive prostate cancer [1][2][3] Astellas' Oncology Programs - The company will present ten abstracts, including new data for PADCEV (enfortumab vedotin) combined with pembrolizumab in muscle-invasive bladder cancer, which will be featured in an ESMO Presidential Symposium [1][2] - Final overall survival data for XTANDI (enzalutamide) in high-risk, biochemically recurrent non-metastatic hormone-sensitive prostate cancer will also be shared [1][2] Clinical Trials and Data - The EV-303 trial (KEYNOTE-905) will evaluate enfortumab vedotin plus pembrolizumab as neoadjuvant and adjuvant treatment in patients with muscle-invasive bladder cancer who are not eligible for cisplatin-based chemotherapy [3][4] - Long-term follow-up data from the EV-302 trial will explore the utility of enfortumab vedotin in patients with challenging baseline characteristics, including older patients and those with comorbidities [3][4] - The EMBARK trial will present final data assessing overall survival with enzalutamide in combination with leuprolide and as monotherapy in patients with non-metastatic hormone-sensitive prostate cancer [3][4] Innovative Treatments - Astellas is advancing its investigational bispecific T cell engager ASP2138, targeting CLDN18.2 in solid tumors, with initial clinical data being presented [2][3][5] - The company continues to explore treatment options for gastric and gastroesophageal junction cancers with new clinical data for ASP2138 [2][5]

Core Viewpoint - IO Biotech's Cylembio (imsapepimut and etimupepimut) will not proceed with a Biologics License Application (BLA) based on the current clinical trial data, as recommended by the FDA, despite showing improved progression-free survival (PFS) in the IOB-013 trial [1][6] Regulatory Update - The FDA advised against submitting a BLA for Cylembio based on IOB-013 trial data, which narrowly missed statistical significance for PFS [1][6] - IO Biotech plans to engage in further discussions with the FDA to design a new registrational study for Cylembio [2][6] Clinical Trials - Cylembio is currently being evaluated in multiple clinical trials, including a pivotal Phase 3 trial (IOB-013/KN-D18) in combination with Merck's KEYTRUDA (pembrolizumab) for advanced melanoma [3][5] - The IOB-013 trial enrolled 407 patients across over 100 centers globally, with topline results reported in Q3 2025 [5][7] Financial and Operational Strategy - The company is implementing a restructuring plan to conserve capital, which includes a workforce reduction of approximately 50% and expects a non-recurring charge of $1.0 - $1.5 million in Q3 2025 [2][6] - IO Biotech has sufficient capital to sustain operations into Q1 2026 while pursuing regulatory approval for Cylembio [2] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines using its T-win platform [8]

Core Insights - Pfizer is showcasing its extensive Oncology portfolio at the ESMO Congress 2025, with over 45 abstracts presented, including five late-breaking presentations and recognition in the Presidential Symposium [1][2][3] Oncology Portfolio Highlights - The company emphasizes the potential of earlier interventions with innovative medicines to improve patient outcomes, as stated by Jeff Legos, Chief Oncology Officer [2] - Key presentations include: - Phase 3 EV-303 trial results for PADCEV (enfortumab vedotin) plus KEYTRUDA (pembrolizumab) in muscle-invasive bladder cancer [6] - Final overall survival results from the Phase 3 EMBARK trial for XTANDI (enzalutamide) in non-metastatic hormone-sensitive prostate cancer [6] - Updated overall survival data from the Phase 2 PHAROS study of BRAFTOVI (encorafenib) plus MEKTOVI (binimetinib) in BRAF V600E-mutant metastatic non-small cell lung cancer [6] Presentation Schedule - Significant presentations scheduled at ESMO include: - Enfortumab vedotin plus pembrolizumab in first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma [7] - Health-related quality of life impacts from the PATINA Trial regarding palbociclib in HR+/HER2+ metastatic breast cancer [8] - Efficacy and safety of ponsegromab in cancer-associated cachexia [8]