Core Insights - Roche announced positive results from the Phase III IMforte study, demonstrating that the combination of Tecentriq and lurbinectedin significantly improves survival outcomes for patients with extensive-stage small cell lung cancer (ES-SCLC) [1][5] - The combination therapy reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to Tecentriq alone [1][5] - The study's findings were presented at the 2025 ASCO Annual Meeting and published in The Lancet, indicating a potential practice-changing option for a disease with high unmet medical needs [1][5] Study Details - The IMforte study is a Phase III, open-label, randomized trial involving 660 patients in the induction phase and 483 patients in the maintenance phase [2] - Patients received induction therapy with Tecentriq, carboplatin, and etoposide for four cycles before being randomized to maintenance therapy with either Tecentriq plus lurbinectedin or Tecentriq alone [2] - The primary endpoints of the study were progression-free survival (PFS) and overall survival (OS) assessed by independent review [2] Treatment Efficacy - The median overall survival for the Tecentriq plus lurbinectedin regimen was 13.2 months compared to 10.6 months for Tecentriq alone, with a stratified hazard ratio of 0.73 [1][2] - Median progression-free survival was 5.4 months for the combination therapy versus 2.1 months for Tecentriq alone, with a stratified hazard ratio of 0.54 [1][2] - No new safety signals were observed, confirming the safety profiles of both Tecentriq and lurbinectedin [1][2] About Tecentriq - Tecentriq is a monoclonal antibody that targets PD-L1, designed to enhance T cell activation against tumors [3] - It is approved for various aggressive cancer types, including small cell lung cancer and hepatocellular carcinoma, and is available in both intravenous and subcutaneous forms [4][6] Roche's Commitment - Roche is a leader in cancer immunotherapy and aims to improve patient outcomes through innovative treatments [7] - The company has a long-standing commitment to sustainability and aims to achieve net zero by 2045 [8]

Core Insights - IMUNON, Inc. has made significant progress in advancing cancer treatment, particularly with its lead candidate IMNN-001 for ovarian cancer, which is currently in the pivotal Phase 3 OVATION 3 Study [1][2][7] Group 1: Clinical Developments - IMNN-001 has shown promising results in the Phase 2 OVATION 2 Study, demonstrating a median overall survival (OS) extension of 13 months compared to standard-of-care treatments [4] - The drug has a favorable safety profile, with manageable adverse events and no reports of severe immune-related issues, positioning it as a first-in-class immunotherapy [4][5] - Enhanced efficacy has been observed in patients receiving PARP inhibitors, with median OS not yet reached in the IMNN-001 arm after over five years [4] Group 2: Financial and Strategic Positioning - The company has attracted interest from institutional investors, reflecting confidence in its scientific advancements and strategic direction [6] - IMUNON is strategically managing its resources to fund the Phase 3 trial while aligning its critical needs with available capital [6] - The recent increase in share price positions the company favorably to meet NASDAQ listing requirements [6] Group 3: Future Outlook - IMUNON is poised for transformative growth with a clear financial strategy and compelling clinical data supporting its TheraPlas platform [7] - The company aims to deliver innovative treatment options for patients with ovarian cancer while creating sustainable value for shareholders [7][8]

Breakthrough Second-Line Treatment Demonstrated Survival Advantage over Standard-of-Care Chemotherapy Late-Breaking Data Presented at ASCO 2025 and Simultaneously Published in The New England Journal of MedicineTHOUSAND OAKS, Calif., June 2, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new interim results from the global Phase 3 DeLLphi-304 trial showing IMDELLTRA® (tarlatamab-dlle) reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months ...

Phase 3 IFx-Hu2.0 trial as an adjunctive therapy with Keytruda® (pembrolizumab) in checkpoint inhibitor (CPI)-naïve patients with advanced or metastatic Merkel cell carcinoma (MCC) detailed in Trial in Progress Poster at ASCOPhase 3 trial of IFx-Hu2.0 to be conducted under Accelerated Approval Pathway and Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA)TAMPA, Fla., June 2, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncolog ...

Median overall survival data in first-line recurrent/metastatic (1L r/m) HNSCC remains durable at 30.0 months with additional follow-up of ~4.5 months beyond the initial abstract HPV16-positive is the most rapidly increasing HNSCC in the US VERSATILE-003 is the only ongoing Phase 3 clinical trial exclusively addressing 1L r/m HPV16-positive HNSCC PRINCETON, N.J., June 02, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy compan ...

New trial arm to evaluate safety, dosing and preliminary anti-tumor activity of the combination therapy in advanced solid tumorsNEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, announces that the first patient has been dosed in the expansion arm of its Phase 1b/2 clinical trial evaluating Decoy20 in combination with BeOne’s (formerly known as Beigene) PD-1 c ...

Core Insights - Innovent Biologics has presented promising clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2025 ASCO Annual Meeting, demonstrating its potential to convert "cold tumors" into "hot tumors" in advanced colorectal cancer [1][2][10] Clinical Data Summary - IBI363 monotherapy showed a median overall survival (OS) of 16.1 months in patients with advanced colorectal cancer, significantly better than standard treatments which range from 6.4 to 9.3 months [6][10] - In Phase 1 studies, IBI363 combined with bevacizumab resulted in a confirmed objective response rate (cORR) of 15.1% and a disease control rate (DCR) of 61.6% among 73 participants [9] - The combination therapy showed a median progression-free survival (PFS) of 4.7 months, with a notable increase in efficacy for patients without liver metastases, achieving a cORR of 31.3% and a DCR of 81.3% [9] Mechanism of Action - IBI363 operates by blocking the PD-1/PD-L1 pathway while activating the IL-2 pathway, specifically targeting tumor-specific T cells, which enhances its therapeutic efficacy in treating colorectal cancer [11][12] - Tumor immune cell infiltration analysis indicated that higher levels of CD8+ T cells were associated with improved clinical responses to IBI363, supporting its mechanism of action [8] Future Development - Innovent is conducting further clinical studies in multiple countries to explore IBI363's efficacy across various tumor indications, including immune-resistant and cold tumors [12] - The company has initiated a pivotal trial for IBI363 targeting unresectable locally advanced or metastatic mucosal or acral melanoma [12][13] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer, and has launched 15 products to date [14][15] - The company has received fast track and breakthrough designations from regulatory authorities for IBI363, indicating its potential in treating specific cancer types [13]

Core Viewpoint - Innovent Biologics has presented promising clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, demonstrating breakthrough efficacy in treating "immune cold tumors" such as acral and mucosal melanoma, which are traditionally resistant to treatment [1][2][4]. Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, cardiovascular, and autoimmune conditions [16]. - The company has launched 15 products and has multiple assets in various stages of clinical trials, indicating a robust pipeline [16]. Clinical Study Insights - IBI363 is currently undergoing clinical studies in China, the United States, and Australia, targeting multiple tumor indications, particularly immune-resistant and cold tumors [2][14]. - The Phase 1/2 studies have shown a confirmed objective response rate (cORR) of 23.3% and a disease control rate (DCR) of 76.7% in patients with advanced melanoma [6][7]. - The median progression-free survival (PFS) for patients treated with IBI363 was reported at 5.7 months, significantly longer than previous studies [7][10]. Efficacy and Safety Profile - IBI363 has demonstrated durable responses with a median duration of response (DoR) of 14.0 months in patients with confirmed responses [7]. - The overall 12-month overall survival (OS) rate was 61.5%, with a median OS of 14.8 months [6][7]. - The treatment was generally well tolerated, with the most common treatment-related adverse events being arthralgia, rash, and hyperthyroidism, primarily Grade 1 or 2 [7]. Future Development Plans - A pivotal Phase 2 registrational study comparing IBI363 with pembrolizumab in patients with unresectable melanoma has been initiated, aiming to enroll 180 patients [8][9]. - The company is also exploring combination therapies with IBI363 across various cancer types, indicating a commitment to expanding its therapeutic applications [9][14]. Market Need and Potential - There is a significant unmet clinical need for effective treatments for advanced acral and mucosal melanoma in China, where current therapies have limited efficacy [10][12]. - IBI363 aims to address this gap by transforming "cold tumors" into "hot tumors" through dual activation of the PD-1 and IL-2 pathways, potentially establishing a new standard in immunotherapy for melanoma [10][13].

Adlai Nortye Ltd. announced topline results from its Phase III BURAN trial evaluating buparlisib (AN2025), a PI3K inhibitor, in combination with paclitaxel for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The study did not meet the primary endpoint of improving overall survival compared to paclitaxel alone. The safety profile of buparlisib was consistent with previous findings, with no new safety signals observed.Detailed results will be presented at ...

REDWOOD CITY, Calif., May 30, 2025 (GLOBE NEWSWIRE) -- Coherus Oncology, Inc. (Coherus Oncology, Nasdaq: CHRS), a commercial-stage innovative oncology company, formerly named Coherus BioSciences Inc., announced its name change today to better align with its exclusive focus on proprietary innovative immuno-oncology medicines. “The field of cancer immunotherapy has been reinvigorated by the promise and power of combination therapies. Coherus Oncology has the expertise and pipeline to become a significant play ...