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Established in 1907, the AACR Association is the world's earliest and largest scientific organization dedicated to comprehensive, innovative and high-level cancer research.
Many large-scale research results will be announced at the conference.
The first week of this AACR annual meeting ended on April 15.
During the meeting, NEPTUNES Research Cohort 1 published research data.
Background: Patients with metastatic castration-resistant prostate cancer (mCRPC) have limited response to single-agent immune checkpoint inhibitors, which may be caused by the "cold" tumor immune microenvironment.
The researchers hypothesized that mCRPC patients are more likely to respond to immunogenicity positive (ImS+) patients.
At this AACR conference, researchers announced the efficacy and safety of nivolumab + ipilimumab in the NEPTUNES study cohort 1 for ImS + mCRPC.
Methods: Patients who have received at least first-line treatment progress and ImS + mCRPC were included in the study.
ImS+ is defined as meeting at least one of the following conditions: 1) Mismatch repair defects (MMRD) detected by immunohistochemistry (IHC); 2) DNA damage repair defects detected by UW-OncoPlex targeted exome sequencing (DDRD) (excluding MMRD); 3) High tumor infiltrating lymphocytes (TIL) (nucleated CD4, CD8 or FoxP3 +> 20%) detected by immunohistochemistry.
Enrolled patients received nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) (Q3W, 4 doses), followed by nivolumab (Q4W, 480 mg).
The primary endpoint is the comprehensive response rate (CRR), which is defined as meeting at least one of the following conditions: 1) Radiological response assessed according to RECIST 1.
1 standard; 2) PSA response rate ≥50%; 3) circulating tumor cells at week 9 ( CTC) changes.
If the CRR is less than 20%, the treatment is considered invalid.
Results: A total of 211 patients were screened, 50 of which were ImS positive, 35 patients received nivolumab + ipilimumab, the median follow-up time was 7.
2 months, and the total CRR was 26% (9/35 ).
Response/Influencing factors for ImS positive in all treated patients include MMRD (n = 4/5), BRCA1/2 (n = 3/4), high TIL (n = 2/9) and CDK12 (n = 1/7) .
The median duration of remission of responders was 4.
9 months, and the incidence of grade 3 to 4 treatment-related adverse events was 49% (17/35).
Conclusion: Nivolumab+ipilimumab showed significant anti-tumor activity in mCRPC patients screened after treatment.
The safety is consistent with previous research.
Reference LB004-Nivolumab (NIVO) and ipilimumab (IPI) treatment in prostate cancer with an immunogenic signature: cohort 1 of the NEPTUNES multi-centre, two-stage biomarker-selected Phase II trial.
Many large-scale research results will be announced at the conference.
The first week of this AACR annual meeting ended on April 15.
During the meeting, NEPTUNES Research Cohort 1 published research data.
Background: Patients with metastatic castration-resistant prostate cancer (mCRPC) have limited response to single-agent immune checkpoint inhibitors, which may be caused by the "cold" tumor immune microenvironment.
The researchers hypothesized that mCRPC patients are more likely to respond to immunogenicity positive (ImS+) patients.
At this AACR conference, researchers announced the efficacy and safety of nivolumab + ipilimumab in the NEPTUNES study cohort 1 for ImS + mCRPC.
Methods: Patients who have received at least first-line treatment progress and ImS + mCRPC were included in the study.
ImS+ is defined as meeting at least one of the following conditions: 1) Mismatch repair defects (MMRD) detected by immunohistochemistry (IHC); 2) DNA damage repair defects detected by UW-OncoPlex targeted exome sequencing (DDRD) (excluding MMRD); 3) High tumor infiltrating lymphocytes (TIL) (nucleated CD4, CD8 or FoxP3 +> 20%) detected by immunohistochemistry.
Enrolled patients received nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) (Q3W, 4 doses), followed by nivolumab (Q4W, 480 mg).
The primary endpoint is the comprehensive response rate (CRR), which is defined as meeting at least one of the following conditions: 1) Radiological response assessed according to RECIST 1.
1 standard; 2) PSA response rate ≥50%; 3) circulating tumor cells at week 9 ( CTC) changes.
If the CRR is less than 20%, the treatment is considered invalid.
Results: A total of 211 patients were screened, 50 of which were ImS positive, 35 patients received nivolumab + ipilimumab, the median follow-up time was 7.
2 months, and the total CRR was 26% (9/35 ).
Response/Influencing factors for ImS positive in all treated patients include MMRD (n = 4/5), BRCA1/2 (n = 3/4), high TIL (n = 2/9) and CDK12 (n = 1/7) .
The median duration of remission of responders was 4.
9 months, and the incidence of grade 3 to 4 treatment-related adverse events was 49% (17/35).
Conclusion: Nivolumab+ipilimumab showed significant anti-tumor activity in mCRPC patients screened after treatment.
The safety is consistent with previous research.
Reference LB004-Nivolumab (NIVO) and ipilimumab (IPI) treatment in prostate cancer with an immunogenic signature: cohort 1 of the NEPTUNES multi-centre, two-stage biomarker-selected Phase II trial.
