Summary of recent research progress in the field of cancer (03.19)
March 19, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];1. New drug for urothelial cancer has been approved by breakthrough therapy
Recently, Johnson & Johnson's Janssen announced that its erdafitinib, a drug candidate for solid tumors, has received the Breakthrough Therapy from the US FDA. Breakthrough therapy is designed to accelerate the development and review of drugs for the treatment of serious or life-threatening diseases, and they have preliminary clinical evidence that the treatment can substantially improve the available therapies for one or more clinically important endpoints.
Erdafitinib is a fibroblast growth factor receptor (FGFR) inhibitor that has been approved by breakthrough therapy for its potential in the treatment of patients with metastatic urothelial cancer. Urinary tract cancer is the most common type of bladder cancer, accounting for about 90% of cases, starting from urothelial cells inside the bladder. It is estimated that there were 77,000 new cases in 2016 and more than 16,000 people died of the disease. In all parts of the world, the incidence of bladder cancer is gradually increasing, and there is still a large medical need. FGFR mutation and overexpression are most common in metastatic urothelial carcinoma, and are more common in early urothelial carcinoma, luminal type I urothelial carcinoma and upper urinary tract tumors, so it is a promising therapeutic target. .
This breakthrough therapy is based on data from Phase 2 clinical trials. According to data from the American Society of Clinical Oncology (ASCO), the overall response rate of erdafitinib in 59 patients with relapsed or refractory metastatic urothelial carcinoma was 42%, and tumors in these patients carry FGFR mutations.
"For patients diagnosed with urothelial cancer, the prognosis is often frustrating due to the aggressiveness of the disease," said Peter Lebowitz, head of global oncology at Yangsen. "We will continue to develop erdafitinib and work closely with the FDA. New treatment options for patients."
2. The overall survival rate is 97.3% , and childhood leukemia is expected to usher in new cell therapy.
Recently, Bellicum Pharmaceuticals, a cancer immunotherapy in Houston, announced that its innovative cell therapy BPX-501 has achieved lasting gratifying effects in children with acute myeloid leukemia (AML) and primary immunodeficiency (PID). .
BPX-501 is a helper T cell therapy. In leukemia and immunodeficiency patients, a common treatment is allogeneic hematopoietic stem cell transplantation. BPX-501 can be injected into patients after transplantation, accelerate the reconstruction of the immune system, enhance the control of viral infection, and strengthen the effect of graft anti-leukemia without increasing the risk of graft versus host. Its CaspaCIDe security lock design couples the signal domain of Caspase-9 with a "chemically induced dimerization" (CID) binding domain. If the patient has serious side effects, doctors can use the drug rimiducid to activate the safety lock, allowing these cells to inject into the patient's T cells to undergo apoptosis, thereby regulating safety.
In a clinical trial called BP-004, the researchers evaluated the effects of BPX-501. They enrolled 38 children with AML who underwent haploid hematopoietic stem cell transplantation supplemented with BPX-501. At a median follow-up of 1 year, the researchers found that the patient's recurrence-free survival rate was 91.5% and the overall survival rate was 97.3%. Compared with the historical data showing 60%-80%, it is undoubtedly a huge improvement. Also in this trial, the researchers found that BPX-501 also resulted in high disease-free survival and overall survival in children with PID. Of the 59 patients, the researchers underwent a median follow-up of 1 year and found a disease-free survival rate of 88.1% and a overall survival rate of 88.6%.
"Recurrence of cancer is a serious risk for AML patients after receiving stem cell transplantation. The excellent results of children with AML indicate that BPX-501 is administered after haploid hematopoietic stem cell transplantation, which can effectively reduce residual cancer cells," BP-004 Researcher Dr. Neena Kapoor, head of the Hematology and Bone Marrow Transplant Program at Los Angeles Children's Hospital, said: "The delay in immune reconstitution can lead to serious infection complications, which is the leading cause of death in PID patients receiving haploid hematopoietic stem cell transplantation. One of the BPX-501 T cells infusion after transplantation can help the immune system to recover. The CaspaCIDe security lock can also launch a safety net to prevent graft-to-host risk from donor T cells."
3. Treatment of cervical cancer, heavy immunotherapy received FDA priority review
Recently, Merck (MSD) announced that the US FDA accepted the company's application for supplemental biologics (sBLA) for the anti-PD-1 therapy KEYTRUDA (pembrolizumab) and granted it priority review. This application uses pembrolizumab to treat patients with advanced cervical cancer who continue to worsen cancer after chemotherapy. This is the 14th FDA-approved regulatory application for pembrolizumab. The FDA is expected to complete the review of this application by June 28 this year.
In 2017, approximately 12820 cases of cervical cancer were diagnosed in the United States. According to statistics, the 5-year survival rate of women with grade 4 cervical cancer is only 15-16%. Although early screening and vaccination have seen results in reducing the incidence of cervical cancer, it is still one of the most important cancers that plague women worldwide.
Pembrolizumab, developed by Merck, is an immunological checkpoint inhibitor that enhances the ability of T lymphocytes to kill tumors by blocking the binding of the PD-1 receptor protein to its ligands PD-L1 and PD-L2. Since its inception, Pembrolizumab has been approved for the treatment of a variety of cancers, including melanoma, non-small cell lung cancer, head and neck cancer and more.
This application is based on a partial result of the KEYNOTE-158 Clinical Phase 2 trial that Merck is still conducting. KEYNOTE-158 is a global, open-label, non-randomized, multi-center clinical trial of multiple patients. Its purpose is to test the efficacy of pembrolizumab in the treatment of a variety of advanced solid tumor patients, including cervical cancer, whose symptoms continue to worsen after receiving standard therapy.
"Advanced cervical cancer is a poorly prognostic disease and it is a highly unmet medical need. We look forward to continuing to work with the FDA in reviewing this application and handing over KEYTRUDA to already treated. In the hands of patients with advanced cervical cancer, Dr. Roger Dansey, senior vice president and head of oncology development at Merck, said.
4. Activate antibody presentation, Merck reached a new agreement on immune combination therapy
Immutep Limited recently announced that it has signed a clinical trial cooperation and supply agreement with Merck (MSD) through a subsidiary to evaluate the company's main immunotherapeutic drug eftilagimod alpha (efti or IMP321) and MSD's anti-PD-1 therapy KEYTRUDA ( Therapeutic effects of combination therapy with pembrolizumab in several different solid tumors.
The trial combines two immuno-tumor therapies with complementary mechanisms of action, such as releasing the brakes of the immune system and pushing the accelerators of the body's immune system at two different locations in the cancer's immune cycle. Immutep's efti is the first antigen-presenting cell (APC) activator that stimulates anti-cancer T cells, and pembrolizumab is an anti-PD-1 therapy that boosts the body's immune system's ability to fight against tumor cells.
A phase 2 clinical trial called TACTI-002 will evaluate the safety and efficacy of this novel immunotherapy combination in patients with non-small cell lung cancer, head and neck cancer, and ovarian cancer. The trial will be a non-comparative, open-label, one-arm, multi-center clinical study. Corresponding to these three indications, the trial plans to treat more than 120 patients in Europe and the United States, and is expected to begin trials in the second half of 2018.
“We are very pleased to be able to work with MSD, one of the world's leading immuno-oncology companies,†said Immutep CEO Marc Voigt. “This clinical trial will simultaneously evaluate two new complementary immunotherapy therapies in three cancer indications. Combinations, which may lead to faster drug development and successful outcomes."
Reference material
[1]J&J's blockbuster hopeful erdafitinib gets 'breakthrough' moniker
[2]Bellicum Announces Interim Results Showing Low Rates of Cancer Recurrence in Pediatric AML Patients Treated with BPX-501
[3]FDA Grants Merck's Keytruda Priority Review for Cervical Cancer
[4]Immutep Strikes Deal with Merck to Pair Product With Keytruda in Phase II Trial
Original title: Summary of recent research progress in the field of cancer (No. 58)
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