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Metabolic abnormalities caused by overexpression of glutaminase (one of the key enzymes in glutamine metabolism) (GLS) are one of the main signs of renal cancer (RCC).
Telaglenastat (Tela) is a pioneering researcher developed , Selective oral GLS inhibitors can prevent the effect of glutamine and block key downstream signaling pathways
.
Preclinical studies have shown that Telaglenastat and Cabozantinib (a VEGFR2/MET/AXL inhibitor) can produce synergistic anti-tumor effects
.
In the phase I study, Telaglenastat+cabotinib showed better safety and efficacy when used in the second-line treatment of metastatic RCC (mRCC)
.
The CANTATA study explored the efficacy and safety of Telaglenastat+Cabotinib versus placebo+Cabotinib in patients with treated metastatic clear cell renal cell carcinoma (NCT03428217)
.
At this year's ASCO conference, the study announced preliminary research data
.
Methods: Eligible mRCC patients have received 1-2 line system therapy, including ≥1 anti-vascular therapy or nivolumab+ipilimumab, KPS ≥70%, and have measurable lesions assessed according to RECIST 1.
1 standard.
He has not been treated with cabozantinib or other MET inhibitors in the past
.
The enrolled patients were randomly assigned to receive Cabotinib (60 mg PO QD) + Telaglenastat (800 mg PO BID) or Cabotinib + placebo at a 1:1 ratio until disease progression or unacceptable toxicity occurs
.
Stratification factors include whether they have received PD-1/PD-L1 inhibitors and IMDC risk classification
.
The primary endpoint was the blinded independent radiology committee (BIRC) assessment of progression-free survival (PFS, assessed according to the RECIST 1.
1 standard)
.
The data deadline is August 31, 2020
.
Results: 444 patients were randomized.
Telaglenastat+cabotinib and placebo+cabotinib had 221 and 223 patients, respectively.
The baseline characteristics of the two groups were balanced and comparable
.
At a median follow-up of 11.
7 months, 276 patients had previously received immune checkpoint inhibitor therapy, of which 128 patients had previously received nivolumab + ipilimumab
.
The median PFS of the Telaglenastat+cabotinib group and the placebo+cabotinib group were 9.
2 months and 9.
3 months, respectively (HR = 0.
94; 95% CI: 0.
74, 1.
21; P = 0.
65).
The response rate (ORR) was 31% and 28%, respectively
.
At the time of data analysis, the overall survival (OS) results were not yet mature
.
In the specific subgroups previously receiving immunotherapy, the median PFS of the Telaglenastat+cabotinib group and the placebo+cabotinib group were 11.
1 months and 9.
2 months, respectively (HR=0.
77; 95% CI: 0.
56, 1.
06)
.
In the placebo+cabotinib group, the median PFS of patients who received immunotherapy was 9.
2 months, the median PFS of patients who did not receive immunotherapy was 9.
5 months, and the ORR was 32% and 20%, respectively.
Including nivolumab + ipilimumab, ORR is 37%
.
The incidence of adverse events in the Telaglenastat+cabotinib group was similar to that in the placebo+cabotinib group.
The incidence of grade 3-4 adverse events was 71% and 79%, including hypertension (17% vs 18%) and diarrhea ( 15% vs 13%)
.
Cabozantinib was discontinued in 10% and 15% of patients in the two groups due to adverse events
.
Conclusion: The addition of Telaglenastat did not further improve the efficacy of mRCC
.
The Telaglenastat+cabotinib combination regimen was well tolerated, and the adverse events were consistent with the known conditions of each single agent
.
This study provides valuable efficacy data for mRCC patients receiving cabozantinib in the second or third line
.
Clinical trial information: NCT03428217
.
Reference: CANTATA: Primary analysis of a global, randomized, placebo (Pbo)-controlled, double-blind trial of telaglenastat (CB-839) + cabozantinib versus Pbo + cabozantinib in advanced/metastatic renal cell carcinoma (mRCC) patients (pts ) who progressed on immune checkpoint inhibitor (ICI) or anti-angiogenic therapies.
.
abstract 4501.
Oral Abstract Session
Telaglenastat (Tela) is a pioneering researcher developed , Selective oral GLS inhibitors can prevent the effect of glutamine and block key downstream signaling pathways
.
Preclinical studies have shown that Telaglenastat and Cabozantinib (a VEGFR2/MET/AXL inhibitor) can produce synergistic anti-tumor effects
.
In the phase I study, Telaglenastat+cabotinib showed better safety and efficacy when used in the second-line treatment of metastatic RCC (mRCC)
.
The CANTATA study explored the efficacy and safety of Telaglenastat+Cabotinib versus placebo+Cabotinib in patients with treated metastatic clear cell renal cell carcinoma (NCT03428217)
.
At this year's ASCO conference, the study announced preliminary research data
.
Methods: Eligible mRCC patients have received 1-2 line system therapy, including ≥1 anti-vascular therapy or nivolumab+ipilimumab, KPS ≥70%, and have measurable lesions assessed according to RECIST 1.
1 standard.
He has not been treated with cabozantinib or other MET inhibitors in the past
.
The enrolled patients were randomly assigned to receive Cabotinib (60 mg PO QD) + Telaglenastat (800 mg PO BID) or Cabotinib + placebo at a 1:1 ratio until disease progression or unacceptable toxicity occurs
.
Stratification factors include whether they have received PD-1/PD-L1 inhibitors and IMDC risk classification
.
The primary endpoint was the blinded independent radiology committee (BIRC) assessment of progression-free survival (PFS, assessed according to the RECIST 1.
1 standard)
.
The data deadline is August 31, 2020
.
Results: 444 patients were randomized.
Telaglenastat+cabotinib and placebo+cabotinib had 221 and 223 patients, respectively.
The baseline characteristics of the two groups were balanced and comparable
.
At a median follow-up of 11.
7 months, 276 patients had previously received immune checkpoint inhibitor therapy, of which 128 patients had previously received nivolumab + ipilimumab
.
The median PFS of the Telaglenastat+cabotinib group and the placebo+cabotinib group were 9.
2 months and 9.
3 months, respectively (HR = 0.
94; 95% CI: 0.
74, 1.
21; P = 0.
65).
The response rate (ORR) was 31% and 28%, respectively
.
At the time of data analysis, the overall survival (OS) results were not yet mature
.
In the specific subgroups previously receiving immunotherapy, the median PFS of the Telaglenastat+cabotinib group and the placebo+cabotinib group were 11.
1 months and 9.
2 months, respectively (HR=0.
77; 95% CI: 0.
56, 1.
06)
.
In the placebo+cabotinib group, the median PFS of patients who received immunotherapy was 9.
2 months, the median PFS of patients who did not receive immunotherapy was 9.
5 months, and the ORR was 32% and 20%, respectively.
Including nivolumab + ipilimumab, ORR is 37%
.
The incidence of adverse events in the Telaglenastat+cabotinib group was similar to that in the placebo+cabotinib group.
The incidence of grade 3-4 adverse events was 71% and 79%, including hypertension (17% vs 18%) and diarrhea ( 15% vs 13%)
.
Cabozantinib was discontinued in 10% and 15% of patients in the two groups due to adverse events
.
Conclusion: The addition of Telaglenastat did not further improve the efficacy of mRCC
.
The Telaglenastat+cabotinib combination regimen was well tolerated, and the adverse events were consistent with the known conditions of each single agent
.
This study provides valuable efficacy data for mRCC patients receiving cabozantinib in the second or third line
.
Clinical trial information: NCT03428217
.
Reference: CANTATA: Primary analysis of a global, randomized, placebo (Pbo)-controlled, double-blind trial of telaglenastat (CB-839) + cabozantinib versus Pbo + cabozantinib in advanced/metastatic renal cell carcinoma (mRCC) patients (pts ) who progressed on immune checkpoint inhibitor (ICI) or anti-angiogenic therapies.
.
abstract 4501.
Oral Abstract Session
