- |||||||||| Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Vafseo (vadadustat) / Akebia Therap
New P3 trial: VOICE: Vafseo Outcomes In-Center Experience (clinicaltrials.gov) - Jul 24, 2024
P3, N=2200, Not yet recruiting,
- |||||||||| Prolia (denosumab) / Amgen
Retrospective data, Journal, Surgery: Postoperative Recurrence of Medication-Related Osteonecrosis of the Jaw: A Retrospective Study of 150 Patients Undergoing Surgery. (Pubmed Central) - Jul 24, 2024
The primary disease was malignancy in eight patients, and denosumab was used in seven patients...In contrast, among the seven successful surgeries, no residual osteolysis, periosteal reaction, or osteosclerosis was observed in all six cases in which postoperative computed tomography was performed. Conclusion Recurrence is more common in patients with residual areas of osteolysis, periosteal reactions, or mixed-type osteosclerosis, and including these areas in the resection is desirable.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Yondelis (trabectedin) / PharmaMar, J&J, Turalio (pexidartinib) / Daiichi Sankyo
Preclinical, Journal, Oncolytic virus: Myelomodulatory treatments augment the therapeutic benefit of oncolytic viroimmunotherapy in murine models of malignant peripheral nerve sheath tumors. (Pubmed Central) - Jul 24, 2024
Additionally, targeting myeloid cells with the myelomodulatory therapy trabectedin, a small molecule activator of caspase-8 dependent apoptosis, augmented the survival benefit of T-VEC in a less immunogenic MPNST model...Furthermore, flow cytometry analysis following combination viroimmunotherapy revealed decreased M2 macrophages and myeloid-derived suppressor cells and increased tumor-specific gp70+ CD8 T cells within the tumor microenvironment. In summary, our findings provide compelling evidence for the potential to leverage viroimmunotherapy with myeloid cell targeting against MPNST and warrant further investigation.
- |||||||||| AMG 193 / Amgen
Phase 1/2, Dose-expansion Study of AMG 193, an MTA-cooperative PRMT5 Inhibitor, In MTAP-deleted NSCLC (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2523;
18 years of age) with MTAP -deleted advanced tumors (determined by NGS or evidence of MTAP depletion determined by IHC); treatment with 1-3 prior lines of systemic therapy in the advanced/metastatic setting including platinum-based chemotherapy. Additionally, patients without actionable mutations must have received treatment with a PD(L)-1 inhibitor (unless contraindicated or PD-L1 < 1%), and patients whose tumors harbor actionable genomic aberrations (i.e. EGFR, ALK, MET, RET, ROS1, KRAS G12C ) should have disease progression on approved systemic therapies for these aberrations.
- |||||||||| Krazati (adagrasib) / BMS, Lumakras (sotorasib) / Amgen
Cost-Effectiveness Analysis of Sotorasib vs. Adagrasib in KRAS G12c-Mutated Previously Treated NSCLC (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2349;
Despite uncertainty on relative OS and PFS outcomes, adagrasib was associated with higher costs to manage the higher adverse event burden. The higher costs of managing adverse events, including higher usage of medications and dose interruptions, led to sotorasib being more cost-effective than adagrasib.
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, Neulasta (pegfilgrastim) / Roche, Tecentriq (atezolizumab) / Roche
The Conflicting Impacts of G-CSF on the Therapeutic Efficacy of Chemoimmunotherapy for Extensive Stage Small Cell Lung Cancer (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2249;
Methods : We selected 65 patients with ES-SCLC who completed four cycles of induction chemo-immunotherapy (atezolizumab or durvalumab combined with carboplatin plus etoposide) in Tokushima University Hospital and four affiliated hospitals between January 2019 and July 2022...G-CSF administration was defined as the following classifications in this study; Classification A: use of any G-CSF (at least one dose of either filgrastim or pegfilgrastim), Classification B: use of at least one dose of pegfilgrastim, and Classification C: use of either more than five doses of filgrastim or at least one dose of pegfilgrastim...Similar results were observed in the other classifications. Conclusions : Our study suggests that the indication of G-CSF administration during chemo-immunotherapy should be carefully considered to avoid attenuating the therapeutic efficacy of chemo-immunotherapy in the patients with ES-SCLC.
- |||||||||| Krazati (adagrasib) / BMS, Lumakras (sotorasib) / Amgen
KRASG12c-Mutant NSCLC Under Targeted Therapy in China: Lessons from Eight Cases (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2184;
Additionally, patients with KRAS G12C have a predilection to bone metastasis, which is consistent with the current literature. Larger prospective study on efficacy of KRASG12Ci will be needed to validate our findings and clarify the markers for further patient classification and stratification.
- |||||||||| Tevimbra (tislelizumab-jsgr) / BeiGene
Efficacy and Influencing Clinical Factors of Tislelizumab Combined with Chemotherapy Plus Bone-Targeted Agents for NSCLC Bone Metastasis (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2081;
For the safety outcomes, mild immune-related AEs such as rash, pruritus,hypothyroidism, pneumonitis were experienced and none ?3irAE occurred. Conclusions : This study demonstrated that tislelizumab combined with platinum-based chemotherapy plus bone-targeted agents is a promising option in the first line therapy for advanced NSCLC patients with bone metastasis and baseline levels of NLR and PLR were important and associated with PFS outcomes of immunotherapy.
- |||||||||| Tagrisso (osimertinib) / AstraZeneca, Lumakras (sotorasib) / Amgen
MALAT1 And NEAT1 Contribute to Adaptive Mutability in the Transition from Drug Tolerance to Drug Resistance in Lung Cancer (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1690;
This work has identified the lncRNAs MALAT1 and NEAT1 as potentially important molecules implicated in the development of acquired drug resistance that emerges from drug tolerance. Further studies are ongoing to determine whether modulating MALAT1 represents a potential approach to augment therapy in patients with lung adenocarcinomas undergoing treatment with targeted therapeutics.
- |||||||||| Lumakras (sotorasib) / Amgen
Real-World Comparative Effectiveness of Sotorasib vs Docetaxel as 2L/2L+ Treatment of KRAS G12c-Mutated Advanced NSCLC (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1606;
3 6 (6%) 4 (6%) 7 (4%) 5 (4%) Not available 20 (20%) 12 (20%) 38 (23%) 27 (23%) Histology, n (%) 0.29 0.25 Non-squamous cell carcinoma 100 (98%) 55 (93%) 157 (96%) 113 (96%) Squamous cell carcinoma 2 (2%) 3 (5%) 2 (1%) 4 (3%) NSCLC histology NOS 0 (0%) 1 (2%) 5 (3%) 1 (1%) Most recent PD-L1 expression at baseline (tumor cell staining), n (%) 0.2 indicate inadequate balance; b Stage was not reported in 1 patient each for sotorasib and docetaxel in the 2L cohort, and in 6 sotorasib-treated patients vs 2 docetaxel-treated patients in the 2L+ cohort. Chemo, chemotherapy; ECOG PS, Eastern Cooperative Oncology Group performance status; NOS, not otherwise specified; NSCLC, non-small cell lung cancer; PD-L1, programmed cell death ligand 1; SD, standard deviation; SMD, standardized mean difference.
- |||||||||| Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Treatment Outcomes in Patients who Received Bevacizumab Therapy for Radiation Induced Brain Necrosis (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1494;
The secondary outcomes were to assess the safety of bevacizumab for the treatment of RBN in adults, evaluate whether clinical benefit varied based on bevacizumab dosing strategy, and determine if there are differences in outcomes with bevacizumab and biosimilar product, bevacizumab-awwb...Bevacizumab possessed a manageable safety profile and was well-tolerated. Additionally, our study demonstrated that clinical benefits were similar across dosing strategies including dosage, frequency, and biological product.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
DeLLphi-306 Trial: A Phase 3 Study of Tarlatamab after Concurrent Chemoradiotherapy in Limited-Stage Small Cell Lung Cancer (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1434;
P3
Other secondary endpoints include investigator-assessed PFS, investigator and BICR-assessed objective response rate, disease control rate, duration of response, time to progression (all per RECIST 1.1), incidence of treatment-emergent and treatment-related adverse events, serum concentrations of tarlatamab, and incidence of anti-tarlatamab antibody formation. This trial is actively recruiting patients.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen, Imfinzi (durvalumab) / AstraZeneca
Tarlatamab Plus Durvalumab as First-Line Maintenance in Extensive-Stage Small Cell Lung Cancer: DeLLphi-305 Phase 3 Trial (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1430;
P3
Key exclusion criteria are prior DLL3 pathway-selective inhibitor therapy, active or documented autoimmune or inflammatory disorders per protocol, known human immunodeficiency virus, hepatitis C and/or hepatitis B infections with exceptions according to the protocol, and a history of severe/life-threatening events from immune-mediated therapy. The primary endpoint is OS and key secondary endpoints include progression-free survival, objective response rate, disease control rate, duration of response, safety, and quality of life assessments.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen, Imfinzi (durvalumab) / AstraZeneca
Tarlatamab Plus Durvalumab as First-Line Maintenance in Extensive-Stage Small Cell Lung Cancer: DeLLphi-305 Phase 3 Trial (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1184;
P3
Key exclusion criteria are prior DLL3 pathway-selective inhibitor therapy, active or documented autoimmune or inflammatory disorders per protocol, known human immunodeficiency virus, hepatitis C and/or hepatitis B infections with exceptions according to the protocol, and a history of severe/life-threatening events from immune-mediated therapy. The primary endpoint is OS and key secondary endpoints include progression-free survival, objective response rate, disease control rate, duration of response, safety, and quality of life assessments.
- |||||||||| Lumakras (sotorasib) / Amgen
Delineating the Mechanism of Resistance to Targeted Therapy via Cellular Transdifferentiation (20D) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1092;
Upon treatment with Sotorasib, tumors initially demonstrated slow tumor growth...Conclusions : We have developed a new experimental system and framework for the study of lung t-SCLC at the single-cell level. Ongoing work includes the integration of new resources to study lineage reprogramming, the regulation of transdifferentiation by the cancer genome, and advancing new therapeutic strategies that combat plasticity by deploying unique drug combinatorial strategies.
- |||||||||| ivabradine / Generic mfg.
Enrollment status: RECOVER-AUTONOMIC Platform Protocol (clinicaltrials.gov) - Jul 23, 2024
P2, N=380, Recruiting,
Active, not recruiting --> Completed Enrolling by invitation --> Recruiting
- |||||||||| Enbrel (etanercept) / Pfizer, Amgen
Trial completion date, Trial primary completion date: TNF-? Treatment of Blast-Induced Tinnitus (clinicaltrials.gov) - Jul 23, 2024
P2, N=310, Recruiting,
Enrolling by invitation --> Recruiting Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
- |||||||||| Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Retrospective data, Journal, Real-world evidence, Real-world: Real-World Use of Off-Label MVASI in the Treatment of Patients With Neovascular AMD and DME. (Pubmed Central) - Jul 23, 2024
In our cohort of patients with n-AMD and DME in the maintenance phase, bevacizumab-awwb seems to represent a viable and cost-effective intravitreal therapy with comparable efficacy and safety to the originator. This study provides a preliminary assessment of the efficacy and safety of intravitreal bevacizumab-awwb, which is widely used off-label in retinal vascular diseases.
- |||||||||| Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Retrospective data, Journal: Romosozumab Followed by Denosumab Versus Denosumab Only: A Post Hoc Analysis of FRAME and FRAME Extension. (Pubmed Central) - Jul 23, 2024
Similar BMD and fracture outcomes were observed with PSW-MI and PSM sensitivity analyses. The sequence of Romo/DMAb resulted in greater BMD gains and higher probability of achieving T-scores > -2.5, significantly reduced new vertebral fracture incidence, and numerically lowered the incidence (not significant) of clinical, nonvertebral, and hip fractures versus DMAb only through 24
- |||||||||| Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J, Enbrel (etanercept) / Pfizer, Amgen
Journal, Adverse events: TNF-Alpha Inhibitors Induced Eosinophilia: An Undervalued Side Effect of Such Biologicals. (Pubmed Central) - Jul 23, 2024
The sequence of Romo/DMAb resulted in greater BMD gains and higher probability of achieving T-scores > -2.5, significantly reduced new vertebral fracture incidence, and numerically lowered the incidence (not significant) of clinical, nonvertebral, and hip fractures versus DMAb only through 24 Furthermore, the pathogenesis of eosinophilia is still unknown, and all the proposed hypotheses do not explain the eosinophilic proliferation in certain subjects.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic virus, IO biomarker: Translation of oncolytic viruses in sarcoma. (Pubmed Central) - Jul 23, 2024
These studies have shown promising responses in heavily pre-treated and immunotherapy-resistant patients associated with increased intratumoral immune infiltration. As new and more potent OVs enter the clinical arena, prospective evaluation in subtype-specific cohorts with correlative studies to define biomarkers of response will be critical to advancing this promising approach for sarcoma therapy.
- |||||||||| Krazati (adagrasib) / BMS, Lumakras (sotorasib) / Amgen
Journal: Clinicopathological, molecular, and prognostic features of colorectal carcinomas with KRAS c.34G>T (p.G12C) mutation. (Pubmed Central) - Jul 23, 2024
Among 1122 BRAF-wild-type colorectal carcinomas, compared with KRAS-wild-type tumors, multivariable-adjusted colorectal cancer-specific mortality hazard ratios (95% confidence interval) were 1.82 (1.05-3.17) in KRAS c.34G>T (p.G12C)-mutated tumors (p?=?0.035) and 1.57 (1.22-2.02) in other KRAS-mutated tumors (p?=?0.0004). Our study provides novel evidence for clinical and tumor characteristics of KRAS c.34G>T (p.G12C)-mutated colorectal carcinoma.
- |||||||||| temozolomide / Generic mfg.
Trial completion date, Trial primary completion date: hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM) (clinicaltrials.gov) - Jul 22, 2024
P2, N=16, Recruiting,
Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jul 2024 | Trial primary completion date: Dec 2024 --> Jul 2024 Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
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