Reference Detail

Ref Type

Journal Article

PMID

(35192397)

Authors

Xu Q, Wang J, Sun Y, Lin Y, Liu J, Zhuo Y, Huang Z, Huang S, Chen Y, Chen L, Ke M, Li L, Li Z, Pan J, Song Y, Liu R, Chen C

Title

Efficacy and Safety of Sintilimab Plus Anlotinib for PD-L1-Positive Recurrent or Metastatic Cervical Cancer: A Multicenter, Single-Arm, Prospective Phase II Trial.

Journal	Vol	Issue	Date	Pages	Journal Short Title
Journal of clinical oncology : official journal of the American Society of Clinical Oncology			2022 Feb 22	1795-1805	J Clin Oncol

URL

Abstract Text

No combined immunotherapy and antiangiogenic therapy have been investigated in exclusively programmed death-ligand 1 (PD-L1)-positive advanced cervical cancer (CA). We investigated the efficacy and safety of sintilimab plus anlotinib as second-line or later therapy for PD-L1-positive recurrent or metastatic (R/M) CA.Patients with PD-L1-positive (Combined Positive Score ≥ 1) R/M CA who progressed after at least one prior systemic chemotherapeutic regimen or could not tolerate chemotherapy were eligible for the phase II trial. The patients received 200 mg sintilimab once on day 1 and 10 mg anlotinib once daily on days 1-14 every 3 weeks. The primary end point was investigator-confirmed objective response rate (ORR) per RECIST v1.1. Secondary end points included progression-free survival (PFS), overall survival, and disease control rate. Biomarkers were explored.Forty-two patients were enrolled. The ORR was 54.8% (95% CI, 38.7 to 70.2). In 39 efficacy-evaluable patients, the ORR was 59.0% (95% CI, 42.1 to 74.4); the disease control rate was 94.9% (95% CI, 82.7 to 99.4). The median PFS was 9.4 months (95% CI, 8.0 to 14.6). The median overall survival was not reached. Furthermore, 85.8% of the patients experienced treatment-related adverse events. The most frequent treatment-related adverse events were hypothyroidism (33.3%), elevated aspartate aminotransferase levels (21.4%), and hypertension (19.0%). Patients with altered PIK3CA, PI3K-AKT signaling, or KMT2D had a higher ORR, whereas those with altered STK11 and/or JAK2 had a significantly shorter PFS.Sintilimab plus anlotinib as second-line or later therapy is efficacious and safe for patients with advanced CA who have failed prior chemotherapy.

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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

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

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	cervical squamous cell carcinoma	predicted - sensitive	Anlotinib + Sintilimab	Phase II	Actionable	In a Phase II study, a combination of Anlotinib (AL-3818) and Sintilimab (IBI308) resulted in a significantly higher objective response rate in CD274 (PD-L1)-positive cervical squamous cell carcinoma patients compared to non-squamous cell cervical cancer patients, 69.7% (23/33) versus 0% (0/6), respectively (P=0.003), and longer median progression-free survival, 11.1 months vs 5.8 months, respectively (P=0.01) (PMID: 35192397).	35192397
CD274 positive	cervical cancer	predicted - sensitive	Anlotinib + Sintilimab	Phase II	Actionable	In a Phase II study, a combination of Anlotinib (AL-3818) and Sintilimab (IBI308) resulted in an objective response rate of 54.8% (23/42, 2 complete responses and 21 partial responses) in CD274 (PD-L1)-positive recurrent or metastatic cervical cancer patients, and led to a disease control rate of 88.1% (37/42, 14 with stable disease), a median progression-free survival (PFS) of 9.4 mos and a 6-mo PFS rate of 73.1%, a median overall survival (OS) not reached, and a 12-mo OS rate of 73.8% (PMID: 35192397).	35192397