J Immunother Cancer: Efficacy and safety of Nivolumab combined with ipilimumab in the treatment of rare advanced gynecological tumors: from the CA209-538 clinical study

Rare cancer patients account for 55% of all gynecological malignancies.
Due to limited treatment options, the prognosis is poor
.
Nivolumab combined with ipilimumab immunotherapy has shown significant clinical efficacy in a series of common malignant tumors

.

Rare cancer patients account for 55% of all gynecological malignancies.

This multicenter phase II study included 43 patients with advanced rare gynecological tumors

.

This multicenter phase II study included 43 patients with advanced rare gynecological tumors

Clinical features

Clinical features Clinical features

Overall, at the time of data analysis (November 2020), 20 of the 43 patients (47%) were alive, with a median follow-up time of 16.

8 months

Overall, at the time of data analysis (November 2020), 20 of the 43 patients (47%) were alive, with a median follow-up time of 16.

The objective remission rate of the image-evaluable population was 36% (12/33), and the objective remission rate of the intention-to-treat population was 28% (12/43)

Efficacy evaluation

Efficacy assessment Efficacy assessment

The median progression-free survival (PFS) and overall survival (OS) of the entire cohort were 2.
8 months (95% CI: 2.
6-6.
7) and 15.

8 months (95% CI: 5.
8-19.
1), respectively

The median progression-free survival (PFS) and overall survival (OS) of the entire cohort were 2.

OS and PFS

OS and PFS

Overall, 31 of the 43 patients (72%) had immune-related adverse events of any grade, and 7 (16%) patients had immune-related toxicities of grade 3 or higher

.

Overall, 31 of the 43 patients (72%) had immune-related adverse events of any grade, and 7 (16%) patients had immune-related toxicities of grade 3 or higher

Adverse reactions

Adverse reactions

At least 1% of the tumor cells of 24 patients (73%) were positive for PD-L1 expression, and 11 patients (46%) had an objective response
.
Among the 9 patients with PD-L1-negative tumors, only 1 (11%) received treatment response
.
Tumor DNA sequencing was performed on the tumors of all 33 patients to assess TMB
.
The majority of these tumors have TMB less than 10/MB (MB), and there is no difference in median TMB between the patient's objective remission and SD or disease progression
.

At least 1% of the tumor cells of 24 patients (73%) were positive for PD-L1 expression, and 11 patients (46%) had an objective response
.
Among the 9 patients with PD-L1-negative tumors, only 1 (11%) received treatment response
.
Tumor DNA sequencing was performed on the tumors of all 33 patients to assess TMB
.
The majority of these tumors have TMB less than 10/MB (MB), and there is no difference in median TMB between the patient's objective remission and SD or disease progression
.

Marker exploration

Marker exploration Marker exploration

In summary, studies have shown that the combined treatment of Ipilimumab and nivolumab has significant clinical activity and good safety in advanced rare gynecological malignancies, and it is worthy of further study
.

In summary, studies have shown that the combined treatment of Ipilimumab and nivolumab has significant clinical activity and good safety in advanced rare gynecological malignancies, and it is worthy of further study
.
Studies have shown that the combination therapy of Ipilimumab and nivolumab has significant clinical activity and good safety in advanced rare gynecological malignancies, and it is worthy of further study
.
Studies have shown that the combination therapy of Ipilimumab and nivolumab has significant clinical activity and good safety in advanced rare gynecological malignancies, and it is worthy of further study
.

Original source:

Original source:

Klein O, Kee D, Gao B, et al.
Combination immunotherapy with nivolumab and ipilimumab in patients with rare gynecological malignancies: results of the CA209- 538 clinical trial.
Journal for ImmunoTherapy of Cancer 2021;9:e003156.
doi:10.
1136/jitc -2021-003156

Klein O, Kee D, Gao B, et al.
Combination immunotherapy with nivolumab and ipilimumab in patients with rare gynecological malignancies: results of the CA209- 538 clinical trial.
Journal for ImmunoTherapy of Cancer 2021;9:e003156.
doi:10.
1136/jitc -2021-003156 leave a message here