Approximately only half of cancer patients see a positive response to treatments, with the remaining experiencing inadequate outcomes. The high costs and potential adverse reactions of treatments make it crucial for clinicians to quickly determine their effectiveness, or if an alternative therapy is more suitable. Presently, it can take weeks or months to fully gauge the success of cancer treatment, typically using CT scans to measure significant size changes in tumors. While tumor biopsies offer more precise data, their infrequency limits the ability to provide ongoing updates. As a solution, many clinicians are now resorting to liquid biopsies, which involve testing for cancer indicators in a patient’s blood, like tumor-shed cancer cells. However, these tests require sufficiently high cell levels for detection. This is particularly challenging in lung cancer, where some FDA-approved methods for detecting blood-borne cancer cells are ineffective, often due to targeting a single, less common protein in ...
Hong Kong, Shanghai & Florham Park, NJ — Tuesday, January 30, 2024: HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announces that the marketing approval of ELUNATE® (fruquintinib) by the Pharmacy and Poisons Board of Hong Kong for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). ELUNATE® is a selective oral inhibitor of vascular endothelial growth factor (“VEGF”) receptors -1, -2 and -3, which play a pivotal role in blocking tumor angiogenesis. This marks the first medicine to be approved under the new mechanism for registration of new drugs (“1+” mechanism) announced by the Government of the Hong Kong Special Administrative Region (“SAR”) in October last year. The mechanism officially commenced on November 1, 2023. It allows drugs which are beneficial for treatment of life-threatening or severely debilitating diseases to apply for registration for use in Hong Kong, if they have supporting local clinical data and recognition ...
Enhertu has been approved by the FDA for indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. Image credit: David A Litman | stock.adobe.com The FDA has granted Priority Review to a supplemental Biologics License Application (sBLA) from AstraZeneca and Daiichi Sankyo’s for Enhertu (trastuzumab deruxtecan [DXd]) to treat adults with previously treated unresectable or metastatic human epidermal growth factor 2 (HER2)-positive (immunohistochemistry [IHC] 3+) solid tumors with no satisfactory alternative therapeutic options.1 Enhertu is a HER2-directed antibody-drug conjugate (ADC) with approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction (GEJ) adenocarcinoma. “Today’s Priority Review for the first tumor-agnostic submission for Enhertu reflects the potential of this medicine to redefine the treatment of HER2-expressing cancers,” Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, in a press release. “Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumor types. ...
Shanghai, China – January 28,2024- Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced the first-time release of interim analysis data for the Phase II clinical trial of oral APL-1202 in combination with the PD-1 inhibitor tislelizumab for neoadjuvant treatment of muscle-invasive bladder cancer (MIBC). Release of the interim analysis data was made in the form of a rapid oral presentation abstract (Abstract No:632)at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). Patient enrollment of the trial was recently completed. Primary objective of the Phase II clinical trial is to evaluate the safety and efficacy of APL-1202 in combination with tislelizumab compared to tislelizumab monotherapy as neoadjuvant therapy for MIBC patients. The trial population includes patients with newly diagnosed MIBC for whom radical cystectomy (RC) is planned, ...
Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. Keytruda slashed the risk of death by 38% compared with placebo when used after kidney removal in patients with clear cell renal carcinoma, the most common form of kidney cancer, according to newly released trial results. After four years of treatment, investigators estimated that 91.2% of patients in the Keytruda arm were still alive, versus 86% for the control group. The results, which reached statistical significance, come from an update of the Keynote-564 trial. Previously, disease-free survival results from the same trial supported Keytruda’s 2021 approval as an adjuvant therapy for certain kidney cancer patients at risk of recurrence after surgery. Keytruda’s survival win comes just as Bristol Myers Squibb’s rival PD-1 inhibitor, Opdivo, failed for a second time in ...
CG Oncology’s upsized IPO will support pivotal testing of cretostimogene, an oncolytic virus for non-muscle invasive bladder cancer. The clinical program spans tests of the engineered virus as a monotherapy and as part of combination treatments. By FRANK VINLUAN CG Oncology, a company that turns viruses into cancer therapies, has raised $380 million to fund clinical development of a therapy that the company believes could become a new first-line treatment for certain bladder cancers. The stock offering marks the first biotech IPO of 2024. CG was able to raise much more than planned. In preliminary financial terms set earlier this week, the company projected selling 17 million shares in the range of $16 to $18 each, which would have raised $289 million at the pricing midpoint. When CG finalized the IPO terms late Thursday, it ended up offering 20 million shares priced at $19 apiece. Those shares will trade on ...
(“AOSAIKANG”) has completed the registration clinical phase III study of ASKB589, a bio-innovative drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer. ASKB589, a bio-innovation drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer, has been administered to the first patient in China in the Phase III registration study: I. About the Registrational Clinical Phase III Study of ASKB589 The study is a multicenter, randomized, double-blind, standard treatment-controlled, efficacy-designed Phase III clinical study, which is planned to enroll 780 first-line gastric cancer patients in China, with the aim of evaluating the efficacy and efficacy of ASKB589 Injection or placebo in combination with CAPOX (oxaliplatin and capecitabine) and PD-1 inhibitor in the first-line treatment of CLDN18.2-positive unresectable locally advanced, recurrent or metastatic gastric and esophageal cancers, and to assess the efficacy and efficacy of the study. efficacy and safety ...
January 23, 2024 Pharmaceutical Executive Editorial Staff The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy.Image credit: Dr_Microbe | stock.adobe.com Data from the Phase III EVOKE-01 trial (NCT05089734) show that Gilead Sciences, Inc’s Trodelvy (sacituzumab govitecan-hziy) did not achieve the primary endpoint of overall survival (OS) in patients with previously treated, metastatic non-small cell lung cancer (NSCLC).EVOKE-01 was comparing Trodelvy with docetaxel for the treatment of patients with metastatic or advanced NSCLC who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy. “The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Gilead Sciences Chief Medical Officer Merdad Parsey, MD, PhD, in a press release. “Treating metastatic NSCLC that has progressed on or ...
Cambridge, MA, Rotterdam, NL, Suzhou, CN – Jan 19, 2023 Harbour BioMed (the “Company”; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, announces a positive profit alert for the year ended December 31, 2023. As disclosed before, there was a turnaround from a loss of US$73.1 million for the six months ended June 30, 2022 to a profit of US$2.9 million for the six months ended June 30, 2023. Based on the preliminary review of the unaudited consolidated management accounts, it is expected that there will be a profit of approximately US$18 million for the year ended December 31, 2023, as compared to a loss of approximately US$137 million for the year ended December 31, 2022. This is the first time that the Company has recorded a net profit on its annual financial statements. The anticipated ...
For more than 2 years, Johnson & Johnson has been plotting its future as a two-sector company. In the wake of the company’s consumer healthcare spinoff last summer, the company’s fourth-quarter results offer plenty of signs of life from the new-look J&J.After wrapping up 2023 with a total haul of $85.2 billion, the company is heading into 2024 with “multiple catalysts for growth,” CEO Joaquin Duato said on J&J’s fourth-quarter and full-year earnings conference call. Across J&J’s innovative medicines portfolio, the company’s oncology and immunology medicines generated the lion’s share of sales in 2023’s fourth quarter, helping the unit achieve operational growth in the U.S. of 9.5% during the period. Worldwide, J&J’s pharma business reeled in $13.72 billion during the fourth quarter, a 4% increase from the same period in 2022.On the immunology front, J&J’s antibody blockbuster Stelara grew its market share and demonstrated continued strength in inflammatory bowel disease (IBD), J&J said in ...
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