Carboplatin

Merck Provides Update on Phase 3 KEYNOTE-B21 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Radiotherapy, for Patients With Newly Diagnosed, High-Risk Endometrial Cancer After Surgery With Curative Intent

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星期四, 五月 9, 2024
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, MSD, B21, Radiation, DFS, Paclitaxel, Food, Merck & Co., Immunotherapy, Eisai, Data monitoring committee, Rated R, PDUFA, ADC, Patient, Endometrial cancer, Cancer, MSI-H, Carboplatin, MRK, Pharmaceutical industry

The study’s other primary endpoint of overall survival (OS) was not formally tested since superiority was not reached for DFS.

Key Points: 
  • The study’s other primary endpoint of overall survival (OS) was not formally tested since superiority was not reached for DFS.
  • The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were identified.
  • Merck will work with investigators to share the results with the scientific community.
  • “We would like to thank all the patients, the investigators and our study collaborators for their participation in this trial.”
    In the U.S., KEYTRUDA has two approved indications in endometrial cancer.

BeiGene Receives European Commission Approval for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

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星期二, 四月 23, 2024
Biotechnology, Pharmaceutical, Health, Oncology, PFS, Patient, Paclitaxel, Hospital, Food, European Commission, Neutropenia, JAMA Oncology, Survival, BGNE, Tislelizumab, Docetaxel, ESCC, European, Disease, Journal, Pemetrexed, Leukopenia, Neoplasm, Civil service commission, Carboplatin, ALK, EGFR, NSCLC, European Medicines Agency, Overalls, Lung cancer, Pharmaceutical industry

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.
  • “Today’s EC authorization marks the second in the region for tislelizumab, with both NSCLC and locally advanced or metastatic esophageal squamous cell carcinoma now approved in the European Union.
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.

Lantern Pharma Receives Regulatory Approval to Expand Harmonic™ Clinical Trial for Non-Small Cell Lung Cancer in Never-Smokers into Japan and Taiwan

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星期一, 四月 22, 2024
Technology, Clinical Trials, Health Technology, Software, Biotechnology, Pharmaceutical, Health, Data Management, Oncology, Artificial Intelligence, Education, National Cancer Center, MET, D.C, Lung cancer, Woman, PMID, Progression-free survival, Harmonic, Machine learning, AME Publishing Company, ClinicalTrials.gov, Collection, Artificial intelligence, IPhone, Adenocarcinoma, ROS1, Disease, Incidence, Patient, Pemetrexed, TMB, SOC, Neoplasm, Lung, ALK, EGFR, NSCLC, Carboplatin, Overalls, Gene, TK, Pharmaceutical industry

Approximately one third of all lung cancer patients in East Asia are never-smokers and the proportion of lung cancer in never smokers (LCINS) has been increasing gradually over time, according to a publication in Translational Lung Cancer Research (1).

Key Points: 
  • Approximately one third of all lung cancer patients in East Asia are never-smokers and the proportion of lung cancer in never smokers (LCINS) has been increasing gradually over time, according to a publication in Translational Lung Cancer Research (1).
  • LCINS are histologically, mutationally, and epidemiologically distinct from smoking-related lung cancers and occur almost exclusively as adenocarcinomas and most commonly in women and individuals of Asian ancestry.
  • Dr. Goto will now lead the trial in Japan, where the incidence of non-small cell lung cancer (NSCLC) in never-smokers is double or more than that of the United States.
  • In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated.

Onchilles Pharma Presents at AACR 2024 New Preclinical Data for N17350 and N17465 Demonstrating the Potential for Potent and Tumor-Selective Treatment

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星期二, 四月 9, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Cancer, Pharma, Blood, Doxorubicin, Oxaliplatin, Breast, San Diego Convention Center, CDX, Prostate cancer, Death domain, Therapy, Immunogenic cell death, Patient, Neoplasm, ICD, Lung, Toxicity, AACR, Immune system, Carboplatin, Ovarian cancer, CD95, Vaccine

N17350 and N17465 are novel first-in-class oncology programs that harness the potent efficacy of the innate immune system and have the potential to become a major new treatment modality for a wide range of cancer types.

Key Points: 
  • N17350 and N17465 are novel first-in-class oncology programs that harness the potent efficacy of the innate immune system and have the potential to become a major new treatment modality for a wide range of cancer types.
  • Lev Becker, Ph.D., Scientific Founder, Onchilles Pharma, said, “We are excited to unveil systemically delivered N17465 that has the potential to redefine the treatment of solid tumors.
  • The data presented today demonstrate that N17465 exhibits potent and tumor-selective efficacy, mobilizes the immune system for anti-tumor immunity, and produces durable responses in mouse models as a monotherapy.
  • We are confident that N17350 and N17465 represent a novel class of molecules that could become the new foundation of cancer treatment.

Orphan designation: carboplatin Treatment of glioma, 19/02/2024 Positive

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星期四, 四月 18, 2024
Patient, Committee, Carboplatin, Glioma, EMA, IRIS, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of glioma on 19 February 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Merck Provides Update on Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer

Retrieved on: 
星期四, 三月 21, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, OS, Pemetrexed, Chemotherapy, NSCLC, Progression-free survival, Patient, Carboplatin, Merck & Co., MRK, PARP, Cisplatin, PFS, Pharmaceutical industry

In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).

Key Points: 
  • In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).
  • The safety profiles of KEYTRUDA and LYNPARZA in this trial were consistent with those observed in previously reported studies for the individual therapies.
  • “These results are an important reminder of how challenging it may be to treat these patients with metastatic nonsquamous non-small cell lung cancer.
  • We sincerely thank the patients and investigators for their important contributions to this study.”

Cardiff Oncology Announces Upcoming Presentations at the AACR Annual Meeting 2024

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星期三, 三月 6, 2024
Online, Carboplatin, CRDF, SAN, Cancer, Progression-free survival, PDX, Cetuximab, EGFR, Bev, Carcinoma, FOLFIRI, PLK1, AACR, Bevacizumab, RAS, Cisplatin, Ovarian cancer, Abstract, Paclitaxel, Patient, Clinical trial, Mutation, Publication, Vaccine

“In RAS-mutated mCRC, we are showing the underlying mechanism through which the combination of onvansertib and bevacizumab targets the hypoxia response pathway.

Key Points: 
  • “In RAS-mutated mCRC, we are showing the underlying mechanism through which the combination of onvansertib and bevacizumab targets the hypoxia response pathway.
  • We believe this mechanism explains the strong clinical results we have seen in both our Phase 1b/2 and ONSEMBLE second-line RAS-mutated mCRC clinical trials.
  • The abstracts are available on the AACR Online Program and will be published in the online Proceedings of the AACR.
  • Following presentation, the posters will be posted to the " Scientific Presentations " section of the Cardiff Oncology website.

G1 Therapeutics Provides Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

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星期三, 二月 28, 2024
G1 Therapeutics, Breast cancer, Carboplatin, Research, PIN, SCLC, Telephone, Update, J. P. Morgan, DMC, Food, Growth, SACT, G1, Trilaciclib, Hospital, ADC, OS, Conjugation, GAAP, Event, Therapy, Webcast, Patent, Patient, Acceleration, Clinical trial, Survival, Oncology, ITT, Pharmaceutical industry

G1 recognized total revenues of $14.9 million and $82.5 million for the fourth quarter and full year of 2023, respectively.

Key Points: 
  • G1 recognized total revenues of $14.9 million and $82.5 million for the fourth quarter and full year of 2023, respectively.
  • Operating expenses for the fourth quarter of 2023 were $23.8 million, compared to $41.1 million for the fourth quarter of 2022.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $7.4 million, compared to $16.6 million for the fourth quarter of 2022.
  • The net loss for the fourth quarter of 2023 was $10.9 million, compared to $33.6 million for the fourth quarter of 2022.

BeiGene Receives Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

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星期一, 二月 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, NSCLC, Carboplatin, European Commission, EMA, JAMA Oncology, EGFR, Committee, Tislelizumab, MAA, Neoplasm, FDA, Quality of life, Cancer, Food, ESCC, Pemetrexed, BGNE, European, Lung cancer, Civil service commission, CHMP, European Medicines Agency, Paclitaxel, Patient, Journal, Survival, ALK, Pharmaceutical industry

As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.

Key Points: 
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
  • Tislelizumab is also under review by the FDA as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.
  • BeiGene has launched more than 17 potentially registration-enabling trials with tislelizumab with over 13,000 patients enrolled to-date, of which 15 have already reported positive readouts.

FDA Grants Priority Review to Merck's Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Primary Advanced or Recurrent Endometrial Carcinoma

Retrieved on: 
星期二, 二月 20, 2024
Oncology, FDA, Health, General Health, Pharmaceutical, Biotechnology, MSD, Carboplatin, MRK, Society of Gynecologic Oncology, Food, PDUFA, Risk, Cancer, Gynecologic Oncology (journal), Death, Paclitaxel, SGO, Patient, Pharmaceutical industry

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 21, 2024.

Key Points: 
  • The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 21, 2024.
  • The sBLA is based on data from the Phase 3 NRG-GY018 trial.
  • Health authorities in Israel, Canada, Australia, Singapore and Brazil will review this application as part of Project Orbis.
  • In endometrial cancer, Merck is evaluating KEYTRUDA in the first-line setting for advanced or recurrent disease that is dMMR (KEYNOTE-C93/ENGOT-en15/GOG-3064) and in the adjuvant setting (KEYNOTE-B21/ENGOT-en11/GOG-3053).