ESMO

Sutro Biopharma Announces Presentation of Data for Luveltamab Tazevibulin (luvelta) from the Phase 1 Dose-Expansion Study in Endometrial Cancers at ESMO 2023

Retrieved on: 
Sunday, October 22, 2023
Neoplasm, Research, Gynaecology, Incidence, ESMO, Ovarian cancer, European Society for Medical Oncology, Folate, Congress, Endometrial cancer, Mortality, American Society of Clinical Oncology, NYU Langone Health, STRO, NYU, Society, Death, ECIS, Sutro, ADC, EOC, Spacecraft, Oncology, New York University Grossman School of Medicine, Obstetrics, Safety, Department of Obstetrics and Gynecology (Massachusetts General Hospital), Patient, Neutropenia, SAN, Pharmaceutical industry, Europe 1, EU

SOUTH SAN FRANCISCO, Calif., Oct. 22, 2023 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced initial results from a Phase 1 dose-expansion study of luveltamab tazevibulin (luvelta), a novel Folate receptor alpha (FolRα)-targeting ADC, in patients with endometrial cancer, in a mini oral presentation at the 2023 European Society For Medical Oncology (ESMO) Congress in Madrid, Spain.

Key Points: 
  • Advanced endometrial cancer is the only gynecologic malignancy with increasing incidence and mortality in both the US and Europe1.
  • Estimated incidence in the EU: 92,746 pts with 23,047 deaths (2022)2 and in the US: 66,000 pts with 13,030 deaths (2023)3.
  • “We are pleased to have the opportunity to present these encouraging early data at ESMO this year,” said Anne Borgman, M.D., Sutro’s Chief Medical Officer.
  • Consistent with previous reported luvelta safety results, the most common adverse event was neutropenia; no new safety signals were observed
    *2: European Cancer Information System (ECIS).

Harpoon Therapeutics Announces Updated Interim Tolerability and Response Data from Phase 1/2 Clinical Trial of T Cell Engager HPN328 at ESMO Congress 2023

Retrieved on: 
Saturday, October 21, 2023
MTD, ESMO, Trae tha Truth, Publication, Carcinoma, CEST, Prostate cancer, Poster, Memorial Sloan Kettering Cancer Center, Index, DLT, Cytokine release syndrome, Webcast, Histology, European Society for Medical Oncology, CRS, DLL3, Therapy, Patient, Medical imaging, Pharmaceutical industry, SCLC

Treatment-related adverse events (TRAEs) occurred in 67 patients (94%), and Grade ≥ 3 TRAEs in 18 patients (25%).

Key Points: 
  • Treatment-related adverse events (TRAEs) occurred in 67 patients (94%), and Grade ≥ 3 TRAEs in 18 patients (25%).
  • The preliminary response data for evaluable patients treated in 1 mg priming dose cohorts showed confirmed response rate of 35% (11/31) across all tumor types.
  • In SCLC, the confirmed response rate was 32% (6/19) with one confirmed complete response.
  • A replay of the webcast will be available shortly after the live event and can be accessed at the same weblink.

Libtayo® (cemiplimab) Neoadjuvant Treatment Demonstrates Encouraging Event-Free Survival in Patients with Resectable Cutaneous Squamous Cell Carcinoma (CSCC)

Retrieved on: 
Saturday, October 21, 2023
Clinical Science (journal), MPR, Hypophysitis, ESMO, MD Anderson Cancer Center, Clinical research, Regeneron Pharmaceuticals, Carcinoma, Lymph, Congress, European Society for Medical Oncology, PCR, PD-1, The Lancet, Observation, Senior, Quality of life, Radiation, Risk, Recurrence, The New England Journal of Medicine, Oncology, University, Safety, Cancer, CSCC, AE, Patient, Translation, Death, Heart failure, Pharmaceutical industry, Medical imaging, Gasoline, Cemiplimab

TARRYTOWN, N.Y., Oct. 21, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentation of key secondary endpoints for an investigational regimen of PD-1 inhibitor Libtayo® (cemiplimab) as a neoadjuvant monotherapy in stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). The results from an international Phase 2 trial were presented in an oral session at the European Society for Medical Oncology (ESMO) Congress 2023 and concurrently published in The Lancet Oncology.

Key Points: 
  • “Advanced, resectable cutaneous squamous cell carcinoma can lead to reduced patient function and quality of life following the cumulative effects of treatment, typically surgery and radiation.
  • “Results from both the single-institution pilot trial and the multi-center Phase 2 trial found neoadjuvant cemiplimab was highly active in patients with resectable cutaneous squamous cell carcinoma.
  • These robust responses were durable, translating into event-free survival for the vast majority of patients at one and two years.”
    The multicenter, single-arm Phase 2 trial included two parts.
  • In Part 1, patients (n=79) received Libtayo 350 mg every three weeks for up to four doses, followed by curative-intent surgery.

Initial Phase 1 Dose Escalation Data of ORIC-114 in Patients with EGFR and HER2 Exon 20 Mutations Demonstrates Potential Best-In-Class Profile

Retrieved on: 
Saturday, October 21, 2023
Patient, First grade, MTD, Q&A, NSCLC, Half-life, ESMO, Trae Elston, Rash, TDD, HER2, Lung cancer, Congress, ORIC, BID, European Society for Medical Oncology, CNS, Great Lakes tornadoes of September 26, 1951, Grade 3, Systemic, Clinical trial, DLT, Webcast, Oncology, ORR, Brain, Toxic leukoencephalopathy, Safety, Diarrhea, Toxicity, SAN, EGFR, Medical imaging, Pharmaceutical industry, Vaccine, MD

“This is the first comprehensive data set for EGFR exon 20 patients with such an exceptionally high rate of CNS disease at baseline and prior exon 20 inhibitor therapy.

Key Points: 
  • “This is the first comprehensive data set for EGFR exon 20 patients with such an exceptionally high rate of CNS disease at baseline and prior exon 20 inhibitor therapy.
  • Patients previously treated with an exon 20 targeted agent are eligible, including patients with CNS metastases that are either treated or untreated but asymptomatic.
  • As of September 26, 2023, 50 patients (21 EGFR exon 20, 24 HER2 exon 20 and 5 HER2+ patients) received ORIC-114 and were heavily pre-treated, with exceptionally high rates of prior exon 20 targeted therapies and brain metastases at baseline.
  • The Phase 1 trial will enroll patients with EGFR exon 20 insertion mutations that are EGFR exon 20 inhibitor-naïve, and additional patients who are post-amivantamab.

Precede Biosciences Unveils Groundbreaking Clinical Data for its Pioneering Liquid Biopsy Platform at ESMO 2023 and Simultaneously Publishes in Nature Medicine

Retrieved on: 
Saturday, October 21, 2023
Plasma, Manuscript, ESMO, Nature Precedings, IHC, Assistant, HER2, Congress, Colorectal cancer, Prevalence, European Society for Medical Oncology, Dana–Farber Cancer Institute, Phenotype, Research, Drug development, News, CRC, Biology, Cancer, Oncology, ER, DLL3, AR, Liquid biopsy, Patient, Immunohistochemistry, Medical device, Medical imaging, MD, Medicine, Nature Medicine

BOSTON, Oct. 21, 2023 (GLOBE NEWSWIRE) -- Precede Biosciences, a company impacting the development and use of precision medicines with a first-in-class liquid biopsy platform, today announced the first clinical data from its proprietary liquid biopsy platform were presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress in Madrid, Spain, and simultaneously published in Nature Medicine. The data demonstrate the platform's unique capability to inform and impact clinical decisions by providing resolution into the activation status of individual disease-defining genes and pathways genome-wide, from a simple blood draw.

Key Points: 
  • In this patient’s case, the signal identified by the Precede blood-based test was confirmed subsequently by tissue biopsy and immunohistochemistry (IHC), enabling this information to be used for clinical care.
  • In the future, a simple blood draw and testing with the Precede platform may be sufficient for clinical decision-making alone.
  • This very real case demonstrates the power of the Precede platform and its potential to impact precision medicine.
  • A copy of the presentation and a link to the manuscript can be found in the News section of the website.

Immunocore presents three-year overall survival data from the KIMMTRAK Phase 3 trial

Retrieved on: 
Saturday, October 21, 2023
Survival, Aes, ESMO, TCR, Congress, European Society for Medical Oncology, Mum, Melanoma, The New England Journal of Medicine, Oncology, Infection, Safety, Cancer, Immunocore, Patient, OS, Neoplasm, DNA, BRAF, Pharmaceutical industry

“These long-term overall survival results further solidify KIMMTRAK as the first-line standard of care for HLA-A*02:01 positive patients with metastatic uveal melanoma,” said Mohammed Dar, Immunocore Chief Medical Officer.

Key Points: 
  • “These long-term overall survival results further solidify KIMMTRAK as the first-line standard of care for HLA-A*02:01 positive patients with metastatic uveal melanoma,” said Mohammed Dar, Immunocore Chief Medical Officer.
  • Overall response rate remained in favor of KIMMTRAK when compared with the control arm (11% vs 5%) and the median duration of response for KIMMTRAK patients was 11.1 months.
  • The trial evaluated circulating tumor DNA (ctDNA) clearance as a predictor of overall survival.
  • Session: Mini oral session – Melanoma and other skin tumours, Saturday 21 October, 2023
    Title: Effect of subsequent therapies including checkpoint inhibitors on overall survival in a phase 3 randomized trial of tebentafusp in first line metastatic uveal melanoma: long-term follow up

Dxcover Awarded First Prize for Poster at ESMO 2023 With Multi-Omic Spectral Analysis in Early Detection of Multiple Cancers Data

Retrieved on: 
Wednesday, October 25, 2023
Biotechnology, Other Health, Health, Pharmaceutical, Oncology, Health Technology, Other Science, Medical Devices, Research, Science, Clinical Trials, Metastasis, ESMO, III, Congress, Colorectal cancer, European Society for Medical Oncology, Kidney, British Journal of Cancer, Poster, Lung, Cancer, Machine learning, Serum, Classification, Algorithm, FTIR, Spectroscopy, Patient, Breast, Diagnosis, Prognosis, Multiple, Medical imaging

Dxcover Limited , a clinical-stage liquid biopsy company pioneering Multi-Omic Spectral Analysis for early detection of cancer, today announced that it has been awarded first prize for its poster focused on the detection of early-stage tumors across multiple cancers at the European Society for Medical Oncology (ESMO) Congress 2023 in the Innovative Diagnostic Tools category.

Key Points: 
  • Dxcover Limited , a clinical-stage liquid biopsy company pioneering Multi-Omic Spectral Analysis for early detection of cancer, today announced that it has been awarded first prize for its poster focused on the detection of early-stage tumors across multiple cancers at the European Society for Medical Oncology (ESMO) Congress 2023 in the Innovative Diagnostic Tools category.
  • The poster titled “A Spectroscopic Liquid Biopsy for the Earlier Detection of Multiple Cancers” is based on a study which was recently published in the British Journal of Cancer.
  • The cancer versus asymptomatic non-cancer classification detected 64% of stage I cancers when specificity was 99%, with an overall sensitivity of 56%.
  • “It is an honor to be recognized by such an esteemed organization as ESMO for Dxcover’s Multi-Omic Spectral Analysis.

CEL-SCI Releases Video Detailing Recent Phase 3 Findings & its Plans to Seek Immediate Regulatory Approvals

Retrieved on: 
Tuesday, October 24, 2023
General Health, Health, Pharmaceutical, Clinical Trials, Oncology, NYSE, ESMO, SCCHN, Target, Congress, Head, European Society for Medical Oncology, Risk, Physician, Survival rate, Patient, Death, Neck, Plasma protein binding, Pharmaceutical industry, Injection

CEL-SCI Corporation (NYSE American: CVM) today released a video presentation in which the Company’s CEO, Geert Kersten, shares the most recent data presented at the European Society for Medical Oncology (ESMO) Congress and the data’s impact on propelling the Company’s immunotherapy drug Multikine* (Leukocyte Interleukin, Injection) toward regulatory approval for the treatment of newly diagnosed, advanced squamous cell carcinoma of the head and neck (SCCHN).

Key Points: 
  • CEL-SCI Corporation (NYSE American: CVM) today released a video presentation in which the Company’s CEO, Geert Kersten, shares the most recent data presented at the European Society for Medical Oncology (ESMO) Congress and the data’s impact on propelling the Company’s immunotherapy drug Multikine* (Leukocyte Interleukin, Injection) toward regulatory approval for the treatment of newly diagnosed, advanced squamous cell carcinoma of the head and neck (SCCHN).
  • Mr. Kersten carefully explains how it is that patients in the target group who were treated with Multikine had a 5-year survival rate of 73% as compared to only 45% for those who did not receive Multikine, cutting the risk of death by half.
  • He goes on to present CEL-SCI’s regulatory submissions plan and timelines based on these compelling findings for a patient population that has not had a new treatment approved in in the U.S. in many decades.
  • Summary of Multikine Results in the Target Population:
    Target population of an estimated 145,000 patients (global, annual) who present with:
    Physicians routinely assess these features at baseline; no extra tests needed
    These features make it easy to write a label for the approval of Multikine, which is essential for drug approval

Qilu Pharmaceutical announces the latest results from its clinical study on QL1706, in combination with chemotherapy, as a first-line treatment for recurrent or metastatic cervical cancer

Retrieved on: 
Wednesday, October 25, 2023
CR, Response evaluation criteria in solid tumors, Bevacizumab, Survival, Patient, PD-L1, Carboplatin, New Drug Application, Cervical cancer, Incidence, ESMO, Progression-free survival, Trae tha Truth, Center for Drug Evaluation and Research, DOR, DCR, Squamous-cell carcinoma, Cisplatin, The New England Journal of Medicine, Neoplasm, Treatment, European Society for Medical Oncology, PFS, PD-1, American Society of Clinical Oncology, HIV disease progression rates, CC, Chinese, CPS, Paclitaxel, Immunotherapy, CDE, Diagnosis, Oncology, ORR, Anemia, RECIST, NDA, Safety, Ira Pastan, OS, Toxicity, Cohort, Performance, CI, Pharmaceutical industry, Medical imaging

This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).

Key Points: 
  • This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).
  • Moreover, the treatment exhibited a manageable safety profile without any new safety signals observed, making it a potential new first-line treatment option for r/mCC patients.
  • Currently, the preferred standard first-line treatment for r/mCC patients is cisplatin or carboplatin and paclitaxel plus bevacizumab, and efficacy and safety of the treatment also need to be considered.
  • For r/mCC patients with positive PD-L1 expression, the PD-1 inhibitor pembrolizumab, administered with chemotherapy and with or without bevacizumab, is recommended as the standard first-line treatment.

Qilu Pharmaceutical announces the latest results from its clinical study on QL1706, in combination with chemotherapy, as a first-line treatment for recurrent or metastatic cervical cancer

Retrieved on: 
Wednesday, October 25, 2023
CR, Response evaluation criteria in solid tumors, Bevacizumab, Survival, Patient, PD-L1, Carboplatin, New Drug Application, Cervical cancer, Incidence, ESMO, Progression-free survival, Trae tha Truth, Center for Drug Evaluation and Research, DOR, DCR, Squamous-cell carcinoma, Cisplatin, The New England Journal of Medicine, Neoplasm, Treatment, European Society for Medical Oncology, PFS, PD-1, American Society of Clinical Oncology, HIV disease progression rates, CC, Chinese, Multimedia, CPS, Paclitaxel, Immunotherapy, CDE, Diagnosis, Oncology, ORR, Anemia, RECIST, NDA, Safety, Ira Pastan, OS, Toxicity, Cohort, Performance, CI, Pharmaceutical industry, Medical imaging

This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).

Key Points: 
  • This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).
  • Moreover, the treatment exhibited a manageable safety profile without any new safety signals observed, making it a potential new first-line treatment option for r/mCC patients.
  • Currently, the preferred standard first-line treatment for r/mCC patients is cisplatin or carboplatin and paclitaxel plus bevacizumab, and efficacy and safety of the treatment also need to be considered.
  • For r/mCC patients with positive PD-L1 expression, the PD-1 inhibitor pembrolizumab, administered with chemotherapy and with or without bevacizumab, is recommended as the standard first-line treatment.