Reviewed by Emily Henderson, B.Sc.Apr 17 2023 A regimen of pre-surgical immunotherapy and chemotherapy followed by post-surgical immunotherapy significantly improved event-free survival (EFS) and pathologic complete response (pCR) rates compared to chemotherapy alone for patients with operable non-small cell lung cancer (NSCLC), according to Phase III trial results presented today by researchers from The University of Texas MD Anderson Cancer Center at the American Association for Cancer Research (AACR) Annual Meeting 2023. The AEGEAN trial evaluated durvalumab given perioperatively, meaning therapy is given both before and after surgery. Participants on the trial received either pre-surgical (neoadjuvant) durvalumab and platinum-based chemotherapy followed by post-surgical (adjuvant) durvalumab or neoadjuvant placebo and chemotherapy followed by adjuvant placebo. These represent the first data presented on the benefits of perioperative immunotherapy for resectable NSCLC and adds to the growing evidence supporting the benefits of both neoadjuvant and adjuvant immunotherapy for these patients. Our goal is to increase cures for lung cancer. ...
The combination of an experimental mRNA vaccine with an immunotherapy reduced the likelihood of melanoma recurring or causing death by 44% when compared to immunotherapy alone, a new clinical trial shows. Led by researchers at NYU Langone Health and its Perlmutter Cancer Center, the randomized phase 2b trial involved men and women who had surgery to remove melanoma from lymph nodes or other organs and were at high risk of the disease returning in sites distant from the original cancer. Among 107 study subjects who were injected with both the experimental vaccine, called mRNA-4157/V940, and the immunotherapy pembrolizumab, the cancer returned in 24 subjects (22.4%) within two years of follow-up, compared with 20 out of 50 (40%) who received only pembrolizumab. “Our phase 2b study shows that a neoantigen mRNA vaccine, when used in combination with pembrolizumab, resulted in prolonged time without recurrence or death compared with pembrolizumab alone,” said study senior investigator ...
[Before the Sartorius buyout, Polyplus had itself been expanding through multiple acquisitions. (Sartorius)] As the biopharma industry struggles with a dire shortage of viral vectors to make cell and gene therapies, contract manufacturers are busy beefing up their capabilities. In the latest example of biopharma’s ongoing investment in cell and gene therapy production, Sartorius has agreed to acquire French company Polyplus for 2.4 billion euros ($2.6 billion), the German CDMO said Friday. The deal gives Sartorius additional know-how in nucleic acid delivery, including transfection reagents and plasmid DNA design, all of which are key elements in the production of viral vectors for building cell and gene therapies. Formed in 2001, Polyplus employs about 270 people in several locations in France, Belgium, the U.S. and China. Before the Sartorius buyout, Polyplus had itself been expanding through M&A deals. In 2021, Polyplus bought Asia-Pacific-focused reagent supplier Biowire. ...
The National Institute for Health and Care Excellence (NICE) has recommended the therapy to treat patients with aromatic L-amino acid decarboxylase (AADC) deficiency who are 18 months and older. PTC has inked a confidential discount access scheme to make Upstaza available to the National Health Service (NHS), NICE says. The drug carries a list price of 3 million pounds sterling (around $3.71 million) per 0.5-mL infusion solution before the confidential discount. AADC deficiency is so rare that it affects an estimated 10 children in the U.K., only a few of whom could be eligible for the treatment. The disease causes a wide range of severe symptoms, but around 80% of patients have a severe form that leaves them fully dependent on caregivers and unable to meet normal developmental milestones. Due to the rarity of this condition, there isn’t much research on the expected life span of a person with AADC deficiency. It’s estimated that most ...
Pfizer, a global pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational treatment for Alzheimer’s disease, called PF-05217917. This designation is intended to accelerate the development and review of promising drugs that have the potential to address serious or life-threatening conditions. Alzheimer’s disease is a progressive brain disorder that affects millions of people worldwide, causing memory loss and other cognitive impairments. There are currently no approved treatments that can slow or stop the progression of the disease. Pfizer’s PF-05217917 is an antibody that targets the tau protein, which is believed to play a key role in the development and progression of Alzheimer’s disease. The FDA’s decision to grant Breakthrough Therapy designation to PF-05217917 was based on the results of a Phase 2 clinical trial that involved patients with mild to moderate Alzheimer’s disease. The trial showed that ...
A new study has found that virtual reality therapy may be an effective treatment for post-traumatic stress disorder (PTSD). PTSD is a mental health condition that can develop after experiencing or witnessing a traumatic event, such as military combat, sexual assault, or a natural disaster. Symptoms of PTSD can include flashbacks, nightmares, and anxiety. The study, published in The Lancet Psychiatry, involved 103 military veterans with PTSD. The veterans were randomly assigned to receive either virtual reality therapy or traditional therapy, which involved talk therapy and other forms of therapy. The virtual reality therapy involved wearing a headset that displayed virtual environments related to the veterans’ traumatic experiences. The veterans were able to interact with the virtual environments and practice coping strategies to manage their symptoms. The researchers found that the veterans who received virtual reality therapy had greater reductions in PTSD symptoms than those who received ...
Recently, Hengrui Medicine’s ADC innovative drug SHR-A1811 for the treatment of HER2-mutated advanced non-small cell lung cancer who failed previous platinum-based chemotherapy was proposed to be included in the public list of breakthrough therapy varieties by the Center for Drug Evaluation of the National Medical Products Administration. The study was led by Professor Lu Shun from the Chest Hospital Affiliated to Shanghai Jiaotong University, and a total of 10 centers across the country participated. At the same time, the other two indications of SHR-A1811 have been included in the list of breakthrough therapy varieties by the Drug Evaluation Center of the State Drug Administration in February this year. The indications are: low expression of human epidermal growth factor receptor 2 (HER2). Recurrent or metastatic breast cancer and human epidermal growth factor receptor 2 (HER2) positive recurrent or metastatic breast cancer. Lung cancer is currently the leading cause of cancer-related death ...
A recent study published in the Journal of Clinical Oncology has shown promising results for a new type of cancer therapy. The therapy, known as a targeted therapy, uses drugs that specifically target the genetic mutations that drive the growth of cancer cells. Traditional cancer treatments like chemotherapy and radiation therapy are often associated with serious side effects because they damage healthy cells along with cancer cells. Targeted therapies, on the other hand, are designed to be more precise and have fewer side effects. The new study focused on a targeted therapy called larotrectinib, which is designed to treat cancers that have a specific genetic mutation called NTRK fusion. NTRK fusion is a rare but important genetic alteration that is found in a variety of cancers, including certain types of lung, colon, and breast cancer. The study included 55 patients with NTRK fusion-positive cancer who were treated with larotrectinib. The ...
Duchenne muscular dystrophy (DMD) is a rare and devastating genetic disorder that causes progressive muscle weakness and eventually leads to death. There is currently no cure for DMD and available treatments only offer modest benefits. However, a recent study published in the journal Nature has shown promising results for a new approach to treating DMD using gene therapy. The researchers used a viral vector to deliver a functional copy of the dystrophin gene, which is mutated in DMD, to muscle cells in mice with the disease. The researchers found that the gene therapy led to an improvement in muscle strength and function in the mice. They also found that the therapy was safe and well-tolerated. The lead author of the study, Dr. Dongsheng Duan, said that the results were “very encouraging” and showed that gene therapy could be a viable option for treating DMD. “This study demonstrates that gene therapy ...
Funding is for onasemnogene abeparvovec and concerns babies with spinal muscular atrophy NICE has published final draft guidance regarding the recommendation of routine NHS funding for onasemnogene abeparvovec. The treatment is a potentially curative one-off gene therapy for treating a rare genetic condition, spinal muscular atrophy (SMA). It will be used specifically among babies aged up to 12 months, before they develop symptoms. The drug – also known as Zolgensma – is produced by Novartis Gene Therapies. The recommendation has emerged after NICE reviewed the evidence to determine whether it should be available for routine NHS funding in England and Wales. Onasemnogene abeparvovec is designed to address the genetic cause of SMA and its effects are thought to be life-long. Under NICE’s original guidance, released in 2021, it was recommended for babies before they develop symptoms of SMA as part of a managed access agreement (MAA). The agreement ensured that ...
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