Associated tags: MSD, Vaccine, Research, Animal, Merck, Health, Pharmaceutical, Biotechnology, MRK, NYSE, Pharmaceutical industry, Clinical Trials, Merck & Co., Oncology, Patient, General Health, FDA, Science
Locations: USA, NEW YORK, EUROPE, CALIFORNIA, AUSTRALIA, JAPAN, ITALY, FRANCE, SAN FRANCISCO, DENMARK, ICELAND, NORWAY, SWITZERLAND, LIECHTENSTEIN, SPAIN, EC, EU, BELGIUM, GERMANY, ISRAEL, VIN, GEORGIA, SOUTH AFRICA, TENNESSEE, III, SWEDEN, NETHERLANDS, UNITED STATES, NORTH AMERICA, NEW JERSEY, CANADA, SG
Research,
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Clinical Trials,
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DFS,
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Merck & Co.,
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Eisai,
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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.
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Caroline Litchfield, executive vice president and chief financial officer, is scheduled to participate in a fireside chat at the Bank of America Securities 2024 Healthcare Conference on Wednesday, May 15, 2024, at 1:40 p.m. PDT / 4:40 p.m. EDT.
Key Points:
- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Caroline Litchfield, executive vice president and chief financial officer, is scheduled to participate in a fireside chat at the Bank of America Securities 2024 Healthcare Conference on Wednesday, May 15, 2024, at 1:40 p.m. PDT / 4:40 p.m. EDT.
Biotechnology,
General Health,
Pharmaceutical,
Health,
MSD,
PFS,
CPS,
FDA,
Congress,
HER2,
Food,
Oncology,
Merck & Co.,
Progression-free survival,
Pembrolizumab,
Survival,
Trastuzumab,
ESMO,
OS,
PD-L1,
Patient,
Neoplasm,
ITT,
MRK,
GEJ,
Pharmaceutical industry Continued approval of this indication may be contingent upon verification and description of clinical benefit at the final analysis of the KEYNOTE-811 study.
Key Points:
- Continued approval of this indication may be contingent upon verification and description of clinical benefit at the final analysis of the KEYNOTE-811 study.
- The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.
- In the U.S., KEYTRUDA is also approved for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma, based on results from KEYNOTE-859.
- Merck has an extensive clinical development program evaluating KEYTRUDA in gastrointestinal cancers and is continuing to study KEYTRUDA for multiple uses in gastric, hepatobiliary, esophageal and colorectal cancers.
Health,
Infectious Diseases,
Clinical Trials,
Research,
Science,
Pharmaceutical,
Biotechnology,
MSD,
Infection,
FDA,
Safety,
10A,
Merck & Co.,
Epidemiology,
Pediatrics,
Abstract,
Vaccine,
PDUFA,
Streptococcus,
Patient,
9N,
EMA,
Medicine,
20A,
Aes,
Emory University,
OPA,
PCV20,
Leucauge,
European Medicines Agency,
Food,
MRK,
Global health The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine.
Key Points:
- The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine.
- V116 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
- The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024.
- V116 is specifically designed to help protect adults from invasive pneumococcal disease; the serotypes in V116 account for approximately 83% of adult invasive pneumococcal disease in individuals 65 and older, according to U.S. Centers for Disease Control and Prevention data from 2018-2021.
Infectious Diseases,
FDA,
Diabetes,
Clinical Trials,
Cardiology,
Biotechnology,
Health,
Pharmaceutical,
Oncology,
Acquisition,
Research,
Drug development,
Ezetimibe,
Investment,
GAAP,
EPS,
Pharmaceutical industry Research and development (R&D) expenses were $4.0 billion in the first quarter of 2024 compared with $4.3 billion in the first quarter of 2023.
Key Points:
- Research and development (R&D) expenses were $4.0 billion in the first quarter of 2024 compared with $4.3 billion in the first quarter of 2023.
- GAAP EPS was $1.87 for the first quarter of 2024 compared with $1.11 for the first quarter of 2023.
- Non-GAAP gross margin was 81.2% for the first quarter of 2024 compared with 76.9% for the first quarter of 2023.
- Non-GAAP EPS was $2.07 for the first quarter of 2024 compared with $1.40 for the first quarter of 2023.
Oncology,
Health,
FDA,
General Health,
Clinical Trials,
Pharmaceutical,
Biotechnology,
MSD,
Congress,
Mutation,
NSCLC,
Progression-free survival,
Patient,
Neoplasm,
Merck & Co.,
Cancer,
Lung cancer,
TPS,
MRK,
ESMO,
Safety,
Pharmacokinetics,
PD-L1,
Astex Pharmaceuticals,
Pharmaceutical industry “KRAS is among the most prevalent mutations in cancer and KRAS G12C is the most common KRAS mutation in patients with non-small cell lung cancer,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.
Key Points:
- “KRAS is among the most prevalent mutations in cancer and KRAS G12C is the most common KRAS mutation in patients with non-small cell lung cancer,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.
- The primary endpoints of the study are progression-free survival and overall survival, and key secondary endpoints include objective response rate and duration of response.
- Preliminary safety and efficacy data from this trial were previously presented at the European Society for Medical Oncology (ESMO) Congress in 2023.
- MK-1084 is being developed through a collaboration with Taiho Pharmaceutical Co. Ltd and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd.
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its first-quarter 2024 sales and earnings conference call with institutional investors and analysts at 9:00 a.m.
Key Points:
- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its first-quarter 2024 sales and earnings conference call with institutional investors and analysts at 9:00 a.m.
- Investors, journalists and the general public may access a live audio webcast of the call via this weblink .
- A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at www.merck.com .
- All participants may join the call by dialing (888) 847-9708 (U.S. and Canada Toll-Free) or (630) 395-0358 and using the access code 4164932.
Biotechnology,
Health,
Pharmaceutical,
Clinical Trials,
Oncology,
MSD,
Civil service commission,
OS,
Lung cancer,
Survival,
Disease,
Risk,
Patient,
Committee,
Neoplasm,
EFS,
Merck & Co.,
Cancer,
Death,
MRK,
European Commission,
Recurrence,
PD-L1,
Marketing,
Pharmaceutical industry Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.
Key Points:
- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.
- For patients who received the KEYTRUDA-based regimen, median OS was not reached (95% CI, NR-NR) versus 52.4 months (95% CI, 45.7-NR) for patients who received the chemotherapy-placebo regimen.
- The KEYTRUDA-based regimen also improved event-free survival (EFS), reducing the risk of disease recurrence, progression or death by 41% (HR=0.59 [95% CI, 0.48-0.72]) compared to the chemotherapy-placebo regimen.
- KEYTRUDA is now approved for six indications in NSCLC, and for 27 indications overall in the EU.
Cardiology,
Biotechnology,
Pharmaceutical,
Oncology,
Health,
FDA,
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Other Health,
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FC,
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MRK,
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WHO,
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PAH,
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Pharmaceutical industry “The Pulmonary Hypertension Association welcomes the development of new therapies for those with PAH,” said Matt Granato, president and chief executive officer, Pulmonary Hypertension Association.
Key Points:
- “The Pulmonary Hypertension Association welcomes the development of new therapies for those with PAH,” said Matt Granato, president and chief executive officer, Pulmonary Hypertension Association.
- In the WINREVAIR treatment group, the placebo-adjusted median increase in 6MWD was 41 meters (95% CI: 28, 54; p
- The median treatment difference in PVR between WINREVAIR and placebo was -235 dynes*sec/cm5 (95% CI: -288, -181; p
- The median treatment difference in NT-proBNP between WINREVAIR and placebo was -442 pg/mL (95% CI: -574, -310; p
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.”
