IIB

Merck Provides Update on Phase 3 KeyVibe-010 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab as Adjuvant Treatment for Patients With Resected High-Risk Melanoma

Retrieved on: 
Montag, Mai 13, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Lung, Patient, INT, TIGIT, Pembrolizumab, Merck & Co., CD112, CD155, Disease, Safety, Data analysis, Cancer, Interim, Melanoma, Ligand, Lung cancer, IIB, RFS, MRK, Data monitoring committee, IIC, DMC, Pharmaceutical industry

The trial is evaluating the investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, compared to KEYTRUDA alone, as adjuvant treatment for patients with resected high-risk melanoma (Stage IIB-IV).

Key Points: 
  • The trial is evaluating the investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, compared to KEYTRUDA alone, as adjuvant treatment for patients with resected high-risk melanoma (Stage IIB-IV).
  • At a pre-planned analysis, data showed that the primary endpoint of recurrence-free survival (RFS) met the pre-specified futility criteria.
  • Merck has an extensive clinical development program evaluating the safety and efficacy of the vibostolimab and pembrolizumab coformulation alone and in combination with other agents in over 3,000 patients.
  • Ongoing Phase 3 studies evaluating the vibostolimab and pembrolizumab coformulation in lung cancer, which are routinely monitored by external data monitoring committees, include KeyVibe-003 , KeyVibe-006 , KeyVibe-007 and KeyVibe-008 .

RemeGen Presents Oral Presentation on Evaluation of Its Proprietary Disitamab Vedotin (RC48) for Cervical Cancer at ESGO 2024

Retrieved on: 
Montag, März 11, 2024
HER2, Cervical cancer, Congress, ECOG, Immunotherapy, Progression-free survival, DCR, Patient, Research, IIB, Șaeș, Safety, Dor, Carcinoma, ESGO, Adenocarcinoma, PFS, FIGO, ADC, Independent Review Committee, Pharmaceutical industry

The cervical cancer cohort includes patients with recurrent or metastatic cervical cancer who have progressed on at least 1L anti-tumor therapy and have HER2 IHC ≥1+.

Key Points: 
  • The cervical cancer cohort includes patients with recurrent or metastatic cervical cancer who have progressed on at least 1L anti-tumor therapy and have HER2 IHC ≥1+.
  • As of October 31, 2023, 25 patients with cervical cancer were enrolled with a median age of 56 years (range: 35-66).
  • In conclusion, RC48 demonstrates a manageable safety profile and positive efficacy in HER2-expressing r/m cervical cancer patients, suggesting it to be a promising new treatment for HER2-expressed cervical cancer.
  • I am delighted to share an oral presentation on the evaluation of our proprietary ADC Disitamab Vedotin at ESGO 2024.

Cervical Cancer Studies Outline Innovative Treatment Options For Patients In 2024

Retrieved on: 
Donnerstag, Februar 15, 2024
Cervical cancer, Research, IIB, Disability, Chemoradiotherapy, CCRT, Social, Vaccination, Risk, Survival rate, Social Security, DFS, SSDI, Patient, Social Security Disability Insurance, Survival, Disease, HPV, Ageing, Cancer, Birth control

Research highlights the critical link between HPV (human papillomavirus) and cervical cancer, with the virus responsible for the majority of cases.

Key Points: 
  • Research highlights the critical link between HPV (human papillomavirus) and cervical cancer, with the virus responsible for the majority of cases.
  • Regular cervical cancer screening is essential for those aged 21 to 65, incorporating HPV testing followed by further assessments for those with positive results.
  • In evaluating treatment efficacy for stage IB2 to IIB cervical carcinoma, a 12-year study involving 626 patients compared neoadjuvant chemotherapy followed by surgery (NACT-S) with concomitant chemoradiotherapy (CCRT).
  • Cervical Cancer Awareness Month is a crucial time to raise public awareness about cervical cancer and the importance of early detection and treatment.

Galderma Reports Record Net Sales of Over 3 B USD for the First Nine Months of 2023 With Strong Growth Momentum Across All Product Categories

Retrieved on: 
Dienstag, November 21, 2023
Cosmetics, Retail, Health, Technology, Health Technology, Artificial Intelligence, Pharmaceutical, Itch, PIH, Prurigo nodularis, Investment, International Chamber of Commerce, Patient, FACE, R, Growth, IIB, Food, International, Patient satisfaction, Commerce, Calcineurin, Science, Sculptra, Atopic dermatitis, Galderma, Neuromodulation, Adapalene, Botulinum toxin, EBITDA, Adolescence, Risk, ICC, Ivermectin, Partnership, Symantec Endpoint Protection, Ipsen, Skin, PN, Nemolizumab, Liquid Lives, Cryptocurrency, Pharmaceutical industry, Dermatology, Cetaphil

For the period, net sales growth was strong across all product categories, with balanced contributions across volume, pricing and brand mix.

Key Points: 
  • For the period, net sales growth was strong across all product categories, with balanced contributions across volume, pricing and brand mix.
  • Internationally, there was particularly strong growth momentum across product categories in fast growing Asian and Latin American markets, including China, India, and Mexico.
  • Based on the strong performance so far, Galderma is on track to deliver at the upper end of its 6-9% net sales constant currency growth range.
  • In Dermatological Skincare, Galderma experienced double-digit net sales growth year-on-year over the first nine months of 2023 on a constant currency basis.

60 Degrees Pharmaceuticals Suspends Phase IIB Study of Tafenoquine for COVID-19, Pivots to Refocus on Commercialization of Treatments for Malaria and Tick-Borne Diseases

Retrieved on: 
Donnerstag, Oktober 12, 2023
Incidence, Infection, Post-exposure prophylaxis, COVID-19, HIV disease progression rates, Lyme disease, United, Letter, Parasitism, Cough, Clinical research associate, Risk, Hospital, Therapy, IND, Death, Smell, FDA, Tafenoquine, IIA, IIB, Malaria, Fever, Literature, Babesiosis, Deer, Patient, Pharmaceutical industry, Medical device

Tafenoquine is the active molecule in ARAKODA®, the Company’s U.S. Food and Drug Administration (FDA)-approved regimen for malaria prevention.

Key Points: 
  • Tafenoquine is the active molecule in ARAKODA®, the Company’s U.S. Food and Drug Administration (FDA)-approved regimen for malaria prevention.
  • However, the FDA has explicitly not authorized the use of those products in patients with low risk of COVID-19 disease progression.
  • Current literature on COVID-19 shows that low risk patients have a very low risk of hospitalization.
  • However, such a combination approach may not make clinical sense in a low-risk population or be Phase III enabling.

Melanoma Research Alliance Applauds Expanded Approval of Nivolumab to Patients with Stage 2 Disease

Retrieved on: 
Montag, Oktober 16, 2023
IIC, MRA, Food, Doctor of Philosophy, Melanoma, Research, Death, Risk, Recurrence, Cancer, FDA, Skin cancer, Nivolumab, IIB, Immune system, Lung, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Blood, Bristol Myers Squibb, Patient, Pharmaceutical industry

While surgery is curative for most patients with early-stage disease, up to one third of patients with stage IIB and up to half of patients with IIC melanoma will have a recurrence within five years.

Key Points: 
  • While surgery is curative for most patients with early-stage disease, up to one third of patients with stage IIB and up to half of patients with IIC melanoma will have a recurrence within five years.
  • Reducing the risk of recurrence after surgery – and the progression to more advanced disease – is an important goal for clinicians and patients alike.
  • Nivolumab, an anti-PD-1 antibody, works by stimulating the patient's immune system to attack melanoma by promoting the tumor-killing effectiveness of T cells.
  • "The expanded approval of nivolumab gives patients with high risk melanoma a new option to prevent recurrence following surgery," says MRA Chief Executive Officer Marc Hurlbert, PhD.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as Adjuvant Treatment for Eligible Patients with Completely Resected Stage IIB or Stage IIC Melanoma1

Retrieved on: 
Samstag, Oktober 14, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, IIC, Confidence interval, Bristol Myers Squibb, NYSE, Food, Death, Risk, Recurrence, Melanoma, Checkmate, Nivolumab, IIB, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BMY, Patient, Pharmaceutical industry, Medical device

Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo® (nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing adjuvant indication for Opdivo and further reinforcing the company’s legacy of providing treatment options for melanoma patients.1 The approval is based on the Phase 3 CheckMate -76K trial, which compared Opdivo (n=526) to placebo (n=264).1,2

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo® (nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing adjuvant indication for Opdivo and further reinforcing the company’s legacy of providing treatment options for melanoma patients.1 The approval is based on the Phase 3 CheckMate -76K trial, which compared Opdivo (n=526) to placebo (n=264).1,2
    In the trial, Opdivo reduced the risk of recurrence, new primary melanoma, or death in patients with completely resected stage IIB or IIC melanoma by 58% compared to placebo (Hazard Ratio [HR] 0.42; 95% Confidence Interval [CI]: 0.30-0.59; P “Following surgical removal of melanoma, patients may believe they are free of disease,” said John M. Kirkwood, M.D., Distinguished Professor of Medicine at the University of Pittsburgh School of Medicine and Co-Director of the Melanoma Center at UPMC Hillman Cancer Center.
  • “However, within five years of diagnosis, one-third of patients with surgically resected stage IIB and nearly one-half of patients with surgically resected IIC melanoma see their cancer return, underscoring the need for additional treatment options that may help reduce the risk of cancer coming back.4 The significant recurrence-free survival improvement observed with nivolumab in CheckMate -76K is an important step forward for these patients.”1
    Opdivo is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.1 Please see Important Safety Information below.
  • “Stage IIB and IIC melanoma patients may still face the threat of disease recurrence, despite the benefit of surgery, which can impact outcomes,” said Catherine Owen, senior vice president and general manager, U.S. Cardiovascular, Immunology and Oncology at Bristol Myers Squibb.4,5 “This approval builds on our existing adjuvant indication in completely resected stage III or IV disease and now provides eligible patients with completely resected stage IIB or IIC melanoma an additional treatment option which may help prevent recurrence.
  • BMS remains committed to its goal of helping improve patient outcomes in melanoma and bringing immunotherapy to more patients, including in the earlier stages of disease.”1
    The FDA previously approved Opdivo for the adjuvant treatment of adult and pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection, based upon data from the CheckMate -238 trial.1
    Additional CheckMate -76K follow-up data will be presented at the Society for Melanoma Research Annual Meeting in November.

Xiaomi to Present Its Global Internet Business Growth Methodology at MIPC 2024

Retrieved on: 
Freitag, Oktober 13, 2023
Acquisition, Publishing, MIUI, Growth, IIB, Map, DMS, Logic, Business development, Conference, Mobile phone

SINGAPORE, Oct. 12, 2023 /PRNewswire/ -- Xiaomi, a global leader in technology, will host the Mi Internet Partner Conference (MIPC) 2024 in Singapore on October 20th.

Key Points: 
  • SINGAPORE, Oct. 12, 2023 /PRNewswire/ -- Xiaomi, a global leader in technology, will host the Mi Internet Partner Conference (MIPC) 2024 in Singapore on October 20th.
  • Xiaomi will also present its business map and explain the commercial logic behind the conference slogan, "Grow with Xiaomi."
  • MIPC 2024 is an occasion for us to introduce how Xiaomi's internet services connect its partners and clients with 456 million overseas MIUI users worldwide through system-level, highly-customized solutions, to achieve their business goals with minimum expense," said Chan Liu, General Manager, Internet Business Department, Xiaomi.
  • Click the link to register for free, and discover how Xiaomi's internet services can power your organization's growth to the next level.

60 Degrees Pharma Withdraws COVID Phase IIB IND, Will Resubmit Pending Assessment of Ability to Meet FDA Requirements

Retrieved on: 
Montag, September 18, 2023
Acceleration, IIB, Lyme disease, Babesiosis, Marketing, COVID-19, Infection, Incidence, Post-exposure prophylaxis, Patient, Clinical research associate, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Malaria, Pharmaceutical industry, Medical device

The Company’s decision to withdraw the IND is in response to recent comments from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • The Company’s decision to withdraw the IND is in response to recent comments from the U.S. Food and Drug Administration (FDA).
  • In the interim, pending additional interaction with FDA, 60P has paused further start-up activities for its Phase IIB trial (ACLR8-LR), thereby decreasing the Company’s burn rate and improving its cash position in the short term.
  • Estimates are that 10 percent of Lyme disease patients are co-infected with babesiosis.
  • In Q2 2023, sales of ARAKODA increased by 150 percent relative to the same period of 2022.

AUA Releases Amendment to the Diagnosis and Treatment of Early-Stage Testicular Cancer Guideline

Retrieved on: 
Donnerstag, September 14, 2023
Cancer, IIB, Teratoma, Guideline, Retroperitoneal space, AUA, IIA, American Urological Association, Bleomycin, Toxicity, Cisplatin, Literature, SUFU, Testicular cancer, Etoposide, Estate (law), Patient, Surveillance, Diagnosis, Rush University Medical Center, Tumor antigen, ULR, Dentistry, Medical imaging, Medical device

BALTIMORE, Sept. 14, 2023 /PRNewswire/ -- Today the American Urological Association (AUA) released the 2023 clinical practice guideline amendment for the diagnosis and treatment of early-stage testicular cancer.

Key Points: 
  • BALTIMORE, Sept. 14, 2023 /PRNewswire/ -- Today the American Urological Association (AUA) released the 2023 clinical practice guideline amendment for the diagnosis and treatment of early-stage testicular cancer.
  • Testicular cancer is the most common solid malignancy in young males and is relatively rare, with outcomes defined by specific cancer and patient-related factors.
  • "Since the last testicular cancer guideline was released, the model for management has substantially changed, making an amendment like this critical to effectively treat and manage testicular cancer."
  • Diagnosis and treatment of early-stage testicular cancer: AUA Guideline amendment 2023.