- |||||||||| MODULE 4: Selection and Sequencing of Therapy for Relapsed/Refractory HCC (San Francisco Marriott Marquis, Golden Gate Ballroom ) - Dec 19, 2024 - Abstract #ASCOGI2025ASCO_GI_994;
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Eisai Inc, and Merck. Effect of patient- and disease-related factors, validated biomarkers and prior exposure and response to treatment on clinical decision-making for advanced HCC that has progressed on first and consecutive lines of therapy Role of approved first-line multitargeted TKIs, such as sorafenib and lenvatinib, among patients with relapsed disease Long-term outcomes with approved anti-angiogenic agents, such as regorafenib, cabozantinib and ramucirumab, for patients with progressive HCC Key findings with anti-PD-1/PD-L1 antibody-based strategies for progressive HCC; role, if any, for patients who have experienced disease progression on first-line immunotherapeutic approaches Other novel agents and strategies under investigation for patients with advanced HCC
- |||||||||| Review, Journal, Metastases: Late-line options for patients with metastatic colorectal cancer: a review and evidence-based algorithm. (Pubmed Central) - Dec 18, 2024
In this Review, we provide a comprehensive overview of advances in the field over the past few years and offer a practical perspective on translation of the most relevant results into the daily management of patients with metastatic colorectal cancer using an evidence-based algorithm. Finally, we discuss some of the most appealing ongoing areas of research and highlight approaches with the potential to further expand the therapeutic armamentarium.
- |||||||||| pemvidutide (ALT-801) / Altimmune
Clinical, Journal: Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study. (Pubmed Central) - Dec 18, 2024 P1 Finally, we discuss some of the most appealing ongoing areas of research and highlight approaches with the potential to further expand the therapeutic armamentarium. In patients with MASLD, weekly pemvidutide treatment yielded significant reductions in LFC, markers of hepatic inflammation, and body weight compared to placebo.
- |||||||||| certepetide (LSTA1) / Lisata Therap, Vectibix (panitumumab) / Amgen
Enrollment closed, Phase classification, Trial completion date, Trial primary completion date: CENDIFOX: CEND-1 in Combination with Neoadjuvant FOLFIRINOX with or Without Panitumumab (clinicaltrials.gov) - Dec 18, 2024 P1/2, N=50, Active, not recruiting, No abstract available Recruiting --> Active, not recruiting | Phase classification: P1b/2a --> P1/2 | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2023 --> Sep 2025
- |||||||||| Tepezza (teprotumumab-trbw) / Roche, Amgen
P4 data, Journal, Adverse events, Real-world evidence, Real-world: Post-marketing Safety Concerns of Teprotumumab: A Real-World Pharmacovigilance Assessment. (Pubmed Central) - Dec 17, 2024 Clinicians and pharmacists should be vigilant regarding these AEs. However, available data are currently insufficient, and further pharmacovigilance and surveillance are needed to fully understand this issue.
- |||||||||| Journal, IO biomarker: Management of Hypercholesterolemia in Patients with Coronary Artery Disease: A Glimpse into the Future. (Pubmed Central) - Dec 17, 2024
The aim of this review is to present the landscape of therapies already approved to reduce LDL-C levels, evaluating their efficacy, tolerability, and indications. Moreover, we take a glimpse into the future to evaluate experimental novel therapies to lower LDL-C levels that will be approved in the next few years or are under clinical evaluation.
- |||||||||| Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Review, Journal: Surgical Management of Adult Spinal Deformity Patients with Osteoporosis. (Pubmed Central) - Dec 17, 2024 Specifically, expandable screws and cement augmentation have been shown to improve fixation stability. However, further research is needed to evaluate the effectiveness of these treatments, specifically in osteoporotic ASD patients.
- |||||||||| AlloStim (bioengineered allogeneic immune cells) / Immunovative
A phase 2, multicenter, open-label study of AlloStim combined with anti-PD-L1 immunotherapy as 4L therapy in patients with MSS/pMMR metastatic colorectal cancer. (Level 1, West Hall; Poster Bd #: M26) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_974; P2 The study is a phase 2, multicenter, single-arm clinical trial of MSS/pMMR mCRC subjects in 4L that have been previously treated with an oxaliplatin-containing and irinotecan-containing chemotherapy regimen, anti-EGFR (RAS wt and left-sided), anti-VEGF and have progressed on 3L TAS-102 +/- bevacizumab or regorafenib or fruquinitinib...CT scans are conducted at baseline, day 56 after AlloStim priming, day 112 after combination of alternating q2w infusions of AlloStim and avelumab and day 168 in all patients...Up to 50 patients will be enrolled with an interim analysis performed to assess efficacy after 20 patients become evaluable. The study is open and has not yet enrolled any patients at time of submission.
- |||||||||| becotarug (JMT101) / CSPC Pharma
A phase II, randomized study of JMT101 in combination with irinotecan and SG001 versus regorafenib in patients with metastatic colorectal adenocarcinoma (mCRC). (Level 1, West Hall; Poster Bd #: M22) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_970; P2 Eligible patients are histologically confirmed mCRC without MSI-H/dMMR, wild-type RAS and BRAF, who progressed on at least 2 prior systemic therapy with chemotherapy based on 5-FU with oxaliplatin and irinotecan, with or without cetuximab and bevacizumab (both parts); no prior treatment with regorafenib, fruquintinib, or TAS-102 (part II)...Secondary endpoints include JMT101 and SG001 pharmacokinetic profile, antidrug antibodies (ADA) (both parts), disease control rate (DCR), duration of response (DOR), progression free survival (PFS), and overall survival (OS), as well as safety (part II). Prespecified goal for safety run-in part was met; randomized treatment part accrual began in February 2024.
- |||||||||| Vectibix (panitumumab) / Amgen, Lumakras (sotorasib) / Amgen, Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
A phase 3 study of first-line sotorasib, panitumumab, and FOLFIRI versus FOLFIRI with or without bevacizumab-awwb for patients with KRAS G12C (Level 1, West Hall; Poster Bd #: N8) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_961; P1, P3 The test statistic will be the number of ORRs in the 22 patients, which we assume to follow a binomial distribution. Clinical Trial Registration Number: NCT06252649 Background: CodeBreaK 300 (NCT05198934) evaluated sotorasib, a selective inhibitor that irreversibly binds to the Kirsten rat sarcoma (KRAS) G12C mutant protein, in combination with panitumumab, an anti
- |||||||||| Focus V (anlotinib) / Advenchen, Sino Biopharm
Efficacy and safety of anlotinib as a later-line treatment for advanced colorectal cancer. (Level 1, West Hall; Poster Bd #: H6) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_874; P2/3 Anlotinib showed promising efficacy and a favorable safety profile as a later-line treatment for advanced colorectal cancer. These findings suggest that anlotinib may be a viable clinical option for advanced CRC, though larger-scale clinical trials are necessary to confirm these results and further define its role in treatment.
- |||||||||| Opdivo (nivolumab) / BMS, Stivarga (regorafenib) / Bayer
Adverse events (AEs) (Level 1, West Hall; Poster Bd #: E18) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_802; P1 Moreover, it discovered that integration of AE-derived biomarkers with molecular biomarkers could produce a more robust classifier than when considered individually. This analysis is the first of its kind to identify subgroups of CRC patients that benefit from IC treatment.
- |||||||||| Stivarga (regorafenib) / Bayer, Tafinlar (dabrafenib) / Novartis
Integrating pharmacogenetic testing in the management of gastrointestinal cancers. (Level 1, West Hall; Poster Bd #: D25) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_780; These findings highlight the therapeutic significance of incorporating genetic testing into clinical practice to tailor treatments, enhance drug efficacy, and minimize side effects in GI cancer management. By integrating pharmacogenetic insights, the safety and effectiveness of therapies can be significantly improved, ultimately leading to better patient care in GI oncology.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, Vectibix (panitumumab) / Amgen
Nationwide analysis of Medicare expenditure and utilization of EGFR inhibitors from 2018-2022. (Level 1, West Hall; Poster Bd #: D24) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_779; As we move away from chemotherapy and shift our focus to targeted therapies, it is imperative to explore generic alternatives and direct policy changes to ensure equitable access across various racial and socio-economic groups. These findings highlight the need for further research into healthcare policy reforms to ease the burden on our health system.
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka, Stivarga (regorafenib) / Bayer
Survival outcomes for right- versus left-sided colon cancer and rectal cancer in patients receiving regorafenib and/or trifluridine/tipiracil for refractory metastatic colorectal cancer: Findings from the multicenter retrospective ReTrITa study. (Level 1, West Hall; Poster Bd #: C4) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_746; Examining the pts groups treated with R and T as monotherapy based on the primary tumour site, however, did not allow us to make any significant conclusions. Treatment decisions should, however, constantly include the patient's characteristics, such as sex, ECOG PS, and the extent of metastatic disease.
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka
Comparative efficacy of TAS-102 and chemotherapy rechallenge in the third-line setting and beyond in patients with advanced colorectal cancer: A retrospective study. (Level 1, West Hall; Poster Bd #: C15) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_734; Options include Trifluridine/Tipiracil (TAS-102), TAS-102 with bevacizumab, regorafenib, chemotherapy rechallenge with or without an anti-EGFR agent, or fruquintinib...Among the chemotherapy rechallenge group, 31% were treated with cetuximab and 6% had panitumumab rechallenge, some of which were guided by cell free DNA liquid biopsy testing... Patients with metastatic colorectal cancer who received chemotherapy rechallenge in the third line setting survived longer compared with patients who received TAS-102 with or without bevacizumab, or regorafenib.
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka, Avastin (bevacizumab) / Roche, Stivarga (regorafenib) / Bayer
Real-world (RW) treatment patterns and clinical outcomes of patients treated with sequential regorafenib and trifluridine/tipiracil (Level 1, West Hall; Poster Bd #: B25) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_726; The one-year median duration of survival in this real-world setting confirms the importance of access to these treatments in patients with mCRC and can inform physicians regarding the choice of medications while sequencing therapies in mCRC. Clinical outcomes among R-T and T-R mCRC patients.1 Entire R-T and T-R cohorts are presented since 16 patients in each cohort initiated T+BEV.
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