On August 14, 2024 MediGene reported its half-yearly 2024 results (Presentation, MediGene, AUG 14, 2024, View Source [SID1234645981]).

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On August 14, 2024 Novocure (NASDAQ: NVCR) reported its participation in the upcoming International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC) from September 7 – 10, 2024 in San Diego, California (Press release, NovoCure, AUG 14, 2024, View Source [SID1234645937]). Novocure will take part in presentations and symposia throughout the event and will exhibit several posters exploring the use of Tumor Treating Fields (TTFields) therapy in the treatment of lung cancer, including a new post-hoc analysis of data from the LUNAR trial in metastatic non-small cell lung cancer (NSCLC).

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"We are eager to share these exciting new analyses with the lung cancer community," said Nicolas Leupin, MD, Novocure’s Chief Medical Officer. "TTFields therapy offers significant potential for the treatment of this prevalent disease. With multiple regulatory reviews underway, there is no better time to examine the promise of TTFields use in the treatment of NSCLC."

The new post-hoc analysis evaluated survival data from the phase 3 LUNAR clinical trial, as well as a data from a simulation study, to assess the effect of body mass index (BMI) on overall survival (OS) and the feasibility of delivering TTFields at a therapeutic intensity to patients of varying BMIs. Investigators did not identify a difference in OS benefit between patients with a BMI <25 kg/m2 compared a BMI >25 kg/m2. Additionally, data from the simulation-based study suggests TTFields can be delivered to the lungs in therapeutic dose and a corresponding clinical benefit observed in patients across a range of BMIs.

The LUNAR trial was designed to evaluate the use of TTFields therapy together with standard systemic therapies for the treatment of metastatic non-small cell lung cancer, following progression on or after platinum-based therapy. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful extension in OS for patients treated with TTFields and standard systemic therapies, as well as a pronounced extension in OS for patients randomized to receive physician’s choice immune checkpoint inhibitor together with TTFields. Novocure has submitted these data to regulatory agencies for approval and anticipates treating patients in late 2024.

Novocure’s presence at the 2024 WCLC will include:

Sunset Seminar: Women in Thoracic Oncology, hosted by Women Leaders in Oncology (WLO), sponsored by Novocure, on September 8, 2024, at 6:00 p.m. UTC-7
Impact of BMI on TTFields in Patients with mNSCLC: Post-hoc Analysis from the Phase 3 LUNAR Study and Simulation Model Data. Poster P1.098B.04 displayed in the Exhibit Hall on September 8, 2024, at 12:00 p.m. UTC-7
Treatment of Non-Small Cell Lung Carcinoma (NSCLC) Cells With Tumor Treating Fields (TTFields) and DNA-Dependent Protein Kinase (PK) Inhibitors. E-Poster EP.03F.04
Tumor Treating Fields (TTFields) Induce Pro-Inflammatory Phenotype Skewing of Macrophages. E-Poster EP.03G.03

ABOUT TUMOR TREATING FIELDS THERAPY

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

ABOUT LUNAR

LUNAR tested the safety and effectiveness of TTFields therapy when used together with either an immune checkpoint inhibitor (ICI) or docetaxel for the treatment of patients diagnosed with metastatic NSCLC following progression on or after the use of platinum-based therapy. Patients randomized to receive TTFields therapy together with standard therapies (n=137) demonstrated median overall survival (OS) of 13.2 months compared to 9.9 months in patients treated with standard therapies alone (n=139). Patients randomized to receive TTFields therapy and physician’s choice ICI (n=66) demonstrated a median OS of 18.5 months versus a median OS of 10.8 months in patients treated with an ICI alone (n=68; HR=0.63; P=0.03). Patients randomized to receive TTFields therapy and docetaxel (n=71) had a positive survival trend with a median OS of 11.1 months vs 8.7 months in patients treated with docetaxel alone (n=71). TTFields therapy was well-tolerated with no added systemic toxicities and few grade 3 (no grade 4 or 5) device-related adverse events.

On August 14, 2024 Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, reported that the US Food and Drug Administration (FDA) has granted the investigation of AC699 a Fast Track designation for the treatment of patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression on or after at least 1 line of endocrine-based therapy (Press release, Accutar Biotechnology, AUG 14, 2024, View Source;Breast-Cancer [SID1234645936]). AC699 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α currently in a Phase 1 trial.

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ER-positive/HER2-negative subtype is the most common subtype of breast cancer (~70%), and mutations in the estrogen receptor 1 (ESR1) gene are common (20-40%) among ER-positive/HER2-negative patients who received endocrine therapy in the metastatic setting. AC699 has demonstrated objective response rate (ORR) of 50% in patients with an ESR1 mutation, in an ongoing Phase 1 trial, presented at ASCO (Free ASCO Whitepaper) 2024.

"Receiving Fast Track designation for AC699 from the FDA highlights their recognition of the serious and life-threatening nature of this malignancy, the critical unmet medical needs not fully addressed by existing therapies, and the potential of AC699 to fill in the gap," said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. "We look forward to working closely with the FDA to optimize and expedite the development program."

The FDA’s Fast Track process is designed to facilitate the development and expedite the review of novel drugs intended to treat serious conditions and address significant unmet medical needs. Companies that receive Fast Track designation are eligible for more frequent meetings and communications with the FDA during clinical development and potentially accelerated approval and priority review, if relevant criteria are met. For more information on Fast Track Designation, please visit the FDA’s website at View Source

About AC699 and the Phase 1 Study (AC699-001)

AC699 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α. In preclinical studies, AC699 has demonstrated potent and selective protein degradation of ERα wildtype and mutants with favorable pharmacological properties, as well as promising anti-tumor activities in ER-positive animal tumor models.

The purpose of the Phase 1 multi-center, open-label study is to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC699 treatment in patients with ER-positive / HER2-negative locally advanced or metastatic breast cancer (NCT05654532). Additional information on this clinical trial can be found on www.clinicaltrials.gov.

On August 14, 2024 Akeso, Inc. (HKEX: 9926.HK) ("Akeso,") reported that the National Center for Drug Evaluation of the State Drug Administration of the People’s Republic of China (NMPA CDE) has granted priority review of the supplemental New Drug Application (sNDA) to 依达方 (ivonescimab), a first-in-class PD-1/VEGF bi-specific antibody developed by Akeso, as monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Akeso Biopharma, AUG 14, 2024, View Source [SID1234645935]).

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This marks the second indication for which ivonescimab has been granted priority review following the treatment of EGFR-mutant non-squamous NSCLC that has progressed after EGFR-TKI therapy, highlighting its significant clinical value.

This new indication application for ivonescimab is based on the HARMONi-2 (AK112-303) study. At a prespecified interim analysis conducted by an independent Data Monitoring Committee, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent radiology review committee (BICR) compared to pembrolizumab, and the hazard ratio (HR) was significantly better than expected. There are no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.

In May 2024, ivonescimab combination therapy for EGFR-mutant non-squamous NSCLC that has progressed after EGFR-TKI therapy was approved through priority review, making it the world’s first approved bispecific antibody that combines "tumor immunotherapy" and "anti-angiogenesis" mechanisms.

About Ivonescimab (AK112/SMT112)

Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics’ license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab’s first indication has been approved in China, and Akeso is conducting 5 Phase III trials including 2 global MRCTs and 4 registrational trials versus anti-PD-1 therapeutics. The Company is also conducting multiple clinical trials of ivonescimab covering 16 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer.

On August 14, 2024 OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, reported that three of its research abstracts have been selected for presentation at the upcoming World Conference on Lung Cancer (WCLC 2024) (Press release, OncoHost, AUG 14, 2024, View Source [SID1234645934]). The abstracts highlight OncoHost’s significant work in developing predictive models for immunotherapy-related toxicities and clinical outcomes.

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The research to be presented includes one oral presentation and two poster presentations, each showcasing the potential of plasma proteomics in advancing personalized treatment strategies for lung cancer patients.

Oral Presentation

Title: Plasma Proteomics-Based Models for Predicting Immunotherapy- and Chemotherapy-Related Toxicity in NSCLC Patients
Presenter: Prof. Jarushka Naidoo

This study addresses a critical need in the management of metastatic non-small cell lung cancer (NSCLC) patients who are treated with PD-1/PD-L1-based immune checkpoint inhibitors (ICIs). Prof. Naidoo will present innovative plasma proteomics-based models designed to predict the likelihood of severe immune-related adverse events (irAEs) and chemotherapy-related adverse events (chemo-AEs) before treatment begins. These models offer a promising approach to improving patient care by identifying those at higher risk of experiencing significant toxicities, thereby allowing for more informed treatment decisions.

"The field of immunotherapy for lung cancer has a well-developed focus on identifying biomarkers of response and resistance to treatment. However, biomarkers of toxicity from immunotherapy and chemotherapy are also of clinical relevance, with the potential to refine treatment selection and monitoring," said Jarushka Naidoo, MD, consultant medical oncologist at Beaumont Hospital Dublin, professor at the Royal College of Surgeons in Ireland, and corresponding author of the study. "These data explore the use of proteomics for this purpose and are an important area for continued study."

Poster Presentations

Title: A Plasma Proteomics-Based Model for Clinical Benefit Prediction in Small Cell Lung Cancer Patients Receiving Immunotherapy
Presenter: Prof. David R. Gandara

This research focuses on small cell lung cancer (SCLC), a particularly aggressive form of lung cancer with limited treatment options. Prof. Gandara will present a novel computational model that utilizes pretreatment plasma proteomic profiles to predict clinical outcomes for SCLC patients receiving immunotherapy (ICIs) combined with chemotherapy. The study highlights the potential of this model to refine treatment strategies by identifying patients most likely to benefit from ICIs, paving the way for more personalized and effective therapies.

"Although checkpoint immunotherapy combined with chemotherapy has extended survival in patients with extensive stage SCLC, many patients do not benefit, and most patients develop recurrence. Identifying those patients most likely to have meaningful benefit is a critical unmet need," said David R. Gandara, MD, Division of Hematology and Oncology, University of California Davis Comprehensive Cancer Center, and corresponding author of the study. "This study describes the development of a blood-based proteomic test to distinguish these patients at the time of diagnosis, prior to therapy. Given the rapid progression and aggressive nature of this malignancy, this assay has the potential to truly personalize initial treatment plans."

Title: Deciphering Immunotherapy Resistance Mechanisms in Metastatic NSCLC: Insights from Plasma Proteomics Analysis
Presenter: Dr. Itamar Sela, VP R&D, OncoHost

This study delves into the mechanisms of immunotherapy resistance in metastatic NSCLC. Dr. Sela will present findings from the PROphetNSCLC test, a plasma proteomics and machine learning-based tool designed to assist in first-line treatment management. The research identifies six distinct groups of resistance-associated proteins (RAPs) linked to the immune system, tumor, and other tissues, offering valuable insights into the biological processes underlying resistance to immunotherapy.

"Our research showcases the groundbreaking potential of plasma proteomics in oncology," said Yehuda Brody, PhD, Senior Computational Biologist Researcher at OncoHost. "By leveraging non-invasive liquid biopsy samples, we’ve identified specific resistance mechanisms and biomarkers within the plasma proteome. This approach provides a multisystem overview, bringing us closer to truly personalized treatment strategies for lung cancer patients. Our study marks a significant advancement in decoding the complex, multifaceted nature of immunotherapy resistance, ultimately aiming to improve personalized patient treatment decisions."

OncoHost’s participation in WCLC 2024 underscores its commitment to advancing the field of oncology through innovative research and technology. The company looks forward to sharing these important findings with the global oncology community.