On October 3, 2025 PharmaMar (MSE:PHM) reported that the U.S Food and Drug Administration (FDA) has granted approval for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide (Press release, PharmaMar, OCT 3, 2025, View Source [SID1234656424]). The approval marks the first combination therapy for first-line maintenance treatment of ES-SCLC, a fast growing and aggressive cancer with limited treatment options.

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The National Comprehensive Cancer Network (NCCN) recently updated the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for SCLC to include the combination as preferred regimen for patients whose disease has not progressed following four cycles of platinum-based chemotherapy and atezolizumab induction.

The FDA approval is based on results from the Phase 3 IMforte trial, which showed that the lurbinectedin and atezolizumab combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to atezolizumab maintenance therapy alone. Following four cycles of induction therapy, from the point of randomization the median overall survival (OS) for the combination regimen was 13.2 months versus 10.6 months (stratified hazard ratio [HR]=0.73; 95% CI: 0.57–0.95; p=0.0174). From the point of randomization, median progression-free survival (PFS) by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54, 95% CI: 0.43–0.67; p<0.0001). Safety was consistent with the known safety profiles of both treatments. The results were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and simultaneously published in The Lancet.

PharmaMar has also submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), which is currently under review.

On October 3, 2025 Coherus Oncology, Inc. (NASDAQ: CHRS), reported an upcoming poster presentation at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 5-9, 2025, in National Harbor, Maryland (Press release, Coherus Oncology, OCT 3, 2025, View Source [SID1234656423]).

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Abstract # 640: CHS-114, an anti-CCR8 cytolytic monoclonal antibody demonstrates selective intratumoral Treg depletion and favorable immune remodeling in participants with advanced solid tumors.

Date: Saturday, November 8, 2025
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
In addition, CHS-114 will be featured in the upcoming Targets for Cancer IO: A Deep Dive live webinar series:
Development of Anti-CCR8 Ab – Mechanisms and Clinical Results
Webinar 6 will address the novel therapeutic target C-C chemokine receptor 8 (CCR8), its role in regulatory T cell (Treg) activity and immunosuppression, and the latest advances and insights in developing monoclonal antibodies that target this chemokine receptor as a promising new strategy to treat a variety of cancers.

Date and Time: October 22, 2025, 12:00 – 2:00 pm Eastern Time
Moderators: Enrico Lugli, PhD, Humanitas Research Hospital and Rahul Roychoudhuri, MD, PhD
University of Cambridge
Faculty: Rosh Dias, MD, MRCP, Coherus Oncology; Varun Kapoor, PhD, Coherus Oncology; Jo Van Ginderachter, PhD, Vrije Universiteit Brussel
To learn more about the webinar series and register to attend, visit SITC (Free SITC Whitepaper)’s Targets for Cancer IO: A Deep Dive website: View Source

On October 3, 2025 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of its lead immune-activating antibody therapeutic, reported the presentation of updated Phase 2 data from its ongoing study of imneskibart (AU-007) in patients with checkpoint inhibitor (CPI)-refractory melanoma and non-small cell lung cancer (NSCLC) (Press release, Aulos Bioscience, OCT 3, 2025, View Source [SID1234656422]). The data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, being held virtually and in National Harbor, Maryland, from November 5-9, 2025.

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Details of the poster presentation are as follows:

Poster Title: Imneskibart, a human monoclonal antibody (mAb) that binds IL-2 and prevents CD25 binding, + low-dose subcutaneous IL-2: Phase 2 update on CPI-refractory melanoma and non-small cell lung cancer (NSCLC)
Abstract: 651
Date and Time: Friday, November 7, 2025, 10:00 a.m.-7:00 p.m. EST

The poster will be presented in the Prince George ABC Exhibit Halls at the Gaylord National Resort and Convention Center. An electronic version will also be available on the SITC (Free SITC Whitepaper) 2025 virtual meeting platform.

About Imneskibart
Imneskibart (AU-007) is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, imneskibart redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. Imneskibart also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the imneskibart Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

On October 3, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported updated data from its Phase 2 ASPEN-06 (NCT05002127) trial will be presented during a poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting taking place November 5–9, 2025, in National Harbor, Maryland (Press release, ALX Oncology, OCT 3, 2025, View Source [SID1234656421]). The Phase 2 trial evaluated evorpacept, the Company’s lead therapeutic candidate, in combination with HERCEPTIN (trastuzumab), CYRAMZA (ramucirumab) and paclitaxel, for patients with previously treated HER2-positive advanced gastric cancer (GC) and gastroesophageal junction (GEJ) cancer.

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Details for the poster presentation at SITC (Free SITC Whitepaper) 2025 are as follows:
Title: CD47 expression as a predictive biomarker for evorpacept in HER2-positive gastric/gastroesophageal cancer from the Phase 2 randomized ASPEN-06 trial
First Author: Zev A. Wainberg, M.D., Professor of Medicine and Co-Director of GI Oncology Program, University of California, Los Angeles
Abstract: 496
Date and Time: Saturday, November 8, 2025, 10:00 a.m. – 6:35 p.m. ET
Location: Poster Hall (Exhibit Halls AB)

About ASPEN-06

ASPEN-06 is a randomized Phase 2 (open-label)/3 (blinded), international, multi-center study, evaluating evorpacept in combination with HERCEPTIN (trastuzumab), CYRAMZA (ramucirumab) and paclitaxel, for patients with metastatic second- or third-line HER2 overexpressing gastric/GEJ adenocarcinoma that has progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy and are suitable for chemotherapy. One hundred twenty-seven adult patients were enrolled in the Phase 2 portion of the study.

On October 2, 2025 Genialis, the RNA biomarker company, reported a collaboration with Cleveland Clinic, one of the world’s leading academic medical centers, to develop AI-powered tools that help doctors identify the most effective treatment options for patients with pancreatic ductal adenocarcinoma (PDAC), the most common and deadliest form of pancreatic cancer (Press release, Cleveland Clinic , OCT 2, 2025, View Source [SID1234656417]).

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The collaboration leverages the Genialis Supermodel, a foundation model built from one of the world’s largest and most diverse RNA-sequencing datasets to create predictive biomarker algorithms. These tools aim to help clinicians identify the most effective therapies for individual PDAC patients, optimize treatment selection, and accelerate access to novel drug strategies.

Addressing an Urgent Need

PDAC is one of the most aggressive and lethal cancers, responsible for more than 90 percent, or over 50,000, of pancreatic cancer deaths annually in the United States alone1. Despite improved survivorship in some common cancers, the Cancer Research Institute cites2 that the PDAC five-year relative survival rate remains around 9 percent, among the lowest across all cancer types.

Together, Genialis and Cleveland Clinic will work on testing Genialis Supermodel predictions across a range of therapies and combinations in the hospital’s patient-derived organoid center to quickly validate and iterate on predictive algorithms.

"For clinicians, time is critical. While standard therapies exist, we lack validated biomarkers to identify which patients are most likely to benefit from various treatment options," said Wen Wee Ma, MD, Director, Novel Cancer Therapeutics Center, Enterprise Vice Chair, Research Cleveland Clinic Cancer Institute. "Emerging therapies, including KRAS inhibitors, offer new hope but require precise patient selection to achieve meaningful outcomes. Our goal is to bring practical, data-driven tools into the clinic that help us choose the best treatment paths for patients who currently have very few effective options." Dr. Ma will serve in an advisory capacity and may receive research funding and royalties.

The majority of PDAC cases harbors a KRAS mutation.3

"Through our work on biomarker algorithms for KRAS inhibitors, Genialis has already made a major investment in understanding the drivers of PDAC," said Rafael Rosengarten, Ph.D., CEO of Genialis. "Our collaboration with Cleveland Clinic aims to extend these insights to give doctors and patients better tools to combat the disease. This is an important step toward truly data-driven, personalized care in one of the most pressing areas of unmet need."

Genialis krasID, powered by the Genialis Supermodel, is the first biomarker algorithm that can predict patient response and clinical benefit to KRAS inhibitors (KRASi) across tissue histology and mutation type. Genialis krasID can help guide drug development from early preclinical phases (e.g., compound/MOA differentiation and selection), to clinical trials (e.g., patient selection for clinical trials and identification of combination therapies), to market access and clinical care (e.g., development of CDx and as a clinical decision tool).