Latest news with #AmericanSocietyofClinicalOncology2025
Korea Herald
4 days ago
- Business
- Korea Herald
J INTS BIO to Present Global Clinical Results from JIN-A02, a Fourth-Generation EGFR-TKI, at ASCO 2025
Significant anti-tumor responses and reduction of brain metastases observed SEOUL, South Korea , June 2, 2025 /PRNewswire/ -- J INTS BIO, a company specializing in the development of therapeutics for cancer and rare diseases, officially announced interim results from the global Phase 1/2 clinical trial of JIN-A02, its fourth-generation EGFR-TKI drug candidate, at the American Society of Clinical Oncology 2025 (ASCO 2025), the world's largest oncology conference, held in Chicago, USA. JIN-A02 is an oral, fourth-generation EGFR-TKI designed to overcome resistance mutations (such as C797S) that develop after treatment failure with third-generation EGFR-TKIs, which are currently the first-line therapy for EGFR-mutant Non-small cell lung cancer (NSCLC). It is currently undergoing clinical trials in South Korea, the United States, Thailand, and other countries. Key efficacy and safety results from Part A (dose escalation) of the multi-center clinical trial (NCT05394831) were presented. 'Confirmed' clinical response observed in patients with disease progression after 3 rd Generation EGFR TKI and chemotherapy One of the key findings of the ASCO presentation was that tumor responses were sustained in specific dose cohorts, with confirmed partial responses (PRs) verified by independent evaluation. Confirmed PRs were observed in 50mg,100mg and 300mg QD dose groups, providing clinical evidence of anti-tumor activity. In the 50 mg dose group, patients achieved a 77.3% reduction in tumor size, maintaining a PR over six consecutive treatment cycles (from cycle 3 to cycle 13). In the 300 mg dose group, a confirmed PR was observed with a 39.7% tumor size reduction, including a significant reduction in brain metastatic lesions. In the 100 mg dose group, a PR was also reported with a 35.3% reduction in tumor size, and brain metastatic lesions remained stable, further supporting the potential of JIN-A02 in treating brain metastases. Safety confirmed up to 300 mg, with therapeutic signals in brain metastases No dose-limiting toxicities (DLTs) or serious adverse events were observed with JIN-A02 at doses up to 300mg, which is six times the dose level when PR was first observed, demonstrating a favorable safety profile even at higher dose levels. The majority of adverse events reported at 300mg were mild (Grade 1-2) and included for the first time, Grade 1 skin rash, diarrhea, and skin desquamation in 3 out of 5 subjects – events commonly associated with EGFR inhibitors and generally considered clinically manageable. Importantly, there were no reports of systemic toxicities such as cardiovascular events or hepatotoxicity, supporting the drug's excellent safety profile. This safety and tolerability have translated into extended treatment durations in real-world settings, with a patient still on JIN-A02 after one year and seven months. In addition, the trial demonstrated notable responses in brain metastases first noted at 100mg, suggesting that JIN-A02 achieves therapeutically relevant concentrations in brain tissue. JIN-A02 gains national spotlight as government grants accelerate development In addition to the ASCO announcement, J INTS BIO continues to achieve noteworthy results in Korea. Recently, it was selected for the '2025 Baby Unicorn Fostering Project' by the Ministry of SMEs and Startups, officially recognizing both our scientific technology and commercialization potential. The 'Baby Unicorn Fostering Project' is a government project that focuses on developing promising startups with innovative technologies and growth potential in the global market as 'potential unicorns'. Companies selected for this project will receive full government support in recognition of their technological prowess and growth potential. With these accolades, JIN-A02 will receive dual funding for its Phase 2 trial and global expansion over the next two years, which is expected to be a decisive point to significantly accelerate the pace of clinical and commercialization in parallel with private investment. It is also significant as a case of securing confidence in the 3 arena of technology, marketability, and global scalability, as the recognition came from different government departments. Based on these achievements, we plan to initiate the Phase 2 clinical trial of JIN-A02 in before the end of this year, in discussions with the US FDA. "The ASCO presentation of JIN-A02's ability to induce anti-cancer responses and its ability to respond to central nervous system metastatic lesions is of great significance," said Dr. Anna Jo, CEO. "The government's continued support is a recognition of our technical capabilities and potential for growth. We will take advantage of this opportunity to accelerate global clinical expansion, technology transfer, and indication expansion to realize our goal of early commercialization"
Yahoo
23-05-2025
- Health
- Yahoo
Alcohol-related cancer deaths have doubled in recent years in the US
The number of annual alcohol deaths due to cancer has doubled in recent years in the U.S., researchers said this week. The tally rose from 11,896 in 1990 to 23,207 by 2021, according to data that was presented at the American Society of Clinical Oncology 2025 conference. 'Alcohol-associated cancer mortality has significantly increased in the U.S. over the past three decades, with a disproportionate burden observed in males and individuals aged 55 and older,' they wrote. They reached these conclusions using data from the Global Burden of Disease database, which provides incidence and mortality estimates for 35 cancer types. They found that the rates increased for all cancers combined and specific cancers across both genders and age groups, with the exception of liver cancer in people aged 55 and up. 'In 2021, for [the 55-plus age group], liver cancer had the highest alcohol-associated proportional [mortality rate] in males (38.5 percent), followed by nasopharyngeal cancer (31.8 percent), while in females, nasopharyngeal (18.9 percent) and oro/hypopharyngeal cancers (18.4 percent) ranked highest. In 20-54 age, lip-oral cavity cancer had the highest alcohol-associated proportional [rates] for both genders,' they noted. The researchers identified Washington, D.C., as the area with the highest rates of alcohol-associated cancer. Utah had the lowest. An increasing number of women have become heavy drinkers, although alcohol abuse still kills more men than women. While drinking rates dropped from the 1970s through the 1990s, they also rose during the Covid pandemic. So did alcohol-related deaths. 'This is death as opposed to getting a disease. We can treat a lot of cancers, and we're getting better at that, but this is really driving home the point that people are dying from cancer due to alcohol,' said Jane Figueiredo, a professor of medicine at the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, who was not involved with the research told NBC News. The research, which has not yet been published in a peer-reviewed journal, comes after former U.S. Surgeon General Dr. Vivek Murthy issued a call for cancer risk warnings to be included on alcoholic beverages. "Alcohol is a well-established, preventable cause of cancer responsible for about 100,000 cases of cancer and 20,000 cancer deaths annually in the United States - greater than the 13,500 alcohol-associated traffic crash fatalities per year in the U.S. - yet the majority of Americans are unaware of this risk," he said in a news release earlier in the year. The researchers cited this warning in their report, noting that alcohol consumption is known to be a significant risk factor for cancer. The International Agency on Cancer Research, a branch of the World Health Organization, classified alcohol as a carcinogen in 1987, and the organization says there's no safe amount of alcohol consumption. The Centers for Disease Control and Prevention had previously said that approximately 20,000 adults in the U.S. die from alcohol-associated cancers each year. The agency noted that most of the deaths may have been avoided if all adults had followed the recommended limits on alcohol use. The authors of the recent research said their findings indicate the need for enhanced prevention. 'Our findings highlight the critical need for targeted prevention efforts, public health policies, and increased awareness to address the rising impact of alcohol consumption on cancer-related mortality across different demographic groups and regions,' they said.
Yahoo
23-05-2025
- Health
- Yahoo
Alcohol-related cancer deaths have doubled in recent years in the US
The number of annual alcohol deaths due to cancer has doubled in recent years in the U.S., researchers said this week. The tally rose from 11,896 in 1990 to 23,207 by 2021, according to data that was presented at the American Society of Clinical Oncology 2025 conference. 'Alcohol-associated cancer mortality has significantly increased in the U.S. over the past three decades, with a disproportionate burden observed in males and individuals aged 55 and older,' they wrote. They reached these conclusions using data from the Global Burden of Disease database, which provides incidence and mortality estimates for 35 cancer types. They found that the rates increased for all cancers combined and specific cancers across both genders and age groups, with the exception of liver cancer in people aged 55 and up. 'In 2021, for [the 55-plus age group], liver cancer had the highest alcohol-associated proportional [mortality rate] in males (38.5 percent), followed by nasopharyngeal cancer (31.8 percent), while in females, nasopharyngeal (18.9 percent) and oro/hypopharyngeal cancers (18.4 percent) ranked highest. In 20-54 age, lip-oral cavity cancer had the highest alcohol-associated proportional [rates] for both genders,' they noted. The researchers identified Washington, D.C., as the area with the highest rates of alcohol-associated cancer. Utah had the lowest. An increasing number of women have become heavy drinkers, although alcohol abuse still kills more men than women. While drinking rates dropped from the 1970s through the 1990s, they also rose during the Covid pandemic. So did alcohol-related deaths. 'This is death as opposed to getting a disease. We can treat a lot of cancers, and we're getting better at that, but this is really driving home the point that people are dying from cancer due to alcohol,' said Jane Figueiredo, a professor of medicine at the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, who was not involved with the research told NBC News. The research, which has not yet been published in a peer-reviewed journal, comes after former U.S. Surgeon General Dr. Vivek Murthy issued a call for cancer risk warnings to be included on alcoholic beverages. "Alcohol is a well-established, preventable cause of cancer responsible for about 100,000 cases of cancer and 20,000 cancer deaths annually in the United States - greater than the 13,500 alcohol-associated traffic crash fatalities per year in the U.S. - yet the majority of Americans are unaware of this risk," he said in a news release earlier in the year. The researchers cited this warning in their report, noting that alcohol consumption is known to be a significant risk factor for cancer. The International Agency on Cancer Research, a branch of the World Health Organization, classified alcohol as a carcinogen in 1987, and the organization says there's no safe amount of alcohol consumption. The Centers for Disease Control and Prevention had previously said that approximately 20,000 adults in the U.S. die from alcohol-associated cancers each year. The agency noted that most of the deaths may have been avoided if all adults had followed the recommended limits on alcohol use. The authors of the recent research said their findings indicate the need for enhanced prevention. 'Our findings highlight the critical need for targeted prevention efforts, public health policies, and increased awareness to address the rising impact of alcohol consumption on cancer-related mortality across different demographic groups and regions,' they said.
