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The 2022 American Society of Clinical Oncology Annual Meeting on Genitourinary Oncology (ASCO-GU) will be held from February 17 to February 19, 2022, Eastern Time.
ASCO-GU is one of the annual events in the field of urologic oncology
.
Recently, the ASCO official website has published the abstract content, and the results of a number of blockbuster studies in the field of urological oncology have been announced
.
In the plenary session, the researchers announced the results of the Phase III QUILT 3.
032 study, which brings a new option for bladder preservation in high-grade non-muscle invasive bladder cancer (NMIBC)
.
Background N-803 is a high-affinity IL-15 immunostimulatory fusion protein that promotes the proliferation and activation of NK cells and CD8+ T cells, but not Treg cells
.
A phase Ib trial showed that intravesical infusion of N-803 + Bacille Calmette-Guérin (BCG) could achieve complete remission in all BCG-naïve NMIBC patients with no recurrence for 24 months
.
QUILT 3.
032 is an open-label, multicenter Phase 3 study to investigate the efficacy of intravesical infusion of BCG + N-803 in BCG-unresponsive high-grade NMIBC carcinoma in situ (CIS) cohorts and papillary lesions
.
At the 2021 ASCO GU meeting, the investigators presented the results of the CIS cohort A, and the interim analysis of the fully enrolled CIS cohort (n = 81) and the papillary lesion cohort B (n = 73) were presented at this ASCO-GU meeting , and the overall efficacy and safety of N-803+BCG
.
Methods: All enrolled patients received N-803+BCG therapy
.
The primary endpoints for the papillary lesion cohort and the CIS cohort were 12-month disease-free survival and complete response (CR) rate, respectively
.
Secondary endpoints were duration of remission and bladder retention rate
.
Results: Cohort A (CIS) Efficacy: Cohort A included 81 patients with a median follow-up of 20.
9 months
.
The CR rate was 72% (95% CI: 60.
5%, 81.
1%), the median duration of 3-month responders was 24.
1 months, and 60% of patients maintained CR for more than 18 months
.
The 12-month bladder preservation (without cystectomy) rate was 89% (95% CI: 80.
1%, 94.
6%), and the 24-month tumor-specific survival rate was 100%
.
Cohort B (Papillary Lesions) Efficacy: To date, 73 patients have been enrolled with a median follow-up of 17.
3 months
.
The study met its primary endpoint, with 12- and 18-month disease-free survival rates of 57% (95% CI: 43.
7%, 68.
5%) and 53% (95% CI: 38.
8%, 64.
8%), respectively
.
The 12-month bladder retention rate was 95% (95% CI: 84.
7%, 98.
3%), and the 24-month tumor-specific survival rate was 98%
.
Composite efficacy: In the BCG-unresponsive NMIBC combination group (n = 154), with a median follow-up of 19.
3 months, the bladder retention rate was 92% (95% CI: 85.
5%, 95.
3%) at 12 months, 92% (95% CI: 85.
5%, 95.
3%) at 24 months The OS rate was 94% (95% CI: 86.
9%, 97.
1%) and the tumor-specific overall survival rate was 99.
5%
.
Safety: No treatment-related serious adverse events (SAEs) and immune-related SAEs occurred.
The incidence of grade 3 or higher adverse events was 3%.
As of September 2021, there were no treatment-related deaths
.
Conclusions: N-803 + BCG was safe and well tolerated, with a 0% incidence of treatment-related or immune-related serious adverse events
.
Both the CIS cohort and the papillary lesion cohort met the primary endpoint with a CR rate of 72% (CIS cohort) and a 12-month disease-free survival rate of 57% (papillary lesion cohort)
.
Durable patient responses were observed in both cohorts, with patients significantly avoiding cystectomy, a bladder retention rate of 92%, and a 24-month tumor-specific survival rate of 99.
5%
.
The study shows that the combination therapy has strong efficacy, good safety and good mode of administration; the study suggests that N-803 can be used as BCG-unresponsive NMIBC patients (CIS, papillary lesions) compared with existing therapies new choice
.
Reference: positive efficacy and safety phase 3 results in both CIS and papillary cohorts BC Gunresponsive nonmuscle invasive bladder cancer (NMIBC) after IL-15RaFc superagonist N-803 (Anktiva) and BCG infusion.
Abstract 431 General Session
ASCO-GU is one of the annual events in the field of urologic oncology
.
Recently, the ASCO official website has published the abstract content, and the results of a number of blockbuster studies in the field of urological oncology have been announced
.
In the plenary session, the researchers announced the results of the Phase III QUILT 3.
032 study, which brings a new option for bladder preservation in high-grade non-muscle invasive bladder cancer (NMIBC)
.
Background N-803 is a high-affinity IL-15 immunostimulatory fusion protein that promotes the proliferation and activation of NK cells and CD8+ T cells, but not Treg cells
.
A phase Ib trial showed that intravesical infusion of N-803 + Bacille Calmette-Guérin (BCG) could achieve complete remission in all BCG-naïve NMIBC patients with no recurrence for 24 months
.
QUILT 3.
032 is an open-label, multicenter Phase 3 study to investigate the efficacy of intravesical infusion of BCG + N-803 in BCG-unresponsive high-grade NMIBC carcinoma in situ (CIS) cohorts and papillary lesions
.
At the 2021 ASCO GU meeting, the investigators presented the results of the CIS cohort A, and the interim analysis of the fully enrolled CIS cohort (n = 81) and the papillary lesion cohort B (n = 73) were presented at this ASCO-GU meeting , and the overall efficacy and safety of N-803+BCG
.
Methods: All enrolled patients received N-803+BCG therapy
.
The primary endpoints for the papillary lesion cohort and the CIS cohort were 12-month disease-free survival and complete response (CR) rate, respectively
.
Secondary endpoints were duration of remission and bladder retention rate
.
Results: Cohort A (CIS) Efficacy: Cohort A included 81 patients with a median follow-up of 20.
9 months
.
The CR rate was 72% (95% CI: 60.
5%, 81.
1%), the median duration of 3-month responders was 24.
1 months, and 60% of patients maintained CR for more than 18 months
.
The 12-month bladder preservation (without cystectomy) rate was 89% (95% CI: 80.
1%, 94.
6%), and the 24-month tumor-specific survival rate was 100%
.
Cohort B (Papillary Lesions) Efficacy: To date, 73 patients have been enrolled with a median follow-up of 17.
3 months
.
The study met its primary endpoint, with 12- and 18-month disease-free survival rates of 57% (95% CI: 43.
7%, 68.
5%) and 53% (95% CI: 38.
8%, 64.
8%), respectively
.
The 12-month bladder retention rate was 95% (95% CI: 84.
7%, 98.
3%), and the 24-month tumor-specific survival rate was 98%
.
Composite efficacy: In the BCG-unresponsive NMIBC combination group (n = 154), with a median follow-up of 19.
3 months, the bladder retention rate was 92% (95% CI: 85.
5%, 95.
3%) at 12 months, 92% (95% CI: 85.
5%, 95.
3%) at 24 months The OS rate was 94% (95% CI: 86.
9%, 97.
1%) and the tumor-specific overall survival rate was 99.
5%
.
Safety: No treatment-related serious adverse events (SAEs) and immune-related SAEs occurred.
The incidence of grade 3 or higher adverse events was 3%.
As of September 2021, there were no treatment-related deaths
.
Conclusions: N-803 + BCG was safe and well tolerated, with a 0% incidence of treatment-related or immune-related serious adverse events
.
Both the CIS cohort and the papillary lesion cohort met the primary endpoint with a CR rate of 72% (CIS cohort) and a 12-month disease-free survival rate of 57% (papillary lesion cohort)
.
Durable patient responses were observed in both cohorts, with patients significantly avoiding cystectomy, a bladder retention rate of 92%, and a 24-month tumor-specific survival rate of 99.
5%
.
The study shows that the combination therapy has strong efficacy, good safety and good mode of administration; the study suggests that N-803 can be used as BCG-unresponsive NMIBC patients (CIS, papillary lesions) compared with existing therapies new choice
.
Reference: positive efficacy and safety phase 3 results in both CIS and papillary cohorts BC Gunresponsive nonmuscle invasive bladder cancer (NMIBC) after IL-15RaFc superagonist N-803 (Anktiva) and BCG infusion.
Abstract 431 General Session
