San Francisco—Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. On Monday, the Swiss pharma’s CEO Vas Narasimhan explained how he’s resisted the temptation. The answer is radioligand therapies, Narasimhan said Monday during the 2024 J.P. Morgan Healthcare Conference in response to a question from Fierce Pharma. “We have a long history within research of ADCs, but we have not been successful,” Narasimhan said. “To be clear, part of our focus strategy is looking at places where we think we can create long-term sustainable leadership. And we are investing in radioligand therapies.” ADCs and radioligand therapies are similar in that both technologies act as guided missiles. For ADCs, the guiding force is an antibody, and the cancer-killing payload is a chemotherapy. A radioligand therapy uses a ligand to target cancer cells and kills them with a therapeutic radioisotope. Radiotherapies may have a safety ...
Shanghai, China, January 5th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that ASTRUM-004, Henlius’ pivotal phase 3 clinical study of anti-PD-1 mAb HANSIZHUANG (serplulimab) plus chemotherapy as first-line treatment for previously untreated locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC), was published in Cancer Cell, a highly regarded oncology journal with an impact factor of 50.3. This publication serves as further evidence of the exceptional performance of HANSIZHUANG in the field of lung cancer. The study was led by Professor Caicun Zhou from Shanghai Pulmonary Hospital. Results of the overall population ASTRUM-004 were initially presented at the IASLC 2023 World Conference on Lung Cancer (WCLC 2023) in the form of oral presentation. Additionally, the data from its Asian subgroup were showcased in a poster session at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2023. Previously in 2022, the new drug application (NDA) of serplulimab for ...
The number of people getting tested over the last decade has increased by 133% The NHS has announced a new analysis showing its highest year on record for providing urgent cancer checks over the last year. Almost three million people in the UK received cancer checks between November 2022 and October 2023. In alignment with the health service’s goal of catching cancer earlier, the new analysis has shown a 133% increase in the number of people getting checked for cancer over the last decade. Between November 2022 and October 2023, over 2.9 million people were seen for urgent cancer checks, an increase of 147,960 people between 2021 and 2022. In October alone, the NHS saw the highest month on record for cancer checks, as well as 269,492 urgent referrals and 192,889 people who received an all-clear or definitive cancer diagnosis. In addition to this, the NHS has made major progress ...
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 ...
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 ...
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 ...
In the future, a little saliva may be enough to detect an incipient cancer. Researchers at the University of Gothenburg have developed an effective way to interpret the changes in sugar molecules that occur in cancer cells. Glycans are a type of sugar molecule structures that is linked to the proteins in our cells. The structure of the glycan determines the function of the protein. It has been known for a while that changes in glycan structure can indicate inflammation or disease in the body. Now, researchers at the University of Gothenburg have developed a way to distinguish different types of structural changes, which may provide a precise answer to what will change for a specific disease. “We have analyzed data from about 220 patients with 11 differently diagnosed cancers and have identified differences in the substructure of the glycan depending on the type of cancer. By letting our newly ...
Roche has shared positive results from a late-stage study of its investigational therapy, inavolisib, as part of a combination treatment for advanced breast cancer. The phase 3 INAVO120 trial has been evaluating the targeted drug alongside Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) and fulvestrant as a potential first-line treatment option for patients with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared to palbociclib and fulvestrant alone. A “clear positive trend” towards improved survival was also observed for the inavolisib combination, Roche said, although overall survival data was immature at the time of the analysis and will continue to be analysed. Breast cancer is the most common cancer worldwide, with more than 290,000 people in the US expected to be diagnosed with the disease in 2023. HR-positive breast cancer is ...
The US Food and Drug Administration (FDA) has started an investigation to review the safety of chimeric antigen receptor (CAR)-T cell immunotherapies following reports of T cell malignancies in patients who received these immunotherapies. The therapies under investigation include six approved B cell maturation antigen (BCMA)- or CD19-directed CAR-T cell therapies. The investigation follows reports collected from clinical trials and post-marketing adverse event surveillance. The FDA had required companies to conduct 15-year long term follow-up observational safety studies to assess the long-term safety and the risk of secondary malignancies as part of the respective therapy’s approval. The risk of post-therapy malignancies applies to all FDA-approved BCMA- or CD19-directed CAR-T cell therapies, as per a 28 November press release. The agency added that although the therapy benefits “continue to outweigh their potential risks for their approved uses”, the FDA is evaluating the need for regulatory action regarding the risk of T-cell ...
By Tyler Patchen Pictured: AstraZeneca office in Gothenburg, Sweden AstraZeneca announced Friday that its adenosine triphosphate (ATP)-competitive inhibitor Truqap (capivasertib), in combination with its endocrine therapy Faslodex (fulvestrant), has been approved by the FDA to treat adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. According to AstraZeneca, the first-in-class inhibitor of all three AKT isoforms (AKT1/2/3) “has potential to reshape treatment for breast cancer patients” with specific biomarker alterations (PIK3CA, AKT1 or PTEN). The company also announced that the FDA has approved a “companion” diagnostic test meant to detect the “relevant” alterations. The FDA approval was based on the CAPItello-291 Phase III trial, which showed that the combination of Faslodex and Truqap reduced the risk of disease progression or death by 50%, compared to Faslodex alone, in patients with tumors having PI3K/AKT pathway biomarker alterations. “The combination of capivasertib and fulvestrant, a first-of-its-kind combination, provides a much-needed ...
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