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  • American Society of Clinical Oncology (ASCO)  (41)
  • 2020-2024  (41)
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  • American Society of Clinical Oncology (ASCO)  (41)
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  • 2020-2024  (41)
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  • 1
    Online Resource
    Online Resource
    Patient-specific tumor-informed circulating tumor DNA (ctDNA) analysis for molecular residual disease (MRD) detection in surgical patients with stage I-IV colorectal cancer (CRC).
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 4_suppl ( 2023-02-01), p. 213-213
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 4_suppl ( 2023-02-01), p. 213-213
    Abstract: 213 Background: Identifying molecular residual disease (MRD) with tailored tumor-informed ctDNA-based next-generation sequencing (NGS) assays after curative surgery could facilitate the individualized management of resected colorectal cancer (CRC) patients. Here, we prospectively evaluated the clinical performance of tumor-informed ctDNA mutation analysis using a novel Burning Rock Patient-specific Prognostic and Potential Therapeutic Marker Tracking (brPROPHET) approach for assessing MRD in resected CRC patients. Methods: The brPROPHET assay was designed to track patient-specific somatic variants based on whole-exome sequencing (WES) of the tumor tissue and matched white blood cells (WBCs). Fixed panel with informed calling (FI) and fixed panel with agnostic calling (FA) assays were performed in a subset of patients with a 168-gene panel spanning 273 kb of the human genome for a head-to-head comparison. Results: A total of 117 patients (stage II/III 53[45.0%]/41[35.0%] ) were analyzed. 60 (51.0%) patients were treated with adjuvant therapy after surgery. brPROPHET assay was designed to target up to 55 variants per patient. Only 6% (344/5835) of designed variants were included in the fixed panels. 75% (2908/3886) of genes selected for panel design were private to a specific patient. Preoperative ctDNA was detected in 97% (113/117) of the patients with 88% (14/16), 98% (52/53), 98% (40/41), and 100% (7/7) in stage I, II, III and IV, respectively. The median ctDNA levels were observed to be higher in patients with advanced stages and significantly correlated with tumor volume. MRD status was tested postoperatively on day 7 and day 30 with a positivity rate of 18% (21/117) and 15% (14/93), respectively. Due to a short follow-up period, only two patients had recurred, and ctDNA was detected prior to radiological relapse, with a lead time of 1 and 2 months, respectively. Among 74 patients enrolled for parallel comparing three MRD assays, preoperative ctDNA was detected in 97.3%, 75.7%, and 68.9% of patients with brPROPHET, FI and FA fixed panel assays, respectively. 20.3% (15/74) of patients had baseline ctDNA captured by brPROPHET assay only. The ctDNA levels of these patients (median:0.3 mean tumor molecules [MTM] / milliliter [mL] ) were lower than those captured by FI/FA fixed panels (median:3.0 MTM/mL, p 〈 0.05). A total of 135 postoperative blood samples were tested by all three assays, the positive rates with brPROPHET, FI and FA fixed panel assays were 14.8%, 8.1%, and 6.7% respectively. Conclusions: This initial study reported the clinical performance of the patient-specific brPROPHET assay in CRC, demonstrating superior sensitivity in detecting preoperative and postoperative ctDNA than the fixed panel assays. The ongoing study including correlation with clinical outcomes and serial testing will be presented.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.4_suppl.213
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or MetastaticNon–Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 27 ( 2022-09-20), p. 3162-3171
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 27 ( 2022-09-20), p. 3162-3171
    Abstract: Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation epidermal growth factor receptor tyrosine kinase inhibitor approved in China. This double-blind phase III trial evaluated the efficacy and safety of aumolertinib compared with gefitinib as a first-line treatment for locally advanced or metastatic EGFR-mutated non–small-cell lung cancer (NSCLC; ClinicalTrials.gov identifier: NCT03849768 ). METHODS Patients at 53 sites in China were randomly assigned 1:1 to receive either aumolertinib (110 mg) or gefitinib (250 mg) once daily. The primary end point was progression-free survival (PFS) per investigator assessment. RESULTS A total of 429 patients who were naïve to treatment for locally advanced or metastatic NSCLC were enrolled. PFS was significantly longer with aumolertinib compared with gefitinib (hazard ratio, 0.46; 95% CI, 0.36 to 0.60; P 〈 .0001). The median PFS with aumolertinib was 19.3 months (95% CI, 17.8 to 20.8) versus 9.9 months with gefitinib (95% CI, 8.3 to 12.6). Objective response rate and disease control rate were similar in the aumolertinib and gefitinib groups (objective response rate, 73.8% and 72.1%, respectively; disease control rate, 93.0% and 96.7%, respectively). The median duration of response was 18.1 months (95% CI, 15.2 to not applicable) with aumolertinib versus 8.3 months (95% CI, 6.9 to 11.1) with gefitinib. Adverse events of grade ≥ 3 severity (any cause) were observed in 36.4% and 35.8% of patients in the aumolertinib and gefitinib groups, respectively. Rash and diarrhea (any grade) were observed in 23.4% and 16.4% of patients who received aumolertinib compared with 41.4% and 35.8% of those who received gefitinib, respectively. CONCLUSION Aumolertinib is a well-tolerated third-generation epidermal growth factor receptor tyrosine kinase inhibitor that could serve as a treatment option for EGFR-mutant NSCLC in the first-line setting.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.21.02641
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 3
    Online Resource
    Online Resource
    A phase Ib/II, multicenter, open-label study of AK104, a PD-1/CTLA-4 bispecific antibody, combined with chemotherapy (chemo) as first-line therapy for advanced gastric (G) or gastroesophageal junction (GEJ) cancer.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 4_suppl ( 2022-02-01), p. 308-308
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 4_suppl ( 2022-02-01), p. 308-308
    Abstract: 308 Background: Anti-PD-1 agent plus chemo as first-line therapy for advanced G/GEJ cancer (Checkmate-649) yields OS and PFS benefits compared to chemo alone, indicating synergistic activity between immune checkpoint inhibitors and chemo. The combination of anti-PD-1 and anti-CTLA-4 has consistently demonstrated higher response rate compared to PD-1 monotherapy but higher toxicity. Here, we performed this phase Ib/II study to evaluate the efficacy and safety of AK104, a PD-1/CTLA-4 bispecific antibody, combined with XELOX (capecitabine combined with oxaliplatin) or modified XELOX (mXELOX) in the first-setting of G/GEJ cancer cohorts. This study is registered on ClinicalTrials.gov (NCT03852251). Methods: Pts with unresectable advanced G/GEJ adenocarcinoma and no prior systemic therapy, regardless of PD-L1 status were enrolled, excluding known HER2-positive pts. Enrolled patients received AK104 (4 mg/kg, 6 mg/kg, 10 mg/kg, Q2W or 10 mg/kg, 15mg/kg Q3W) + chemo (mXELOX Q2W or XELOX Q3W). The primary endpoint was objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Results: As of 13 Aug 2021, 96 pts were enrolled with median age 62.7 years (range: 29–75), 70.8% male, 62.5% ECOG PS 1, 44.8% liver metastasis. The median follow-up was 9.95 months (range, 0.4-26.8). 88 patients (92%) had at least one post-baseline tumor evaluation. The ORR was 65.9% (58/88) with 2 (2.3%) complete responses and 56 (63.6%) partial responses. The disease control rate (DCR) was 92.0% (81/88). The median duration of response (DoR) was 6.93 months (95%CI, 4.60 to 11.20). The median PFS was 7.10 months (95%CI, 5.55 to 10.48). The median OS was 17.41 months (95%CI, 12.35 to NE). In pts with PD-L1 CPS≥1 vs CPS＜1, median OS was 17.41 months and 14.65 months, respectively. Treatment-related adverse events (TRAEs) occurred in 97.9% of pts, and the most frequent were platelet count decreased (60.4%), white blood cell count decreased (58.3%), neutrophil count decreased (56.3%), anaemia (47.9%), nausea (30.2%), vomiting (30.2%), aspartate aminotransferase increased (30.2%). Grade ≥3 TRAEs occurred in 62.5% pts. No new safety signals were identified. Conclusions: AK104 in combination with mXELOX/XELOX showed promising activity and manageable safety in previously untreated pts with advanced G/GEJ adenocarcinoma. AK104 + chemo represents a potential new first-line treatment option for these pts. A phase III study of AK104 combined with chemo as first-line therapy for G/GEJ cancer is underway. Clinical trial information: NCT03852251.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.4_suppl.308
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 4
    Online Resource
    Online Resource
    A phase Ib/II, multicenter, open-label study of AK104, a PD-1/CTLA-4 bispecific antibody, combined with chemotherapy (chemo) as first-line therapy for advanced gastric (G) or gastroesophageal junction (GEJ) cancer: 2-Year update data.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 4031-4031
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 4031-4031
    Abstract: 4031 Background: Anti-PD-1 monoclonal antibodies plus chemo as first-line therapy for advanced G/GEJ cancer yields OS and PFS benefits compared to chemo alone while the survival benefits are limited, especially in patients with low PD-L1 expression (CPS 〈 5). Simultaneous blockade of the PD-1 and CTLA-4 pathways has shown synergistic anti-tumor activity and has been proven effective across multiple cancer types. This phase Ib/Ⅱ dose-escalation study evaluated the safety and efficacy of AK104, a PD-1/CTLA-4 bispecific antibody, combined with XELOX or modified XELOX (mXELOX) in the first-line treatment of G/GEJ cancer cohorts (NCT03852251). Methods: Pts with unresectable advanced G/GEJ adenocarcinoma and no prior systemic therapy, regardless of PD-L1 status, were enrolled, excluding known HER2-positive pts. Enrolled patients received AK104 (4 mg/kg, 6 mg/kg or 10 mg/kg Q2W, 10 mg/kg or 15mg/kg Q3W) + chemo (mXELOX Q2W or XELOX Q3W). The primary endpoint was safety and the objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Results: As of 31 Oct. 2022, 98 pts were enrolled with only 4 pts in 10 mg/kg Q3W, the safety and efficacy of the regimen of 10mg/kg Q3W will be reported in the phase III study and not be reported here. 94 pts were enrolled with median age of 62.7 years (range: 29–75), 70.2% male, 62.8% ECOG PS 1, and 45.7% liver metastasis. The median follow-up was 24.0 months (range: 0.5-33.3). 88 patients (94%) had at least one post-baseline tumor evaluation. The ORR was 68.2% (60/88), with 5 (5.7%) complete responses and 55 (62.5%) partial responses. The disease control rate (DCR) was 92.0% (81/88). The median duration of response (DoR) was 9.69 months (95%CI, 5.82 to 14.00). The median PFS was 9.20 months (95%CI, 6.67 to 10.48). The median OS was 17.41 months (95%CI, 12.35 to 29.77). In pts with PD-L1 CPS≥5 and CPS＜5, the median OS was 20.24 months and 17.28 months, respectively. Treatment-related adverse events (TRAEs) occurred in 97.9% of pts. The most frequent were platelet count decreased (62.8%), white blood cell count decreased (61.7%), neutrophil count decreased (59.6%), anemia (51.1%), aspartate aminotransferase increased (33.0%), nausea (30.9%), and vomiting (30.9%). Grade ≥3 TRAEs occurred in 69.4% of pts. No new safety signals were identified. Conclusions: AK104, combined with mXELOX/XELOX, showed promising activity and manageable safety in previously untreated patients with advanced G/GEJ adenocarcinoma. AK104 + chemo represents a potential new first-line treatment option for these pts. A phase III study of AK104 combined with chemo as first-line therapy for G/GEJ cancer is underway (NCT05008783). Clinical trial information: NCT03852251 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.4031
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 5
    Online Resource
    Online Resource
    A multicenter, open-label, single-arm, phase 1 dose-escalation and phase 2 dose-expansion study to evaluate the safety, tolerability, and anti-tumor activity of FCN-159 in adults with neurofibromatosis type 1.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 3103-3103
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 3103-3103
    Abstract: 3103 Background: Neurofibromatosis type 1 (NF1) is a common autosomal dominant genetic disease characterized by elevated RAS-mitogen activated protein kinase (MAPK) signaling that causes tumors to grow along the nerves. There is currently no medical cure for adult patients (pts). Plexiform neurofibromas (PN) is present in 20-50% of NF1 pts and may cause serious complications. FCN-159 is a highly potent anti-tumorigenic agent that functions via selective inhibition of MEK1/2. This study assessed the safety and efficacy of FCN-159 in adult NF1 pts with PN. Methods: This was a multi-center, open-label, single-arm phase 1 dose-escalation (data have been published in ASCO 2022, abstract no. 3011) and phase 2 dose-expansion study. Participants with NF1-related PN that was not completely resectable or not suitable for surgery were enrolled in the study to receive FCN-159 monotherapy continuously on a 28-day cycles. Herein, we report the safety and clinical efficacy of adult participants in both phase 1 and phase 2. Results: As of November 21, 2022, 82 pts were enrolled, including 19 pts in phase 1 and 63 pts in phase 2. The median follow-up was 10.2 months (range 9.4-11.0 months) at the data cut-off. All pts received more than one dose of FCN-159 and 78 had at least one tumor assessment based on REiNS critiera. A total of 26 (33%) pts had achieved partial response (PR) as best response, 51 (65%) pts had stable disease (SD), and only one pt was not evaluable for not meeting the minimum SD requirement of at least 16 weeks. The overall response rate (ORR) was 31.7% (95% CI: 21.9-42.9%). After 6-8 cycles of treatment, 68.2% (15/22) of pts with definite tumor pain (NRS-11 score≥2 points) at baseline had a decrease in pain intensity of at least 2 points at C7/C9 assessment. Pain scores decreased by an average of 2.7 points across all 22 pts. A total of 82 (100%) pts experienced treatment emergent adverse events (TEAEs). The most common TEAEs (≥ 20%) included folliculitis (69.5%), mouth ulcer (47.6%), diarrhea (41.5%), paronychia (41.5%), alopecia (32.9%), elevated lactate dehydrogenase (30.5%), elevated alkaline phosphatase (29.3%), tricuspid insufficiency (26.8%), and mitral insufficiency (26.8%). The most common grade ≥3 TEAEs were folliculitis (25.6%), paronychia (4.9%). There were no grade ≥ 4 treatment-related adverse events. One pt (1.2%) experienced a serious adverse event (duodenal ulcer) considered related to the study drug. 9.8% reported TEAEs leading to dose reductions, and 12.2% reported TEAEs leading to discontinuation. No death occurred during the study. Conclusions: Overall, FCN-159 has a manageable safety profile and demonstrated evidence of anti-tumor activity in the adult population with NF1-related PN. These promising findings warrant further investigation with long-time follow-up. Clinical trial information: NCT04954001 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.3103
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 6
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    Detection and localization of gastrointestinal cancers based on multi-dimentional signatures from a single cfDNA targeted sequencing assay.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 4169-4169
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 4169-4169
    Abstract: 4169 Background: Five major gastrointestinal (GI) cancers - colorectal (CRC), gastric (GC), liver (LC), esophageal (EC), and pancreatic cancer (PC) - are responsible for hundreds of thousands of mortalities annually worldwide. Unfortunately, there is a lack of cost-effective, blood-based screening method for their early detection. To address this issue, we aimed to develop GutSeer, a noninvasive, targeted methylation sequencing-based test by leveraging methylation and fragmentomic signatures carried by cell-free DNA (cfDNA). Methods: The panel of GutSeer consists of 1656 target regions which were either differentially methylated between healthy and cancer samples, or distinctively methylated in a specific GI cancer. Cancer and healthy participants were recruited and randomly divided into a training and a validation cohort. Their plasma DNA samples were analyzed to generate DNA methylation and fragmentomic features. These multi-dimensional features were integrated to build ensemble stacked machine learning models to differentiate cancer against healthy, and to determine the tissue-of-origin (TOO) of the cancer. Results: A total of 1844 cases (787 healthy, 342 LC, 239 GC, 209 EC, 180 CRC, and 87 PC cases) were recruited for this study. A cancer- vs-healthy model achieved an AUC of 0.94 and 0.95 (sensitivity of 77.7% and 77.1% under the specificity around 96%) using either methylation or fragmentomic features only, respectively. Combining both methylation and fragmentomic features further improved performances, achieving an AUC of 0.96 (sensitivity = 86.2% at a specificity of 96.7%). For individual type of cancer, GutSeer has a sensitivity of 93.3% for CRC, 81.1% for EC, 70.3% for GC, 96.5% for LC, and 86.4% for PC. An independent test using 629 benign cases as controls achieved a specificity of 87.1%. A separate TOO model was built using all features and achieved an overall accuracy of 82% for all cancer cases (66.7% for CRC, 87.0% for GC and EC combined, 89.0% for LC, and 63.2% for PC). Same as the cancer detection model, using multi-dimensional features in TOO prediction yielded higher accuracy than when models using only methylation or fragmentomics features (accuracy = 75.6% or 75.4%, respectively). When compared with whole-genome sequencing (WGS) based approaches, GutSeer showed a comparable performance in cancer detection but a higher accuracy in TOO identification, further confirming its effectiveness for detection of GI cancers. Conclusions: GutSeer, a non-invasive test integrating multi-dimensional features, was demonstrated to detect and localize the 5 main types of GI cancer with high accuracy. Our results further showed that a reasonably sized panel can perform comparably or even better than WGS-based methods in cancer detection and TOO localization, indicating GutSeer may be a low-cost solution for blood-based early screening for GI cancers.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.4169
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 7
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    First-line (1L) nivolumab (NIVO) plus chemotherapy (chemo) vs chemo in patients (pts) with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC): CheckMate 649 Chinese subgroup analysis with 3-year follow-up.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 4_suppl ( 2023-02-01), p. 353-353
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 4_suppl ( 2023-02-01), p. 353-353
    Abstract: 353 Background: NIVO + chemo demonstrated clinically meaningful improvement in overall survival (OS) and an acceptable safety profile vs chemo in previously untreated Chinese pts from CheckMate 649, consistent with the overall study population with advanced GC/GEJC/EAC. Results from CheckMate 649 led to approval of 1L NIVO + chemo in multiple countries, including China. We report 3-year follow-up results in Chinese pts. Methods: Adults with previously untreated, unresectable advanced or metastatic, non-HER2-positive GC/GEJC/EAC were enrolled regardless of programmed death ligand 1 (PD-L1) expression. Randomized pts received NIVO (360 mg Q3W or 240 mg Q2W) + chemo (XELOX Q3W or FOLFOX Q2W), NIVO + ipilimumab, or chemo. Dual primary endpoints for NIVO + chemo vs chemo were OS and progression-free survival (PFS) by blinded independent central review (BICR) in pts with PD-L1 combined positive score (CPS) ≥ 5. Results: 208 Chinese pts were randomized to NIVO + chemo or chemo. At 37 month (mo) minimum follow-up, NIVO + chemo continued to demonstrate clinically meaningful improvement in OS and PFS vs chemo in pts with PD-L1 CPS ≥ 5 and in all randomized pts. The 36-mo OS rate was 31% with NIVO + chemo vs 11% with chemo in pts with PD-L1 CPS ≥ 5 and 26% vs 9% in all randomized pts, respectively. Objective response rate (ORR) (95% CI) per BICR in pts with PD-L1 CPS ≥ 5 who had measurable lesions at baseline was 68% (56-79) with NIVO + chemo and 48% (36-60) with chemo, and in all randomized patients was 66% (55-76) and 45% (35-56), respectively. Responses were more durable with NIVO + chemo vs chemo in pts with PD-L1 CPS ≥ 5, with median duration of response (mDOR) (95% CI) of 12.5 mo (7.2-23.4) vs 6.9 mo (3.9-8.5); in all randomized pts, mDOR was 12.5 mo (7.2-17.7) vs 5.6 mo (4.4-8.3), respectively. No new safety signals were identified. Conclusions: After 3 years of follow-up, NIVO + chemo continued to demonstrate clinically meaningful survival benefit and durable objective responses vs chemo in Chinese pts, with an acceptable safety profile, consistent with the overall study population with advanced GC/GEJC/EAC. These results further support NIVO + chemo as a 1L treatment option for Chinese pts. Clinical trial information: NCT02872116 . [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.4_suppl.353
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 8
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    CTONG1104: Adjuvant gefitinib versus chemotherapy for resected N1-N2 NSCLC with EGFR mutation—Final overall survival analysis of the randomized phase III trial 1 analysis of the randomized phase III trial.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 9005-9005
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 9005-9005
    Abstract: 9005 Background: ADJUVANT-CTONG1104, a randomized phase 3 trial showed adjuvant gefitinib treatment significantly improved disease-free survival (DFS) vs standard doublet chemotherapy in patients (pts) with epidermal growth factor receptor ( EGFR) mutation-positive resected stage II-IIIA (N1-N2) non-small-cell lung cancer (NSCLC). 5-year survival rate of N1N2 were 38%-50% in IASLC staging system. Here, we present the final overall survival (OS) results from the study. Methods: From Sep 2011 to April 2014, 222 patients, aged 18-75 years, with EGFR activating mutation through completely resection and diagnosed as stage II-IIIA (N1-N2) NSCLC pathologically from 27 sites were enrolled. The enrolled patients were 1:1 randomized to receive adjuvant gefitinib (250 mg once per day) for 24 months (G, n=111) or vinorelbine (25 mg/m 2 , d1 and d8) plus cisplatin (75 mg/m2, d1) every 3 weeks for 4 cycles (C, n=111). The primary endpoint was DFS in the ITT population. Secondary endpoints included OS, 3 and 5-year DFS rate, 5-year OS rate. The subsequent therapy data were collected, including crossover from C to G, re-challenge TKI and other treatment. Data cut-off date was Jan. 13, 2020. Results: A median follow-up was 76.9 months. The median OS (mOS) was 75.5 months based on 95 (42.8%) events in ITT whole population. The mOS was 75.5m in G arm and 79.2m in C arm (HR 0.96, 95%CI 0.64-1.43, p=0.823). The 3, 5-year OS rate were 68.6%, 53.8% in G and 67.5%, 52.4% in C respectively. DFS in 3, 5-y were 40.3%, 23.4% in G and 33.2%, 23.7% in C, respectively (P 3-y =0.395, P 5-y =891). All predefined subgroups including age, gender, lymph node, EGFR mutation type had no significant difference in statistics but in favor of G arm in trend. Subsequent treatment especially targeted therapy contributed most to OS (HR = 0.46, 95% CI 0.26 – 0.83). Median OS of patients receiving subsequent target therapy was75.5m (n=35), 36.4m in other treatment (n=33; (P 〈 0.001). For G mOS were 75.5 (n=15; target therapy) and 35.0 (n=18; other, p 〈 0.001), for C 62.8m (n=20) and 46.8m (n=15; p=0.251). The RR was 26.7%, DCR 66.7%, mPFS 14.1m and mOS 19.6m for patients with rechallenged EGFR TKI in G arm (n=15). No novel unexpected SAE was observed during follow up. Conclusion The DFS survival advantage did not translate to OS difference in ADJUVANT trial. The OS with 75.5m was the best one of survival in completely resected N1N2 NSCLC comparing with historical data and sequent TKI treatment contribute to overall survival. Clinical trial information: NCT01405079.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.9005
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 9
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    Toripalimab Plus Chemotherapy for Patients With Treatment-Naive Advanced Non–Small-Cell Lung Cancer: A Multicenter Randomized Phase III Trial (CHOICE-01)
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 3 ( 2023-01-20), p. 651-663
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 3 ( 2023-01-20), p. 651-663
    Abstract: The CHOICE-01 study investigated the efficacy and safety of toripalimab in combination with chemotherapy as a first-line treatment for advanced non–small-cell lung cancer (NSCLC). PATIENTS AND METHODS Patients (N = 465) with treatment-naive, advanced NSCLC without EGFR/ALK mutations were randomly assigned 2:1 to receive toripalimab 240 mg (n = 309) or placebo (n = 156) once every 3 weeks in combination with chemotherapy for 4-6 cycles, followed by the maintenance of toripalimab or placebo once every 3 weeks plus standard care. Stratification factors included programmed death ligand-1 expression status, histology, and smoking status. The primary end point was progression-free survival (PFS) by investigator per RECIST v1.1. Secondary end points included overall survival and safety. RESULTS At the final PFS analysis, PFS was significantly longer in the toripalimab arm than in the placebo arm (median PFS, 8.4 v 5.6 months, hazard ratio = 0.49; 95% CI, 0.39 to 0.61; two-sided P 〈 .0001). At the interim OS analysis, the toripalimab arm had a significantly longer OS than the placebo arm (median OS not reached v 17.1 months, hazard ratio = 0.69; 95% CI, 0.53 to 0.92; two-sided P = .0099). The incidence of grade ≥ 3 adverse events was similar between the two arms. Treatment effects were similar regardless of programmed death ligand-1 status. Genomic analysis using whole-exome sequencing from 394 available tumor samples revealed that patients with high tumor mutational burden were associated with significantly better PFS in the toripalimab arm (median PFS 13.1 v 5.5 months, interaction P = .026). Notably, patients with mutations in the focal adhesion-PI3K-Akt signaling pathway achieved significantly better PFS and OS in the toripalimab arm (interaction P values ≤ .001). CONCLUSION Toripalimab plus chemotherapy significantly improves PFS and OS in patients with treatment-naive advanced NSCLC while having a manageable safety profile. Subgroup analysis showed the OS benefit was mainly driven by the nonsquamous subpopulation.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.22.00727
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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    A multicenter, open-label, phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of JMT-101 in patients (pts) with advanced colorectal cancer (ACC).
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e16025-e16025
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e16025-e16025
    Abstract: e16025 Background: JMT101 is a fully human monoclonal IgG1 antibody targeting epidermal growth factor receptor (EGFR). This study aimed to evaluate the safety and tolerability of JMT101 alone or in combination with chemotherapy in ACC. Methods: This is an open label, dose-escalating, phase I clinical trial. The pts with ACC and naïve to systemic EGFR-targeted therapy were assigned to receive JMT101 monotherapy (JMT101 group, pts with wild-type RAS ACC and had experienced failure of at least one standard regimen) or JMT101 in combination with mFOLFOX6/FOLFIRI (combination group, pts with wild-type RAS/non-BRAF V600E mutant ACC). JMT101 was infused intravenously by accelerated titration and traditional "3+3" dose-escalation scheme. The initial dose of JMT101 monotherapy was 0.5 mg/kg (q1w), and sequentially escalated to 2.0, 4.0, 6.0, 8.0, and 10.0 mg/kg (q2w). Until the dose of JMT101 group was escalated to the higher dose and sufficient safety data were obtained, the dose of the combination group would be escalated sequentially from 6.0, 8.0, to 10.0 mg/kg (q2w). The primary endpoints were safety and tolerability. The secondary endpoints were clinical efficacy and pharmacokinetic parameters. Results: From April 2017 to December 2019, 16 enrolled pts in JMT101 group (13 males, 3 females, median age 59.5 [27-64] years) and 7 in combination group (4 males, 3 females, median age 49 [39-68] years) were evaluable. The dose of JMT101 was escalated to 10.0, 8.0, 6.0 mg/kg in JMT101 group, mFOLFOX6 group and FOLFIRI group, respectively. Dose-limiting toxicity was not observed, maximum tolerated dose was not reached, and treatment-related SAE was not reported so far. JMT101 monotherapy and combination therapy were associated with grade 1 (15 and 7 cases), grade 2 (10 and 7 cases), and grade 3 (5 and 5 cases) AEs. In all groups, the most common AEs were skin rash (81.3% [13/16] in JMT101 group, 100% [7/7] in combination group), proteinuria (62.5% [10/16] in JMT101 group, 28.6% [2/7] in combination group) and oral mucositis (86.0% [6/7] in combination group). JMT101 monotherapy and combination therapy resulted in partial response (2 and 4 pts), objective response rate (12.5% and 57.1%), disease control rate (56.2% and 100%), and disease control 〉 24 weeks (4 and 3 pts). Conclusions: JMT101 shows good safety, tolerability, and antitumor activity in pts with ACC. Clinical trial information: 20160904 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e16025
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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