Reference Detail

Ref Type

Journal Article

PMID

(33046518)

Authors

Shi Y, Cai Q, Jiang Y, Huang G, Bi M, Wang B, Zhou Y, Wang G, Ying H, Tao Z, Shi C, Guo Q, Gao C

Title

Activity and Safety of Geptanolimab (GB226) for Patients with Unresectable, Recurrent, or Metastatic Alveolar Soft Part Sarcoma: A Phase II, Single-arm Study.

Journal	Vol	Issue	Date	Pages	Journal Short Title
Clinical cancer research : an official journal of the American Association for Cancer Research			2020 Oct 12	6445-6452	Clin Cancer Res

URL

Abstract Text

Patients with alveolar soft part sarcoma (ASPS) are rare and have few treatment options. We assessed the activity of geptanolimab (GB226), a fully humanized programmed cell death protein 1 antibody, for patients with unresectable, recurrent, or metastatic ASPS.We conducted this multicenter, single-arm, phase II study (Gxplore-005, NCT03623581) in patients aged 18-75 years who had unresectable, recurrent, or metastatic ASPS at 11 sites in China. Patients received intravenous geptanolimab (3 mg/kg) every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was objective response rate assessed by independent review committee (IRC) per RECIST 1.1 in the full analysis set population.Between September 6, 2018 and March 6, 2019, we enrolled and treated 37 patients with 23 (62.2%) having received prior systemic treatment. Fourteen [37.8%; 95% confidence interval (CI), 22.5-55.2] of 37 patients had an objective response assessed by IRC with a 6-month duration of response rate of 91.7%. Median progression-free survival was 6.9 months (95% CI, 5.0-not reached) and disease control was achieved in 32 (86.5%; 95% CI, 71.2-95.5) patients. Three of 37 patients reported grade 3 treatment-related adverse events (TRAEs), including anemia, hypophysitis, and proteinuria [one each (2.7%)]. No grade 4 TRAEs were observed. Two (5.4%) patients discontinued treatment due to TRAEs (one with hypophysitis and one with Mobitz type I atrioventricular block). The baseline percentage of CD4+ T cells was adversely associated with patient response (P = 0.031).Geptanolimab has clinically meaningful activity and a manageable safety profile in unresectable, recurrent, or metastatic ASPS.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials
GB226	GB226	1	0

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
GB226		Geptanolimab\|GB-226\|GB 226\|CBT501\|CBT-501\|Genolimzumab	Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122	Geptanolimab (GB226) is a monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (PMID: 29932513, PMID: 33046518).

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
CD274 positive	alveolar soft part sarcoma	not predictive	GB226	Phase II	Actionable	In a Phase II trial (Gxplore-005), patients with CD274 (PD-L1)-positive (CPS >=1%) alveolar soft part sarcoma achieved an objective response rate (ORR) of 33.3% (4/12; 95% CI 9.9-65.1) and a disease control rate (DCR) of 83.3% (10/12; 95% CI 51.6-97.9) in response to Geptanolimab (GB226) treatment, which were not different from the 40.0% ORR (10/25; 95% CI 21.1-61.3) and 88.0% DCR (22/25; 95% CI 68.8-97.5) observed in CD274 (PD-L1)-negative (CPS <1%) patients (PMID: 33046518; NCT03623581).	33046518