J Clin Oncol: PD-1 and CTLA-4 dual blocking second-line treatment of advanced cervical cancer has a significant effect

Cervical cancer is still the most common gynecological malignant tumor worldwide and the fourth leading cause of cancer deaths in women
.

The prognosis of recurrent and/or metastatic cervical cancer is poor, and there is still a need to find more effective treatment options, especially for patients who have progressed after first-line chemotherapy + bevacizumab treatment

Cervical cancer is still the most common gynecological malignant tumor worldwide and the fourth leading cause of cancer deaths in women

The study is an open-label phase II clinical study (NCT03495882).
The included patients were given balstilimab 3mg/kg intravenously every 2 weeks + zalifrelimab 1mg/kgonce every 6 weeks for a total of 24 months of treatment
.

The primary endpoint is the objective response rate (ORR, reviewed and assessed by an independent center)

The study is an open-label phase II clinical study (NCT03495882).

From August 27, 2018 to May 7, 2020, 155 patients were included in the study

The median follow-up time was 21.

Efficacy evaluation

Efficacy assessment Efficacy assessment

ORR subgroup analysis found that the ORR of PD-L1 positive patients (n=67) was 32.
8%, the ORR of PD-L1 negative patients (n=33) was 9.
1%, and the PD-L1 patients with unknown status (n=25) ORR is 28%
.

Patients with squamous cell carcinoma (n=89) had an ORR of 32.

ORR subgroup analysis found that the ORR of PD-L1 positive patients (n=67) was 32.

At the time of the data cutoff, the median progression-free survival (PFS) was 2.

PFS and OS

PFS and OS PFS and OS

The most common treatment-related adverse events (TRAE) of all grades were hypothyroidism (16.
8%), diarrhea (14.
2%), fatigue (11.
6%) and nausea (9.
0%).
Most events were grade 1 or Level 2
.

The overall incidence of grade 3 TRAE was 20.

The most common treatment-related adverse events (TRAE) of all grades were hypothyroidism (16.

Adverse reactions

Adverse reactions adverse reactions

 

69 patients (44.
5%) had imAEs, the most common ones were hypothyroidism (22 cases, 14.
2%), hyperthyroidism and diarrhea (11 cases, 7.
1%)
.

69 patients (44.
5%) had imAEs, the most common ones were hypothyroidism (22 cases, 14.
2%), hyperthyroidism and diarrhea (11 cases, 7.
1%)
.

In summary, this largest clinical trial to date has evaluated the application of PD-1 and CTLA-4 dual blockade in patients with relapsed and/or metastatic cervical cancer, and found promising and long-lasting clinical activity with good Tolerance
.

In summary, this largest clinical trial to date has evaluated the application of PD-1 and CTLA-4 dual blockade in patients with relapsed and/or metastatic cervical cancer, and found promising and long-lasting clinical activity with good Tolerance
.
This largest clinical trial to date evaluated the application of PD-1 and CTLA-4 dual blockade in patients with relapsed and/or metastatic cervical cancer, and found promising and long-lasting clinical activity, with good tolerance Sex
.
This largest clinical trial to date evaluated the application of PD-1 and CTLA-4 dual blockade in patients with relapsed and/or metastatic cervical cancer, and found promising and long-lasting clinical activity, with good tolerance Sex
.

 

Original source:

Original source:

O'Malley DM, Neffa M, Monk BJ, Melkadze T, Huang M, Kryzhanivska A, Bulat I, Meniawy TM, Bagameri A, Wang EW, Doger de Speville Uribe B, Hegg R, Ortuzar Feliu W, Ancukiewicz M, Lugowska I .
Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study.
J Clin Oncol.
2021 Dec 21:JCO2102067.
doi: 10.
1200/JCO.
21.
02067.
Epub ahead of print.
PMID: 34932394.

O'Malley DM, Neffa M, Monk BJ, Melkadze T, Huang M, Kryzhanivska A, Bulat I, Meniawy TM, Bagameri A, Wang EW, Doger de Speville Uribe B, Hegg R, Ortuzar Feliu W, Ancukiewicz M, Lugowska I .
Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study.
J Clin Oncol.
2021 Dec 21:JCO2102067.
doi: 10.
1200/JCO.
21.
02067.
Epub ahead of print.
PMID: 34932394.
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