Summary of recent progress in the field of cancer (11.27) November 27, 2017 Source: WuXi PharmaTech 1. New CAR-T therapy targeting CD22 can bring long-term relief This year is a year of great growth in CAR-T therapy. The current common target protein for CAR-T therapy is CD19, but recent scientists from the Stanford University School of Medicine and the National Cancer Institute (NCI) have discovered another target protein, CD22, and Tests were performed in patients with acute lymphoblastic leukemia (ALL). CAR-T therapy uses the body's own immune system to identify specific proteins on the surface of cancer cells with engineered T cells, thereby efficiently killing cancer cells. This is very effective for many patients. However, rapidly dividing cancer cells can rapidly develop resistance to different therapies. In some patients, cancer cells can cause disease recurrence or no response to treatment by no longer producing the existing major target CD19 protein. This new discovery by Stanford University and NCI is expected to overcome this problem. In a phase 1 clinical trial, 15 patients who had relapsed or did not respond to CAR-T therapy targeting CD19 received CAR-T therapy targeting CD22, and 10 of them had been treated with targeted CD19. But it produces resistance. It was found that 1 of the 6 patients receiving the lowest dose achieved complete remission; 11 of the 15 patients receiving the higher dose achieved remission, with a remission rate of 73% and a median remission time of 6 months. Three of them remained completely relieved in the 6th, 9th and 21st months after receiving treatment. In addition, patients are well tolerated by this therapy. “We found another CAR-T cell therapy that showed high levels of activity in this phase 1 clinical trial,†said Dr. Crystal Mackall, deputy director of the Stanford University Cancer Institute and director of the Park Cancer Immunotherapy Institute. "But it has a high recurrence rate. This makes the whole field more complicated. How many goals does a successful, long-lasting treatment require? What happens if we target both CD19 and CD22?" “This is an exciting time, we are at the forefront of promoting CAR-T cell immunotherapy and through a groundbreaking strategy to improve the long-term prognosis of children and adolescents,†Principal Investigator of the PLAT-05 trial, Seattle Children's Oncologist Dr. Rebecca Gardener commented: "By launching a bilateral attack on cancer cells, we hope this trial will help us develop a T-cell therapy that will bring long-term relief to more patients." 2. Roche's new therapy significantly prolongs PFS in patients with lung cancer Recently, Roche announced that its non-small cell lung cancer triple therapy significantly prolonged progression-free survival (PFS) in phase 3 clinical trials, reaching a common primary clinical endpoint. This result is expected to change the treatment criteria for non-small cell lung cancer. The non-small cell lung cancer targeted by this clinical trial is the most common type of lung cancer, accounting for about 85% of the total number of lung cancer cases. As one of the most deadly cancers in the world, lung cancer kills nearly 1.59 million people every year and there is still a huge medical need. The triple therapy brought by Roche is one of the latest attempts to meet this need. This therapy consists of the PD-L1 inhibitor atezolizumab (trade name TECENTRIQ), the VEGF inhibitor bevacizumab (trade name Avastin), and chemotherapy (paclitaxel + carboplatin). The effect of this triple therapy was validated in a multicenter, open-label, randomized, controlled, phase 3 clinical trial called IMpower150. In this clinical trial, the researchers recruited a total of 1,202 patients. These patients all had stage IV non-squamous non-small cell lung cancer and did not receive chemotherapy for this advanced disease. These patients were randomly divided into three groups at a ratio of 1:1:1. The first group received a combination of atezolizumab and chemotherapy, the second group received triple therapy, and the third group received a combination of bevacizumab and chemotherapy (current standard first-line therapy). The results showed that patients who underwent triple therapy had significantly longer progression-free survival (PFS) compared with patients receiving current standard first-line therapy, reaching the common primary endpoint of the study. Even more gratifying is that the data obtained in patients without ALK or EGFR mutations or with T-effector gene expression are significant. Another common primary endpoint of the study was overall survival (OS). The data is not yet mature, and researchers are expected to conduct the next OS analysis in the first half of 2018. But as far as the current figures are concerned, the researchers point out that the initial observations of the OS are exciting. “We are very excited about these results and will submit these data to the global health regulator, hoping to bring this potential new initial lung cancer standard to patients,†said Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. The doctor said: "In addition to first-line treatment of non-small cell lung cancer, we are still testing whether TECENTRIQ and Avastin can enhance the immune system's ability to fight a variety of other cancers." 3. FDA approves cancer accurate diagnostic test The US FDA recently approved an in vitro diagnostic test for the IMPACT tumor distribution that commemorates the Sloan-Kettering Cancer Center (MSK), which can detect more cancer gene mutations than all previous tests. According to the National Cancer Institute (NCI), approximately 38.5% of Americans are diagnosed with cancer during their lifetime. Cancer data testing is gaining wider acceptance. By identifying genetic mutations in specific tumors, test results can provide useful information to patients and medical professionals to help better treat cancer. The IMPACT test uses Next Generation Sequencing (NGS) technology to rapidly identify mutations in 468 unique genes, as well as other molecular changes in the patient's tumor genome. Unlike many cancer diagnostic tests that use a single drug to detect a cancer biomarker, IMPACT detects genetic changes by comparing tumor tissue with "normal" tissue or cell samples from the same patient to provide guidance for treatment. The IMPACT test passes the FDA's “de novo premarket review†approach, which addresses the accuracy, accuracy and detection limits of the ability to detect genetic mutations (analytical performance) for new low- and medium-risk devices that are not legally marketed. Evaluation. The results show that the test is highly accurate (greater than 99%) and can detect mutations with a frequency of approximately 5% (range 2-5%). In addition, certain molecular changes detected using the IMPACT test were consistent over more than 92% of the 175 cases of multiple cancers compared to conventional assays. This approval paves the way for an effective review of other NGS-based cancer data analysis tools. The FDA also announced that the New York State Department of Health (NYSDOH) has become the FDA's third-party in vitro diagnostic review facility, which includes tests similar to IMPACT. Looking ahead, laboratories that have received NYSDOH approval for NGS tumor analysis testing do not need to submit a separate 510(k) application to the FDA. Instead, the developer can request a NYSDOH application, and the state's review memo and recommendations are forwarded to the FDA for a 510(k) license. Other accredited third-party FDA review bodies may also be eligible for such review and make licensing recommendations to the agency. “Allowing an accredited third-party organization to review the NGS tumor data analysis test is designed to ease the burden on test developers and simplify the regulatory assessment of these types of innovative products. As this area evolves, we are experimenting with FDA Room testing effective approval methods for modernization improvements, allowing developers to voluntarily seek 510(k) licenses.†FDA Director Scott Gottlieb said: “This is the FDA's efforts to find innovative and flexible regulatory approaches that promote the development and effectiveness of innovative technologies. Another example of a listing is that we will continue to look for opportunities to improve regulatory efficiency where possible, to make it easier to get health-improving tools, and to meet patient expectations of FDA reviewing product safety and efficacy standards. “NGS technology can detect hundreds or even millions of DNA variants at a time, and we are just beginning to realize the true potential of these devices to help patients and healthcare providers understand the genetic basis of their disease,†Dr. Jeffrey Shuren, Director of the FDA's Center for Equipment and Radiology, said: "Recognizing that the important impact of individual biomarker information may affect their care plans and outcomes, the FDA works closely with NYSDOH and MSK to ensure the accuracy of IMPACT testing. , reliability and clinical significance. This collaboration is a good example of how the FDA works with the healthcare and development communities to review innovative tests as quickly as possible." 4. Genentech's new drug for lymphoma is approved Genentech, a member of the Roche group, recently announced that the US FDA has approved Gazyva (obinutuzumab) in combination with chemotherapy for patients with previously untreated advanced follicular lymphoma (stage II, stage III or IV). Patients with relief in treatment can then be treated with Gazyva alone. The approval of the Gazyva was based on the results of a phase 3 clinical trial of GALLIUM. The study showed that patients receiving the Gazyva regimen had better progression-free survival (PFS) than patients who initially received Rituxan (rituximab) as a first-line treatment. Currently, Gazyva has three approved indications in the United States, including two common types of blood cancer. Follicular lymphoma is the most common type of slow-growing non-Hodgkin's lymphoma (NHL), accounting for about one-fifth of NHL cases. The tumor is incurable and often relapses, becoming more difficult to treat after each relapse, and early progression may be associated with a prolonged poor prognosis. This year, the United States estimates that more than 14,000 new cases of follicular lymphoma have been diagnosed. This patient population is in desperate need of new therapies to control the condition. Gazyva is expected to provide disease relief for these patients. It is a monoclonal antibody that binds to CD20, a protein found on certain types of B cells. It is thought to attack target cells directly or with the body's immune system. Experiments to study Gazyva's anti-cancer combination with other approved or researched drugs, including cancer immunotherapy and small molecule inhibitors, are underway. The efficacy of Gazyva was validated in the clinical trial GALLIUM. This is a global, open-label, multi-center, randomized, double-armed, head-to-head trial comparing Gazyva with chemotherapy, followed by Gazyva for up to two years, combined with Rituxan chemotherapy, followed by Rituxan for up to two years. Efficacy and safety. The chemotherapy regimen was selected by each participating study site prior to the start of recruitment. A total of 1385 previously untreated patients with NHL were enrolled in the GALLIUM study, of which 1,202 were patients with advanced follicular lymphoma (stage II, stage III or IV). After a median of 38 months of observation, the Gazyva treatment regimen significantly reduced the risk of disease progression or death by 28% compared with the Rituxan treatment regimen (PFS assessed by the Independent Review Panel [IRC]; HR=0.72, 95% CI : 0.56-0.93; p=0.0118). In terms of safety, the most common grade 3-5 side effects (in at least 5% of patients) in the Gazyva treatment group included low white blood cell count, infusion response, low white blood cell count with fever, and low platelet count. The most common side effects (occurring in at least 20% of patients) include infusion reactions, low white blood cell counts, upper respiratory tract infections, cough, constipation, and diarrhea. "Gazyva's approval is an important advancement for thousands of patients diagnosed with follicular lymphoma each year, and they want to delay the progression of the disease as much as possible," said Dr. Sandra Horning, Roche's chief medical officer and head of global product development. "We are delighted to be able to offer an initial treatment option that is superior to Rituxan for this type of incurable blood cancer patient. This standard treatment has been used for more than 10 years." Original title: Summary of recent progress in the field of cancer (No. 46) Reference material [1] Stanford trial points to a new CAR-T drug, spotlighting a fresh target for next-gen cell therapies [2] Phase III IMpower150 study showed Roche's TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus chemotherapy significantly reduced the risk of disease worsening or death in the initial treatment of people with a type of advanced lung cancer [3] FDA clears next-gen tumor sequencing test from Memorial Sloan Kettering [4] On a Roll: FDA OKs Genentech's Gazyva for Untreated Follicular Lymphoma Tetanus Vaccine,Hepatitis B Vaccine For Adults,Tetanus Booster,Td Vaccine FOSHAN PHARMA CO., LTD. , https://www.fspharmaapi.com
