- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: Blinatumomab infusion interruptions in pediatric patients rarely lead to readmission. (Pubmed Central) - Aug 23, 2024
Clinical staff intervention was required in 31 (45%) cycles, only six (8.7%) cycles needed readmission. Management of outpatient blinatumomab infusions requires education and training of clinical staff and caregivers to quickly troubleshoot interruptions.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Review, Journal: Tarlatamab: First Approval. (Pubmed Central) - Aug 23, 2024
Tarlatamab is under regulatory review in Brazil, Canada, Israel and the UK, and clinical studies are underway in multiple countries. This article summarizes the milestones in the development of tarlatamab leading to this first approval for ES-SCLC with disease progression on or after platinum-based chemotherapy.
- |||||||||| olpasiran (AMG 890) / Amgen, pelacarsen (AKCEA-APO(a)-LRx) / Ionis, Novartis, lepodisiran (LY3819469) / Eli Lilly
Review, Journal: New insights into the therapeutic options to lower lipoprotein(a). (Pubmed Central) - Aug 23, 2024
This article summarizes the milestones in the development of tarlatamab leading to this first approval for ES-SCLC with disease progression on or after platinum-based chemotherapy. If the results from the cardiovascular outcome trials, designed to demonstrate whether the reduction of Lp(a) of more than 80% as observed with pelacarsen, olpasiran or lepodisiran translates into the decrease of cardiovascular mortality and major adverse cardiovascular events, will be positive, lowering Lp(a) will become a new additional target in the management of patients with elevated cardiovascular risk.
- |||||||||| Stivarga (regorafenib) / Bayer
Journal, Surgery: Reirradiation with radiosurgery or stereotactic fractionated radiotherapy in association with regorafenib in recurrent glioblastoma. (Pubmed Central) - Aug 23, 2024
If the results from the cardiovascular outcome trials, designed to demonstrate whether the reduction of Lp(a) of more than 80% as observed with pelacarsen, olpasiran or lepodisiran translates into the decrease of cardiovascular mortality and major adverse cardiovascular events, will be positive, lowering Lp(a) will become a new additional target in the management of patients with elevated cardiovascular risk. For recurrent GBM, re-RT with SRT/FSRT plus regorafenib is a
- |||||||||| Journal: Interaction of Purine and its Derivatives with A1, A2-Adenosine Receptors and Vascular Endothelial Growth Factor Receptor-1 (Vegf-R1) as a Therapeutic Alternative to Treat Cancer. (Pubmed Central) - Aug 23, 2024
Besides, adenosine, cgs-15943, rolofylline, cvt-124, wrc-0571, luf-5834, cvt-6883, AZD-4635, cabozantinib, pazopanib, regorafenib, and sorafenib drugs were used as controls...Besides, the inhibition constants (Ki) values for purine and their derivatives 5: , 9: , 10: , 14: , 15: , 16: , and 20: were lower compared with the controls Theoretical data suggest that purine and their derivatives 5: , 9: , 10: , 14: , 15: , 16: , and 20: could produce changes in cancer cell growth through inhibition of A1, A2-adenosine receptors and VEGFR-1 inhibition. These data indicate that these purine derivatives could be a therapeutic alternative to treat some types of cancer.
- |||||||||| Enbrel (etanercept) / Pfizer, Amgen
Enrollment change: TNF-? Treatment of Blast-Induced Tinnitus (clinicaltrials.gov) - Aug 23, 2024
P2, N=88, Recruiting,
These data indicate that these purine derivatives could be a therapeutic alternative to treat some types of cancer. N=310 --> 88
- |||||||||| Ibrance (palbociclib) / Pfizer
Trial completion, HEOR, Combination therapy, Real-world evidence, Real-world, Metastases: Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy (clinicaltrials.gov) - Aug 23, 2024
P=N/A, N=813, Completed,
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- |||||||||| ganitumab (AMG 479) / Takeda, ImmunityBio
Phase classification, Trial termination, Combination therapy: QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - Aug 23, 2024
P1/2, N=213, Terminated,
Active, not recruiting --> Completed Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; Subjects discontinued study
- |||||||||| Ravicti (glycerol phenylbutyrate) / Immedica, Amgen
Trial completion date, Trial primary completion date: PBA Use for Treatment of ATF6-/- Patients (clinicaltrials.gov) - Aug 22, 2024
P1, N=2, Not yet recruiting,
Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; Subjects discontinued study Trial completion date: Mar 2024 --> May 2025 | Trial primary completion date: Mar 2024 --> May 2025
- |||||||||| Prolia (denosumab) / Amgen
Biomarker, Enrollment change: Denosumab and MRI Breast Imaging (clinicaltrials.gov) - Aug 22, 2024
P2, N=42, Completed,
Trial completion date: Mar 2024 --> May 2025 | Trial primary completion date: Mar 2024 --> May 2025 N=30 --> 42
- |||||||||| azelaprag (BGE-105) / BioAge Labs
Macrocyclic peptides and small molecules targeting the apelin receptor as promising analgesics (MCP Hall A) - Aug 22, 2024 - Abstract #Neuroscience2024Neuroscience_3699;
We also used a scaffold-hoping strategy to create new druggable small-molecule ligands starting from the first identified G?i-biased small-molecule ligand at APJ, CMF-019, and studied their functional activity in comparison with other small-molecule agonists (BMS986224, AMG986)...The small molecule LT02-20 was also effective in reversing the formalin-induced pain behaviors, while the parent compound CMF-019 had no analgesic effect. Overall, these results highlight the therapeutic potential of biased macrocyclic APJ analogs and small molecules for managing pain.
- |||||||||| Remicade (infliximab) / J&J, Enbrel (etanercept) / Pfizer, Amgen
Observational data, Journal, Checkpoint inhibition, IO biomarker: Tumor necrosis factor inhibitors enhance corticosteroid therapy for Stevens-Johnson syndrome and toxic epidermal necrolysis linked to immune checkpoint inhibitors: a prospective study. (Pubmed Central) - Aug 22, 2024
In this single-center, prospective, observational study, patients with irEN received either corticosteroid monotherapy or a combination therapy of corticosteroids and TNFi (etanercept for SJS, infliximab for TEN)...Despite higher SCORTEN scores in the combination group (3 vs. 2, p = 0.008), these patients experienced faster re-epithelization (14 vs. 21 days; p < 0.001), shorter corticosteroid treatment duration (22 vs. 32 days; p = 0.005), and lower prednisone cumulative dose (1177 mg vs. 1594 mg; p = 0.073)...Corticosteroids combined with TNFi markedly promote re-epithelization, reduce corticosteroid use, and decrease acute mortality in irEN patients without increasing major adverse events, offering a superior alternative to corticosteroid monotherapy. Inflammatory markers and lymphocyte subsets are valuable for assessing disease activity and prognosis.
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka, Ibrance (palbociclib) / Pfizer, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
Trial completion, Trial completion date, Metastases: ACCRU-GI-1618: Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer (clinicaltrials.gov) - Aug 22, 2024
P2, N=102, Completed,
Inflammatory markers and lymphocyte subsets are valuable for assessing disease activity and prognosis. Trial completion date: Apr 2024 --> Jul 2024 | Active, not recruiting --> Completed
- |||||||||| AMG 193 / Amgen
Trial completion date, Trial primary completion date: A Study of AMG 193 in Subjects With Advanced MTAP-null Solid Tumors (clinicaltrials.gov) - Aug 21, 2024
P1/2, N=649, Recruiting,
Trial completion date: Apr 2024 --> Jul 2024 | Active, not recruiting --> Completed Trial completion date: Mar 2029 --> Dec 2027 | Trial primary completion date: Nov 2027 --> Mar 2026
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Enrollment open: Haploidentical HCT for Severe Aplastic Anemia (clinicaltrials.gov) - Aug 21, 2024
P2, N=21, Recruiting,
Trial completion date: Mar 2029 --> Dec 2027 | Trial primary completion date: Nov 2027 --> Mar 2026 Active, not recruiting --> Recruiting
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Journal: Evolving Evidence-Based Value Assessment of One-Time Therapies: Tisagenlecleucel as a Case Study. (Pubmed Central) - Aug 21, 2024
Projections at launch of the likely cost effectiveness of tisagenlecleucel appear to have underestimated its ultimate economic value given more recent trial and real-world data. To balance uncertainty in initial valuation with the need to provide access to novel oncology therapies, payers can consider flexible reimbursement policies alongside ongoing assessments as new data emerge.
- |||||||||| camizestrant (AZD9833) / AstraZeneca, saruparib (AZD5305) / AstraZeneca
Enrollment open, Trial initiation date, Metastases: EvoPAR-Breast01: Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer (clinicaltrials.gov) - Aug 21, 2024
P3, N=500, Recruiting,
To balance uncertainty in initial valuation with the need to provide access to novel oncology therapies, payers can consider flexible reimbursement policies alongside ongoing assessments as new data emerge. Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Aug 2024
- |||||||||| Dupixent (dupilumab) / Sanofi, Regeneron, Repatha (evolocumab) / Amgen, Astellas, Synagis (palivizumab) / AbbVie, AstraZeneca, SOBI
Journal: Treatment patterns and factors associated with discontinuation of monoclonal antibodies. (Pubmed Central) - Aug 21, 2024
Monoclonal antibodies were prescribed for the management of a wide range of clinical conditions. The study reports appropriate utilization of most monoclonal antibodies and identifies factors such as patient education level, BMI, concomitant medications, and treatment duration as independent predictors of monoclonal antibody treatment discontinuation.
- |||||||||| Prolia (denosumab) / Amgen
Review, Journal: Bibliometric analysis of bone metastases from lung cancer research from 2004 to 2023. (Pubmed Central) - Aug 21, 2024
Burst analysis of keywords showed that "skeletal complications" had the highest burst intensity from 2005 to 2013, while recent research trends include "immunotherapy" and "denosumab," with bursts from 2021 to 2023...China and the United States have contributed the most, but international cooperative research on BMLC should be strengthened. The pathogenesis, early prevention, and individualized treatment of BMLC need to be strengthened for further study, and immunotherapy is the next hotspot of lung cancer bone metastasis research.
- |||||||||| Stivarga (regorafenib) / Bayer
Journal, Stroma, Metastases: Regorafenib-related erythrocytosis in metastatic extra-gastrointestinal stromal tumor: a case report. (Pubmed Central) - Aug 21, 2024
However, after six months, due to disease progression, we prescribed sunitinib, which the patient received for four years...Secondary erythrocytosis might be a marker of TKI efficacy, given the patient's prolonged clinical benefit during regorafenib treatment (48 months). In patients receiving regorafenib, monitoring blood count as well as any symptoms associated with erythrocytosis may be suggested.
- |||||||||| Ibrance (palbociclib) / Pfizer
Metastatic Lobular Adenocarcinoma Presenting as Gastric Outlet Obstruction (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_5565;
It is more difficult, as in this case, when the endoscopic biopsy serves as the first tissue diagnosis of the primary cancer in the absence of a previously known focal mass. Figure: Gastric outlet obstruction endoscopy findings
- |||||||||| Ravicti (glycerol phenylbutyrate) / Immedica, Amgen, Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health
Think Outside the Box! Not All Hyperammonemia is Due to Liver Disease (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_5327;
Urea cycle disorders should be considered in patients who present with neuropsychiatric symptoms in the emergency room with hyperammonemia. A prompt recognition of symptoms will prevent permanent neurological damage or even death.
- |||||||||| Tavneos (avacopan) / Amgen, Rituxan (rituximab) / Roche
ANCA-Associated Vasculitis Flare Presenting as Refractory Gastrointestinal Bleeding (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_4751;
A bipolar circum-active probe (BICAP) was done without success, followed by epinephrine, hemospray and endoclips placement achieving temporary hemostasis, but he continued to have melena...Rituximab infusion was started to achieve remission; dapsone was also given for its immunomodulator properties to prevent AAV relapse...AAV flare presenting as refractory GI bleed may be managed surgically along with using immunomodulators to achieve remission. Newer therapies like avacopan, a C5a receptor inhibitor that was found non-inferior to prednisone in clinical trials poses as an alternative treatment option.
- |||||||||| Vectibix (panitumumab) / Amgen
A Case of Prolonged Generalized Weakness in a Patient With Metastatic Rectal Cancer 6 Weeks After Last Dose of Panitumumab (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_4374;
This case highlights the need for vigilant monitoring and replacement of serum potassium and magnesium in metastatic colorectal cancer patients on Panitumumab, extending from initiation of agent to at least 8 weeks post-therapy. Note: The table for this abstract can be viewed in the ePoster Gallery section of the ACG 2024 ePoster Site or in The American Journal of Gastroenterology's abstract supplement issue, both of which will be available starting October 27, 2024.
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen, uridine triacetate (PN 401) / Wellstat
Neutropenic Enterocolitis After Single Dose of CAPOX in Newly Diagnosed Colon Cancer (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_4236;
He had received his first dose of adjuvant chemotherapy, CAPOX (capecitabine and oxaliplatin), four days after surgery...Oncology recommended Filgrastim and Uridine Triacetate, and gastroenterology advised bowel rest, an nasogastric tube, and Octreotide infusion...Early recognition and intervention are crucial to mitigate complications like septic shock. Further research is needed to reduce NE-associated morbidity and mortality.
- |||||||||| Ibrance (palbociclib) / Pfizer
Unveiling the Hidden Giant: Multidisciplinary Management of a Retroperitoneal Dedifferentiated Liposarcoma (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_4213;
He responded well to adjuvant Palbociclib 125 mg for 2 years...Figure: CT of the abdomen reveals a large de-differentiated liposarcoma arising in the retroperitoneum causing flattening of the inferior vena cava with the development of collateral veins. The mass is characterized by irregularity, and heterogeneity with mixed density, reflecting its aggressive and invasive growth pattern.
- |||||||||| Epogen (epoetin alfa) / Amgen
Iron Overload: A Case of Hidden Hemochromatosis (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_3556;
Patient was recommended to switch from IV iron to Epogen therapy, and discharged with outpatient follow-up, which were not pursued...While, the diagnosis of acquired hemochromatosis typically requires a TSAT > 45% alongside elevated ferritin levels, prior literature has shown these values to not be the most reliable indicator of hepatic iron stores. Chelation is typically initiated prophylactically in patients receiving over 10 units of blood, but was delayed in our patient with acquired hemochromatosis, underscoring the need for physician vigilance and timely intervention in these cases.
- |||||||||| aldafermin (NGM282) / NGM Biopharma, efruxifermin (AKR-001) / Akero Therap, pegozafermin (BIO89-100) / 89Bio
Fibroblast Growth Factor Analogues in Metabolic Dysfunction Associated Steatotic Liver Disease: A Network Meta-Analysis (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_3435;
Twelve RCTs comprising 1,420 patients with MASLD were included, involving four FGF agonists: efruxifermin, aldafermin, pegbelfermin, and pegozafermin at various doses. Most significant mean reduction in hepatic fat fraction (HFF) [MD = -67.98, 95% CI [-102.12; -33.84], P 30% [RR=4.68, 95% CI [2.57; 7.97], P1 stage without MASH worsening followed by efruxifermin at 50 mg ( P =0.04).
- |||||||||| Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
A Survey Among IBD Patients Following Switching From Originator Infliximab to Its Biosimilars (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_3058;
Most significant mean reduction in hepatic fat fraction (HFF) [MD = -67.98, 95% CI [-102.12; -33.84], P 30% [RR=4.68, 95% CI [2.57; 7.97], P1 stage without MASH worsening followed by efruxifermin at 50 mg ( P =0.04). Since 2016, the FDA has approved three IFX biosimilar agents (SB2), Renflexis
- |||||||||| Enbrel (etanercept) / Pfizer, Amgen, Opdivo (nivolumab) / BMS
A Rare Case of Dual Pathogen Infectious Esophagitis (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_2770;
Case Description/ A 39 year old male with a history of metastatic colon cancer on FOLFOX and Nivolumab and GERD presented with a full body blistering rash...He was treated with Etanercept, IVIG, pulse dose steroids with steroid taper...He was treated with Acyclovir in addition to Fluconazole...Without biopsy this patient may have required repeat interventions and delay in proper treatment. Figure: Figure A and B: White plaques and exudates throughout the esophagus
- |||||||||| Enbrel (etanercept) / Pfizer, Amgen
A Case of May-Thurner Syndrome in a Patient With Active Crohn's Colitis (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_1503;
Case Description/ A 39-year-old woman with a history of seronegative inflammatory arthritis on etanercept, uterine fibroids, and anemia presented with subacute bloody diarrhea over a two-month period...This case highlights the importance of considering thrombotic complications associated with IBD in patients that present with a new diagnosis or flare. Figure: A and B: Endoscopic findings of moderate to severe colonic ulcerations C and D: Lower extremity venogram showing stenosis of L external iliac vein and L common iliac vein where R common iliac artery crosses over the vein
- |||||||||| Remicade (infliximab) / J&J, Enbrel (etanercept) / Pfizer, Amgen
De Novo Inflammatory Bowel Disease in the Setting of TNF-Alpha Inhibitor Use (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_1485;
In fact, Etanercept has been associated with the emergence of de novo Crohn's disease when being used to treat another autoimmune condition.The patient presented in the case above was found to have new-onset peri-anal Crohn's, which itself is a rare diagnosis and is often found as an initial manifestation of de novo IBD. Thus, it is important to keep IBD high on the differential for patients on immunomodulating medication who present with new onset gastrointestinal symptoms.
- |||||||||| Ibrance (palbociclib) / Pfizer, Truqap (capivasertib) / Otsuka, AstraZeneca
An Uncommon Case of Metastatic Breast Cancer to the Esophagus Causing Pseudoachalasia (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_1031;
Case Description/ A A 65-year-old female with recurrent ER/PR+ stage II (T2N0) breast cancer on anastrozole and palbociclib presented with dysphagia to solids and liquids along with nausea and vomiting...The patient subsequently received palliative esophageal radiation therapy along with initiation of capivasertib and fulvestrant...Figure: EUS notable for circumferential esophageal wall thickening to 7mm. Enlarged lymph node at 25 cm from incisors (red arrow) measured at 18.6 x 6.6mm status post fine needle biopsy
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