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The 2021 American Association for Cancer Research (AACR) Annual Meeting will be held online on April 10-15 and May 17-21, 2021.
This annual conference covers the most cutting-edge research results in the field of oncology.
In the special clinical research plenary session, two major studies in the field of liver cancer were announced.
The details are as follows.
IMbrave150 study results are updated again: patients with high-risk liver cancer still benefit! Background: According to the IMbrave150 phase III clinical trial, atelizumab + bevacizumab has been approved globally and is the standard treatment for patients with unresectable HCC who have not received systemic treatment in the past.
After the initial analysis, the follow-up was continued for 12 months (median follow-up time: 15.
6 months).
Atelizumab+bevacizumab showed consistent clinically significant efficacy and safety benefits.
This report reports the latest analysis results considering high-risk factors.
Methods: The patients were randomized 2:1 to receive ativizumab (1200 mg IV q3w) and bevacizumab (15 mg/kg IV q3w) combined therapy or sorafenib (400 mg PO BID).
Until there is no clinical benefit or unacceptable toxicity.
High-risk patients are defined as: patients with tumor invasion of the main portal vein, and/or portal vein tumor thrombi involving the main portal vein or the contralateral first-level branch (Vp4), and/or bile duct invasion and/or patients with tumors accounting for ≥50% of the total liver.
Results: In the ITT population, 64 (19%) patients received atilizumab + bevacizumab, and 37 (22%) patients received sorafenib.
There were 10 patients with biliary invasion, 73 patients with Vp4 portal vein invasion, and 31 patients with tumors accounting for ≥50% of the total liver.
There were 2 high-risk factors in 9 patients in the atilizumab+bevacizumab group, and 2 high-risk factors in 4 patients in the sorafenib group.
Regardless of whether it is a non-high-risk patient or a high-risk patient, the OS, PFS and ORR of the atilizumab+bevacizumab group are better than those of the sorafenib group.
The efficacy results are shown in the table.
Table Efficacy analysis.
Among the safety-evaluable atelizumab+bevacizumab patients, 122 (45%) of the 269 non-high-risk patients had grade 3/4 treatment-related AEs (TRAEs), 60 Among the high-risk patients, 21 (35%) had grade 3/4 TRAEs.
Grade 5 TRAEs occurred in 5 (2%) non-high-risk patients and 1 (2%) high-risk patients.
Conclusion: Regardless of whether the patients with liver cancer are at high risk, compared with sorafenib, atilizumab + bevacizumab can have therapeutic benefits.
Although there are differences in the median OS between non-high-risk and high-risk patients, HRs are still similar.
In addition, there is a significant difference in overall safety between non-high-risk patients and high-risk patients of atilizumab + bevacizumab, and is consistent with the known safety of each drug.
Futibatinib treats intrahepatic cholangiocarcinoma with an ORR of 41.
7%.
Background: The incidence of FGFR2 fusion in intrahepatic cholangiocarcinoma (iCCA) is about 15%, which is a rare cancer with a poor prognosis.
Futibatinib is a highly selective and irreversible covalently bound FGFR1-4 inhibitor.
In the phase 1 study, it showed activity in a variety of tumor types, including iCCA.
The global phase 2 FOENIX-CCA2 study (NCT02052778) aims to evaluate the efficacy and safety of futibatinib in patients with FGFR2 gene fusion/rearrangement iCCA.
This meeting reported for the first time the effectiveness, safety and quality of life (QoL) data of the overall patient population of the FOENIX-CCA2 study.
Methods: The study included patients with unresectable/metastatic iCCA who had FGFR2 fusion/rearrangement, and had disease progression after receiving ≥1 line therapy.
All patients received futibatinib 20 mg once a day until disease progression/intolerance.
The primary endpoint of the study was the ORR assessed by the independent review committee according to RECIST v1.
1 (the default ORR was 20%).
Secondary endpoints include duration of remission (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, and patient-reported outcomes (PROs).
Analyze patient characteristics and molecular changes between different subgroups.
Results: Among 103 patients (56% were women), 53% had previously received ≥2 line therapy.
FGFR2 fusion accounted for 78% (23% of them were patients with FGFR2-BICC1 fusion mutation), and FGFR2 rearrangement accounted for 22%.
As of October 1, 2020, 72 patients have stopped treatment.
The study reached the primary endpoint, with a confirmed ORR of 41.
7% (43/103).
The remission was durable, with a median DOR of 9.
7 months, and 72% of patients had remission duration ≥ 6 months.
The DCR is 82.
5%.
The median PFS was 9.
0 months; the median OS was 21.
7 months, and the 12-month OS rate was 72%.
The ORR results were consistent in all subgroups (≥65 years old: 65.
2%; previous second-line treatment: 38.
7%).
Common treatment-related AEs (TRAE) are hyperphosphatemia (85%), alopecia (33%) and dry mouth (30%).
The most common grade 3 TRAE is hyperphosphatemia (30%), which can be resolved through appropriate management strategies (median: 7 days).
Retinopathy occurred in 8% of patients (all grades 1-2).
For TRAEs, the adverse reaction management strategy of dose interruption (50%)/dose reduction (54%) was adopted; 2 patients stopped treatment due to TRAEs.
No treatment-related deaths occurred.
The ORR of patients who received dose interruption (40.
2%) or dose reduction (46.
8%) was consistent.
After 11.
0 months of treatment, PROs remained stable.
In exploratory biomarker analysis, FGFR2 fusion (43.
8%) and other FGFR2 rearrangements (34.
8%) and BICC1 (41.
7%) and non-BICC1 (44.
6%) fusion patients had the same ORR.
It is worth noting that in patients with coexisting gene mutations, including TP53 mutations (ORR, 38.
5% [5/13]), no significant differences in ORR were observed.
Conclusion: Regardless of the patient's baseline characteristics, molecular changes or gene mutations, futibatinib can achieve long-lasting objective remission in iCCA patients with FGFR2 fusion/rearrangement.
AEs can be managed through dose adjustment strategies without affecting the efficacy.
QoL is maintained.
References: 1.
CT009-IMbrave150: Updated efficacy and safety by risk status in patients (pts) receiving atezolizumab (atezo) + bevacizumab (bev) vs sorafenib (sor) as first-line treatment for unresectable hepatocellular carcinoma (HCC) 2.
CT010-Primary results of phase 2 FOENIX-CCA2: The irreversible FGFR1-4 inhibitor futibatinib in intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions/rearrangements
This annual conference covers the most cutting-edge research results in the field of oncology.
In the special clinical research plenary session, two major studies in the field of liver cancer were announced.
The details are as follows.
IMbrave150 study results are updated again: patients with high-risk liver cancer still benefit! Background: According to the IMbrave150 phase III clinical trial, atelizumab + bevacizumab has been approved globally and is the standard treatment for patients with unresectable HCC who have not received systemic treatment in the past.
After the initial analysis, the follow-up was continued for 12 months (median follow-up time: 15.
6 months).
Atelizumab+bevacizumab showed consistent clinically significant efficacy and safety benefits.
This report reports the latest analysis results considering high-risk factors.
Methods: The patients were randomized 2:1 to receive ativizumab (1200 mg IV q3w) and bevacizumab (15 mg/kg IV q3w) combined therapy or sorafenib (400 mg PO BID).
Until there is no clinical benefit or unacceptable toxicity.
High-risk patients are defined as: patients with tumor invasion of the main portal vein, and/or portal vein tumor thrombi involving the main portal vein or the contralateral first-level branch (Vp4), and/or bile duct invasion and/or patients with tumors accounting for ≥50% of the total liver.
Results: In the ITT population, 64 (19%) patients received atilizumab + bevacizumab, and 37 (22%) patients received sorafenib.
There were 10 patients with biliary invasion, 73 patients with Vp4 portal vein invasion, and 31 patients with tumors accounting for ≥50% of the total liver.
There were 2 high-risk factors in 9 patients in the atilizumab+bevacizumab group, and 2 high-risk factors in 4 patients in the sorafenib group.
Regardless of whether it is a non-high-risk patient or a high-risk patient, the OS, PFS and ORR of the atilizumab+bevacizumab group are better than those of the sorafenib group.
The efficacy results are shown in the table.
Table Efficacy analysis.
Among the safety-evaluable atelizumab+bevacizumab patients, 122 (45%) of the 269 non-high-risk patients had grade 3/4 treatment-related AEs (TRAEs), 60 Among the high-risk patients, 21 (35%) had grade 3/4 TRAEs.
Grade 5 TRAEs occurred in 5 (2%) non-high-risk patients and 1 (2%) high-risk patients.
Conclusion: Regardless of whether the patients with liver cancer are at high risk, compared with sorafenib, atilizumab + bevacizumab can have therapeutic benefits.
Although there are differences in the median OS between non-high-risk and high-risk patients, HRs are still similar.
In addition, there is a significant difference in overall safety between non-high-risk patients and high-risk patients of atilizumab + bevacizumab, and is consistent with the known safety of each drug.
Futibatinib treats intrahepatic cholangiocarcinoma with an ORR of 41.
7%.
Background: The incidence of FGFR2 fusion in intrahepatic cholangiocarcinoma (iCCA) is about 15%, which is a rare cancer with a poor prognosis.
Futibatinib is a highly selective and irreversible covalently bound FGFR1-4 inhibitor.
In the phase 1 study, it showed activity in a variety of tumor types, including iCCA.
The global phase 2 FOENIX-CCA2 study (NCT02052778) aims to evaluate the efficacy and safety of futibatinib in patients with FGFR2 gene fusion/rearrangement iCCA.
This meeting reported for the first time the effectiveness, safety and quality of life (QoL) data of the overall patient population of the FOENIX-CCA2 study.
Methods: The study included patients with unresectable/metastatic iCCA who had FGFR2 fusion/rearrangement, and had disease progression after receiving ≥1 line therapy.
All patients received futibatinib 20 mg once a day until disease progression/intolerance.
The primary endpoint of the study was the ORR assessed by the independent review committee according to RECIST v1.
1 (the default ORR was 20%).
Secondary endpoints include duration of remission (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, and patient-reported outcomes (PROs).
Analyze patient characteristics and molecular changes between different subgroups.
Results: Among 103 patients (56% were women), 53% had previously received ≥2 line therapy.
FGFR2 fusion accounted for 78% (23% of them were patients with FGFR2-BICC1 fusion mutation), and FGFR2 rearrangement accounted for 22%.
As of October 1, 2020, 72 patients have stopped treatment.
The study reached the primary endpoint, with a confirmed ORR of 41.
7% (43/103).
The remission was durable, with a median DOR of 9.
7 months, and 72% of patients had remission duration ≥ 6 months.
The DCR is 82.
5%.
The median PFS was 9.
0 months; the median OS was 21.
7 months, and the 12-month OS rate was 72%.
The ORR results were consistent in all subgroups (≥65 years old: 65.
2%; previous second-line treatment: 38.
7%).
Common treatment-related AEs (TRAE) are hyperphosphatemia (85%), alopecia (33%) and dry mouth (30%).
The most common grade 3 TRAE is hyperphosphatemia (30%), which can be resolved through appropriate management strategies (median: 7 days).
Retinopathy occurred in 8% of patients (all grades 1-2).
For TRAEs, the adverse reaction management strategy of dose interruption (50%)/dose reduction (54%) was adopted; 2 patients stopped treatment due to TRAEs.
No treatment-related deaths occurred.
The ORR of patients who received dose interruption (40.
2%) or dose reduction (46.
8%) was consistent.
After 11.
0 months of treatment, PROs remained stable.
In exploratory biomarker analysis, FGFR2 fusion (43.
8%) and other FGFR2 rearrangements (34.
8%) and BICC1 (41.
7%) and non-BICC1 (44.
6%) fusion patients had the same ORR.
It is worth noting that in patients with coexisting gene mutations, including TP53 mutations (ORR, 38.
5% [5/13]), no significant differences in ORR were observed.
Conclusion: Regardless of the patient's baseline characteristics, molecular changes or gene mutations, futibatinib can achieve long-lasting objective remission in iCCA patients with FGFR2 fusion/rearrangement.
AEs can be managed through dose adjustment strategies without affecting the efficacy.
QoL is maintained.
References: 1.
CT009-IMbrave150: Updated efficacy and safety by risk status in patients (pts) receiving atezolizumab (atezo) + bevacizumab (bev) vs sorafenib (sor) as first-line treatment for unresectable hepatocellular carcinoma (HCC) 2.
CT010-Primary results of phase 2 FOENIX-CCA2: The irreversible FGFR1-4 inhibitor futibatinib in intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions/rearrangements
