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  • American Society of Clinical Oncology (ASCO)  (7)
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  • American Society of Clinical Oncology (ASCO)  (7)
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  • 1
    Online Resource
    Online Resource
    Analysis of overall survival (OS) and progression-free survival (PFS) in the phase 1b clinical trial of anti–PD-1 ab (toripalimab) plus intrahepatic injection of orienX010 in stage IV melanoma with liver metastases.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 9564-9564
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 9564-9564
    Abstract: 9564 Background: Advanced melanoma with liver metastasis has a lower response rate and survival even in immunotherapy era which might because of its immunosuppressive tumor microenvironment. CPI combined with TVEC had showed a remarkable in cutaneous melanoma. The initial results of the phase 1b trial, systemic toripalimab (anti-programmed cell death-1 antibody) combined with Intratumoral injection of liver with OrienX010 - a HSV-1-derived oncolytic virotherapy with expression of GM-CSF in liver metastasis patients without extra-hepatic injectable lesions had shown its efficacy. Here we present the PFS and overall survival (OS) outcomes. Methods: Eligible pts included those over 18 with injectable liver metastasis confirmed by biopsy with or without extra-hepatic metastasis; the ocular melanoma and brain metastasis were excluded. Pts received intravenous toripalimab Q2W combined with ultrasound guided intratumoral injection of OrienX010 Q2W (8×10 7 pfu/ml, 10ml per injection) until intolerance or disease progression per iRECIST criteria. Liver biopsy would be performed at baseline and first tumor evaluation (8-12weeks). The primary endpoint was toxicity; secondary endpoints included ORR, disease control rate (DCR), PFS and OS. NCT04206358. Results: From Jul 2019 to Feb 2023, 30 pts enrolled. 60.0% pts primary from mucosal,; 73.3% got extra-hepatic metastasis; median size of injected lesions: 24mm(10-94mm); median number of liver metastasis: 7(1-10); median number of injection: 10 (3-36). Among these pts, 29 pts could be evaluated for efficacy. The median PFS was 7.0months (95%CI: 4.7-9.3 months) and the median OS was not reached. The 3-year OS rates 51.5%. The global ORR by investigator was 20.7% (6/29), DCR 48.3% (14/29); the response rate was 31.0%(9/29) for injected lesions, 30.0%(6/20) for non-injected lesions in liver, and 27.8% (5/18) for extra-hepatic metastases. For pts（21.7%( 2 PR and 3 SD)）with no melanoma cells residual by immunohistochemistry in biopsies the median PFS was 14.0 months (95%CI: 3.7-24.4 months), and it was much longer than that of other pts which was 4.1 months (95%CI: 1.4-6.8 months). The median OS of the pts with no melanoma cells was 19.7 months (95%CI: 7.5-31.9 months). Most adverse events (AE) were grade 1-2 and manageable. The grade 3-4 treatment-related AE included elevated transaminase (3 [10.0%]), nausea (1 [3.3%] ), pulmonary embolism (1 [3.3%]) and vomiting (1 [3.3%] ). No treatment-related deaths occurred. Conclusions: Systemic toripalimab combined with intrahepatic OrienX010 injection has shown remarkable long PFS, OS and ORR in melanoma pts with liver metastases with manageable toxicity. Clinical trial information: Clinical trial information: NCT04206358 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.9564
    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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  • 2
    Online Resource
    Online Resource
    Disitamab vedotin, a novel humanized anti-HER2 antibody-drug conjugate (ADC), combined with toripalimab in patients with locally advanced or metastatic urothelial carcinoma: An open-label phase 1b/2 study.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 4566-4566
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 4566-4566
    Abstract: 4566 Background: Disitamab vedotin has shown promising data across a spectrum of HER2 expression in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who progressed on chemotherapy. This study was conducted to evaluate the safety and efficacy of disitamab vedotin plus anti-PD-1 antibody in advanced urothelial carcinoma. Methods: This is an open-label, multicenter, phase 1b/2 trial to evaluate the safety and activity of RC48-ADC combined with toripalimab, a humanized immunoglobin G 4 monoclonal antibody against PD-1 in mUC. Patients received RC48-ADC at 1.5 or 2 mg/kg, in combination with 3mg/kg toripalimab every two weeks in a dose-escalation and expansion cohort until confirmed disease progression assessed by the investigators, unacceptable toxicity, or voluntary withdrawal. The primary endpoint was safety; secondary endpoints included efficacy and tumor tissue biomarkers. Results: Forty-one la/mUC patients were enrolled (22 males; median age 66 y [42-76]; 61% treatment-naïve). 54% of patients had visceral metastases (mets), including 24% with liver mets. The primary site was in upper tract UC in 54%. HER2 expression IHC 2+ or 3+ was in 59% patients, and PD-L1 positive in 32%. No dose-limiting toxicity was observed and the recommended dose was RC48-ADC 2mg/kg plus toripalimab 3mg/kg every two weeks. By the cutoff date of 18 November 2022, the confirmed ORR was 73.2% (95%CI: 57.1, 85.8), including 9.8% CR. The ORR was 76.0% for treatment-naïve patients. In HER2 IHC 3+/2+, IHC 1+, and IHC 0 subgroups, the ORR was 83.3%, 64.3%, and 33.3%, respectively. The ORR was 61.5% and 78.6% in PD-L1 positive and negative subgroups. DCR was 90.2% (95% CI, 76.9–97.3), with a median progression-free survival (PFS) of 9.2 months (95%CI: 5.7-10.3) and 2-year overall survival (OS) rate of 63.2%. All patients experienced treatment-related adverse events (TRAEs). The most common TRAEs were AST/ALT increase (68.3%), peripheral sensory neuropathy (61.0%), asthenia (61.0%), γ-glutamyl transferase increase (56.1%), hypertriglyceridemia (53.7%), and appetite decrease (51.2%). Grade 3 or greater TRAEs occurred in 43.9% of patients. Twenty-three patients (56.1%) had immune-related AEs (14.6% ≥ G3), including immune-related skin reactions, hyperglycemia, pneumonitis, hepatitis, and myositis. Conclusions: RC48-ADC in combination with toripalimab demonstrated promising efficacy in patients with la/mUC and a manageable safety profile. A phase 3 study is currently ongoing to compare the safety and efficacy of this regimen with standard of care. Clinical trial information: NCT04264936 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.4566
    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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  • 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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  • 4
    Online Resource
    Online Resource
    Early safety and efficacy from a phase I clinical study of TWP-101, a novel CD137 agonist antibody, in patients with advanced melanoma and urothelial carcinoma.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 9530-9530
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 9530-9530
    Abstract: 9530 Background: CD137 plays the roles as a potent co-stimulator of both adaptive and innate immune cells, being an attractive target for cancer immunotherapy. TWP-101 is a fully humanized agonistic anti-CD137 monoclonal IgG4 antibody, targeting a novel epitope of CD137 with a unique mechanism of actions as a CD137 agonist but not CD137 ligand antagonist. The phase I study of TWP-101 in patient (pt)s with advanced melanoma and urothelial carcinoma was initiated (NCT04871334). Methods: Enrolled pts were advanced melanoma refractory to standard therapy. Dose-escalation includes accelerated titration (0.01 and 0.03mg/kg) and conventional Fibonacci 3+3 dose levels (0.1, 0.3, 1.0 and 3.0 mg/kg). TWP-101 was administered intravenously every Q2W until confirmed progressive disease, unacceptable toxicity or withdrawal of consent. The primary objectives were to define the safety profile, to determine the maximum tolerated dose and RP2D of TWP-101. Secondary objectives were to evaluate pharmacokinetics (PK), immunogenicity and preliminary clinical efficacy. Exploratory objectives were to determine pharmacodynamics (PD) biomarkers. Results: From Feb 2021 to Mar 2022,13 melanoma pts (median age 54 years, range 39-73; 6 men, 7 women; median 2 prior lines of therapy, range 1-6; 12 with prior immunotherapy) were treated. The following five dose levels had been evaluated from 0.01 to 1.0 mg/kg. 3mg/kg dose escalation is ongoing, no MTD has been reached. The median treatment time was 16 wks. (range 2-59). On cutoff date of October 31, 2022, 13 pts discontinued treatment due to progression disease (n = 12) and protocol deviation (n = 1). No DLTs were observed. 9 pts (69.2%) experienced treatment-related adverse events (TRAE). The most common TRAEs (≥10%) were neutropenia (23.1%), leukopenia (15.4%), hypertriglyceridemia (15.4%), anemia (15.4%), hyponatremia (15.4%). 1 pt experienced grade 3-4 TRAEs: hyponatremia, Asthenia and reduced appetite. In all TRAEs, one grade 1 decreased free triiodothyronine and one grade 2 pyrexia were possibly related, and all other TRAEs, including 2 treatment-related SAEs (1 grade 4 hyponatremia and 1 grade 2 subarachnoid hemorrhage), were identified as possibly unrelated. Deaths were due to progression disease (n = 3). Preliminary PK analysis showed dose-proportional kinetics. For 12 evaluable pts, 2 pts achieved PR (16.7%), 5 pts was SD. DCR was 58.3%. Median PFS was 16 wks. (range 16-60), PFS of 2 PR pts was 24 and 60 wks. Conclusions: TWP-101 demonstrated a good safety profile without hepatotoxicity frequently observed with other studied CD137 antibodies. Both favorable tolerability and preliminary antitumor activity warrant further evaluation in pts with advanced melanoma and urothelial carcinoma. Clinical trial information: NCT04871334 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.9530
    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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  • 5
    Online Resource
    Online Resource
    Toripalimab plus axitinib versus toripalimab or axitinib alone in patients with treatment-naive unresectable or metastatic mucosal melanoma: Interim results from a randomized, controlled, phase II trial.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 9512-9512
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 9512-9512
    Abstract: 9512 Background: A phase IB trial had showen promising antitumor activity with toripalimab (T, a PD-1 antibody) plus axitinib (A, a VEGF receptor inhibitor) in treatment-naive unresectable or metastatic mucosal melanoma. Now we conducted a phase II trial to compare the combined treatment with monotherapy. Methods: In this randomized, controlled, phase II trial, patients with pathologically confirmed treatment-naive unresectable or metastatic mucosal melanoma were stratified by PD-L1 expression and randomized 1:1:1 into three groups to receive treatment of T+A (toripalimab 240 mg i.v. every 3 weeks, axitinib 5 mg orally twice a day), T (toripalimab 240 mg i.v. every 3 weeks) or A (axitinib 5 mg orally twice a day). Subjects in T or A who meet the criteria after disease progression may cross over to receive T+A. The primary endpoint was progression-free survival (PFS). Secondary endpoints included Objective response rate (ORR), Duration of response (DOR), overall survival (OS), and safety. The protocol was registered at ClinicalTrials.gov (NCT03941795). This is the interim analysis for efficacy and safety. Results: Between Nov 2019 and Jan 2022, 51 patients were randomized (18 to T+A, 20 to T, and 13 to A due to preliminary efficacy analysis). Anatomic site of head and neck, gastrointestinal, gynecological were 49.0%, 29.4%, 21.6%, respectively. Stage II or III unresectable, M1a, M1b, M1c were 3.9%, 23.5%, 17.6%, 51.0%, respectively. PD-L1 positivity was defined as ≥1% of tumor cells and/or infiltrating immune cells and were identified in 55.6%, 45.0%, 53.8% patients in T+A, T, A group, respectively. 17, 17 and 12 patients could be evaluated in T+A, T and A group, respectively. 24 patients from T or A crossover to T+A group. At a median follow-up of 6.60 months, patients receiving T+A had a higher median PFS (5.83 vs 2.80 vs 1.40 months; HR = 0.538; 95% CI, 0.237 to 1.221; HR = 0.444; 95% CI, 0.182 to 1.081; P = 0.170), ORR (35.3% (29.7% if including crossover patients ) vs 17.6% vs 8.3%), DOR (82.4% (70.3% if including crossover patients) vs 52.9% vs 58.3%) versus T or A group. The median OS was not reached. 80.4% patients experienced treatment-related adverse events (TRAEs). The most common TRAEs were mild (grade 1 or 2) and included diarrhea, proteinuria, hand and foot syndrome, fatigue, elevated transaminase, elevated bilirubin, hypertension, hypo- or hyperthyroidism, and rash. Grade 3 or greater TRAEs occurred in 33.3%, 30.0%, 30.8% of patients in T+A, T, A groups. Conclusions: Toripalimab plus axitinib showed promising antitumor activity versus toripalimab or axitinib alone in patients with treatment-naive unresectable or metastatic mucosal melanoma. Clinical trial information: NCT03941795.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.9512
    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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  • 6
    Online Resource
    Online Resource
    Safety, tolerability, and preliminary antitumor activity of sitravatinib plus tislelizumab (TIS) in patients (pts) with unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC).
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 4_suppl ( 2022-02-01), p. 281-281
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 4_suppl ( 2022-02-01), p. 281-281
    Abstract: 281 Background: Sitravatinib is a selective tyrosine kinase inhibitor targeting TAM and VEGFR2 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 designed to minimize binding to FcγR on macrophages and abrogate antibody-dependent phagocytosis, has shown activity in pts with 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 GC/GEJC cohort receiving sitravatinib plus TIS. Methods: Eligible pts were aged ≥ 18 years, had inoperable locally advanced or metastatic GC/GEJC, had failed or were ineligible for current standard of care, must not have received prior immunotherapy, had an ECOG PS of 0–1, and ≥1 measurable lesion (RECIST v1.1). 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). Secondary endpoints included duration of response (DoR), disease control rate (DCR), progression-free survival (PFS) (all per RECIST v1.1; by investigator), and safety and tolerability. Exploratory endpoints included overall survival (OS). Results: As of July 12, 2021, 24 pts were enrolled. Median age was 62.5 years (range: 44–74), 83.3% of pts were male, and 62.5% of pts had received ≥ 2 prior lines of systemic therapy. Median study follow-up was 5.2 months (range: 1.0–8.0); 5 pts (20.8%) remained on treatment. Confirmed ORR was 12.5% in 3 pts (95% CI: 2.7–32.4), all of whom achieved partial responses. DoR was not estimable (95% CI: 3.5 months–NE), DCR was 66.7% (95% CI: 44.7–84.4), and PFS was 3.4 months (95% CI: 2.0–NE). Median OS was not estimable (95% CI: 4.7 months–NE); the landmark OS rate at 6 months was 71.3% (95% CI: 46.1–86.3). Treatment-emergent adverse events (TEAEs) of any Grade/Grade ≥ 3 were reported in 95.8%/50.0% of pts. Serious TEAEs were observed in 45.8% of pts (n = 11). The most common Grade ≥ 3 TEAEs included hypertension, upper abdominal pain, and respiratory failure (all n = 2; 8.3%). In total, 3 pts (12.5%) experienced ≥ 1 TEAE leading to discontinuation of sitravatinib, and 2 pts (8.3%) experienced ≥ 1 TEAE leading to discontinuation of TIS. Dose reductions of sitravatinib due to TEAEs occurred in 6 pts (25.0%). Conclusions: The combination of sitravatinib plus TIS showed preliminary antitumor activity, and a manageable safety profile, in pts with pre-treated, advanced GC/GEJC. 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.281
    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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  • 7
    Online Resource
    Online Resource
    A phase II clinical trial of camrelizumab (CAM, an IgG4 antibody against PD-1) combined with apatinib (APA, a VEGFR-2 tyrosine kinase inhibitor) and temozolomide (TMZ) as the first-line treatment for patients (pts) with advanced acral melanoma (AM).
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 9508-9508
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 9508-9508
    Abstract: 9508 Background: PD-1 monotherapy as the first line stand treatment for advanced melanoma yields an objective response rate (ORR) of 〈 20% in AM. Although multiple clinical trials are ongoing testing TMZ/APA, TMZ/PD-1 and APA/PD-1 combo therapies in AM, the reported ORR (range 17-23.8%) are far from satisfactory. We therefore conducted a phase II study of CAM/APA/TMZ combo in this subtype aiming for improved efficacy. Methods: We performed a single center, single arm phase II study (NCT04397770) testing the efficacy and safety of CAM/APA/TMZ combo as first-line therapy in pts with advanced AM. The primary endpoint was ORR per RECIST1.1, secondary endpoints included progression free survival (PFS), disease control rate (DCR), overall survival (OS), and safety. All pts received iv CAM (200mg q2w), iv TMZ (200mg/m2 d1-5, q4w) and po APA (250mg qd) until disease progression or intolerable toxicity. Results: By Jan 2022, fifty pts were enrolled (48 evaluable), the median follow-up was 12.1 mo (IQR 8.4-14.5). Thirty-one pts achieved CR/PR as the best response (including 1 CR and 30 PR), the ORR was 64.6% (95% CI 49.4-77.4%). The DCR was 95.8% (95%CI, 84.6-99.3%). Both the median PFS and OS was not reached (NR); 6-mo and 12-mo PFS rate was 81.7% (95%CI 71.6-93.3%) and 62.9% (95%CI 48.4-81.7%), respectively; 12-mo OS rate was 82.3% (95%CI 68.2-99.2%). The incidence of treatment-related adverse events (TRAEs) was 94% (47/50). Of 50 patients, the most common grade ≥3 TRAEs included γ-glutamyl transferase elevation (24.0%), direct bilirubin elevation (22.0%), aspartase transaminase elevation (20.0%), alanine transaminase elevation (16.0%), and hypertriglyceridemia (14.0%). No treatment-related deaths occurred. Conclusions: The CAM/APA/TMZ combination demonstrated promising efficacy as the first-line treatment for pts with advanced AM, and was generally well tolerated. Phase III randomized control trial is warranted. Clinical trial information: NCT04397770.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.9508
    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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