The research results of Hengrui Medicine's innovative drugs in the treatment of brain metastases from breast cancer are listed in "The Lancet. Oncology"

On January 25, the research results of pyrotinib combined with capecitabine in the treatment of HER2-positive breast cancer brain metastases led by Professor Yan Min from Henan Cancer Hospital were officially published online in the international authoritative medical journal "The Lancet.
Oncology" ( "Lancet Oncology", impact factor 41.
32)
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The results of this study show that pyrotinib combined with capecitabine is well tolerated and can effectively inhibit both intracranial and extracranial lesions, especially in patients with previously untreated brain metastases
.
This study is the first prospective study to report the efficacy and safety of pyrotinib combined with capecitabine in patients with brain metastases from HER2-positive breast cancer in the entire enrolled population.
The previous local treatment situation was divided into two independent cohorts for analysis and comparison of prospective clinical studies, which brought new enlightenment for clinical breast cancer brain metastases treatment and individualized decision-making
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In the era of trastuzumab-based therapy, about 30%-50% of patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer will still develop brain metastases, resulting in poor prognosis.
The treatment is mainly based on local treatment methods, including surgical resection, stereotactic radiotherapy and whole brain radiotherapy.
However, the recurrence rate within 6-12 months after local treatment is still high, and it will bring adverse reactions such as cognitive function decline, which is not suitable for clinical treatment.
bring great challenges
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The PERMEATE study is a multi-center, single-arm, double-cohort, phase II clinical study conducted in 8 centers across the country, aiming to investigate the efficacy and safety of pyrotinib combined with capecitabine in the treatment of brain metastases from HER2-positive breast cancer Professor Yan Min, the principal investigator of the PERMEATE study, said: "The treatment of breast cancer in China must be guided by the disease development characteristics and clinical diagnosis and treatment status of the Chinese population in order to guide clinical practice.
The most important significance of the phase II clinical study of cancer brain metastases lies in the findings that for HER2-positive breast cancer brain metastases, pyrotinib combined with capecitabine can effectively control both intracranial and extracranial lesions, especially for previous Pyrotinib is expected to become the preferred treatment option for patients with HER2-positive brain metastases in China for patients who have not received local radiotherapy to the brain, and it is expected to provide a systemic treatment option for patients who need to delay local treatment.
" The PERMEATA study started in January 2019, with a total of A total of 78 patients with brain metastases from HER2-positive breast cancer with measurable intracranial lesions were enrolled.
Among them, 69 patients received trastuzumab in the past.
According to the previous local treatment of central nervous system lesions, they were divided into - Cohort A: Patients with brain metastases without local radiotherapy (N=59) Cohort B: Patients with brain metastases (N=19) who re-progressed after local radiotherapy received pyrotinib (400 mg, qd, po) combined with capecitabine (1000 mg) /m2, bid, po, d1-14, q3w) The primary endpoint of the study was the objective response rate (CNS ORR) of central nervous system lesions.
The results showed that the objective response rate (CNS ORR) of cohort A was as high as 74.
6% (95%).
%CI: 61.
6-85.
0), of which 7 (11.
9%) patients achieved complete remission (CR) The objective response rate (CNS ORR) of central nervous system lesions in cohort B was 42.
1% (95%CI: 20.
3-66.
5) times The primary endpoint results showed that among 31 patients with concomitant extracranial measurable disease, the objective response rate (Non-CNS ORR) for non-central nervous system disease in the two cohorts was 70.
4% and 50%, respectively, with a median follow-up of 15.
7 months , the median progression-free survival (PFS) of cohort A and cohort B were 11.
3 months (95% CI: 7.
7-14.
6) and 5.
6 months (95% CI: 3.
4-10.

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The PERMEATA study was presented as a poster at the 2020 European Society of Medical Oncology (ESMO) meeting and the 2021 American Society of Clinical Oncology (ASCO) annual meeting, and received extensive attention from domestic and foreign experts.
Today, the clinical research results are listed in the international authoritative academic journal " The Lancet.
Oncology, showing the recognition of the international academic community
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Pyrotinib is an oral epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor 2 (HER2)/human epidermal growth factor receptor 4 (HER4) tyrosine kinase inhibitor independently developed by Hengrui Medicine with intellectual property rights.
It is the first original EGFR/HER2/HER4 targeted drug in China.
In 2018, pyrotinib was approved by the National Medical Products Administration (NMPA) with conditional approval based on the phase II clinical study data.
In 2019, pyrotinib was included in the national medical insurance, greatly improving accessibility and affordability.
In 2020, pyrotinib obtained the results of two important phase III studies (PHENIX, PHOEBE) The National Medical Products Administration has fully approved the listing.
At present, pyrotinib is still conducting a number of clinical studies covering breast cancer, lung cancer, biliary tract cancer and other tumor types, and continues to explore treatment options for different diseases at different stages to benefit more Chinese patients.

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