New breast cancer therapy can slow advance of disease, prolong survival
A new triple therapy for aggressive, advanced breast cancer slows the progression of the disease, delays the need for further chemotherapy and helps patients live longer, research revealed.
The combination treatment is made up of two targeted drugs: inavolisib and palbociclib, and the hormone therapy fulvestrant. It improved overall survival by an average of seven months, compared with the patients in the control group, who were given palbociclib and fulvestrant.
It also delayed progression of the disease by 17.2 months, on average, compared with 7.3 months in the control group, and patients taking inavolisib were able to delay subsequent chemotherapy treatment by almost two years longer than the patients in the control group.
The results of the study, funded by Roche, were presented at the American Society of Clinical Oncology (Asco) annual meeting in Chicago and published in the New England Journal of Medicine.
The international trial involved 325 patients from 28 countries, including the US, UK, Australia, Singapore, Brazil, France and Germany.
Experts said it demonstrated the potential of the triple therapy for targeting PIK3CA-mutated HR+, HER2- breast cancer - a common form of the disease.
About 70 percent of patients have HR+, HER2- breast cancer. PIK3CA mutations are found in 35 to 40 percent of HR+ breast cancers, and are linked to tumour growth, disease progression and treatment resistance.
"The INAVO120 trial has identified a targeted treatment regimen that meaningfully improves survival in patients with untreated PIK3CA-mutated hormone receptor-positive metastatic breast cancer - a big step forward for these patients,' said Dr Jane Lowe Meisel, Co-Director of Breast Medical Oncology at Winship Cancer Institute of Emory University, and an Asco expert in breast cancer.
The results also showed a substantial shrinking in cancer growth in about 62.7 percent of patients in the triple therapy group compared with 28 percent in the control group. Dr. Simon Vincent, Director of Research, support and influencing at Breast Cancer Now, said the findings were a "significant breakthrough'.
Dr. Nisharnthi Duggan, a research information manager at Cancer Research UK, said, "The trial showed that adding inavolisib to targeted treatment plans improved survival. On top of this, it also delayed the progression of people's cancer and the need for chemotherapy, which could improve quality of life. We hope that more research like this will help to give people kinder cancer treatment options, and more time with their loved ones.'
In the trial, more than half of the patients had disease that had already spread to three or more organs. The researchers used circulating tumour DNA (ctDNA) liquid biopsy blood tests to determine whether patients had a PIK3CA mutation. Participants were then allocated to receive either the inavolisib-based regimen or a combination of palbociclib, fulvestrant and a dummy pill.
The new drug inavolisib works by blocking the activity of the PIK3CA protein. The inavolisib combination was generally well tolerated with only a few patients experiencing side-effects that led them to discontinue the treatment.
Nick Turner, Professor of Molecular Oncology at the Institute of Cancer Research, London, and consultant medical oncologist at the Royal Marsden NHS Foundation Trust, led a UK arm of the trial.
"The key findings from this study showed that the inavolisib-based therapy not only helped patients live longer but it more than doubled the time before their cancer progressed or worsened. It also gave them more time before needing subsequent chemotherapy which we know is something that patients really fear and want to delay for as long as possible," he stated.
WAM
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Gulf Today
3 days ago
- Gulf Today
New breast cancer therapy can slow advance of disease, prolong survival
A new triple therapy for aggressive, advanced breast cancer slows the progression of the disease, delays the need for further chemotherapy and helps patients live longer, research revealed. The combination treatment is made up of two targeted drugs: inavolisib and palbociclib, and the hormone therapy fulvestrant. It improved overall survival by an average of seven months, compared with the patients in the control group, who were given palbociclib and fulvestrant. It also delayed progression of the disease by 17.2 months, on average, compared with 7.3 months in the control group, and patients taking inavolisib were able to delay subsequent chemotherapy treatment by almost two years longer than the patients in the control group. The results of the study, funded by Roche, were presented at the American Society of Clinical Oncology (Asco) annual meeting in Chicago and published in the New England Journal of Medicine. The international trial involved 325 patients from 28 countries, including the US, UK, Australia, Singapore, Brazil, France and Germany. Experts said it demonstrated the potential of the triple therapy for targeting PIK3CA-mutated HR+, HER2- breast cancer - a common form of the disease. About 70 percent of patients have HR+, HER2- breast cancer. PIK3CA mutations are found in 35 to 40 percent of HR+ breast cancers, and are linked to tumour growth, disease progression and treatment resistance. "The INAVO120 trial has identified a targeted treatment regimen that meaningfully improves survival in patients with untreated PIK3CA-mutated hormone receptor-positive metastatic breast cancer - a big step forward for these patients,' said Dr Jane Lowe Meisel, Co-Director of Breast Medical Oncology at Winship Cancer Institute of Emory University, and an Asco expert in breast cancer. The results also showed a substantial shrinking in cancer growth in about 62.7 percent of patients in the triple therapy group compared with 28 percent in the control group. Dr. Simon Vincent, Director of Research, support and influencing at Breast Cancer Now, said the findings were a "significant breakthrough'. Dr. Nisharnthi Duggan, a research information manager at Cancer Research UK, said, "The trial showed that adding inavolisib to targeted treatment plans improved survival. On top of this, it also delayed the progression of people's cancer and the need for chemotherapy, which could improve quality of life. We hope that more research like this will help to give people kinder cancer treatment options, and more time with their loved ones.' In the trial, more than half of the patients had disease that had already spread to three or more organs. The researchers used circulating tumour DNA (ctDNA) liquid biopsy blood tests to determine whether patients had a PIK3CA mutation. Participants were then allocated to receive either the inavolisib-based regimen or a combination of palbociclib, fulvestrant and a dummy pill. The new drug inavolisib works by blocking the activity of the PIK3CA protein. The inavolisib combination was generally well tolerated with only a few patients experiencing side-effects that led them to discontinue the treatment. Nick Turner, Professor of Molecular Oncology at the Institute of Cancer Research, London, and consultant medical oncologist at the Royal Marsden NHS Foundation Trust, led a UK arm of the trial. "The key findings from this study showed that the inavolisib-based therapy not only helped patients live longer but it more than doubled the time before their cancer progressed or worsened. It also gave them more time before needing subsequent chemotherapy which we know is something that patients really fear and want to delay for as long as possible," he stated. WAM
Zawya
21-02-2025
- Zawya
US aid freeze sows disruption in HIV, malaria product supply chains
The U.S. government's foreign aid freeze has upended the supply chain for medical products crucial for fighting diseases including HIV and malaria in some of the world's poorest countries, and life-threatening gaps could persist for months, according to two sources familiar with the sector. The U.S. Agency for International Development (USAID) usually places around $600 million of orders annually for products such as medicines, diagnostic tests and equipment like bed nets, as part of one of its biggest health supply contracts including HIV, malaria and reproductive health. But the freeze has put orders and forecasts, particularly those made months in advance, on hold. That will likely have far-reaching implications for deliveries, cost, and timings, according to two sources with knowledge of the global health supply chain and others working in the sector. Companies including the U.S. firm Abbott, Switzerland's Roche, and India's Cipla are all likely to be affected, alongside others including Hologic , Viatris, Hetero and Aurobindo, the first of the sources told Reuters. "We are monitoring the situation closely. Our highest priority is to ensure that patients have continuous access to our diagnostic tests and treatments around the world," said a Roche spokesperson in response to Reuters' questions. The other companies either declined to comment or did not respond. The U.S. State Department did not immediately respond to requests for comment. The first source said waivers from the U.S. government, intended to allow lifesaving work to restart, only applied to orders already moving around the world. Even those were not fully functional as the USAID payment system remained down, he said. Future funding and orders were more uncertain, even for companies where the raw materials have been assembled or the manufacturing capacity booked, he added. Medicines and diagnostic tests for HIV and malaria, as well as preventive tools like bed nets and contraceptives, could be impacted, he said. "There will be a huge backlog," said Fitsum Lakew Alemayehu, the African Union liaison manager at WACI Health, an African advocacy organization. "In Africa, millions have been on those treatments." 'BULLWHIP' EFFECT The dismantling of USAID has already had significant impact across the globe, including shuttering HIV clinics, stranding emergency food aid, and halting research. For medical supplies, the freeze could also hit prices, because companies have been able to operate more efficiently knowing that they would continue to get orders from USAID, all of the sources said. Prashant Yadav, a medical supply chain expert and senior fellow at the nonpartisan Council on Foreign Relations think tank, said the upheaval could upend this system of advance demand forecasts entirely, hitting prices and ultimately risking budget shortfalls across other buyers, like governments and global health funders. He said it was an example of the "bullwhip" effect in supply chains, where "any small changes, even if they are for a short duration of time, get amplified at every level in the system". The term is derived from a scientific concept in which movements of a whip are amplified from the origin - the hand cracking the whip - to the endpoint. Even if the aid freeze ends after a 90-day review, as the Trump administration originally suggested, restarting production will be complex and there could be legal issues, several experts said. "This is a huge mess to untangle," said Tom Cotter, chief executive officer at Health Response Alliance, a nonprofit organization dedicated to ensuring equitable access to health services during emergencies. (Reporting by Jennifer Rigby, additional reporting by Maggie Fick in London, Rishika Sadam in Hyderabad)
Zawya
03-12-2024
- Zawya
Gypto Pharma and Roche celebrate the successful completion of the first phase of transferring biotechnology
This milestone marks a significant contribution to Egypt's transformation from a technology user into a technology leader Cairo, Egypt: The Medicine City "GYPTO Pharma", one of the largest pharmaceutical manufacturing hubs in the Middle East, announced today the completion of the first phase of transferring the Swiss world-class biotechnology manufacturing to Egypt, in partnership with Roche, the leading pharmaceutical and diagnostic solutions company in Egypt and considered the first globally in the manufacturing of biologic drugs. This unprecedented achievement by Gypto Pharma aligns with Egypt's Vision 2030 and its strategy to localize the pharmaceutical industry, positioning the country as a regional hub for manufacturing and exporting pharmaceuticals in the Middle East. It marks a significant step toward realizing the aspirations of the state and its political leadership, ensuring that Egyptian citizens have access to safe, effective drugs that meet international quality standards and good manufacturing practices. Furthermore, this initiative seeks to establish Egypt as both a regional and global leader in the pharmaceutical industry, attract investment, support the national economy, and keep pace with global technological advancements. Among notable attendees were H.E. Dr. Khaled Abdel Ghaffar, Deputy Prime Minister for Human Development Affairs and Minister of Health and Population, Major General Dr. Bahaa El-Din Zidan, Chairman of UPA, Dr. Aly El Ghamrawy, Chairman of EDA, H.E. Dr. Andreas Baum Ambassador of Switzerland in Egypt, Dr. Mohamed Swilam, General Manager Roche Egypt, and Dr. Amr Mamdouh, CEO of Gypto Pharma. H.E. Dr. Khaled Abdel Ghaffar stated that this achievement represents an important step toward achieving Egypt's goals of localizing advanced and specialized industries in the pharmaceutical sector. He emphasized the importance of expediting all stages of the partnership between Gypto Pharma and Roche to produce this type of medication locally. He also expressed his aspiration to expand this partnership to begin exporting to various countries after achieving self-sufficiency. The Deputy Prime Minister highlighted the significance of localizing the production of biological medicines in parallel with expanding presidential initiatives to treat patients with chronic diseases, reducing the cost of importing medications, and making them available to patients at affordable prices. Dr. Khaled Abdel Ghaffar noted that the pharmaceutical market in Egypt is valued at approximately EGP 330 billion annually. He highlighted the importance of collaborating with companies interested in research and development, pointing out that Egypt possesses strong infrastructure supportive of innovation, as well as research centers and pharmacy faculties that include distinguished research and academic talents. Dr. Amr Mamdouh explained that "Gypto Pharma is steadily advancing toward providing high-quality medicines that the Egyptian patient deserves and supporting the localization of medicines in accordance with the vision and directives of the political leadership. Currently, we are collaborating with seven global companies to localize medicines for specialized diseases, in addition to manufacturing essential medicines for chronic diseases under Gypto Pharma through a research and development system. Our production volume of these medicines is expected to reach nearly 65 million packages in 2024." Commenting on the successful transfer and enhancement of skills for the Egyptian workforce in manufacturing biological treatments, Dr. Mohamed Swilam, General Manager of Roche Pharma in Egypt, said, 'For 40 years, Roche has diligently collaborated with the Egyptian government, the Ministry of Health and Population, and the entire healthcare ecosystem to develop advanced medical solutions and improve the quality of life for people in Egypt and the Arab world. We are very proud of our cooperation with Gypto Pharma to build the manufacturing capabilities of biological products, both technically and in medical engineering, for the Egyptian pharmaceutical experts at Gypto.' H.E. Dr. Andreas Baum Ambassador of Switzerland in Egypt stated, 'Today's event is more than the celebration of an industrial success; it highlights the power of collaborative innovation. In the healthcare industry, scientific breakthroughs must reach patients to make a difference. Roche, alongside its Egyptian partners, has shown a remarkable commitment to this goal, by helping to build a strong and resilient healthcare system in Egypt.' In his speech, Dr. Ali El-Ghamrawy, Head of the Egyptian Drug Authority, emphasized that the Authority places significant importance on localizing medicines, medical supplies, and raw materials necessary for developing the pharmaceutical industry. He noted that this goal is a priority to support the Egyptian economy and enhance capabilities in the healthcare sector. Major General Dr. Bahaa El-Din Zidan, Chairman of UPA expressed his appreciation for the efforts of Medicine City and Roche in the field of localization, particularly regarding today's announcement. He stated that these efforts aim not only at localization but also at exportation. The biological drug being localized in Egypt is a key component of the latest international protocols and recommendations, representing a global standard in liver cancer treatment. It is also included in the national guidelines under the presidential initiative for liver cancer detection and treatment. Over the past two years, since the initiative's launch in March 2022, the Egyptian state has made significant efforts in this area. With advanced biological treatments being the first-line option for liver cancer, this localization project marks a substantial advancement and a valuable asset in strengthening the Egyptian healthcare system's ability to combat liver cancer. The Egyptian Medicine City (Gypto Pharma) spans an area of 180,000 square meters and comprises two factories producing a wide range of pharmaceutical forms, including tablets, capsules, effervescent tablets, liquid preparations, and creams. These products are manufactured using cutting-edge technology recognized as the highest quality worldwide. During the project's implementation, the Egyptian state prioritized equipping the facility with the most advanced machinery, sourced from leading European and American suppliers renowned in the global pharmaceutical industry. The Medicine City adheres to international "Good Manufacturing Practices" (GMP) standards and places a strong emphasis on human resources, ensuring a workforce that is both highly trained and professional. Roche stands out for its seamless integration of research and development with modern technology, allowing it to offer high-quality and effective pharmaceutical products. By making substantial investments in research and development, Roche is committed to providing advanced solutions that are affordable for patients. This strategic partnership marks the beginning of a long-term relationship aimed at addressing a wide range of incurable diseases with Roche's innovative medicines. It is the first initiative of its kind in Egypt and the entire region. The transfer of biotechnology will soon enable the production of a drug for solid cancers, including liver cancer. This shift marks Egypt's transition from being a technology consumer to becoming a producer, elevating the country to a higher scientific and economic standing while offering significant long-term benefits and returns. This technology transfer represents the first step in this journey, with additional advancements expected over the next two years.
