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  • Online Resource  (6)
  • American Society of Clinical Oncology (ASCO)  (6)
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  • Online Resource  (6)
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  • American Society of Clinical Oncology (ASCO)  (6)
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  • 1
    Online Resource
    Online Resource
    Toripalimab plus bevacizumab as first-line treatment for advanced hepatocellular carcinoma: A single-arm phase II study.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 4_suppl ( 2022-02-01), p. 435-435
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 4_suppl ( 2022-02-01), p. 435-435
    Abstract: 435 Background: Anti-PD-1/PD-L1 combining with antiangiogenic agents has showed encouraging anti-tumor efficacy for treating advanced hepatocellular carcinoma (HCC). Toripalimab, a humanized monoclonal antibody against PD-1, has already been approved for melanoma, nasopharyngeal carcinoma and urothelial carcinoma in China. Therefore, we aimed to assess the safety and efficacy of toripalimab plus bevacizumab as a first-line treatment for unresectable HCC. Methods: This is a multicenter, single-arm, open-label, phase II study. Patients with unresectable locally advanced or metastatic HCC, BCLC stage C or B, Child-Pugh stage A, ECOG PS ≤ 1, at least one measurable lesion, no prior systemic therapy, were enrolled and treated with toripalimab (240mg, IV, D1) plus bevacizumab (15 mg/kg, IV, D1) every 3 weeks as first-line treatment until disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoints were tolerability and objective response rate (ORR, per RECIST 1.1 by investigators). The secondary endpoints included the ORR (per mRECIST by independent review committee), the disease control rate (DCR) and progressive free survival (PFS), DoR, time-to-progression (TTP), time-to-response (TTR) and OS. Tumor response was assessed every 6 weeks. Results: As the data cut-off dateofJune 23, 2021,54 pts were enrolled (males 48; median age 54 years [range 26-68]; ECOG PS 0-1; 87.0% with HBV infection; 74.1% in BCLC stage C; 74.1% had received previous local treatment). All pts received at least one cycle of toripalimab plus bevacizumab treatment with median cycles 10 [range 1-18] . Among 52 evaluable patients, per RECIST v1.1, ORR was 32.7% (17/52) with 1 CR and 16 PR, and DCR was 78.8% (41/52); per mRECIST, ORR was 46.2% (95% CI: 32.2-60.5%) and DCR was 94.2% (95% CI: 84.1-98.8%). The median PFS was 9.9 months (95%CI: 5.5-11.0) and median OS has not reached. Most treatment related adverse events (TRAEs) were grade 1-2. Grade ≥3 TRAEs occurred in 25.9% pts, SAEs occurred in 27.8% pts, and grade ≥3 irAEs occurred in 11.1% pts. No treatment-emergent adverse event (TEAE) leading to death occurred in the study. Conclusions: Toripalimab in combination with bevacizumab as first-line treatment showed promising antitumor activity in patients with advanced HCC, and a manageable safety profile. A randomized phase 3 trial of toripalimab plus bevacizumab versus sorafenib (NCT04723004) are ongoing to further validate the efficacy of combination as first-line treatment in advanced HCC patients. Clinical trial information: NCT04605796.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.4_suppl.435
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 2
    Online Resource
    Online Resource
    Tebotelimab, a PD-1/LAG-3 bispecific antibody, in patients with advanced hepatocellular carcinoma who had failed prior targeted therapy and/or immunotherapy: An open-label, single-arm, phase 1/2 dose-escalation and expansion study.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 4_suppl ( 2023-02-01), p. 578-578
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 4_suppl ( 2023-02-01), p. 578-578
    Abstract: 578 Background: Immune checkpoint inhibitors (CPIs) targeting PD-1/PD-L1 have become established treatments for advanced hepatocellular carcinoma (aHCC) but yield low objective response rates (ORRs) in treated patients (pts). Dual inhibition of LAG-3 and PD-1 pathways has demonstrated synergy in activating T-cells and improving immune response. Tebotelimab, also known as MGD013, is a bispecific tetravalent DART molecule that can bind both PD-1 and LAG-3. We initiated an open-label, single-arm, phase 1/2 dose escalation and expansion study to assess the safety and efficacy of tebotelimab in pts with aHCC. Methods: Eligible pts with aHCC who received ≥1 prior systemic treatment with or without prior CPI exposure were enrolled. The dose escalation phase evaluated doses at 120, 240, 400, and 600 mg. Tebotelimab was administered intravenously once every two weeks (Q2W) on days 1 and 15 of each 28-day cycle. The dose expansion phase consisted of one CPI-experienced cohort and one CPI-naïve cohort, both treated at recommended phase 2 dose (RP2D). Primary endpoints were safety for the escalation phase, and safety and ORR per RECIST v1.1 for the expansion phase. Investigator-assessed efficacy results are reported. Results: At data cut-off as of 27 April 2022, 13 pts received tebotelimab in the escalation phase. No dose-limiting toxicity was observed and RP2D was determined as 600 mg Q2W. In the expansion phase, 69 pts (CPI-experienced 33, CPI-naïve 36) were enrolled (median age, 57.0 years; male, 87.0%; ECOG 1, 58.0%; BCLC Stage C, 89.9%; and HBV etiology, 84.1%). Thirteen (18.8%) pts had Grade ≥3 treatment-related adverse events (TRAEs), most commonly hepatic function abnormal (n=3), amylase increased (n=2), and aspartate aminotransferase increased (n=2). Serious TRAEs occurred in nine (13.0%) pts, immune-related adverse events in 30 (43.5%), TRAEs leading to treatment discontinuation in five (7.2%), and treatment-related death in one (1.4%). Of the 30 evaluable pts in the CPI-experienced cohort, one achieved confirmed partial response (PR) and 14 achieved stable disease (SD), with a 3.3% ORR and a 50.0% disease control rate (DCR); of the 30 evaluable pts in the CPI-naïve cohort, four achieved confirmed PR and 10 achieved SD, with a 13.3% ORR and a 46.7% DCR. Median progression-free survival was 2.4 and 3.1 months for CPI-experienced and CPI-naïve cohorts, respectively, with median overall survival not reached in both. Conclusions: Tebotelimab demonstrated a manageable safety profile in pts with aHCC. Antitumor activity, mainly as disease stabilization, was observed in both the CPI-naïve setting and the CPI-experienced setting. No additional clinical trials are planned at this time. Clinical trial information: NCT04212221 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.4_suppl.578
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 3
    Online Resource
    Online Resource
    Safety, tolerability, and preliminary antitumor activity of sitravatinib plus tislelizumab (TIS) in patients (pts) with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC).
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 4_suppl ( 2022-02-01), p. 418-418
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 4_suppl ( 2022-02-01), p. 418-418
    Abstract: 418 Background: Sitravatinib is a selective tyrosine kinase inhibitor that reduces the number of myeloid-derived suppressor and regulatory T cells and increases the ratio of M1/M2-polarized macrophages. This may help to overcome an immunosuppressive tumor microenvironment and augment antitumor responses. TIS, an anti-programmed cell death protein-1 (PD-1) antibody, has shown activity in multiple advanced solid tumors. This multicohort, phase 1/2 study assessed the safety/tolerability and efficacy of sitravatinib alone or with TIS (BGB-900-104; NCT03941873). We report results from the phase 2 HCC cohort receiving sitravatinib plus TIS. Methods: Eligible pts were aged ≥ 18 years, had unresectable locally advanced or metastatic HCC, had received 1 or 2 prior lines of systemic treatment, had an ECOG PS of 0–1, ≥ 1 measurable lesion (per RECIST v1.1), and had Barcelona Clinic Liver Cancer (BCLC) stage B or C disease. Pts with anti-PD-1/PD-L1 antibody-naïve HCC must have failed or been ineligible for current standard of care. Pts received sitravatinib 120 mg orally once daily and TIS 200 mg intravenously every three weeks. The primary endpoint was objective response rate (ORR) (RECIST v1.1; by investigator [INV]). Secondary endpoints included duration of response (DoR), disease control rate (DCR), progression-free survival (PFS) (all per RECIST v1.1; by INV), and safety and tolerability. Exploratory endpoints included overall survival (OS). Results: As of July 12, 2021, 43 pts were enrolled (21 pts were anti-PD-1/PD-L1 antibody naïve and 22 pts were refractory/resistant [R/R] ) and 10 pts (23.3%) remained on treatment. The median age of pts was 55 years (range: 29–71), 88.4% were male, and 74.4% had BCLC stage C disease at study entry. With a median study follow-up of 8.6 months (mo) (range: 0.7–10.6), confirmed ORR was 10.0% (4 pts) (95% CI: 2.8–23.7); all 4 pts achieved partial responses. Median DoR and PFS were 5.4 mo (95% CI: 4.1–5.7) and 4.8 mo (95% CI: 3.2–6.9), respectively. DCR was 85.0% (95% CI: 70.2–94.3). Median OS was not estimable (95% CI: 8.6 mo–NE); the landmark OS rate at 9 mo was 71.4% (95% CI: 47.2–86.0) and 52.7% (95% CI: 23.2–75.5) in pts with anti-PD-1/PD-L1 antibody-naïve HCC and R/R HCC, respectively. Treatment-emergent adverse events (TEAEs) of any grade/grade ≥ 3 were reported in 97.7%/48.8% of pts. Serious TEAEs were observed in 27.9% of pts (n=12). The most common grade ≥ 3 TEAE was palmar-plantar erythrodysesthesia (n=4; 9.3%). Pts experienced ≥ 1 TEAE that led to discontinuation of both sitravatinib (n=4; 9.3%) and TIS (n=4; 9.3%), respectively. Dose reductions of sitravatinib due to TEAEs occurred in 15 pts (34.9%). Conclusions: Sitravatinib plus TIS was tolerable and showed preliminary antitumor activity in pre-treated, advanced HCC. Further investigation in this pt population is warranted. Clinical trial information: NCT03941873.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.4_suppl.418
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 4
    Online Resource
    Online Resource
    Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO)
    Abstract: In a phase IIb trial of nimotuzumab plus gemcitabine, substantial clinical benefits were observed in patients with locally advanced or metastatic pancreatic cancer (PC). Therefore, we conducted a phase III clinical study to verify the efficacy and safety of this combination regimen in patients with K-Ras wild-type tumors (ClinicalTrials.gov identifier: NCT02395016 ). PATIENTS AND METHODS Eligible patients were randomly assigned to receive nimotuzumab (400 mg once per week) or placebo followed by gemcitabine (1,000 mg/m 2 on days 1, 8, and 15, once every 4 weeks) until disease progression or unacceptable toxicity. The primary end point was overall survival (OS) and the secondary end points were progression-free survival (PFS), response rates, and safety. RESULTS A total of 480 patients were screened; 92 patients were enrolled and 82 patients with K-Ras wild-type tumors were eligible. In the full analysis set, the median OS was 10.9 versus 8.5 months, while the restricted mean survival time (RMST) was 18.05 versus 11.14 months for the investigational versus control arm (ratio of control v investigation = 0.62 [0.40-0.97]; P = .036). Median PFS was 4.2 versus 3.6 months in the investigational versus control arm (log-rank P = .04; hazard ratio, 0.60 [0.37-0.99] ) and the restricted mean PFS time was 8.08 versus 4.76 months (RMST ratio, 0.58 [0.38-0.90]; P = .036). Both OS and PFS were longer in the nimotuzumab group than in the placebo group. The objective response rates and disease control rates were 7% versus 10% and 68% versus 63% for the investigational and control groups, respectively. The incidence of adverse events were comparable between the two groups. CONCLUSION In patients with locally advanced or metastatic K-Ras wild-type PC, nimotuzumab plus gemcitabine significantly improved OS and PFS with a good safety profile.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.22.02630
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 5
    Online Resource
    Online Resource
    Nimotuzumab combined with gemcitabine versus gemcitabine in K-RAS wild-type locally advanced or metastatic pancreatic cancer: A prospective, randomized-controlled, double-blinded, multicenter, and phase III clinical trial.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 17_suppl ( 2022-06-10), p. LBA4011-LBA4011
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 17_suppl ( 2022-06-10), p. LBA4011-LBA4011
    Abstract: LBA4011 Background: Pancreatic cancer is one of the most lethal malignancies diagnosed at an advanced stage, and current treatment regimens are ineffective, with only 6-8 months of median overall survival (mOS). The present study aims to assess the clinical efficacy and safety of nimotuzumab (anti-EGFR humanized monoclonal antibody) combined with gemcitabine in K-Ras wild-type patients with locally advanced or metastatic pancreatic cancer. Methods: Patients with locally advanced or metastatic pancreatic cancer were randomized to receive nimotuzumab (400 mg, every one week) followed by gemcitabine (1000 mg/m 2 on days 1, 8, and 15, every four weeks), or placebo plus gemcitabine until progression or unacceptable toxicity. The primary endpoint was overall survival (OS), and secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety. Use restricted mean survival time (RMST)-Log function to analyze the survival benefits when the proportional hazards assumption is untrue. Results: A total of 92 Chinese patients were randomly assigned to the nimotuzumab- gemcitabine (n = 46) or placebo-gemcitabine group (n = 46). In the full analysis set (FAS, n = 82), the mOS was significantly longer in the nimotuzumab-gemcitabine group (10.9 vs. 8.5 months, p = 0.025 by RMST-Log test, hazard ratio [HR], 0.50, 95% Confidence Interval [CI] , 0.06 to 0.94). The one-year survival rate was 43.6% in the nimotuzumab-gemicitabine group vs. 26.8% in the placebo-gemicitabine group, and 13.9% vs. 2.7% at three years. Subgroup analyses showed more survival benefit in patients without treatment of biliary obstruction (11.9 vs. 8.5 months, HR = 0.54, 95%CI 0.33-0.88, p = 0.037) and no surgical history (15.8 vs. 6.0 months, HR = 0.40, 95%CI 0.19-0.84). The median progression-free survival (mPFS) was 4.2 months in the nimotuzumab-gemicitabine group, as compared with 3.6 months in the placebo-gemicitabine group (HR = 0.56; 95% CI, 0.12 to 0.99; p = 0.013 ); Patients without treatment of biliary obstruction had significantly longer PFS (5.5 vs. 3.4 months; p = 0.008 ). No statistical difference in the ORR between the two groups ( p 〉 0.05). Nimotuzumab was safe and the incidence of adverse events in the nimotuzumab-gemicitabine group is similar to placbo-gemicitabine group. The most common grade 3 TRAEs in Nim-Gem group were neutropenia (11.1%), leukopenia (8.9%) and thrombocytopenia (6.7%). No grade 4 TRAEs. Conclusions: Nimotuzumab combined with gemcitabine increases OS and PFS in patients with K-Ras wild-type locally advanced or metastatic pancreatic cancer, particularly for those without treatment of biliary obstruction. The safety profile of nimotuzumab is similar to placebo. Clinical trial information: 02395016.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.17_suppl.LBA4011
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 6
    Online Resource
    Online Resource
    A phase 2 study of HMPL-453, a selective FGFR tyrosine kinase inhibitor (TKI), in patients with previously treated advanced cholangiocarcinoma containing FGFR2 fusions.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. e16118-e16118
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. e16118-e16118
    Abstract: e16118 Background: Patients (pts) with advanced cholangiocarcinoma (CCA) who progressed on or after 1L chemotherapy have few treatment options. FGFR2 fusions or rearrangements occur in 10–16% of pts in global and 6.14% in Chinese pts with intrahepatic cholangiocarcinoma (iCCA), and may predict tumor susceptibility to FGFR inhibitors. HMPL-453 is a novel, selective tyrosine kinase inhibitor against FGFR1, 2, and 3. Here, we report results from an open-label, multi-cohort, single-arm phase 2 study (NCT04353375). Methods: Pts with histologically or cytologically confirmed locally advanced or metastatic iCCA with FGFR2 fusions who were treated at least one previous line of systemic therapy were eligible and included in this analysis. They received 21-day cycles of HMPL-453 orally with 150 mg (QD, cohort 1) or 300 mg (QD, 2w on/1w off, cohort 2) until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) per RECIST 1.1. Results: At data cutoff (Sep 21, 2022), a total of 25 iCCA pts (12 in cohort 1, 13 in cohort 2) were enrolled and treated with HMPL-453. Median age was 51 yrs (range 28-76) and 12 (48%) were male. All pts had received ≥1 prior treatment line and 21 (84%) had received previous gemcitabine-based chemotherapy. The median follow-up duration was 12 months (mos) and 4.1 mos for cohort 1 and cohort 2, respectively. Of 22 evaluable pts (12 in cohort 1 and 10 in cohort 2) who had at least one post-baseline tumor assessment, the best overall response by investigator assessment was confirmed partial response in seven (31.8%) pts and stable disease in an additional 12 pts (54.5%), resulting in a disease control rate (DCR) of 86.4%. Specifically, in cohort 2 the confirmed ORR was 50% (95% CI, 18.7%–81.3%) and DCR was 90% (95% CI, 55.5%–99.7%). Duration of response was not reached in either cohort. Median progression-free survival was 5.7 (95% CI, 2.6, NR) mos in cohort 1 and not yet mature in cohort 2. Of all pts, 23 (92%) experienced ≥1 treatment-related adverse events (TRAEs). The most common TRAEs (any grade) were diarrhea (56%), dry mouth (44%), and blood phosphorus increased (44%). The common Gr ≥3 TRAEs (≥5% pts) were decreased neutrophil count (8%), nail toxicity (8%) and palmar-plantar erythrodysesthesia syndrome (8%). Compared to cohort 1, pts in cohort 2 experienced a lower incidence of Gr ≥3 TRAEs (23.1% vs 58.3%), less dose interruption/reduction (32.0% vs 41.7%) and less treatment discontinuation (0.0% vs 16.7%) due to TRAE. Based on the better safety profile and preliminary efficacy, 300mg, QD, 2w on/1w off was chosen as the recommended phase 2 dose (RP2D). Conclusions: HMPL-453 showed promising efficacy, particularly in RP2D regimen (300 mg, QD, 2w on/1w off) and acceptable toxicity in pts with previously-treated advanced iCCA and FGFR fusions. These results warrant further study in pts with advanced iCCA. Clinical trial information: NCT04353375 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.e16118
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
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