Patient tissue samples are commonly examined on slides by pathologists, a process integral to diagnosis. This traditional method, while effective, is notably time-intensive and subject to variability in interpretations among different pathologists. Moreover, some subtle details in pathology images might escape human observation but could hold critical insights into a patient’s health status. Over recent years, several artificial intelligence (AI) models have been developed to undertake certain tasks typically performed by pathologists, such as classifying cell types or gauging cellular interactions based on proximity. Nevertheless, these models have not fully captured the more intricate aspects of tissue image analysis that pathologists conduct, including recognizing complex cell spatial arrangements and filtering out irrelevant image ‘noise’ that could distort interpretations. Addressing this gap, researchers have now introduced an innovative AI model that is capable of examining the spatial organization of cells within tissue samples, offering precise predictions about cancer patient outcomes and ...
Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California pharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod. Lumakras was granted accelerated approval in May 2021 to treat second line KRAS G12C-mutated NSCLC. The company was asked by the FDA to launch a confirmatory trial and a dose optimization study to gain a full approval. The therapy faced an advisory committee meeting in October where a panel was asked to consider whether the primary endpoint for the phase 3 CodeBreak 200 trial could be reliably interpreted in Amgen’s study. The committee voted 10-2 against the measure, suggesting that they were unimpressed with Amgen’s trial design. Despite the negative vote, the agency was not expected to remove Lumakras from the market, but instead request another confirmatory trial. Amgen now says that’s exactly ...
Dec 23 (Reuters) – Bayer has won a trial in a lawsuit brought by a California man who said he developed cancer from exposure to its Roundup weedkiller, ending what had been a five-trial losing streak for the company in trials over similar claims. The verdict was handed down on Friday by a jury in San Benito County, California Superior Court, Bayer announced. The company said in a statement that the verdict was “consistent with the evidence in this case that Roundup does not cause cancer and is not responsible for the plaintiff’s illness.” Lawyers for plaintiff Bruce Jones did not immediately respond to requests for comment. Like most plaintiffs in Roundup lawsuits, Jones alleged that the product caused him to develop a form of cancer called non-Hodgkin lymphoma. Around 165,000 claims have been made against the company for personal injuries allegedly caused by Roundup, which Bayer acquired as part ...
Recently, the “Pyrotinib Combined with Docetaxel as First-Line Treatment for HER2-Positive Metastatic Breast Cancer: An Open, Multicenter Phase II Clinical Study (PANDORA)” led by Professor Wang Xiaojia from the Affiliated Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) was officially published in the internationally renowned journal “Nature Communications,” a sub-journal of ‘Nature’ (Impact Factor: 16.6). The research results indicate that the combination therapy of pyrotinib and docetaxel demonstrates excellent anti-tumor activity and brings about progression-free survival (PFS) benefits. Research Background: Dual-targeted therapy with trastuzumab combined with taxanes has established the first-line standard treatment for HER2-positive advanced breast cancer [Progression-Free Survival (PFS): 18.7m vs. 12.4m, P<0.001; 8-year Overall Survival (OS) rate: 37% vs. 23%, P<0.001]. However, the inclusion of trastuzumab in the Cleopatra study in a population with prior trastuzumab (referred to as “H”) treatment was only 11%, and it may no longer fully guide current ...
Pharmaceutical Executive Editorial Staff Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy. Findings from the KEYNOTE-942/mRNA-4157-P201 clinical trial show that Moderna’s investigational individualized neoantigen therapy plus Merck’s Keytruda (pembrolizumab) lowered the risk of death or relapse by nearly half in patients with resected high-risk melanoma (stage III/IV) following complete resection. A planned analysis of the Phase IIb randomized trial found that at a median follow-up of approximately three years, adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Keytruda continued to show a clinically meaningful improvement in recurrence-free survival (RFS) by lowering the risk of recurrence or death by 49% compared with Keytruda monotherapy. “As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with Keytruda ...
Pharmaceutical Executive Editorial Staff Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula as maintenance therapy produced a statistically significant and clinically meaningful benefit in progression-free survival in patients with primary advanced or recurrent endometrial cancer. GSK’s Jemperli (dostarlimab) produced a significant improvement in survival among adults with primary advanced or recurrent endometrial cancer in a Phase III trial.1 Findings from the RUBY/ENGOT-EN6/GOG3031/NSGO trial show that Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula (niraparib) as maintenance therapy, achieved the primary endpoint of progression-free survival (PFS). The combination led to a statistically significant and clinically meaningful benefit across the overall patient population and among a subpopulation of patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) tumors in those with primary advanced or recurrent endometrial cancer. “Patients with MMRp/MSS primary advanced or recurrent endometrial cancer have few approved treatment options,” Hesham Abdullah, senior ...
GSK gains rights to a Hansoh Pharma antibody drug conjugate that targets a protein abundant on lung cancer cells and other types of solid tumors. The pharmaceutical giant plans to start its own slate of clinical trials with this ADC in 2024. By FRANK VINLUAN GSK’s cancer drug pipeline is getting bigger with the addition of another antibody drug conjugate, or ADC. It’s the second time in as many months that GSK has turned to Hansoh Pharma for one of the China-based biotech’s drugs. Per deal terms announced Wednesday, GSK is paying $185 million up front for rights to HS-20093, a Hansoh ADC that has been tested in lung cancer. GSK gains global rights to the drug candidate excluding mainland China, Hong Kong, Macau, and Taiwan. ADCs are made by chemically linking an antibody to a toxic drug payload. The targeting ability of the antibody is meant to provide a ...
Illumina has decided against further appeals of U.S. and European antitrust litigation challenging its acquisition of liquid biopsy company Grail. Illumina expects to have terms of the divestiture set by the end of the second quarter of 2024. By FRANK VINLUAN Illumina is done fighting in the courts to keep cancer-detection company Grail. The gene-sequencing giant had previously pledged to divest Grail if it did not win either the U.S. or European appeals of anti-trust cases challenging the acquisition. A U.S. appeals court came down against the Federal Trade Commission’s case on Friday, but in a narrow way that hardly handed Illumina a clear victory. After reviewing the decision, Illumina said Sunday that it has decided against further litigation. The company will divest Grail. The planned divestiture is the latest step in a journey that started within Illumina. Grail began as research within the San Diego company. Grail spun out ...
Despite achieving its Phase 3 study’s main goal, the results for Point Biopharma’s therapy are short of what Novartis radiopharmaceutical Pluvicto achieved in a similarly designed clinical trial. Nevertheless, the data readout should clear the way for Eli Lilly to complete its $1.4 billion acquisition of Point. By FRANK VINLUAN A Point Biopharma Global cancer therapy key to a $1.4 billion Eli Lilly M&A deal has met the main goal of its pivotal clinical trial in prostate cancer. But the results raise questions about how well the drug will match up against a radiopharmaceutical marketed by Novartis. The Point drug, PNT2002, is also a radiopharmaceutical. It offers targeted delivery of a radioactive particle by linking it to a ligand that targets PSMA, a protein abundant on the surface of prostate cancer cells. The open-label Phase 3 study evaluated the Point radiopharmaceutical in patients with cases of prostate cancer that has ...
On a mission to grow in oncology, GSK has more positive data to report in endometrial cancer. This time, the company is touting results for its PD-1 inhibitor Jemperli and PARP inhibitor Zejula, which could become a threat to a rival therapy at AstraZeneca. Adding Jemperli and Zejula to chemotherapy significantly extended the time before tumor progression or death in patients with primary advanced or recurrent endometrial cancer that’s mismatch repair proficient or microsatellite stable (pMMR/MSS), GSK said Monday. The results came from the second part of the phase 3 RUBY trial. The trial also showed that the Jemperli-Zejula-chemo regimen was better at delaying disease worsening than chemo alone in the overall population, regardless of genetic stability. But GSK appears to think that the combo has more value in the pMMR/MSS subgroup. Patients with pMMR/MSS endometrial cancer have few treatment options, Hesham Abdullah, GSK’s head of oncology R&D, said in ...
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