- |||||||||| Tagrisso (osimertinib) / AstraZeneca
Good Results of Osimertinib in a Patient with EGFR (L861Q) and MET Amplification NSCLC: A Case Report (Exhibit Hall) - Aug 16, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2592; A next-generation sequencing study of cerebrospinal fluid revealed that these new lesions had developed a resistance mutation (MET amplification), for which Amivantamab was requested. Our patient achieved partial response by RECIST 1.1 criteria twice, reaching a progression-free survival rate of 8.13 months with an uncommon EGFR mutation(L861Q) which is characterized by high or complete resistance to EGFR-TKIs, and even developed MET amplification that is a mechanism of resistance by itself, unfortunately, could not be treated properly due to administration problems.
- |||||||||| CT-P41 (denosumab biosimilar) / Celltrion
Trial completion date, Trial primary completion date: A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - Aug 15, 2023 P3, N=479, Active, not recruiting, Our patient achieved partial response by RECIST 1.1 criteria twice, reaching a progression-free survival rate of 8.13 months with an uncommon EGFR mutation(L861Q) which is characterized by high or complete resistance to EGFR-TKIs, and even developed MET amplification that is a mechanism of resistance by itself, unfortunately, could not be treated properly due to administration problems. Trial completion date: Mar 2023 --> Nov 2023 | Trial primary completion date: Sep 2022 --> May 2023
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Preclinical, Journal: ? Humanized RANKL Transgenic Mouse Model of Progestin-Induced Mammary Carcinogenesis for Evaluation of Novel Therapeutics. (Pubmed Central) - Aug 12, 2023 The prophylactic treatment of humTgRANKL mice with Denosumab significantly prevented the rate of appearance of mammary tumors from 86.7% to 15.4% and the early stages of carcinogenesis, whereas therapeutic treatment did not lead to any significant attenuation of tumor incidence or tumor burden compared to control mice, suggesting the importance of RANKL primarily in the initial stages of tumorigenesis. Overall, we provide unique genetic tools for investigating the involvement of RANKL in breast carcinogenesis, and allow the preclinical evaluation of novel therapeutics that target hormone-related breast cancers.
- |||||||||| Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date: OsteoNAFLD: Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease (clinicaltrials.gov) - Jul 31, 2023 P4, N=70, Recruiting, The patient died of liver dysfunction due to liver metastasis 5 months following the extensive loss of the maxillary bone. Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Ibrance (palbociclib) / Pfizer
Colonic Metastasis From Lobular Breast Carcinoma (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_3629; she was on an aromatase inhibitor and denosumab...Since then, she has been on fulvestrant and palbociclib...The patient started on Xeloda 1 week on and one week off...Screening colonoscopy in a breast cancer patient with high-risk features may offer early diagnosis and management, thus improving survival. Figure: Colonoscopy demonstrating ( A) ascending colon severe stenosis and (B) moderate stenosis at the sigmoid colon.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Kisqali (ribociclib) / Novartis
Disseminated Invasive Lobular Carcinoma Metastasis of the Gastrointestinal Tract: An Oncologic Anomaly (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_2162; An adjuvant therapy of Letrozole + Ribociclib was immediately initiated, and patient was discharged to follow up with oncology...Due to presence of skeletal metastasis, Denosumab was added for suppression of skeletal metastasis and secondary fracture prevention...Figure: Endoscopy and Colonoscopy evaluation of lesions: Endoscopy demonstrated Schatzki ring at the gastroesophageal junction (a), scattered inflammation and erythema in stomach (b), and severe intrinsic stenosis of pylorus (c). Colonoscopy demonstrating intrinsic stenosis of proximal rectum (d), and nodular erythematous mucosa of the transverse colon (e) and cecum (f).
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, Surgery: Sixty-Month Follow Up of Clinical MRONJ Cases Treated with CGF and Piezosurgery. (Pubmed Central) - Jul 29, 2023 A comprehensive preoperative evaluation and collaboration among dental, endocrinology, and oncology specialists are crucial for personalized and multidisciplinary management. Ongoing research efforts are necessary to explore new therapeutic modalities and improve our understanding of MRONJ management, providing better support to patients dealing with this complex condition.
- |||||||||| Are bone targeted agents (BTAs) still useful in times of immunotherapy? The SAKK 80/19 BTA study () - Jul 27, 2023 - Abstract #ESMO2023ESMO_3603;
Methods Pts with BM treated with IO within the Alpine Tumor Immunology Registry who received an additional BTA (denosumab, zoledronic acid) were compared with pts who have not received a BTA...Results In total, 197 pts with BM and treated with IO such as nivolumab (48%), pembrolizumab (40%), atezolizumab (12%), ipilimumab (9%) and other IO (5%) were included...Based on these retrospective results the indication of BTAs in cancer pts under treatment with IO must be challenged. Further prospective evaluation in a larger patient cohort is on the way.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Extending the interval of denosumab treatment for unresectable giant cell tumor of bone () - Jul 27, 2023 - Abstract #ESMO2023ESMO_3411; Conclusions 12-weekly de-escalated treatment of denosumab can sustain symptomatic relief, tumor reduction, and new bone formation achieved with standard treatment, resulting in effective maintenance treatment in patients with unresectable GCTB. 24-weekly treatment can also be selected, with careful attention to local recurrence.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Keytruda (pembrolizumab) / Merck (MSD)
Pembrolizumab and denosumab in clear cell renal cell carcinoma (ccRCC): A phase II trial (KeyPAD, ANZUP1601) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_3340; P2 One pt died of myositis attributed to study treatment. Conclusions Compared to studies of anti-PD1 ICI in ccRCC progressing after VEGFi (Table), KeyPAD shows encouraging activity without overlapping toxicity, warranting further studies combining RANKL inhibitors like D with ICI like P. Table: 1886P
- |||||||||| The impact of CDK4/6 inhibitors on bone health: An Italian real-world experience () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2008;
Background Palbociclib, Ribociclib and Abemaciclib, in combination with endocrine therapy (ET), are considered the first-line treatment for hormone-responsive (HR+) disease...Results We enrolled 1139 pts (Abemaciclib n=154, Ribociclib = 316, Palbocilib= 668), 562 (49.4%) treated with Denosumab, 235 (20.7%) with zoledronic acid and 341 (30%) did not receive any anti-resorptive therapy...These findings can be important for the management of bone metastases in pts with HR+ metastatic breast cancer. Further prospective studies are needed to confirm these results.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
DEnosumab plus PD-1 Inhibitor for MAINtenance Therapy of Advanced KRAS-Mutant NSCLC - A Prospective, Single-Arm, Phase II Study (DEMAIN) (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2232; A new project is ongoing to assess the rate of fractures in Italian pts after the approval of Note 79 by AIFA. The combination of denosumab and PD-1 inhibitors demonstrated anti-tumor activity in the advanced KRAS-mutated NSCLC with a good safety profile, which warrants further investigation.Table 1 Treatment-Related Adverse Events in the Overall PopulationAEsn (%)Any AEs11 (55)Specific AEs-Tooth-related AEs*4 (20)Arthralgia2 (10)Fatigue1 (5)Hypothyroidism2 (10)ALT/AST elevation2 (10)Creatinine elevation2 (10)Serious AEs0Deaths due to AEs0AEs leading to discontinuation1 (5)
- |||||||||| Ameile (aumolertinib) / Jiangsu Hansoh Pharma, EQRx
A Case of Long PFS by Aumolertinib in Advanced Lung Cancer with Multiple Metastases lncluding Brain Metastasis (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_1714; In our case, aumolertinib monotherapy brought more surprises for advanced lung adenocarcinoma patients with multiple metastases in addition to brain metastasis,which could take into account both efficacy and safety. The rapid effect brought by EGFR-TKI can delay the timing of local treatment for brain and bone metastases, thereby enabling patients to have a higher quality of life.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Osteoporotic Vertebral Fractures in Non-small Cell Lung Cancer : A Cracking Connection (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_1194; Diagnosis and management of OVF in this setting requires a multidisciplinary approach. Identifying risk factors such as corticosteroid exposure and malnutrition should be part of a comprehensive prevention policy to mitigate osteoporosis complications.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Histopathological response to denosumab in giant cell tumours of bone - A review of 11 cases. (Pubmed Central) - Jul 20, 2023 There may be complete resolution or may be confused with benign or malignant lesions Rarely they may show sarcomatous transformation. It is imperative that the pathologist is aware of these changes to prevent diagnostic pitfalls as it poses therapeutic and prognostic implications.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Recent advance of small-molecule drugs for clinical treatment of osteoporosis: A review. (Pubmed Central) - Jul 19, 2023 The current treatment options for osteoporosis include bisphosphonates, hormone replacement therapy (HRT), selective estrogen receptor modulators (SERMs), and denosumab...This review aims to provide an overview of the clinical applications and synthetic routes of representative small-molecule drugs for the treatment of osteoporosis. A comprehensive understanding of the synthetic methods of drug molecules for osteoporosis may inspire the development of new, more effective, and practical synthetic techniques for treating this condition.
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