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    Home > Medical News > Latest Medical News > Keystone Pharmaceuticals' three new drugs will accelerate commercialization in 2020.

    Keystone Pharmaceuticals' three new drugs will accelerate commercialization in 2020.

    • Last Update: 2020-08-01
    • Source: Internet
    • Author: User
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    Keystone Pharmaceuticals is a rapid rise in the country in the past two years of biopharmaceutical enterprises, not only to independent research and development of the way of two-wheel drive to create a competitive cancer drug product pipeline, but also in the creation of less than 3 years on the successful IPO, among the leading pharmaceutical companies in the domestic team.
    with the steady progress of product clinical development, Keystone Pharmaceuticals is in a critical period of transition from the research and development stage to the commercial stage, so the clinical data of its core products in its pipeline has received more and more attention in the industry.
    Keystone PharmaceuticalS Product Pipeline Source: Keystone Pharmaceuticals And its partners at the 2020 ASCO Conference, Stone Pharma and its partners shared key clinical data on three new drugs, CS1001 (PD-L1 monoantiphoresis), apraitinib (KIT/PDGFRA inhibitors), and pralsetinib (RET inhibitors), which will further raise awareness of the future commercialization prospects of Keystone Pharmaceuticals products.
    CS1001: First-line treatment of advanced non-small cell lung cancer Phase III results worthy of expectation CS1001 by the cornerstone independent research and development, is based on the United States Ligand company authorized the introduction of OmniRat ® genetically modified animal platform found in an all-human source full-length anti-PD-L1 monoclonal anti-health anti-body antibody, is the closest to the human natural IgG4 mono-anti-drug, compared to similar drugs with immunogens and related to lower toxic risk safety advantages.
    Keystone Pharmaceuticals presented key conceptual validation (POC) data for the CS1001-101 study of advanced non-small cell lung cancer (NSCLC) cohort Ib phase.
    non-scaly NSCLC team included 21 patients in the group, as of February 19, 2020, 10 patients achieved partial remission (PR), objective mitigation rate (ORR) was 47.6%, median progression-free survival (mPFS) was 6.5 months, and median response duration (DoR) was 8.7 months.
    the 20 patients in the scaly NSCLC team, orR reached 75% as of February 19, 2020, with a median PFS of 8.4 months and a median DoR of 6.4 months.
    safety, CS1001 is well tolerated and there have been no cases of patient withdrawal due to adverse events associated with CS1001 treatment.
    as of July 1, 2019, the incidence of non-scaly NSCLC cohort drug therapy-related adverse events (TRAE) was 85.7% (18/21) and the incidence of TRAE above level 3 was 28.6% (6/21). The incidence of
    immuno-related adverse reactions (irAE) was 23.8% (5/21), all of which were level 2, of which 4 cases were increased by Tianmen doninene transaminase (AST) and 3 cases were increased by alanine transaminase (ALT).
    the incidence of stular NSCLC patients with a cohort traE rate of 90.0% (18/20), and the incidence of TRAE above level 3 was 25% (5/20).
    15% (3/20) of irAE incidence, including 2 cases of rash below level 2.
    overall, CS1001 showed excellent anti-tumor activity and good safety data in the Ib phase study, which contained both non-scaly and scaly NSCLC, especially for the scaleNSCLC up to 75% ORR was almost the best result of similar products in Phase I, and suggested that CS1001 was expected to achieve the ideal efficacy data in the sample-scale Amplification Phase III study.
    Cornerstone Pharmaceuticals has now completed a Phase III study of CS1001 combined platinum chemotherapy vs placebo combined chemotherapy for advanced NSCLC treatment, and enrolled in a group of 480 patients, with key findings expected to be published in a few months.
    this is the first clinical study in China to cover both scaly NSCLC and non-scale NSCLC subtypes of PD-1/PD-L1 first-line therapy Phase III clinical studies, the results are worth looking forward to.
    lung cancer is the highest incidence and mortality in the world and in China, where there were about 770,000 new lung cancer cases and 690,000 lung cancer deaths in 2018.
    lung cancer has always been a battleground in the cancer drug market, first-line therapy is the high point of lung cancer market competition.
    NSCLC (85 percent of lung cancer) is about 70 percent and scalies about 30 percent.
    Keystone Pharmaceuticals will be in a favorable competitive position in the market if it submits a listing application covering both squamous and non-scale NSCLC after completing Phase III.
    Pralsetinib: Tackling RET-positive solid-tumor pralsetinib is a highly selective RET (rearranged transfection) single target inhibitor developed by Blueprint Medicines.
    Cornerstone Pharmaceuticals entered into a partnership with Blueprint Medicines in June 2018 to introduce pralsetinib's Greater China development interest.
    previously, Blueprint Medicines has submitted a listing application to the FDA and EMA for pralsetinib's treatment of RET fusion-positive locallate or metastatic NSCLC.
    Cornerstone Pharmaceuticals completed the first patient administration in China in August 2019 for the Pralsetinib Global Phase I Study, and is expected to submit a listing application in China in the third quarter of 2020.
    RET is an primary cancer gene located on chromosome 10 that encodes the RET protein, a receptor tyrosine kinase found on the cell membrane.
    when the growth factor binds to the extracellular region of RET, it triggers a series of intracellular chain chemical reactions that cause the cells to divide, mature and function accordingly.
    reT fusion-positive cancer and RET mutation-positive thyroid myelin cancer tumor cell differentiation and proliferation are highly dependent on the activation of THE RET protein, which is often referred to as "carcinogenic gene addiction", so RET-positive tumors are very sensitive to high-choice single-target RET inhibitors. the incidence of reT gene fusion in Patients with the
    is about 1% to 2% in Patients with NSCLC, and the incidence of thyroid papilloma cancer (about 85% of all thyroid cancers) is 10% to 20%.
    the incidence of RET gene mutations in thyroid myelin cancer is about 60%.
    Blueprint Medicines presented the latest data from the clinical remission assessment analysis set, including 116 reT gene fusion-positive NSCLC patients, 11 RET gene fusion-positive thyroid cancer patients, and 12 other tumor types of RET gene fusion-positive patients.
    as of November 18, 2019, 80 patients who had previously received platinum-containing chemotherapy for RET fusion-positive NSCLC had a PRalsetinib treatment with a PRalsetinib orr of 61% (95% CI: 50-72), of which 2 PrMs were confirmed as of the time the data were available but subsequently confirmed.
    5% of patients achieved confirmed CR, and 14% of patients achieved the complete reenterment of the target lesions tumor.
    26 cases of untreated RET fusion-positive patients treated with pralsetinib had an ORR of 73% (95% CI: 52-88) and CR 12%.
    for NSCLC patients with an assessment of brain metastasis at 9 baselines, pralsetinib also showed strong and long-lasting intracranial antitumor activity.
    9 patients had CNS metastasis lesions, the proportion of patients with complete intracranial remission was 33% (3/9), no CNS progression events occurred in patients with CNS remission, and the median DOR of CNS remission had not yet been achieved.
    by the data deadline, patients with assessable brain metastasis had a treatment duration of up to 12 months, and no new CNS metastasis were found in patients without CNS at baseline.
    in general, pralsetinib showed consistent and excellent clinical anti-tumor activity in patients with RET fusion-positive NSCLC, regardless of whether the patient had ever been treated or whether the patient had been treated with A RET fusion partner type or whether it was exhausted or not.
    for the above 116 patients with RET fusion-positive NSCLC patients, the median DOR of the patient who achieved remission did not reach (95% CI: 11 months to not reach), and the proportion of patients with DOR reaching 6 months was 86%.
    as of the data, 74% of patients who have been confirmed to have remission (including all CR patients) are still undergoing treatment.
    for other types of RET fusion-positive tumor patients, pralsetinib also showed significant clinical activity.
    as of February 13, 2020, in 11 cases of RET fusion-positive thyroid cancer (10 have received systemic treatment), the confirmed ORR was 91% (95% CI: 59-100), the disease control rate was 100% (95% CI: 72-100), and 70% of the remission patients were still being treated for 22 months.
    of the 12 other RET fusion-positive tumor patients who had previously received systemic treatment, the researchers assessed an ORR of 50% (95% CI:21?u201279), of which 1 was to be confirmed.
    observed varying degrees of remission in all assessable patients with pancreatic cancer (n s 3) and bile duct cancer (n s 2), and these types of tumors are generally poorly prognosis.
    safety, as of November 18, 2019, 354 patients had participated in ARROW clinical trials and were treated with pralsetinib at a starting dose of 1 daily dose of 400 mg.
    Pralsetinib's overall security results are consistent with previously reported data results.
    Pralsetinib showed good tolerance in each tumor species, with the TRAE majority being 1/2. The most common TRAEs reported by
    researchers included elevated AST, anemia, elevated ALT, constipation, hypertension, and neutrophil reduction.
    researchers reported that 5 percent of TRAE 3 or above included high blood pressure, neutrophilulite and anemia. only 4% of patients
    discontinued pralsetinib treatment because of TRAE.
    the current treatment for RET fusion mutant tumors is mainly the use of multikinase inhibitor drugs, such as cabotinib, vanedtanib, because of the low target selectivity, the efficacy is very limited and toxic.
    it can be found from the above data that pralsetinib not only provides strong and stable efficacy for patients with RET-positive solid tumors, but also has a low rate of adverse events above level 3, and the survival benefits are significant.
    Pralsetinib was granted the FDA's grant of RET fusion NSCLC for progression after platinum chemotherapy and breakthrough therapy for RET mutant-positive thyroid myelin cancer that requires systematic treatment and no alternative treatment options, which will provide a new treatment option for these patients.
    Although the proportion of PATIENTs with RET gene fusion positive in NSCLC is much lower than that of EGFR mutations, the large base of lung cancer population and the exact clinical benefits of RET single target inhibitors determine the good market potential of RET inhibitors.
    Avapritinib: Breaking the drug-free dilemma for patients with advanced gastrointestinal interstitonoma Avapritinib is a KIT/PDGFRA inhibitor developed by Blueprint Medicines, and Keystone Pharmaceuticals partnered with Blueprint Medicines in June 2018 to introduce Avapritinib's Greater China development interest.
    January 9, 2020, avapritinib was approved by the FDA for the treatment of non-surgical or metastatic adult gastrointestinal interstitial (GIST) patients carrying PDGFRA18 exosome mutations, including the most common D842V site mutations. On April 23,
    , Keystone Pharmaceuticals filed a listing application for avapritinib at the Chinese mainland for the treatment of non-surgical excision or metastatic GIST adult patients carrying PDGFRA exosome 18 mutations, including the D842V mutation, as well as four-line treatments for non-surgical excision or metastasis in adult patients.
    FDA approval of avapritinib is based primarily on data from the NAVIGATOR study.
    at the 2020 ASCO conference, Keystone Pharmaceuticals announced the results of a bridging trial conducted by avapritinib in patients with GIST in China.
    this open-label, multi-center, I/II clinical study group is previously advanced after treatment with imatinib and one other tyrosine kinase inhibitors, or not tolerated to standard treatment or carries PDGFRAD842V mutation of non-removable or metastatic GIST adult patients, the main assessment of avapritinib safety, pharmacokinetic characteristics and antitumor efficacy.
    as of December 25, 2019, 12 patients with GIST in China completed a phase I dose climbing study, the preliminary results showed that patients with late non-removal or metastasis in China had good resistance to avapritinib 200mg and 300 mg, and no dose-restrictive toxicity was observed.
    safety data is consistent with previously published global research safety results, no 4-5 adverse events (AE) reported, no drug-related treatment discontinuation events, the most common level 3 TRAE is anemia (n-2);
    the average half-life of avapritinib is 42.2-44.4 hours, supporting daily administration; Avapritinib is carrying PDGFRA D842V.
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