Clinical Trial News
Immutep Announces Positive Preliminary Topline Results from TACTI-003 Cohort B
Immutep Limited has revealed encouraging preliminary topline results from Cohort B of the TACTI-003 Phase IIb trial, showing a 26.9% response rate in first-line head and neck squamous cell carcinoma patients with negative PD-L1 expression. The study evaluates the combination of eftilagimod alpha (efti) with MSD’s anti-PD-1 therapy KEYTRUDA®.
Highlighted Clinical Trials:
Immutep S.A.S.
Posted 8/27/2021
FDA Grants Full Approval to Elahere for Platinum-Resistant Ovarian Cancer
- The FDA has granted full approval to mirvetuximab soravtansine-gynx (Elahere) for advanced, platinum-resistant ovarian cancer with FR-α overexpression.
- The approval was based on the MIRASOL trial, which demonstrated improved overall and progression-free survival compared to standard chemotherapy.
- Elahere, an antibody-drug conjugate, targets FR-α on cancer cells, delivering a cytotoxic drug while sparing healthy cells, reducing severe side effects.
- Testing tumors for FR-α is now crucial to identify patients who can benefit from Elahere, marking a significant advancement in ovarian cancer treatment.
Highlighted Clinical Trials:
Medicare Expands Coverage for Wegovy to Include Cardiovascular Risk Reduction
- The FDA approved Wegovy (semaglutide) for reducing the risk of heart attacks and stroke in overweight or obese individuals with cardiovascular disease, opening the door for Medicare coverage.
- An estimated 3.6 million Medicare beneficiaries (7%) with established cardiovascular disease and obesity or overweight could be eligible for Wegovy under this expanded indication.
- Medicare Part D plans can now include Wegovy in their formularies, although coverage may vary, and out-of-pocket costs could range from $325 to $430 monthly.
- Broader Medicare coverage of GLP-1s like Wegovy for various approved uses could influence the cost of legislation aimed at lifting the ban on Medicare coverage for anti-obesity drugs.
FDA Approves ImmunityBio's Anktiva for Bladder Cancer, Marking Major Milestone for Soon-Shiong's Immunotherapy Approach
- The FDA has approved ImmunityBio's lead drug Anktiva for treating a common form of bladder cancer, representing a significant breakthrough after years of development and regulatory challenges.
- Anktiva harnesses the body's natural killer cells and T-cells to fight cancer, with clinical trials showing the ability to eliminate bladder cancer cells for at least four years.
- ImmunityBio plans to begin distributing Anktiva to healthcare providers by mid-May 2024, with the company having built a three-year stockpile of the drug during the FDA review process.
Tirzepatide Shows Promise as First Pharmaceutical Treatment for Obstructive Sleep Apnea in Obesity
- Phase 3 clinical trial results published in The New England Journal of Medicine demonstrate tirzepatide reduces obstructive sleep apnea severity by up to 62.8% in adults with obesity.
- The SURMOUNT-OSA trial showed that 43-51.5% of participants receiving the highest dose of tirzepatide met criteria for "disease resolution" of obstructive sleep apnea.
- Researchers believe tirzepatide could become the first pharmaceutical treatment for obstructive sleep apnea, potentially offering an alternative to continuous positive airway pressure (CPAP) therapy.
Tislelizumab Approved in Europe for Non-Small Cell Lung Cancer Treatment
The European Commission has approved tislelizumab for treating non-small cell lung cancer (NSCLC) in both frontline and second-line settings. This approval is based on positive outcomes from three phase 3 trials, offering new hope for patients with advanced stages of the disease.
Highlighted Clinical Trials:
BeiGene
Posted 7/23/2018
Actinogen XanaMIA ACW0009 Phase 2b Trial for MCI and Mild Alzheimer's Disease
The Actinogen XanaMIA ACW0009 Phase 2b trial is seeking participants aged 50 or older diagnosed with MCI or mild Alzheimer's disease for a 9-month study involving daily oral tablets, with a 50% chance of receiving a placebo.
Sanofi's Rilzabrutinib Achieves Primary Endpoint in Phase 3 ITP Trial
- Sanofi's rilzabrutinib met the primary endpoint in the LUNA 3 phase 3 study for immune thrombocytopenia (ITP), demonstrating a durable platelet response in adult patients.
- The study showed a statistically significant improvement in platelet counts to above 50,000/μL for at least 8 of the last 12 weeks compared to placebo in refractory ITP patients.
- Rilzabrutinib, an oral BTK inhibitor, exhibited a safety profile consistent with prior studies, supporting its potential as a novel treatment for ITP.
- Regulatory submissions to the US and EU are anticipated by the end of the year, marking a significant step toward a new treatment option for ITP patients.
Highlighted Clinical Trials:
Principia Biopharma, a Sanofi Company
Posted 12/14/2020
FDA Approves ImmunityBio's Anktiva for Bladder Cancer Treatment
- The FDA has approved Anktiva, an immunotherapy agent developed by ImmunityBio, for bladder cancer patients who do not respond to standard Bacillus Calmette-Guerin (BCG) therapy.
- Clinical trials showed that Anktiva, used in conjunction with BCG, resulted in a 55% successful response rate at three months and 45% after one year in a group of patients.
- Anktiva mimics a type of cell that stimulates the immune system to produce memory killer T cells, which recognize and attack bladder cancer cells, offering a new treatment option.
- Experts note that while Anktiva presents a promising alternative, the current worldwide shortage of BCG could potentially limit the number of patients who can receive the treatment.
FDA Approves Alvotech/Teva's Ustekinumab Biosimilar, SELARSDI
- The FDA has approved SELARSDI (ustekinumab-aekn), a biosimilar to Johnson & Johnson’s STELARA® (ustekinumab), for treating moderate to severe plaque psoriasis and active psoriatic arthritis.
- SELARSDI, developed by Alvotech and to be commercialized by Teva in the U.S., is administered as a subcutaneous injection for adult and pediatric patients aged six years and older.
- This marks the second ustekinumab biosimilar approved by the FDA, following Amgen’s WEZLANA, and Alvotech and Teva settled with Johnson & Johnson to market it no later than February 21, 2025.