AUS Food and Drug Administration (FDA’s) Oncology Advisory Committee (AdCom) has raised questions about the upcoming decision to grant traditional approval of Amgen’s high-profile KRAS G12C inhibitor Lumakras (sotorasib). Lumakras was granted accelerated approval in May 2021 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutations, who had received at least one prior systemic therapy. This approval was based on the CodeBreaK 200 trial (NCT04303780) of sotorasib versus docetaxel. Lumakras generated $285m in sales last year worldwide, according to Amgen’s 2022 annual report to shareholders. The latest AdCom questioned the reliability of the data In the briefing document released by the FDA from the meeting, several features of the Codebreak trial were listed that were inconsistent with a sufficient well-controlled trial. The main issue noted was that too many patients were allowed to swap between the treatment and control arms ...
In a recent study published in the journal Environmental Health Perspectives, researchers have found that women living in neighborhoods characterized as walkable, based on factors like population density and accessibility to destinations, have a reduced risk of obesity-related cancers, including postmenopausal breast cancer, as well as multiple myeloma, ovarian, and endometrial cancers. Background Obesity is a growing health concern, with over 40% of adults in the United States being obese or overweight. This condition also significantly increases the risk of various cancers, particularly among women. About 55% of diagnosed cancers in women are linked to obesity, while the figure is approximately 24% for men. Inactivity among women is believed to further exacerbate the risk of obesity-related cancers. Increasing evidence highlights walking as a moderate-intensity physical activity that contributes significantly to recommended exercise levels for maintaining good health. Recent research has focused on how the built environment affects physical activity and, ...
By Tristan Manalac Pictured: Merck signage outside its office in California/iStock, hapabapa Merck on Thursday reported that its blockbuster PD-1 inhibitor Keytruda (pembrolizumab) met one of its dual primary endpoints in the Phase III AMBASSADOR trial in muscle-invasive urothelial carcinoma. Details of the study were limited but Merck said that at a pre-specified interim analysis review Keytruda treatment led to a statistically significant and clinically meaningful improvement in disease-free survival compared with simple observation. AMBASSADOR is ongoing and will continue to assess the effects of Keytruda on overall survival (OS), the study’s second primary endpoint. The promising initial data from AMBASSADOR point to the “potential of Keytruda to prevent recurrence” in patients who had undergone surgery, Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, said in a statement. AMBASSADOR, also known as KEYNOTE-123, is a randomized and open-label study enrolling approximately ...
Nanobiotix has shared positive new data from an early-stage study evaluating a drug designed to enhance the efficacy of radiotherapy in patients with locally advanced pancreatic cancer. Results from the phase 1 study of NBTXR3, which is being conducted as part of an ongoing collaboration between Nanobiotix and the University of Texas MD Anderson Cancer Center, were presented at this year’s American Association for Cancer Research Special Conference on Pancreatic Cancer. Pancreatic ductal adenocarcinoma (PDAC) is associated with a poor prognosis and remains one of the leading causes of cancer-related death worldwide. For more than 90% of patients with locally advanced disease who are not eligible for surgery, there are few treatment options with curative intent, and the five-year overall survival rate for patients with unresectable PDAC remains less than 5%. Radiotherapy is one of the most common treatment modalities for cancer, with approximately 50% of patients undergoing it at ...
While the White House recently touted the FDA’s efforts to mitigate the ongoing chemotherapy shortage in the U.S., a recent survey by the National Comprehensive Cancer Network (NCCN) shows that many treatment centers do not have enough supply of key medicines.、 NCCN surveyed 29 of its member institutions throughout the month of September and found that 72% of centers are still experiencing a carboplatin shortage, while 59% are short on cisplatin. The report is a follow-up to a June survey evaluating supply levels of the key platinum-based chemotherapies carboplatin and cisplatin. The June survey showed that 93% of centers were experiencing a carboplatin shortage, while 70% were low on cisplatin. “It is extremely concerning that this situation continues despite significant attention and effort over the past few months,” NCCN’s CEO Robert Carlson, M.D., said in a statement. “We need enduring solutions in order to safeguard people with cancer and address ...
Merck on Thursday reported that its blockbuster PD-1 inhibitor Keytruda (pembrolizumab) met one of its dual primary endpoints in the Phase III AMBASSADOR trial in muscle-invasive urothelial carcinoma. Details of the study were limited but Merck said that at a pre-specified interim analysis review Keytruda treatment led to a statistically significant and clinically meaningful improvement in disease-free survival compared with simple observation. AMBASSADOR is ongoing and will continue to assess the effects of Keytruda on overall survival (OS), the study’s second primary endpoint. The promising initial data from AMBASSADOR point to the “potential of Keytruda to prevent recurrence” in patients who had undergone surgery, Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, said in a statement. AMBASSADOR, also known as KEYNOTE-123, is a randomized and open-label study enrolling approximately 740 patients with localized muscle-invasive or locally advanced urothelial carcinoma. Pembrolizumab was ...
The Institute of Cancer Research (ICR) and Merck KGaA have announced a renewal of their strategic alliance to discover and develop new small-molecule cancer drugs. Throughout the multi-year, multi-target collaboration, both organisations will contribute their expertise in drug discovery to the partnership. As part of the agreement, significant financial and staff commitments from both organisations will be made, including the funding of nine full-time research posts at the ICR by Merck. Scientists at the ICR’s Centre for Cancer Drug Discovery will cooperate with researchers at German science and technology company Merck on a variety of projects that aim to discover and develop new small-molecule inhibitors of a new class of cancer targets. In 2021, the ICR opened a new building worth £70m as part of its site in Sutton, South London, which houses around 300 scientists working across a range of disciplines in cancer drug discovery. Earlier this month, ICR ...
As Seagen prepares for its takeover by Pfizer, the company’s Astellas-partnered cancer drug Padcev has chalked up a key trial win—in combination with Merck’s Keytruda—in previously untreated metastatic bladder cancer. In the study, Seagen and Astellas’ antibody-drug conjugate Padcev and Merck’s PD-1 superstar Keytruda scored on both overall survival and progression-free survival compared with chemotherapy. An independent data monitoring committee found that the combo’s life extension benefit surpassed the pre-specified efficacy boundary at an interim analysis, the companies said in a Friday release. The results could open the combo up to patients who are eligible for platinum-based chemotherapies cisplatin or carboplatin, regardless of their PD-L1 status. “This study has the potential to be practice changing and offer a new standard of care for first-line metastatic bladder cancer,” Seagen’s R&D head Roger Dansey, M.D., said in the release. “We look forward to presenting the results at an upcoming medical conference and ...
The investment will support research into cancer treatments and diagnosis Cancer Research UK (CRUK) has announced its largest ever investment of £123m in Scotland as part of a seven-year commitment to the CRUK Scotland Institute. The institute, which is facilitated in partnership with the University of Glasgow, will use the investment to support research into new and improved cancer treatments and diagnosis, as well as bolster Scotland as a major global hub for cancer research. It will also aid in attracting research talent to the Scotland Institute and will support major studies into specific types of cancer that largely affect Scotland’s population, including liver, pancreatic, bowel and lung. Despite mortality rates falling by 8% in the past decade, more than 34,000 people are diagnosed with cancer every year in Scotland. Previously known as the CRUK Beatson Institute, the CRUK Scotland Institute studies the roots of how cancer begins, the genetics ...
Cancer Research UK has announced its international partnership with France’s Institut National Du Cancer (INCa), investing £8.6m to drive world-class global cancer research. As part of the global Cancer Grand Challenges initiative, the partnership will help fund world-class researchers to take on cancer’s toughest challenges. Claiming almost ten million lives every year, cancer is the second leading cause of death worldwide. The INCa is currently the first to pledge funds to support several teams in a single round of the Cancer Grand Challenges initiative, as well as the initiative’s original founding partners, Cancer Research UK and the US National Cancer Institute (NCI). Since its founding in 2020, more than £210m has been invested in the initiative, which aims to build a scientifically elite, interdisciplinary community to fill knowledge gaps in cancer and drive progress. The initiative comprises diverse international organisations, collaborators and research leaders, including the Scientific Foundation of the ...
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