Bring you the latest information in the field of tumor diagnosis and treatment every week!
21CC (cancer care ), we focus on everything related to cancer! The innovative information column of 21st Century New Health Research Institute – 21CC tumor information, combs a week of tumor information, comprehensively focuses on cancer prevention and treatment, early detection, early diagnosis and early treatment, and walks with Jun Health!
1. Approval of new drugs (new indications)
●Betta PharmaceuticalsThe new indication of Ensatinib Hydrochloride Capsule was approved, and lung cancer patients ushered in a new choice
March 21,Betta PharmaceuticalsCo., Ltd. received a notice from the National Medical Products Administration (NMPA) that Ensatinib Hydrochloride Capsules (Bemena, hereinafter referred to as “Ensatinib”) single drug is intended to be used in “Anaplastic Lymphoma Kinase (ALK)” Treatment of Patients with Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)”, “Drug Registration Certificate”.
Ensatinib is a novel potent, highly selective, next-generation ALK inhibitor.Betta PharmaceuticalsJointly developed with holding subsidiary Xcovery Holdings, Inc. On November 17, 2020, ensatinib was approved by the NMPA for marketing, and the approved indications are: suitable for ALK-positive topical patients who have progressed after receiving crizotinib treatment or who are intolerant to crizotinib. Treatment of patients with advanced or metastatic NSCLC (ie, second-line treatment indications), and was included in the National Basic Medical Care in December 2021insurancework injuryinsuranceand fertilityinsuranceDrug List (2021). In February 2022, the clinical trial application of ensatinib proposed by Betta for the adjuvant treatment of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) during II-IIIB stage was accepted by the NMPA.
FDA approves drug K as a monotherapy for patients with advanced endometrial cancer
March 22,MSD(MSD) announced that the U.S. Food and Drug Administration (FDA) has approved the blockbuster PD-1 inhibitor Keytruda (pembrolizumab) as a single agent for the treatment of patients with advanced endometrial cancer. These patients had tumors characterized by microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR) using FDA-approved tests. They had disease progression after prior systemic therapy and were not candidates for curative surgery or radiation.
FDA approves Novartis nuclear drug for the treatment of some prostate cancers
On March 23, Novartis announced that 177Lu-PSMA-617 was approved by the FDA for the treatment of PSMA-positive, treatment-progressed castration-resistant prostate cancer under the trade name Pluvicto. The FDA also approved gallium-68 as an angiography for PSMA-positive tumors The radiation dose is measured under the trade name of Locametz. Pluvicto is 1000MBq/ml, and the half-life of lutetium 177 is 6.647 days.
As a nuclear drug, Pluvicto combines targeting ligands and radioisotope therapy, targeting PSMA-positive cells, and causing DNA damage through radioisotopes to kill tumor cells. The approval of Pluvicto is based on the data of the Phase III clinical VISION, the overall response rate of the treatment is 30%, of which the complete response rate is 6%, and the treatment reduces the risk of death by 38%.
●The 7th domestic PD-1 monoclonal antibody was approved for marketing for the treatment of solid tumors
On March 24, according to the approval document on the NMPA official website,HenliusThe PD-1 monoclonal antibody slulimumab has been approved for marketing for unresectable or metastatic high-grade microsatellite unstable solid tumors that have failed standard therapy.This is the 7th domestic PD-1 monoclonal antibody, alsoHenliusThe first innovative drug approved for marketing.
according toHenliusThe 2021 financial report disclosed that while the Chinese market was deployed, slulimumab was simultaneously conducting 9 clinical trials of immunocombination therapy around the world, covering lung cancer, esophageal cancer, head and neck cancer, and gastric cancer and other high-incidence large tumors. In the field of lung cancer, clinical trials are conducted for the first-line treatment of sqNSCLC, non-squamous non-small cell lung cancer and small cell lung cancer, covering more than 90% of lung cancer patients. As of the end of 2021, more than 2,800 people have been enrolled globally with slulimumab.
New indications for Novartis rafenib combined with trametinib dual-target combination therapy are approved, and lung cancer patients usher in a new choice
On March 25, Novartis (China) announced its dual-targetedcombination therapyThe drugs Tefiler (dabrafenib mesylate capsules) and Megenin (trametinib tablets) were recently approved by the State Drug Administration for new indications for the treatment of BRAFV600 mutation-positive metastatic non-small cell lung cancer. cell lung cancer.This is not only the third indication approved by Tefera and Megenin, but also the first dual-targeted drug approved in China for BRAFV600 mutation-positive metastatic non-small cell lung cancer.combination therapydrug. Previously, Tefera and Megenin have been approved for the treatment of patients with BRAFV600 mutation-positive unresectable or metastatic melanoma and BRAFV600 mutation-positive stage III melanoma as adjuvant therapy after complete resection. The approval this time brings new treatment options for Chinese patients with rare mutations in lung cancer, and is another important milestone in the field of lung cancer targeted therapy.
Brigatinib tablets are approved for marketing, and patients with ALK-positive lung cancer usher in a new treatment option
On March 25, Takeda China’s innovative drug Amberlite (Brigatinib) in the field of lung cancer was officially approved by the National Medical Products Administration (NMPA), and is a single drug for anaplastic lymphoma kinase (ALK) positive treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Brigatinib is a new ALK tyrosine kinase inhibitor. Its efficacy in prolonging patient survival, controlling brain metastases, and improving quality of life has been clinically verified. It is listed as first-line by the NCCN Oncology Clinical Practice Guidelines. The preferred drug is listed in the “CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer”[1]，[2]，[3]，[4]. The approval of this product marks that Takeda China will officially enter the field of lung cancer treatment, bringing new treatment options to more Chinese lung cancer patients.
2. Positive progress in R&D/clinical
Reduce the risk of breast cancer disease progression by 72%, and the pivotal phase 3 results of the blockbuster ADC are on the NEJM
Recently, AstraZeneca (AstraZeneca) and Daiichi Sankyo (Daiichi Sankyo) jointly developed antibody-drug conjugate (ADC) Enhertu as a second-line therapy in a pivotal Phase 3 clinical trial in adult patients with unresectable or metastatic HER2-positive breast cancer The results were published in the prestigious medical journal The New England Journal of Medicine. Trial results showed that Enhertu reduced the risk of disease progression or death in patients by 72% and the risk of death by 45% compared to the active control group.
In March 2019, AstraZeneca and Daiichi Sankyo reached a global collaboration to jointly develop and commercialize Enhertu. The drug is an ADC drug designed using Daiichi Sankyo’s proprietary DXd ADC technology platform. The oligomeric monoclonal antibody is composed of a tetrapeptide cleavable linker linked to a topoisomerase 1 inhibitor payload.
● In renal cell carcinoma, early clinical results of microbial therapy/Keytruda combination are positive
On March 24, 4D pharma announced that the company’s investigational microbiome-based therapy MRx0518 wasMSD(MSD) The company’s anti-PD-1 therapy, Keytruda, in combination, met the primary efficacy endpoint in a Phase 1/2 clinical trial in renal cell carcinoma. These patients had previously been treated with immune checkpoint inhibitors and their disease had progressed.
4D pharma develops live biotherapeutics, an emerging class of medicines that includes a living organism (such as bacteria). The company’s live biotherapeutics product is derived from the healthy human gut and is an orally administered bacterial strain. This ongoing study is conducted in patients with metastatic solid tumors who have received multiple prior therapies. Their disease progressed after treatment with immune checkpoint inhibitors. The primary endpoint of Part B of the study was clinical benefit in more than 3 out of 30 patients in each cancer type, defined as complete response, partial response, or stable disease for at least 6 months.
3. Listing/R&D failure
FDA rejects remarketing of Takeda’s parathyroid hormone Natpara
Recently, the U.S. Food and Drug Administration (FDA) rejected the re-marketing of Natpara, a parathyroid hormone from Takeda. Natpara is a drug developed by Takeda to help patients cope with hypocalcemia caused by hypoparathyroidism, and it is also the first prescription parathyroid hormone approved by the US FDA. But in September 2019, Takeda finally had to announce a recall of all batches of Natpara injectable products in the U.S. market due to safety risks due to the possibility of rubber particles from the rubber septum of Natpara cartridges.
During the 14 days of Natpara treatment, the patient was given daily injections after piercing a rubber septum with a needle. Repeated piercing operations could have directly resulted in pieces of rubber on the cartridges detaching, and Takeda claimed at the time that the detached rubber stopper could clog the needle and result in an insufficient dose of the drug injected into the patient’s body. The recall was classified as a Category I incident.
The FDA failed to approve the marketing application of sintilimab
March 24, according toInnovent Bioannouncement, the company has received a complete response letter from the FDA for the New Drug Application (BLA) of sintilimab in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC).Sintilimab is aInnovent BioandEli LillyPharma co-developed innovative PD-1 inhibitor.
The FDA said in its response letter that it had completed its review of the BLA but failed to approve the application, in line with the results of the Oncology Drugs Advisory Committee (ODAC) meeting held in February. The response letter included a recommendation for an additional clinical study, suggesting that a multi-regional non-inferiority clinical trial of Sindice combined with chemotherapy and standard therapy for first-line metastatic NSCLC with overall survival as the endpoint was conducted.
4. Cancer Investment
●More than $1 billion to help develop “synthetic lethal” anti-cancer treatments,Bristol-Myers Squibbreach cooperation
On March 22, Volastra Therapeutics announced thatBristol-Myers SquibbReached a research and development cooperation, and used Volastra’s drug discovery platform based on the exploration of chromosomal instability (CIN) to discover synthetic lethal drug targets related to chromosomal instability. Synthetic lethality is a proven target discovery strategy that kills tumor cells while avoiding harming healthy cells by exploring the weaknesses of tumor cells.
A breakthrough study published in Nature in 2018 by the scientific founders of Volastra pointed out that the CIN of tumor cells is an important factor driving cancer metastasis. CIN is caused by mistakes made by tumor cells during mitosis, causing chromosomal fragments to dissociate outside the nucleus. This DNA located in the cytoplasm not only promotes cancer metastasis by stimulating the NF-κB signaling pathway, but also stimulates tumor cells to release cytokines with immunosuppressive ability, preventing tumor cells from being discovered by the body’s immune system, thereby further promoting tumor cells transfer. Volastra’s preclinical studies have shown that the synthetic lethal strategy is particularly effective in tumors with high levels of CIN.
●$175 million to help develop new TCR cell therapy, targeting KRAS gene mutation
On March 23, Affini-T Therapeutics announced today that it has closed a $175 million financing. The funds received will fuel its drug discovery engine platform and seek to advance multiple oncogene-targeting R&D programs into the clinic.
Affini-T is committed to developing potentially life-changing medicines for patients with refractory solid tumors, and its proprietary platform has the potential to provide transformative therapies for patients with KRAS mutations, one of the most prevalent oncogenic driver mutations in solid tumors. KRAS mutations account for 30 percent of all cancers and are especially common in cancers with higher mortality rates, including lung, colorectal, and pancreatic cancers. Affini-T’s proprietary platform is designed to select and engineer the right immune cells to generate a durable and coordinated immune response.The company’s innovationssynthetic biologyA chemical switch could rewrite the rules of the tumor microenvironment, improving T cell function by increasing T cell persistence, building sustained responses and enhancing tumor infiltration.
●Mainly positive early clinical results of liver cancer therapy, $17 million to help develop individualized cancer vaccines
On March 24, Geneos Therapeutics announced the completion of a $17 million Series A round of financing. Funding from this round will be used to expand a Phase 1b/2a clinical trial in patients with advanced hepatocellular carcinoma (HCC) to evaluate the company’s personalised cancer vaccine GNOS-PV02. In addition, the funding also Funding will be provided for Geneos product pipeline expansion.
Geneos is committed to developing individualized therapies to unleash the full power of the body’s own immune system to fight cancer. Geneos’ proprietary GT-EPIC neoantigen targeting technology platform is based on highly optimized synthetic DNA plasmids. The GT-EPIC platform enables Geneos to develop precise, individualized therapies targeting each patient’s unique tumor mutations. The development of this platform offers the following key advantages: the ability to drive a potent and broad T-cell immune response; the ability to accommodate an unprecedented number of neoantigens in a single formulation; and rapid production turnaround times.
Five, 21CC one week view
●Strengthen the training and certification of basic-level cancer screening practitioners, and establish a standardized and feasible data sharing mechanism
Ji Jiafu, Dean of Peking University Cancer Hospital, said in an interview with 21st Century Business Herald that while my country’s key high-incidence cancer screening, early diagnosis and early treatment work has been gradually rolled out and achieved good results, there are also certain problems, such as lack of corrective measures. Systematic evaluation of the effect of cancer and early diagnosis and treatment projects has been carried out in the past, and the uneven distribution of clinical screening practitioners and equipment resources in different regions has limited the high-quality development of cancer early diagnosis and treatment.
At the same time, there are great differences in the level of informatization in different regions, and the information management platforms in different regions are still independent of each other. To this end, Ji Jiafu suggested strengthening the standardized training of grass-roots cancer screening practitioners and certifying their qualifications, as well as realizing the interconnection between the national-level information management platform for cancer screening and local and regional platforms, and improving the data sharing mechanism.
●Du Peng, Peking University Cancer Hospital: Cancer is not contagious, but there is a phenomenon of “aggregation”
Du Peng, chief physician of the Department of Urology of Peking University Cancer Hospital and chairman of the Early Cancer Screening Committee of Beijing Anti-Cancer Association, pointed out in an interview with a reporter from the 21st Century Business Herald that cancer is not contagious, but there is indeed a phenomenon of “aggregation”, that is, a family of Multiple family members of a person or a family have cancer.
According to Du Peng’s analysis, there are two main factors for the phenomenon of cancer aggregation. First, cancer has genetic factors. There are both oncogenes and tumor suppressor genes in the human body. When oncogenes or tumor suppressor genes mutate, tumor cells will It will become malignant, this oncogene will be inherited, and the next generation of cancer patients will have a higher risk of cancer.
In addition, the existence of some carcinogens also promotes the appearance of cancer aggregation. For example, hepatitis B virus is one of the main causes of liver cancer, papilloma virus is one of the risk factors for cervical cancer, and the infection of Helicobacter pylori causes Increased incidence of gastric cancer, etc. Residents’ living environment and eating habits are also risk factors for cancer.
●”King of Cancer” pancreatic cancer, early screening research is the focus of future development
Zhao Dongbing, chief physician and doctoral supervisor of the Department of Pancreatic and Gastric Surgery, National Cancer Center and Cancer Hospital of the Chinese Academy of Medical Sciences, pointed out to the 21st Century Business Herald reporter that pancreatic cancer has three main characteristics. One is that it is discovered late; The effect of treatment is relatively poor, mainly because the probability of surgical resection is small. Most of pancreatic cancer patients are in the advanced stage when they go to the clinic, and 85% of the patients have no chance of surgery, so the treatment is very difficult.
Professor Liu Xiangde, deputy director of the Department of Hepatobiliary Surgery of Shenzhen University General Hospital, also pointed out in an interview with the 21st Century Business Herald that pancreatic cancer is very hidden, the early diagnosis rate is very low, and most of them are in the middle and late stages when they are discovered. At present, there are no specific tumor markers for early screening of pancreatic cancer, and early detection is difficult. Therefore, early screening of pancreatic cancer is also the focus of research by experts.
Zhao Dongbing said that the general population is not recommended for pancreatic cancer screening, but it is recommended for high-risk groups to do pancreatic cancer screening. What are high-risk groups? Zhao Dongbing introduced that, firstly, first-degree relatives, including parents, siblings, have people diagnosed with pancreatic cancer; secondly, people who have been diagnosed with diabetes in the short term, or people with poor blood sugar control; in addition, patients with chronic pancreatitis, long-term smokers People who drink alcohol belong to the high-risk group.
6. Others
●Pfizer11 batches of antihypertensive drug carcinogens exceeding the standard urgently recalled
March 22,PfizerThe company announced on its official website that it has voluntarily recalled a large number of ACCURETIC (quinapril hydrochloride/hydrochlorothiazide) and two authorized generic drugs sold by its wholly-owned subsidiary Greenstone, quinapril HCI/hydrochlorothiazide tablets across the United States.PfizerThe recall is due to higher than acceptable daily intake levels of nitrosamines, a cancer-causing impurity in the drug.
The 21st Century Business Herald reporter checked Pfizer’s official website and found that the recall involves a total of six batches of ACCURETIC tablets, one batch of quinapril and hydrochlorothiazide tablets, and four batches of quinapril hydrochloride and hydrochlorothiazide tablets. It was distributed to wholesalers and distributors in the United States and Puerto Rico between March. The recalled products are suitable for the treatment of high blood pressure and can help reduce the risk of cardiovascular diseases, such as stroke and myocardial infarction.
●The anticancer drug orelabrutinib will drive the revenue of Nuocheng Jianhua to surge in 2021
On March 23, Nuocheng Jianhua released 2021performance, the annual revenue has risen sharply from 1.4 million yuan in 2020 to 1.043 billion yuan in 2021, mainly due to the sales revenue of Orbrutinib and the down payment of Biogen. R&D expenses increased from 402.8 million yuan in 2020 to 721.6 million yuan in 2021, mainly due to the increase in the down payment of license-in tafasitamab, etc.
●The second domestic HPV vaccine is launched, providing a powerful weapon for the global goal of eliminating cervical cancer
On March 24, the official website of the State Food and Drug Administration showed that,Watson BioreorganizationThe bivalent human papillomavirus (HPV) vaccine was officially approved for marketing, becoming the second domestic HPV vaccine. So far, the number of HPV vaccines approved for marketing in my country has increased to 5. Previously,Wantai BioThe bivalent HPV vaccine became the first approved domestic HPV vaccine. The other three are the bivalent HPV vaccine produced by GlaxoSmithKline,MSDThe company produces quadrivalent HPV and nine-valent HPV vaccines.
The HPV vaccine is commonly known as the cervical cancer vaccine. Cervical cancer is one of the malignant tumors with the highest morbidity and mortality among women in the world, and my country accounts for 20% of the new cases of cervical cancer in the world. Studies have found that persistent infection of high-risk HPV virus is the main cause of cervical cancer, and HPV vaccination can significantly reduce the incidence.
(Article source: 21st Century Business Herald)