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  • American Society of Clinical Oncology (ASCO)  (2)
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  • American Society of Clinical Oncology (ASCO)  (2)
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  • 1
    Online Resource
    Online Resource
    Report of adverse events of special interest (AESIs) for sintilimab plus a bevacizumab biosimilar (IBI305) in unresectable hepatocellular carcinoma.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 4_suppl ( 2023-02-01), p. 530-530
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 4_suppl ( 2023-02-01), p. 530-530
    Abstract: 530 Background: In the phase III Orient-32 trial (NCT03794440), sintilimab plus IBI305 demonstrated a meaningful improvement in overall survival (OS) and progression-free survival (PFS) vs. sorafenib (Sor) in patients (pts) with unresectable HCC. Here we report the AESIs for sintilimab and IBI305 in Orient-32. Methods: 571 eligible pts with unresectable HCC were randomly assigned (2:1) to receive either sintilimab plus IBI305 or Sor (400 mg orally twice daily), until disease progression or unacceptable toxicity. The co-primary endpoints were OS and independent radiological review committee (IRRC)-assessed PFS according to RECIST 1.1. AESIs were defined by the sponsor and reported without judgement of causality. Analyses explored the incidence and severity of AESIs as well as correlation between AESIs and efficacy. Results: The safety set included 402 pts in the sintilimab plus IBI305 group and 184 pts in the Sor group. At the data cutoff on Dec 30th, 2021, the median follow-up time was 26.7 months. Any AESIs (≥1%) for sintilimab plus IBI305 group and Sor group occurred in 77.9% pts and 53.3% pts, respectively. The incidence of treatment-related grade 3-4 AESI for sintilimab+IBI305 was 31.3% and treatment-related serious AESI was 13.9%. The most common any AESIs were proteinuria (61.7% ), hypertension (41.8%), hemorrhage (15.4%) and hyperthyroidism (14.2%) (Table). In the characteristics of baseline, ages can be a predictor of the onset of proteinuria, hypertension and hyperthyroidism. In addition, the occurrence of of proteinuria and hypertension can be a predictor for a better survival. Conclusions: AESIs for sintilimab and IBI305 were tolerable and manageable in Orient-32 trial. Further, the incidence and severity of AESIs were consistent with the known safety profiles of the individual agents. Clinical trial information: NCT03794440 . [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.4_suppl.530
    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
  • 2
    Online Resource
    Online Resource
    ORIENT-32: Updated characterization of response to sintilimab plus bevacizumab biosimilar (IBI305) vs sorafenib for unresectable hepatocellular carcinoma.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 4_suppl ( 2023-02-01), p. 570-570
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 4_suppl ( 2023-02-01), p. 570-570
    Abstract: 570 Background: ORIENT-32 trial (NCT03794440) assessed sintilimab (anti-PD-1 antibody) plus a bevacizumab biosimilar (anti-VEGF antibody) versus sorafenib (Sor) as first-line treatment for unresectable HCC and demonstrated a significant improvement in both overall survival and progression-free survival. Here we report the updated results of objective response rate (ORR), time to response (TTR), duration of response (DoR) and depth of response (DpR). Methods: 571 eligible patients (pts) with unresectable HCC were enrolled and randomized (2:1) to receive sintilimab (200 mg IV Q3W) plus IBI305 (15 mg/kg IV Q3W) or Sor (400 mg orally, BID) until disease progression or unacceptable toxicity. Tumors were evaluated using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)and HCC-modified RECIST (mRECIST). ORR, TTR, DoR, and DpR were analyzed. The DpR was defined as the minimum percentage of (1) sum of longest diameter (SLD) change and (2) longest diameter (LD) change described as mean (standard deviation, SD). Results: At the data cutoff on Dec 30th, 2021, the median follow-up time was 26.7 months. The ORR in sintilimab plus IBI305 and Sor group was 21.0% (77/367) vs 4.7 (8/169) per RECIST 1.1 and 25.1% (92/367) vs 7.7% (13/169) per mRECIST. The median TTR in sintilimab plus IBI305 group was 2.8 (2.4–3.3) months per RECIST 1.1 and 2.6 (1.6–2.9) months per mRECIST. The median DoR in sintilimab plus IBI305gourp was 20.3 (12.3-NE) months per RECIST 1.1. The minimum percentage of SLD change was larger in the sintilimab plus IBI305 arm than in the Sor arm: (−13.4% (35.8) vs 3.2%(26.5) per RECIST 1.1). Similarly, the LD change in the largest liver lesion also favored sintilimab plus IBI305 arm (−27.6% (31.6) vs −11.5% (20.9)), including larger tumors (≥7 cm; −21.2% (30.4) vs −9.9% (23.7)) all per RECIST 1.1. Conclusions: Sintilimab plus IBI305 showed a significant improvement in ORR, TTR, DOR and DpR vs Sor in unresectable HCC. Clinical trial information: NCT03794440 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.4_suppl.570
    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
    BibTip Others were also interested in ...
    Online Resource
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