2021 ESMO: Corning Jerry announces the latest clinical data of two dual antibodies, PD-L1/CTLA-4 dual antibodies will be reported for production in the first half of 2022

On September 13, according to the company’s announcement, Corning Jereh will present KN046 (an anti-PD-L1/CTLA-4 bispecific antibody) and KN026 (an anti-PD-L1/CTLA-4 bispecific antibody) at the 2021 European Society of Medical Oncology Conference (2021 ESMO).
HER2 targeting bispecific antibody) research results
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At the same time, Corning Jerry also stated that it plans to submit a listing application for KN046 in the first half of 2022

Source: Company announcement

Preliminary efficacy and safety results of a prospective phase II clinical trial of KN046 combined with lenvatinib for the first-line treatment of advanced unresectable or metastatic hepatocellular carcinoma

Preliminary efficacy and safety results of a prospective phase II clinical trial of KN046 combined with lenvatinib for the first-line treatment of advanced unresectable or metastatic hepatocellular carcinoma

This is a phase II clinical trial conducted in China to evaluate the efficacy and safety of KN046 combined with lenvatinib in the treatment of advanced unresectable or metastatic hepatocellular carcinoma
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All enrolled patients were BCLC stage B or C receiving lenvatinib (12 mg/day, body weight ≥60 kg; or 8 mg/day, body weight <60 kg) combined with KN046 (5 mg/kg) treatment every three weeks (21 days) is a treatment cycle until disease progression, toxicity intolerance, or treatment for two years

As of April 8, 2021, a total of 25 patients were enrolled, with a median treatment duration of 10 weeks
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• Efficacy
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Among 21 evaluable patients, ORR was 57% (95% CI: 34.

• Security
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64% of patients have experienced TEAE, 20% of which are grade 3 or above

Conclusion: KN046 combined with lenvatinib shows good safety and preliminary efficacy, including good anti-tumor activity, higher ORR and may further extend the survival period of patients with advanced hepatocellular carcinoma
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Preliminary efficacy and safety results of KN026 combined with KN046 in the treatment of patients with HER2-positive gastrointestinal tumors

Preliminary efficacy and safety results of KN026 combined with KN046 in the treatment of patients with HER2-positive gastrointestinal tumors

This is a clinical study conducted in China to evaluate the safety, tolerability and preliminary efficacy of KN026 combined with KN046 in the treatment of patients with HER2 abnormal solid tumors
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Chinese patients with HER-2 positive gastrointestinal tumors in the group received three doses of KN026 combined with KN046 (dose 1: KN026 (20 mg/kg Q2W), KN046 (3 mg/kg Q2W); dose 2: KN026 (20 mg/kg) Q2W, increase the loading dose on the 8th day of the first cycle), KN046 (5 mg/kg Q3W); dose 3: KN026 (30 mg/kg Q3W, increase the loading dose on the 8th day of the first cycle), KN046 (5 mg /kg Q3W))

As of January 12, 2021, a total of 32 patients were enrolled, of which 7 patients had not received treatment for metastatic gastric cancer or gastroesophageal junction cancer, and 25 patients had received a large number of previous treatments for gastrointestinal cancer
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The median treatment durations of KN026 and KN046 exposure were 17 weeks (range: 4 to 60 weeks) and 15 weeks (range: 4 to 58 weeks), respectively

• Efficacy
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Among the 25 patients with curative effect evaluation, the ORR of the first-line mGC/GEJ cohort was 86% (6/7; 95% CI: 42%-100%, including 1 unconfirmed partial response), while the advanced gastrointestinal cancer cohort The ORR was 44% (8/18; 95% CI: 22%-69%)

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TRAEs mainly include anemia (31.

Conclusion: KN026 combined with KN046 as a chemotherapy-free method has shown good safety in patients with HER2-positive gastrointestinal tumors who have not received treatment and have undergone a large number of previous treatments, and has shown potential clinical benefits over existing standard therapies
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The company plans to carry out a key trial of HER2-positive GC/GEJ
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KN046 combined with platinum-containing dual-drug chemotherapy as the first-line therapy for patients with advanced NSCLC with drug-resistant oncogenic driver gene mutations

KN046 combined with platinum-containing dual-drug chemotherapy as the first-line therapy for patients with advanced NSCLC with drug-resistant oncogenic driver gene mutations

This study is a phase II, open, multi-center clinical study aimed at evaluating the efficacy, safety and tolerability of KN046 combined with platinum-containing dual-drug chemotherapy in the treatment of patients with advanced NSCLC
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Patients with stage IV non-small cell lung cancer who have not received systemic treatment and are accompanied by drug-resistant oncogenic driver gene mutations were enrolled and received KN046 (5 mg/kg Q3W) combined with 4 cycles of standard chemotherapy until disease progression and toxicity Intolerance, withdrawal of informed consent or death
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The researcher will make a general evaluation based on RECIST 1.
1
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As of January 19, 2021, a total of 12 NSCLC patients were enrolled, including 8 cases of EGFR exon 20 insertion mutation, 1 case of HER2 exon 20 insertion mutation, 2 cases of EGFR amplification, and 1 case of RET fusion
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The median treatment time was 21 weeks
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• Efficacy
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ORR was 50% (6/12; 95% CI: 21.
1 to 78.
9), and DCR was 91.
7% (11/12; 95% CI: 61.
5 to 99.
8)
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The median PFS was 8.
7 months (95% CI: 4.
1.
NE), the median OS had not yet been reached; the 6-month OS rate was 100%
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TEAEs of grade 3 or above mainly include decreased neutrophil count (33.
3%), increased alanine aminotransferase (25.
0%), anemia (16.
7%), decreased white blood cell count (16.
7%), and increased aspartate aminotransferase (16.
7%)
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Five patients had immune-related adverse events, all of which were grade 1 or 2
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Conclusion: As the first-line therapy for patients with stage IV non-small cell lung cancer with oncogenic-driven changes of drug resistance, KN046 combined with platinum-based chemotherapy is well tolerated and has shown encouraging preliminary anti-tumor activity
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