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Neuroendocrine tumors (NEN) are made up of a diverse group of tumors, including low-grade gastrointestinal and pancreatic neuroendocrine tumors (GEP-NET), thymic and pulmonary neuroendocrine tumors, and aggressive, fast-growing neuroendocrine carcinomas
.
Treatment options for patients with metastatic neuroendocrine tumors are limited
.
The results
of a phase 2 non-randomized trial of nivolumab plus temozolomide for advanced EN are reported here.
This is a non-randomized, multi-cohort, single-center Phase 2 trial that enrolled patients with advanced NEN and relapsed/metastatic small cell lung cancer to be treated with nivolumab (480 mg/4 weeks) plus temozolomide (150 mg/m2 orally, days 1-5/28) until disease progression or intolerable toxicity
.
The primary endpoint was remission rate
.
Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety
.
Progression-free survival and overall survival
A total of 28 patients with advanced NEN were enrolled, with a response rate of 32.
1% (9/28; 95% CI 15.
9 to 52.
4%)
.
In 11 patients with pulmonary NEO, the response rate was as high as 64% (7/11); Response rates vary significantly between sites of primary tumour (lung versus other sites; p=0.
020）
。 The median PFS was 8.
8 months (95% CI 3.
9 to 11.
1 months) and the median OS was 32.
3 months (95% CI 20.
7 - not reached).
Number of CD8+ and CD4+ T cells before and after treatment
Exploratory blood immune cell profiling showed that after two weeks of treatment, the number of circulating CD8+ T cells increased (27.
9±13.
4% vs 31.
7±14.
6%, p=0.
03) and the number of CD4+ T cells decreased (59.
6±13.
1% vs 56.
5±13.
0%, p=0.
001).
In patients who achieved a partial response, the number of total T cells expressing LAG-3 was low (0.
18±0.
24% versus 0.
83±0.
55%, p=0.
028).
MDSC levels were elevated during the study, but were not
associated with the response.
In conclusion, nivolumab combined with temozolomide has shown promising activity
in patients with neuroendocrine tumors.
Original source:
Dwight H.
Owen, Brooke Benner, Lai Wei, et al.
A phase 2 clinical trial of nivolumab and temozolomide for neuroendocrine neoplasms.
Clin Cancer Res 2022; https://doi.
org/10.
1158/1078-0432.
CCR-22-1552
