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DRUG:

erfonrilimab (KN046)

i
Other names: KN046, KN-046, KN 046
Company:
Alphamab
Drug class:
PD-L1 inhibitor, CTLA4 inhibitor
Related drugs:
5ms
Surufatinib Combined With KN046 and AG Regimen Chemotherapy as First-Line Treatment for Unresectable Advanced Pancreatic Cancer (clinicaltrials.gov)
P1/2, N=41, Recruiting, Shanghai Zhongshan Hospital | Trial primary completion date: Jun 2024 --> Nov 2024
Trial primary completion date • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
gemcitabine • albumin-bound paclitaxel • erfonrilimab (KN046) • Sulanda (surufatinib)
6ms
Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC (clinicaltrials.gov)
P2, N=18, Recruiting, Peking University | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
capecitabine • oxaliplatin • erfonrilimab (KN046) • anbenitamab (KN026)
7ms
Study of KN046 in Subjects With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
P2, N=54, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Enrolling by invitation --> Recruiting | Trial completion date: Mar 2024 --> Dec 2027 | Trial primary completion date: Mar 2023 --> May 2027
Enrollment status • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
ALK translocation • EGFR negative
|
Inlyta (axitinib) • erfonrilimab (KN046)
7ms
KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor (clinicaltrials.gov)
P1, N=48, Completed, Peking University | Active, not recruiting --> Completed
Trial completion
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
erfonrilimab (KN046) • anbenitamab (KN026)
8ms
KN046, a bispecific antibody against PD-L1 and CTLA-4, plus chemotherapy as first-line treatment for metastatic NSCLC: A multicenter phase 2 trial. (PubMed, Cell Rep Med)
In this multicenter phase 2 trial, patients with nonsquamous (non-sq) NSCLC receive pemetrexed, whereas those with sq-NSCLC receive paclitaxel, plus KN046 and carboplatin. These findings indicate that first-line treatment with KN046 and chemotherapy is effective and tolerable in metastatic NSCLC patients, warranting further investigation in a larger phase 3 trial. The trial is registered at ClinicalTrials.gov (NCT04054531).
P2 data • Journal • Metastases
|
PD-L1 (Programmed death ligand 1)
|
carboplatin • paclitaxel • pemetrexed • erfonrilimab (KN046)
8ms
The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
P2, N=55, Completed, Peking University Cancer Hospital & Institute | Recruiting --> Completed | Trial completion date: May 2023 --> Mar 2024
Trial completion • Trial completion date • Combination therapy • Metastases
|
Lenvima (lenvatinib) • erfonrilimab (KN046)
8ms
ENREACH-Thymic: KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma (clinicaltrials.gov)
P2, N=95, Terminated, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | The overall safety of KN046 is good, and no new safety signals have been found. The decision to terminate this study was made due to the adjustment of the sponsor's development strategy.
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
|
erfonrilimab (KN046)
8ms
ENREACH-PDAC-01: KN046 in Subjects With Advanced Pancreatic Ductal Adenocarcinoma. (clinicaltrials.gov)
P3, N=408, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Active, not recruiting --> Recruiting
Enrollment open • Metastases
|
gemcitabine • albumin-bound paclitaxel • erfonrilimab (KN046)
9ms
A Phase Ib/II Study of GT90001 Combined With KN046 in Solid Tumors (clinicaltrials.gov)
P1/2, N=216, Recruiting, Suzhou Kintor Pharmaceutical Inc, | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Apr 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
erfonrilimab (KN046) • ascrinvacumab (GT90001)
9ms
The anti-PD-L1/CTLA-4 bispecific antibody KN046 in combination with nab-paclitaxel in first-line treatment of metastatic triple-negative breast cancer: a multicenter phase II trial. (PubMed, Nat Commun)
Patients tolerated well the combination therapy. In general, KN046 combined with nab-paclitaxel showed favorable efficacy and survival benefits with tolerable toxicity in the first-line treatment of metastatic TNBC, especially PD-L1 positive, which is worth further investigation.
P2 data • Journal • Combination therapy • Metastases
|
CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
PD-L1 expression • PD-L1 negative
|
albumin-bound paclitaxel • erfonrilimab (KN046)
10ms
68Ga-FAPI PET imaging monitors response to combined TGF-βR inhibition and immunotherapy in metastatic colorectal cancer. (PubMed, J Clin Invest)
68Ga-FAPI PET/CT imaging is powerful in assessing tumor immunity and response to immunotherapy in metastatic CRC. This study supports future clinical application of 68Ga-FAPI PET/CT to guide CRC patients for precise TGF-β inhibition plus immunotherapy, recommending 68Ga-FAPI and 18F-FDG dual PET/CT for CRC management.
Journal • Metastases
|
TGFB1 (Transforming Growth Factor Beta 1)
|
erfonrilimab (KN046)
1year
Surufatinib Combined With KN046 and AG Regimen Chemotherapy as First-Line Treatment for Unresectable Advanced Pancreatic Cancer (clinicaltrials.gov)
P1/2, N=41, Recruiting, Shanghai Zhongshan Hospital | Not yet recruiting --> Recruiting | Phase classification: P2 --> P1/2 | Initiation date: Jul 2023 --> Oct 2023
Enrollment open • Phase classification • Trial initiation date • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1) • FGFR (Fibroblast Growth Factor Receptor) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
PD-L1 expression • CTLA4 expression
|
gemcitabine • albumin-bound paclitaxel • erfonrilimab (KN046) • Sulanda (surufatinib)
1year
New P2 trial • Combination therapy
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
|
MSI-H/dMMR
|
AiTan (rivoceranib) • Stivarga (regorafenib) • erfonrilimab (KN046)
1year
New P2 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
capecitabine • oxaliplatin • erfonrilimab (KN046) • anbenitamab (KN026)
1year
KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer (clinicaltrials.gov)
P2, N=98, Recruiting, Peking University Cancer Hospital & Institute | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • IO biomarker • Metastases
|
BRAF (B-raf proto-oncogene)
|
BRAF V600E • BRAF V600
|
Stivarga (regorafenib) • oxaliplatin • irinotecan • erfonrilimab (KN046)
over1year
KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer (clinicaltrials.gov)
P2, N=98, Not yet recruiting, Peking University Cancer Hospital & Institute
New P2 trial • Combination therapy • IO biomarker • Metastases
|
BRAF (B-raf proto-oncogene)
|
BRAF V600E • BRAF V600
|
Stivarga (regorafenib) • oxaliplatin • irinotecan • erfonrilimab (KN046)
over1year
New P2 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
|
HER-2 positive • HER-2 amplification • RAS wild-type • RAS wild-type + BRAF wild-type
|
capecitabine • oxaliplatin • erfonrilimab (KN046) • anbenitamab (KN026)
over1year
Efficacy and safety of KN046, a novel bispecific antibody against PD-L1 and CTLA-4, in patients with non-small cell lung cancer who failed platinum-based chemotherapy: a phase II study. (PubMed, Eur J Cancer)
Both 3 mg/kg and 5 mg/kg KN046 showed promising efficacy and favourable safety profile for advanced NSCLC after failure or intolerance to previous platinum-based chemotherapy.
P2 data • Journal
|
PD-L1 (Programmed death ligand 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
erfonrilimab (KN046)
over1year
KN046 in patients with thymic carcinoma: A prospective, single-arm, multi-centre, phase II study (ESMO 2023)
8 patients experienced ≥ grade 3 irAE, 7 (15.2%) patients discontinued study treatment due to TRAE, but there was no death event related with KN046. Conclusions KN046 demonstrated promising antitumor activity and acceptable toxicity in thymic carcinoma patients who have received at least one line of chemotherapy.
P2 data • Clinical • PD(L)-1 Biomarker • IO biomarker
|
CD80 (CD80 Molecule) • CD86 (CD86 Molecule)
|
PD-L1 expression • PD-L1 negative
|
PD-L1 IHC 22C3 pharmDx
|
erfonrilimab (KN046)
over1year
Updated results of the efficacy and safety of KN046 (a bispecific anti-PD-L1/CTLA-4) in patients with metastatic non-small cell lung cancer (NSCLC) who failed prior EGFR-TKI(s) (ESMO 2023)
All subjects enrolled received KN046 5 mg/kg Q3W combined with chemotherapy (Pemetrexed, 500 mg/m2, Q3W and carboplatin AUC5, Q3W), until disease progression, intolerable toxicity and other discontinuation criteria. Conclusions KN046 demonstrated encouraging OS benefit and a favorable safety profile in advanced NSCLC with EGFR sensitivity mutation who progressed after EGFR-TKI(s). Further study is warranted to confirm the clinical results.
Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
|
CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD80 (CD80 Molecule) • CD86 (CD86 Molecule)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
carboplatin • pemetrexed • erfonrilimab (KN046)
over1year
Preliminary efficacy and safety of KN046 (a bispecific anti-PD-L1/CTLA-4) in patients with metastatic non-small cell lung cancer who previously treated with immune checkpoint inhibitor(s) (ESMO 2023)
Conclusions KN046 was well tolerated and demonstrated encouraging OS benefit in NSCLC patients who had failed prior ICI(s) therapy. Further study is warranted to confirm the clinical results.
Clinical • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD80 (CD80 Molecule) • CD86 (CD86 Molecule)
|
EGFR mutation • ALK translocation
|
erfonrilimab (KN046)
over1year
KN046 in Subjects With Advanced Solid Tumors and Lymphoma (clinicaltrials.gov)
P1a/1b, N=139, Completed, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Recruiting --> Completed | N=285 --> 139 | Trial completion date: Oct 2022 --> Feb 2023 | Trial primary completion date: Jan 2022 --> Jan 2023
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
erfonrilimab (KN046)
over1year
A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
P1/2, N=52, Completed, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> Oct 2022
Trial completion • Trial completion date • Combination therapy • Metastases
|
albumin-bound paclitaxel • erfonrilimab (KN046)
over1year
Phase I trial of KN046, a novel bispecific antibody targeting PD-L1 and CTLA-4 in patients with advanced solid tumors. (PubMed, J Immunother Cancer)
KN046 was well tolerated and showed promising antitumor efficacy in advanced solid tumors, especially in patients with NPC. The combination of both CD8 and PD-L1 expression improved the prediction of KN046 response.
P1 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
|
EGFR (Epidermal growth factor receptor) • CD8 (cluster of differentiation 8) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
PD-L1 expression • EGFR mutation • CD8-H • PD-L1 expression + CD8 positive
|
erfonrilimab (KN046)
over1year
ENREACH-PDAC-01: KN046 in Subjects With Advanced Pancreatic Ductal Adenocarcinoma. (clinicaltrials.gov)
P3, N=408, Active, not recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Recruiting --> Active, not recruiting
Enrollment closed • Metastases
|
gemcitabine • albumin-bound paclitaxel • erfonrilimab (KN046)
over1year
New P2 trial • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1) • FGFR (Fibroblast Growth Factor Receptor) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
PD-L1 expression • CTLA4 expression
|
gemcitabine • albumin-bound paclitaxel • erfonrilimab (KN046) • Sulanda (surufatinib)
over1year
Efficacy and safety of KN026 in combination with KN046 in patients with locally advanced unresectable or metastatic HER2-positive other solid tumors. (ASCO 2023)
KN026 combined with KN046 treatment had demonstrated favorable efficacy and safety profile in HER2 positive other solid tumors (non-GC/GEJ and non-BC). Especially very promising efficacy were observed in ≥3 lines HER2 positive CRC. Based on these results, a pivotal study was planned to verify the efficacy and safety of KN026 and KN046 combo.
Clinical • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD80 (CD80 Molecule) • CD86 (CD86 Molecule)
|
HER-2 positive • HER-2 amplification • HER-2 expression
|
erfonrilimab (KN046) • anbenitamab (KN026)
over1year
KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor (clinicaltrials.gov)
P1, N=48, Active, not recruiting, Peking University | Recruiting --> Active, not recruiting | N=24 --> 48
Enrollment closed • Enrollment change
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
erfonrilimab (KN046) • anbenitamab (KN026)
2years
Study of KN046 in Subjects With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
P2, N=54, Enrolling by invitation, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Not yet recruiting --> Enrolling by invitation
Enrollment open • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
ALK translocation • EGFR negative
|
Inlyta (axitinib) • erfonrilimab (KN046)
2years
Enhanced antitumor immune responses via a new agent [I]-labeled dual-target immunosuppressant. (PubMed, Eur J Nucl Med Mol Imaging)
Use of low-dose [I] combined with a dual-target immunosuppressant could be exploited to identify the subset of treatment responders but also exhibited great potential for enhancing antitumor immune responses.
Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • GZMB (Granzyme B)
|
erfonrilimab (KN046)
2years
Efficacy, safety, and tolerability of KN046 (an anti-PD-L1/CTLA-4 bispecific antibody) in combination with Nab-paclitaxel in metastatic triple-negative breast cancer (mTNBC):Final results of the Phase II trial (SABCS 2022)
Background: Despite recent FDA approval of immune checkpoint inhibitor pembrolizumab and drug-antibody conjugate in the treatment of mTNBC, the overall survival benefit of these patients remains modest. The combination therapy of KN046 plus nab-paclitaxel has shown favorable clinical efficacy in mTNBC, especially in PD-L1 positive patients. By the cut-off date, the mOS is not mature and there is still more than half of pts alive, which demonstrated an encouraging 2- year OS rate. Pts in this trial tolerated well to the combination therapy and safety profile was manageable.
Clinical • P2 data • Combination therapy
|
CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • albumin-bound paclitaxel • erfonrilimab (KN046)
over2years
The preliminary efficacy and safety of KN026 combined with KN046 treatment in HER2-positive locally advanced unresectable or metastatic gastric/gastroesophageal junction cancer without prior systemic treatment in a phase II study (ESMO 2022)
Conclusions KN026 combined with KN046 treatment had demonstrated outstanding efficacy and manageable safety in HER2 positive GC/GEJ patients without prior systemic treatment. It might be deserved to plan a randomized study to compare the KN026+KN046 treatment and the standard of care to further confirm the efficacy and safety.
Clinical • P2 data
|
HER-2 (Human epidermal growth factor receptor 2) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD86 (CD86 Molecule)
|
HER-2 positive
|
erfonrilimab (KN046) • anbenitamab (KN026)
over2years
A phase II study of KN046 (a bispecific anti-PD-L1/CTLA-4) in patients with metastatic non-small cell lung cancer (NSCLC) who failed prior EFGR-TKIs (ESMO 2022)
All subjects enrolled will receive KN046 5 mg/kg Q3W combined with chemotherapy (Pemetrexed, 500 mg/m2, Q3W and carboplatin AUC5, Q3W), until disease progression, intolerable toxicity and other discontinuation criteria. The most common TRAEs of grade 3 or higher were infusion reaction (6/26 [23.1%]), decreased platelet cell count (4/26 [15.4%]) and anemia(3/26 [11.5%]), etc. Conclusions The bispecific antibody, KN046 was well tolerated and effective in treatment of advanced NSCLC with EGFR sensitivity mutation who failed prior EGFR-TKIs. Prospective study is needed to validate the clinical outcome.
Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD86 (CD86 Molecule)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
carboplatin • pemetrexed • erfonrilimab (KN046)
over2years
A phase II study of KN046 (a bispecific anti-PD-L1/CTLA-4) in patients with metastatic non-small cell lung cancer (NSCLC) who failed first line treatment (ESMO 2022)
The most common TRAEs of grade 3 or higher were infusion reaction (7/64 [10.9%]), hepatic dysfunction (3/64 [4.7%]), pneumonia (2/64 [3.1%]), etc. Conclusions The bispecific antibody, KN046 was well tolerated and effective as second line treatment of advanced NSCLC. KN046 showed promising OS benefit in both squamous and non-squamous NSCLC.
Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD86 (CD86 Molecule)
|
EGFR mutation • ALK translocation
|
erfonrilimab (KN046)
over2years
New P2 trial • Combination therapy
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
ALK translocation • EGFR negative
|
Inlyta (axitinib) • erfonrilimab (KN046)
over2years
A phase II study combining KN046 (an anti-PD-L1/CTLA-4 bispecific antibody) and lenvatinib in the treatment for advanced unresectable or metastatic hepatocellular carcinoma (HCC): Updated efficacy and safety results. (ASCO 2022)
KN046+Lenvatinib demonstrated a promising efficacy in ORR and PFS and the manageable safety profile in the first-line advanced unresectable or metastatic HCC treatment. These result support the KN046 plus Lenvatinib as a potential new treatment option for this population.
Clinical • P2 data
|
CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
Lenvima (lenvatinib) • erfonrilimab (KN046)
over2years
KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor (clinicaltrials.gov)
P1, N=24, Recruiting, Peking University | Trial completion date: Dec 2020 --> Dec 2023 | Trial primary completion date: Dec 2020 --> Dec 2022
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
erfonrilimab (KN046) • anbenitamab (KN026)
over2years
Preliminary safety and efficacy results of KN046 in combination with KN026 in patients with locally advanced unresectable or metastatic HER2-positive solid cancer (AACR 2022)
This chemotherapy-free regimen of KN046 in combination with KN026 has shown promising clinical efficacy and manageable toxicity in HER2-positive non-breast and non-gastric solid tumors with ≥ 1 line prior systemic therapy.The trial is currently ongoing. ClinicalTrials.gov Number, NCT04521179
Clinical • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD86 (CD86 Molecule)
|
HER-2 positive • HER-2 overexpression • HER-2 amplification
|
erfonrilimab (KN046) • anbenitamab (KN026)
almost3years
A Phase Ib/II Study of GT90001 Combined With KN046 in Solid Tumors (clinicaltrials.gov)
P1/2, N=216, Recruiting, Suzhou Kintor Pharmaceutical Inc, | Not yet recruiting --> Recruiting
Clinical • Enrollment open • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
erfonrilimab (KN046) • ascrinvacumab (GT90001)
3years
Preliminary safety and efficacy results of KN046 (an anti-PD-L1/CTLA-4 bispecific antibody) in combination with KN026 (a HER2-targeted bispecific antibody) in patients with metastatic HER2-positive breast cancer: A phase II trial (SABCS 2021)
Here we reported the preliminary results from an ongoing phase II trial assessing the safety and efficacy for KN046 (a bispecific antibody blocks both PD-L1 interaction with PD-1/CD80 and CTLA-4 interaction with CD80/CD86) in combination with KN026 (a bispecific antibody that binds to two different HER2 epitopes shared by trastuzumab and pertuzumab) in HER2-positive metastatic breast cancer patients, who have progressed after prior anti-HER2 combinational therapies. The combination of KN046 and KN026, as a chemo free regimen, has shown favorable clinical efficacy with manageable side effects in heavily pre-treated patients with metastatic HER2-positive breast cancer. This trial is currently ongoing. ClinicalTrials.gov number, NCT04521179.
Clinical • P2 data • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD86 (CD86 Molecule)
|
HER-2 positive
|
Herceptin (trastuzumab) • Perjeta (pertuzumab) • erfonrilimab (KN046) • anbenitamab (KN026)
over3years
A Phase Ib/II Study of GT90001 Combined With KN046 in Solid Tumors (clinicaltrials.gov)
P1/2, N=216, Not yet recruiting, Suzhou Kintor Pharmaceutical Inc,
New P1/2 trial
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
erfonrilimab (KN046) • ascrinvacumab (GT90001)
over3years
[VIRTUAL] KN046 (an anti-PD-L1/CTLA-4 bispecific antibody) in combination with platinum doublet chemotherapy as first-line (1L) treatment in patients with advanced NSCLC harboring resistant oncogenic driver alterations (ESMO 2021)
Here, we report from a cohort of systemic therapy naive NSCLC pts with resistant oncogenic driver alterations. Patients (pts) with systemic treatment naive, stage IV NSCLC harboring a driver oncogenic alteration were enrolled and received KN046 at 5mg/kg Q3W in combination with 4 cycles’ pemetrexed (500 mg/m2, for non-squamous NSCLC) or paclitaxel (175 mg/m2, for squamous NSCLC) and carboplatin (area under the curve 5 mg/m2) until progressive disease, unacceptable toxicity, withdrawal of informed consent or death. KN046 combined with platinum-based chemotherapy is well tolerated and has demonstrated promising, albeit preliminary anti-tumor activity as 1L treatment for stage IV NSCLC pts with resistant oncogenic driver alterations (including EGFR and HER2 exon 20 insertion mutation, EGFR amplification, RET fusion).
Clinical • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • RET (Ret Proto-Oncogene) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
EGFR mutation • HER-2 amplification • HER-2 mutation • RET fusion • EGFR amplification • EGFR exon 20 insertion • HER-2 exon 20 insertion • RET mutation • EGFR exon 20 mutation
|
carboplatin • paclitaxel • pemetrexed • erfonrilimab (KN046)