Induction chemotherapy

Gritstone bio Announces Positive Preliminary Progression-free Survival and Long-term Circulating Tumor DNA (ctDNA) Data from Phase 2 Portion of Ongoing Phase 2/3 Study of its Personalized Cancer Vaccine, GRANITE, in Front-line Metastatic Microsatellite St

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Monday, April 1, 2024
Lung cancer, Survival, Immunotherapy, Disease, Colorectal cancer, Progression-free survival, Medicine, Patient, Common, DNA, Aes, Cancer, Death, Doctor of Philosophy, Gritstone bio, MD, Kinetics, Induction chemotherapy, MSS, Circulating tumor DNA, VAF, Melanoma, PFS, Vaccine, Data, UCLA, Liver disease, Neoplasm, Pharmaceutical industry

EMERYVILLE, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced positive preliminary data from the ongoing, signal seeking Phase 2 portion of the Phase 2/3 study evaluating GRANITE, its personalized neoantigen cancer vaccine, in front-line metastatic microsatellite stable colorectal cancer (MSS-CRC). The randomized, controlled, open-label study is designed to quantify the clinical benefit of maintenance therapy with GRANITE (GRT-C901/GRT-R902) in combination with immune checkpoint blockade in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone. Overall progression free survival (PFS) data show an early trend in benefit for GRANITE patients (HR=0.82, [95% CI, 0.34-1.67]; 62% censored) and extended PFS benefit in high-risk patients (HR=0.52 [95% CI, 0.15-1.38]; 44% censored), in whom progression occurs faster. Circulating tumor DNA (ctDNA) analysis over several months of treatment shows the expected relationship with disease progression and favors GRANITE, while short-term ctDNA response analysis (molecular response as defined per protocol) did not demonstrate a difference between study arms. Gritstone bio successfully manufactured GRANITE product candidate for every eligible patient (i.e., 100% vaccine manufacturing success rate).

Key Points: 
  • Gritstone bio successfully manufactured GRANITE product candidate for every eligible patient (i.e., 100% vaccine manufacturing success rate).
  • “Today's preliminary Phase 2 results are highly encouraging and represent the first randomized trial evidence, albeit early, that a personalized neoantigen-directed vaccine can potentially drive efficacy in a metastatic ‘cold’ tumor.
  • Fortunately, long-term analysis demonstrates the expected correlation of ctDNA with clinical benefit and favors GRANITE patients.
  • This analysis was performed on 44 patients who received study treatment (control and GRANITE arms) and have available baseline ctDNA data.

Otsuka and Astex announce that the European Commission has approved INAQOVI® (oral decitabine and cedazuridine) for the treatment of adults with newly diagnosed acute myeloid leukaemia

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Tuesday, September 19, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, EEA, IV, Civil service commission, Acute leukemia, Fatigue, Astex Pharmaceuticals, European Medicines Agency, Clinical trial, Multimedia, EMA, Induction chemotherapy, AML, Patient, European Economic Area, Physician, EC, European Commission, Nursing, Vaccine, Decitabine, EU

Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that the European Commission (EC) has approved INAQOVI® (oral decitabine and cedazuridine) as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.

Key Points: 
  • Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that the European Commission (EC) has approved INAQOVI® (oral decitabine and cedazuridine) as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.
  • The EC decision applies to the European Economic Area (EEA), which includes the EU member states, Iceland, Liechtenstein and Norway.
  • INAQOVI® is the first and only oral hypomethylating agent licensed in the EEA in this patient population.
  • Safety findings for the fixed-dose combination of decitabine and cedazuridine were generally consistent with those anticipated for IV decitabine1.

Servier Presents Updated Results for TIBSOVO® (ivosidenib tablets) in IDH1-mutated Relapsed/Refractory Myelodysplastic Syndromes at the 2023 European Hematology Association (EHA) Congress

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Friday, June 9, 2023
Civil service commission, European Hematology Association, Associate professor, New Drug Application, Survival, Drug, Trae tha Truth, Mutation, Hyponatremia, Acute myeloid leukemia, MD Anderson Cancer Center, Tablet, MDS, MSCE, Breakthrough therapy, Congress, Induction chemotherapy, AML, Azacitidine, Shanda, HIV disease progression rates, Patient, Division, Syndrome, University, EHA, IDH, CR, IDH1, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ORR, Food, European Commission, Safety, Fatigue, Pharmaceutical industry

BOSTON, June 9, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced updated data from the Phase 1 trial of TIBSOVO® (ivosidenib tablets) as monotherapy for patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS). The results presented today at the European Hematology Association (EHA) 2023 Annual Congress in Frankfurt, Germany demonstrate that the efficacy and safety profile of TIBSOVO may provide an important new treatment option for MDS patients within this molecularly defined subset.

Key Points: 
  • The results presented today at the European Hematology Association (EHA) 2023 Annual Congress in Frankfurt, Germany demonstrate that the efficacy and safety profile of TIBSOVO may provide an important new treatment option for MDS patients within this molecularly defined subset.
  • The Phase 1, open-label study included an evaluation of the safety, tolerability, and clinical activity of TIBSOVO in patients with IDH1-mutated R/R MDS.
  • In the efficacy analysis set (n=18), a complete remission (CR) rate of 38.9% and overall response rate (ORR) of 83.3% were documented in patients treated with TIBSOVO.
  • Servier plans to submit a supplemental New Drug Application (sNDA) based on these results to the U.S. FDA for TIBSOVO in adult patients with R/R IDH1-mutated myelodysplastic syndromes.

Servier receives European Commission approval of Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma

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Wednesday, May 10, 2023
Civil service commission, Quality of life, Mutation, Prognosis, CCA, Life expectancy, Acute myeloid leukemia, Tablet, Induction chemotherapy, AML, Azacitidine, HIV disease progression rates, Patient, IDH, IDH1, EC, European Commission, Cholangiocarcinoma, Pharmaceutical industry, Laboratoires Servier

It has received orphan medicine designation recognizing the significant benefit brought to patients by Tibsovo® over available therapies for both CCA and AML.

Key Points: 
  • It has received orphan medicine designation recognizing the significant benefit brought to patients by Tibsovo® over available therapies for both CCA and AML.
  • "The prognosis for patients diagnosed with acute myeloid leukemia or cholangiocarcinoma has historically been poor with very limited treatment options.
  • With today's approval by the European Commission, Tibsovo® is now the first targeted IDH1 inhibitor approved in Europe.
  • "IDH1 mutations are major drivers of disease progression in acute myeloid leukemia and cholangiocarcinoma, which are usually diagnosed at an advanced stage, highlighting the urgent need for a targeted therapeutic option.

Servier receives European Commission approval of Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma

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Wednesday, May 10, 2023
Neutropenia, Cholangiocarcinoma, The New England Journal of Medicine, Civil service commission, Progression-free survival, CRH, Acute leukemia, OS, Bone marrow, Quality of life, Mutation, Prognosis, CCA, Life expectancy, Immunotherapy, QT, PFS, Acute myeloid leukemia, Tablet, Induction chemotherapy, Vomiting, Insomnia, AML, Azacitidine, HIV disease progression rates, Patient, European, Risk, Blood, IDH, IDH1, EFS, EC, Cirrhosis, AGILE, Thrombocytopenia, ORR, European Commission, Disease, Pharmaceutical industry, Laboratoires Servier

"The prognosis for patients diagnosed with acute myeloid leukemia or cholangiocarcinoma has historically been poor with very limited treatment options.

Key Points: 
  • "The prognosis for patients diagnosed with acute myeloid leukemia or cholangiocarcinoma has historically been poor with very limited treatment options.
  • With today's approval by the European Commission, Tibsovo® is now the first targeted IDH1 inhibitor approved in Europe.
  • "IDH1 mutations are major drivers of disease progression in acute myeloid leukemia and cholangiocarcinoma, which are usually diagnosed at an advanced stage, highlighting the urgent need for a targeted therapeutic option.
  • The European Commission's approval in cholangiocarcinoma is supported by data from the ClarIDHy trial, the first and only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma.

Biosight Launches a Phase 1/2 Clinical Trial of Aspacytarabine in Combination with Venetoclax for First-Line AML Induction Therapy, Followed by Aspacytarabine Consolidation

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Tuesday, November 22, 2022
Cytarabine, Disorder, Metabolism, AML, Lymphatic system, EMA, Therapy, Safety, Orphan drug, FDA, Acute myeloid leukemia, Induction chemotherapy, Pharmacokinetics, Patient, Asparagine, MDS, Myelodysplastic syndrome, Toxicity, BCL2, Clinical trial, Fast track (FDA), Bone marrow, Pharmaceutical industry

The trial, conducted in leading clinical centers in the United States, enrolls newly-diagnosed AML patients who are unfit for standard induction chemotherapy due to age or comorbidities.

Key Points: 
  • The trial, conducted in leading clinical centers in the United States, enrolls newly-diagnosed AML patients who are unfit for standard induction chemotherapy due to age or comorbidities.
  • We are therefore very excited to be launching this first combination therapy trial".
  • Results from a recently completed Phase 2b study evaluating aspacytarabine as a single-agent first-line AML therapy demonstrate safety and impressive single-agent activity.
  • Additional studies are ongoing to evaluate aspacytarabine as a second line treatment for patients with relapsed or refractory MDS or AML.

Biosight Granted Orphan Drug Designation from the FDA for Aspacytarabine for the Treatment of Myelodysplastic Syndromes

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Monday, August 1, 2022
Cytarabine, Orphan drug, Toxicity, Disorder, Fast track (FDA), Orphan, CEO, EMA, Bcl-2, Safety, Induction chemotherapy, Lymphatic system, Metabolism, Clinical trial, FDA, AML, Bone marrow, Patient, Pharmacokinetics, Asparagine, GFM, Acute myeloid leukemia, Therapy, Microdeletion syndrome, MDS, Pharmaceutical industry

AIRPORT CITY, Israel, Aug. 1, 2022 /PRNewswire/ -- Biosight Ltd ., a pharmaceutical development company focused on the development of innovative therapeutics for hematological malignancies and disorder, announced today that theUnited States Food & Drug Administration(FDA) has granted Orphan Drug Designation to aspacytarabine (BST-236), an investigational novel antimetabolite, for the treatment of myelodysplastic syndromes, in addition to the Orphan Drug Designation granted in 2019 for aspacytarabine for the treatment of acute myeloid leukemia (AML).

Key Points: 
  • AIRPORT CITY, Israel, Aug. 1, 2022 /PRNewswire/ -- Biosight Ltd ., a pharmaceutical development company focused on the development of innovative therapeutics for hematological malignancies and disorder, announced today that theUnited States Food & Drug Administration(FDA) has granted Orphan Drug Designation to aspacytarabine (BST-236), an investigational novel antimetabolite, for the treatment of myelodysplastic syndromes, in addition to the Orphan Drug Designation granted in 2019 for aspacytarabine for the treatment of acute myeloid leukemia (AML).
  • "We are very pleased to have received from theFDA the Orphan Drug Designation for aspacytarabine for the treatment of MDS, which adds to the designation granted already for the treatment of AML" saidDr.
  • Orphan Drug Designation by the FDA entitles Biosight to seven years of market exclusivity for the use of aspacytarabine for the treatment of MDS, if approved, plus significant development incentives, including tax credits related to clinical trial expenses, an exemption from the FDA-user fee, and FDA assistance in clinical trial design.
  • Biosight is a private Phase 2 clinical stage biotech company developing innovative therapeutics for hematological malignancies and disorders.

Kronos Bio Reports Recent Business Progress and Fourth-Quarter and Full-Year 2021 Financial Results

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Thursday, February 24, 2022
Risk, GLOBE, Therapy, Board of directors, D, Board, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Induction chemotherapy, Investment, Health policy, Security (finance), Annual report, Research, Intelligence, COVID-19, Clinical trial, Private Securities Litigation Reform Act, CDK9, Cytarabine, U.S. Securities and Exchange Commission, MRD, Gilead Sciences, Acute myeloid leukemia, Food, Precision medicine, LinkedIn, MYC, Nasdaq, Cancer, SAN, Forward-looking statement, Patient, KRON, SYK, SEC, Pharmaceutical industry, Lithium, AML, Tempus, Kronos

SAN MATEO, Calif. and CAMBRIDGE, Mass., Feb. 24, 2022 (GLOBE NEWSWIRE) --  Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer and other serious diseases, today reported recent business progress and fourth-quarter and full-year 2021 financial results.

Key Points: 
  • Kronos Bio is continuing to enroll patients in the Phase 1/2 trial of KB-0742.
  • Kronos Bio reported positive initial data from the study last year and is continuing to dose escalate.
  • Kronos Bio expects to dose the first patient in a Phase 1b/2 clinical trial of lanraplenib in the first quarter of 2022.
  • Kronos Bio announced its multi-year collaboration with Tempus Labs, Inc., a leader in artificial intelligence and precision medicine, during the fourth quarter.

Biosight Reports Final Primary Endpoint Data from Phase 2b Study of Aspacytarabine (BST-236) for First-Line Acute Myeloid Leukemia Therapy

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Thursday, January 6, 2022
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AIRPORT CITY, Israel, Jan. 06, 2022 (GLOBE NEWSWIRE) --  Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced final results for the primary study endpoint, complete remission (CR), from the Company’s Phase 2b clinical trial evaluating single-agent aspacytarabine (BST-236) as a first-line acute myeloid leukemia (AML) therapy for patients unfit for standard induction chemotherapy. These results, presented at the 2021 American Society of Hematology (ASH) Annual Meeting held in December, 2021, demonstrated efficacy, safety, and tolerability of BST-236 as a monotherapy in treatment of newly-diagnosed AML patients unfit for standard induction therapy.

Key Points: 
  • Key highlights from the poster presentation titled, Aspacytarabine (BST-236) as Monotherapy is Safe, Well-tolerated and Effective for the Treatment of Adults with Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Therapy.
  • For more information regarding the Phase 2b clinical study of BST-236, please visit www.clinicaltrials.gov .
  • Biosight is a private Phase 2 clinical stage biotech company developing innovative therapeutics for hematological malignancies and disorders.
  • Aspacytarabine is currently being investigated as a single agent in a Phase 2b clinical trial, which recently completed enrollment and primary endpoint analysis, for the first-line treatment of AML.

Kronos Bio Reports Recent Business Progress and Third-Quarter Financial Results

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Tuesday, November 9, 2021
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SAN MATEO, Calif. and CAMBRIDGE, Mass., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today reported recent business progress and third-quarter financial results.

Key Points: 
  • The companys existing development candidate, KB-0742, targets CDK9 and is being evaluated in a Phase 1/2 clinical study.
  • Additionally, Kronos Bio yesterday announced a multi-year collaboration with Tempus, a leader in artificial intelligence and precision medicine.
  • Kronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering and developing therapies that seek to transform the lives of those affected by cancer.
  • Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass.