- |||||||||| misetionamide (GP-2250) / Panavance Therap
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine (clinicaltrials.gov) - Sep 28, 2023 P1, N=64, Recruiting, Trial completion date: Jan 2024 --> Sep 2024 Trial completion date: Dec 2022 --> Aug 2024 | Trial primary completion date: Dec 2022 --> Mar 2024
- |||||||||| zolbetuximab (IMAB362) / Astellas
Updated efficacy and safety results from phase III SPOTLIGHT study evaluating zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patients with claudin-18 isoform 2-positive (CLDN18.2+), HER2?, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma (Bilbao Auditorium - NCC) - Sep 27, 2023 - Abstract #ESMO2023ESMO_4229; P3 Methods Pts were randomly assigned 1:1 to zolbetuximab IV 800 mg/m2 (cycle 1, day [D] 1) followed by 600 mg/m2 (every 3 weeks) + mFOLFOX6 IV (D1, 15, 29) for four 42-day cycles or to PBO + mFOLFOX6; pts without progressive disease (PD) continued with zolbetuximab or PBO, + folinic acid and 5-FU at investigator's discretion, until PD or discontinuation criteria were met...Most common TEAEs with zolbetuximab + mFOLFOX6 were nausea (zolbetuximab arm: 82.4% vs PBO arm: 61.5%), vomiting (67.4% vs 36.3%), and decreased appetite (48.7% vs 34.9%); incidences of serious TEAEs were similar between arms (47.0% vs 46.4%). Conclusions With longer follow-up, zolbetuximab + mFOLFOX6 continued to demonstrate statistically significant improvement in PFS and OS compared with PBO + mFOLFOX6, with no new safety signals
- |||||||||| nisevokitug (NIS793) / Novartis
TGF? blockade in pancreatic cancer enhances sensitivity to combination chemotherapy (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1127; P1, P2, P3 This study provides scientific rationale for evaluation of NIS793 with either FOLFIRINOX or gemcitabine/n(ab)paclitaxel chemotherapy backbone in the clinical setting (NCT04390763, NCT04935359, NCT05546411, NCT05417386). We also support the concept of manipulating cancer cell plasticity to increase efficacy of combination therapy regimens.
- |||||||||| givastomig (TJ-CD4B) - I / Mab, ABL Bio
Givastomig, a novel Claudin18.2/4 (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1121; We also support the concept of manipulating cancer cell plasticity to increase efficacy of combination therapy regimens. In addition, givastomig-mediated T cell activation and tumor-killing was enhanced in combination with chemotherapies used in 1L or 2L treatment for gastric cancer, including 5-fluorouracil plus oxaliplatin (FOLFOX) and paclitaxel...2 expression (25
- |||||||||| Repeated dosing of anti-Claudin 18.2 CAR-T in metastatic gastrointestinal cancer (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_996;
P1b/2 Patients received a pre-conditioning regimen of fludarabine, cyclophosphamide, and 100mg/m2 nab-paclitaxel before CT041 CAR-T infusion...Results A 57-year-old man with metastatic gastric cancer to the liver (HER2 negative, PD-L1 CPS 10%) progressed after 5 cycles of FOLFOX+Nivolumab and 4 cycles of FOLFIRI/Ramucirumab...Again, he had G1 CRS with fever, which was resolved without tocilizumab...Conclusions Repeated dosing of anti-claudin 18. 2 CAR-T cells (CT041) was safe and deepened tumor response was observed after repeated dosing.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Dissecting pancreatic cancer tumor-immune microenvironment crosstalk using spatial transcriptomics (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_992; P2 14 A randomized multi-institutional clinical trial of FOLFIRINOX +/- losartan +/- nivolumab (anti-PD1) for PDAC has been completed (NCT03563248)...15 A pilot trial demonstrated a 29% disease control rate with combined nivolumab + ipilimumab and radiation therapy...Conclusions Spatial transcriptomics and proteomics reveal insights into the spatial relationship between PDAC tumor cell EMT plasticity, CAFs, and immune infiltrates. This enables the discovery of novel immune response biomarkers and potential therapeutic avenues to target tumor and microenvironment interactions.
- |||||||||| Onivyde (nanoliposomal irinotecan) / Servier, Ipsen, Takeda
P2 data, Review, Journal: A phase II study of neoadjuvant liposomal irinotecan with 5-FU and oxaliplatin (NALIRIFOX) in pancreatic adenocarcinoma. (Pubmed Central) - Sep 27, 2023 In an effort to reduce toxicities and optimize outcomes, this investigation explores the safety and feasibility of substituting liposomal irinotecan (nal-IRI) for nonliposomal irinotecan to improve tumor drug delivery and potentially reduce toxicity. This regimen, NALIRIFOX, has the potential to be both safer and more effective when administered in the preoperative setting.
- |||||||||| Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci
Enrollment open, Trial initiation date: TORCH-R: The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer (clinicaltrials.gov) - Sep 26, 2023 P2, N=93, Recruiting, This trial will help define the best neoadjuvant treatment sequence for borderline resectable PDAC and aims to evaluate if a total neoadjuvant treatment integrating iHD-SBRT improves the patients' oncological outcomes. Not yet recruiting --> Recruiting | Initiation date: Dec 2022 --> Aug 2022
- |||||||||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
Clinical, Journal: Modeling Tumor Growth Using Partly Conditional Survival Models: A Case Study in Colorectal Cancer. (Pubmed Central) - Sep 19, 2023 The PC modeling approach offers flexible characterization of associations between longitudinal covariates, such as serially assessed tumor burden, and survival time. It can be applied to a variety of data of this nature and used as clinical trials are ongoing to incorporate new disease assessment information as it is accumulated, as indicated by an example from colorectal cancer.
- |||||||||| Journal, Surgery, Metastases: Comparison of neoadjuvant versus upfront surgery for treatment of locally advanced gastric cancer. (Pubmed Central) - Sep 19, 2023
It can be applied to a variety of data of this nature and used as clinical trials are ongoing to incorporate new disease assessment information as it is accumulated, as indicated by an example from colorectal cancer. Although we found no significant difference between the patients undergoing standard gastrectomy and those undergoing NACT before gastrectomy, we believe that NACT may contribute to the favorable prognosis of patients with locally advanced disease with improved OS and DFS and this should be examined in future studies.
- |||||||||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Journal, Real-world evidence, Real-world, Metastases: Comparative Analysis of First-Line FOLFOX Treatment With and Without Anti-VEGF Therapy in Metastatic Colorectal Carcinoma: A Real-World Data Study. (Pubmed Central) - Sep 19, 2023 Although we found no significant difference between the patients undergoing standard gastrectomy and those undergoing NACT before gastrectomy, we believe that NACT may contribute to the favorable prognosis of patients with locally advanced disease with improved OS and DFS and this should be examined in future studies. Our real-world data analysis suggests that the addition of anti-VEGF to FOLFOX offers limited and short-lived benefits in the context of mCRC and may provide differential survival benefit based on tumor sidedness.
- |||||||||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Journal, Patient reported outcomes: Patient-reported outcomes in PROSPECT trial (Alliance N1048) - FOLFOX is not a panacea. (Pubmed Central) - Sep 18, 2023 Our real-world data analysis suggests that the addition of anti-VEGF to FOLFOX offers limited and short-lived benefits in the context of mCRC and may provide differential survival benefit based on tumor sidedness. No abstract available
- |||||||||| zolbetuximab (IMAB362) / Astellas
Journal, HEOR, Cost-effectiveness, Cost effectiveness, Metastases: Cost-effectiveness analysis of zolbetuximab plus mFOLFOX6 as the first-line treatment for CLDN18.2-positive, HER2-negative advanced gastric or Gastroesophageal Adenocarcinoma. (Pubmed Central) - Sep 18, 2023 At a willingness-to-pay threshold of $38,201/QALY, ZOL-FO had a 0% probability of cost-effectiveness compared with PLB-FO. From the perspective of the Chinese healthcare system, ZOL-FO is unlikely to be cost-effective as the first-line treatment option for CLDN18.2-positive, HER2-negative advanced G/GEJ adenocarcinoma.
- |||||||||| 5-fluorouracil / Generic mfg.
Journal: Babao Dan alleviates gut immune and microbiota disorders while impacting the TLR4/MyD88/NF-?B pathway to attenuate 5-Fluorouracil-induced intestinal injury. (Pubmed Central) - Sep 18, 2023 Furthermore, at the genus level on the fifth day, BBD upregulated the abundance of unidentified_Corynebacteriaceae, Aerococcus, Blautia, Jeotgalicoccus, Odoribacter, Roseburia, Rikenella, Intestinimonas, unidentified_Lachnospiraceae, Enterorhabdus, Ruminiclostridium, and downregulated the abundance of Bacteroides, Parabacteroides, Parasutterella, Erysipelatoclostridium, which were highly correlated with intestinal injury or the TLR4/MyD88/NF-?B pathway. In conclusion, we established a network involving 5-FU, BBD, the immune response, gut microbiota, and key pathways to explain the pharmacology of oral BBD in preventing 5-FU-induced intestinal injury.
- |||||||||| Tevimbra (tislelizumab-jsgr) / BeiGene
Phase classification: SYLT-023: Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab (clinicaltrials.gov) - Sep 18, 2023 P1/2, N=20, Recruiting, In conclusion, we established a network involving 5-FU, BBD, the immune response, gut microbiota, and key pathways to explain the pharmacology of oral BBD in preventing 5-FU-induced intestinal injury. Phase classification: P1 --> P1/2
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