- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Prognostic Utility of Peripheral Myeloid Cells for Clinical Outcomes in Patients with NSCLC Treated with Cemiplimab (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1428; P3 Conclusions : This analysis shows that peripheral blood cell count parameters, including putative immunosuppressive neutrophils and monocytes as well as protective lymphocytes and eosinophils, may predict outcomes with anti-PD-1 therapy in patients with advanced NSCLC. While the variables in the nomogram were statistically significant and enhanced the ability to discern difference over the baseline model, overall discrimination was moderate, indicating that more data are needed to better predict clinical outcomes in this setting.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
Phase 2 Peri-Operative Study of Fianlimab+Cemiplimab+Chemotherapy vs Cemiplimab+Chemotherapy in Resectable Early-Stage NSCLC (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1369; P1, P2, P2 The key secondary endpoints are event-free survival by investigator assessment, major pathological response by BIPR, tumor response by investigator assessment, safety, pharmacokinetics, immunogenicity, and patient-reported outcomes. In addition, there are two Phase 2/3 studies (NCT05785767 and NCT05800015) exploring fianlimab + cemiplimab
- |||||||||| fianlimab (REGN3767) / Regeneron
Fianlimab-Based Combination Therapies in Patients with Advanced Non-Small Cell Lung Cancer: Trials in Progress Updates (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1223; P1, P2, P2 Secondary endpoints for both studies include tolerability, safety, ORR per investigator assessment, disease control rate, time to tumor response, duration of response, progression-free survival, OS (Phase 2), patient-reported outcomes, pharmacokinetics, and immunogenicity. Both studies are currently open for enrollment, along with a third Phase 2 study in which fianlimab + cemiplimab + chemotherapy versus cemiplimab + chemotherapy will be evaluated as perioperative therapy in patients with stage II/III NSCLC (NCT06161441).
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Tecentriq (atezolizumab) / Roche
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Evolving Precision First-Line Systemic Treatment for Patients with Unresectable Non-Small Cell Lung Cancer. (Pubmed Central) - Jul 13, 2024 Lastly, for the remaining ~50% of patients who are fit and whose tumors have no or low PD-L1 expression (TPS of 0-49%) and no sensitizing EGFR/ALK aberrations, platinum-containing chemotherapy with the addition of a PD-1/L1 inhibitor alone or in combination of a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor improves PFS and OS compared to chemotherapy alone. The objectives of this review are to summarize the current data and perspectives on first-line systemic treatment in patients with unresectable NSCLC and propose a practical algorithm for implementing precision biomarker testing at diagnosis.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, Opdivo (nivolumab) / BMS, Cabometyx (cabozantinib tablet) / Exelixis, Ipsen
Biomarker, Review, Journal, PD(L)-1 Biomarker, IO biomarker: Exploring potential predictive biomarkers through historical perspectives on the evolution of systemic therapies into the emergence of neoadjuvant therapy for the treatment of hepatocellular carcinoma. (Pubmed Central) - Jul 12, 2024 Despite no widely recognized predictive biomarkers for HCC individualized treatment, we believe neoadjuvant trials hold the most promise in identifying and validating them. This is because they can collect multiple samples from resectable HCC patients across stages, especially with multi-omics, bridging preclinical and clinical gaps.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal: Guidelines for the diagnosis and treatment of cutaneous squamous cell carcinoma: a GRADE approach for evidence evaluation and recommendations by the Italian Association of Medical Oncology. (Pubmed Central) - May 26, 2024 These guidelines, developed by the Italian Association of Medical Oncologists (AIOM) using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach, aim to guide clinicians in diagnosing, treating, and monitoring patients with CSCC, covering key aspects from primitive tumors to advanced stages, selected by a panel of experts selected by AIOM and other national scientific societies. The incorporation of these guidelines into clinical practice is expected to enhance patient care and address the evolving landscape of CSCC management.
- |||||||||| Trial completion date, Trial primary completion date, Checkpoint inhibition, IO biomarker: Exercise to Boost Response to Checkpoint Blockade Immunotherapy (clinicaltrials.gov) - May 22, 2024
P1, N=32, Recruiting, The incorporation of these guidelines into clinical practice is expected to enhance patient care and address the evolving landscape of CSCC management. Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: May 2024 --> Sep 2024
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