Enrollment Completed in Phase 3 Clinical Study of Disitamab Vedotin Combined with PD-1 Inhibitor as First-Line Treatment for Advanced Urothelial Carcinoma

On August 14, 2024 RemeGen Co. Ltd. (688331.SH/09995.HK) reported that 484 subjects have been enrolled in 74 sites across China in the "randomized, open-label, parallel, controlled and multicenter phase 3 clinical study of Disitamab Vedotin for injection plus Toripalimab vs Gemcitabine plus cisplatin/carboplatin for HER2-expressing locally advanced or metastatic urothelial carcinoma" led by Professor Jun Guo from Beijing Cancer Hospital and Professor Aiping Zhou from Cancer Hospital Chinese Academy of Medical Sciences (Press release, RemeGen, AUG 14, 2024, View Source;cid=115&id=2261 [SID1234656127]).

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This study was initiated in June, 2022 and aimed at comparing the efficacy and safety between Disitamab Vedotin plus Toripalimab and Gemcitabine plus cisplatin/carboplatin in treating HER2-expressing (HER2 IHC 1+, 2+ or 3+) locally advanced or metastatic urothelial carcinoma. HER2-expressing locally advanced or metastatic urothelial carcinoma patients who did not receive systemic treatment (including chemotherapy, targeted therapy and immunotherapy) before were enrolled in this study.

Platinum-based chemotherapy is the current standard of care (SOC) for locally advanced or metastatic urothelial carcinoma but has less favorable long-term efficacy. Urothelial carcinoma is the second indication of Disitamab Vedotin approved in China at the end of 2021 for the treatment of locally advanced or metastatic urothelial carcinoma patients with HER2 IHC 2+ or 3+, who received platinum-containing chemotherapy before. According to the clinical data for the initial BLA submission, the objective response rate (ORR) based on assessment by the Independent Review Committee reached 50.5%, the median progression-free survival (PFS) was 5.9 months and the median overall survival (OS) was 14.2 months, demonstrating significant efficacy and clinical benefit. Another exploratory study of Disitamab Vedotin combined with PD-1 inhibitor also had remarkable results which have been reported by ASCO (Free ASCO Whitepaper) for several times. The phase 3 study based on the above clinical data will be helpful for the transition of Disitamab Vedotin from later-line treatment to first-line treatment, bringing better survival benefits for more patients.

Half-year interim report

On August 14, 2024 Evotec reported its half-year interim report 2024 (Presentation, Evotec, AUG 14, 2024, View Source [SID1234647164]).

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Q2 2024 quarterly report

On August 14, 2024 Oncopeptides reported its second quarter 2024 results (Presentation, Oncopeptides, AUG 14, 2024, View Source [SID1234646759]).

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Half-Year Report 2024

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

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Novocure Highlights TTFields Therapy in Treatment of Non-Small Cell Lung Cancer at 2024 World Conference on Lung Cancer

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.