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Introduce the information disclosure of the 2022 ASCO conference summary, and publish the results of a number of studi.
One of the studies of MEDI5752 monotherapy in advanced renal cell carcinoma has published efficacy data, which deserves attenti.
Background MEDI5752 is a monovalent bispecific antibody targeting PD-1 and CTLA-A phase 1, open-label study demonstrated encouraging antitumor activity of MEDI5752 as a single agent (25-2500 mg IV every 3 weeks) in advanced solid tumo.
The study has not yet reached the maximum tolerated do.
When the dose is less than 1500 mg, the patient's tolerance is better than that of the dose ≥ 1500 .
At this meeting, the researchers announced the preliminary results of patients with advanced renal cell carcinoma (RCC) in the Escalation (ESC) cohort and the Expansion (EXP) coho.
STUDY METHODS Eligible patients ≥18 years of age (ECOG PS 0-1) were included in the stu.
Patients in the ESC and EXP cohorts were previously treatment-naïve (1L) or refracto.
Patients in the EXP cohort were clear cell renal cell carcinoma (ccRCC), immunotherapy-naïve and ≤2 prior lines of thera.
Patients were treated until disease progression or unacceptable toxici.
The study mainly observed drug safety and tolerability (ESC cohort), and assessed antitumor activity according to RECIST v1 criteria (EXP cohor.
RESULTS: A total of 46 RCC patients received treatment, 19 in the ESC cohort and 27 in the EXP coho.
In the ESC cohort, patients (none immunotherapy-naïve, 77% nephrectomy, 23% 1L, 85% histological clear cell carcinoma) received 3 dose gradients: 750 mg (n=1), 2000 mg ( n=16), 2500mg (n=
Seven patients (38%) achieved objective response (all partial response.
In the EXP cohort, patients (none were immunotherapy-naïve, 60% had nephrectomy, 41% were 1L [of which 62% were IMDC intermediate/high risk], 93% histologically clear cell carcinoma) received MEDI5752 (1500 mg) , intravenous injection every 3 weeks), 10 patients achieved objective remission (2 complete remission, 8 partial remissio.
In the 1L EXP cohort, 53% achieved objective responses (1 complete response, 6 partial responses), with a disease control rate (DCR) of 97% (see Table
The incidence of grade 3/4 treatment-related adverse events (TRAEs) in the ESC cohort and EXP cohort was 64% and 71%, respective.
In the EXP cohort, treatment-emergent adverse events (TEAEs), especially liver toxicity, were the most common reasons for discontinuation of treatment (D/.
With a median follow-up of 16 months, median duration of response (DOR, including discontinuation of MEDI5752 treatment due to adverse events), median progression-free survival, and median overall survival were not reached for patients in the EXP coho.
Table 1 Efficacy data from different cohorts of patients Conclusions MEDI5752 monotherapy demonstrated deep and durable antitumor activity in advanced RCC patients despite a high rate of discontinuation of treatme.
To better characterize the risk-benefit profile, investigators are exploring MEDI5752 doses <1500mg in the 1L ccRCC expansion cohort, let's look forward to the follow-up resul.
Reference: Laurence Albiges, Safety and clinical activity of MEDI5752, a PD-1/CTLA-4 bispecific checkpoint inhibitor, as monotherapy in patients (pts) with advanced renalcell carcinoma (RCC): Preliminary results from an FTIH tri.
J Clin Oncol 40, 2022 (suppl 16; abstr 10
DOI 11200/J.
202416_sup.
10 Editor: LR Reviewer: LR Execution: LR
One of the studies of MEDI5752 monotherapy in advanced renal cell carcinoma has published efficacy data, which deserves attenti.
Background MEDI5752 is a monovalent bispecific antibody targeting PD-1 and CTLA-A phase 1, open-label study demonstrated encouraging antitumor activity of MEDI5752 as a single agent (25-2500 mg IV every 3 weeks) in advanced solid tumo.
The study has not yet reached the maximum tolerated do.
When the dose is less than 1500 mg, the patient's tolerance is better than that of the dose ≥ 1500 .
At this meeting, the researchers announced the preliminary results of patients with advanced renal cell carcinoma (RCC) in the Escalation (ESC) cohort and the Expansion (EXP) coho.
STUDY METHODS Eligible patients ≥18 years of age (ECOG PS 0-1) were included in the stu.
Patients in the ESC and EXP cohorts were previously treatment-naïve (1L) or refracto.
Patients in the EXP cohort were clear cell renal cell carcinoma (ccRCC), immunotherapy-naïve and ≤2 prior lines of thera.
Patients were treated until disease progression or unacceptable toxici.
The study mainly observed drug safety and tolerability (ESC cohort), and assessed antitumor activity according to RECIST v1 criteria (EXP cohor.
RESULTS: A total of 46 RCC patients received treatment, 19 in the ESC cohort and 27 in the EXP coho.
In the ESC cohort, patients (none immunotherapy-naïve, 77% nephrectomy, 23% 1L, 85% histological clear cell carcinoma) received 3 dose gradients: 750 mg (n=1), 2000 mg ( n=16), 2500mg (n=
Seven patients (38%) achieved objective response (all partial response.
In the EXP cohort, patients (none were immunotherapy-naïve, 60% had nephrectomy, 41% were 1L [of which 62% were IMDC intermediate/high risk], 93% histologically clear cell carcinoma) received MEDI5752 (1500 mg) , intravenous injection every 3 weeks), 10 patients achieved objective remission (2 complete remission, 8 partial remissio.
In the 1L EXP cohort, 53% achieved objective responses (1 complete response, 6 partial responses), with a disease control rate (DCR) of 97% (see Table
The incidence of grade 3/4 treatment-related adverse events (TRAEs) in the ESC cohort and EXP cohort was 64% and 71%, respective.
In the EXP cohort, treatment-emergent adverse events (TEAEs), especially liver toxicity, were the most common reasons for discontinuation of treatment (D/.
With a median follow-up of 16 months, median duration of response (DOR, including discontinuation of MEDI5752 treatment due to adverse events), median progression-free survival, and median overall survival were not reached for patients in the EXP coho.
Table 1 Efficacy data from different cohorts of patients Conclusions MEDI5752 monotherapy demonstrated deep and durable antitumor activity in advanced RCC patients despite a high rate of discontinuation of treatme.
To better characterize the risk-benefit profile, investigators are exploring MEDI5752 doses <1500mg in the 1L ccRCC expansion cohort, let's look forward to the follow-up resul.
Reference: Laurence Albiges, Safety and clinical activity of MEDI5752, a PD-1/CTLA-4 bispecific checkpoint inhibitor, as monotherapy in patients (pts) with advanced renalcell carcinoma (RCC): Preliminary results from an FTIH tri.
J Clin Oncol 40, 2022 (suppl 16; abstr 10
DOI 11200/J.
202416_sup.
10 Editor: LR Reviewer: LR Execution: LR