Latest news with #PD-L1
Yahoo
13-06-2025
- Business
- Yahoo
Merck Gets FDA Approval to Expand Use of Its Top-Selling Drug, Keytruda
Merck has received approval from the Food and Drug Administration to expand use of its blockbuster drug, Keytruda, to treat head and neck cancers. Studies found patients taking Keytruda can reduce the risk of head and neck cancer recurrence, progression, or death by 30% compared to current treatments. Keytruda is Merck's best-selling drug, generating more than $7 billion in revenue in the first (MRK) has received the go-ahead to expand use of its blockbuster cancer drug, Keytruda. The Food and Drug Administration (FDA) has approved Keytruda's use for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express the protein PD-L1. The study's overall principal investigator, Dr. Ravindra Uppaluri, said the approval "represents a potentially significant shift in how we manage this disease." Dr. Uppaluri added Keytruda "has been shown to reduce the risk of recurrence, progression, or death by 30%, compared with standard of care adjuvant chemoradiotherapy or radiotherapy alone." Merck noted that it's estimated that in 2025, there will be approximately 72,680 new cases of head and neck cancer diagnosed, and more than 16,680 deaths from the disease. Keytruda is the company's best-selling drug, with first-quarter revenue of $7.2 billion, making up nearly half of its total sales. Entering Friday trading, shares of Merck were down about 18% year-to-date. Read the original article on Investopedia Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Malaysian Reserve
11-06-2025
- Business
- Malaysian Reserve
Kelun-Biotech Announces Breakthrough Therapy Designation Granted for Sacituzumab Tirumotecan (Sac-TMT) in Combination With Tagitanlimab in China for Certain Types of Non-Small Cell Lung Cancer
CHENGDU, China, June 10, 2025 /PRNewswire/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the 'Company') today announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) (佳泰莱®) in combination with the PD-L1 monoclonal antibody tagitanlimab (科泰莱®) was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. Breakthrough Therapy Designation is granted for treatment options that demonstrate significant clinical advantages over currently available treatments and is aimed at expediting the research, development and marketing of innovative treatment options that address clinically urgent medical needs. This designation is based on the efficacy and safety data from the non-squamous cohort of the Phase II OptiTROP-Lung01 study. This marks the fifth Breakthrough Therapy Designation granted to sac-TMT by the NMPA. Sac-TMT has previously received this designation for: Locally advanced or metastatic triple-negative breast cancer (TNBC) in July 2022; EGFR-mutant, locally advanced or metastatic NSCLC after progression on EGFR-TKI therapy in January 2023; Locally advanced or metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) in patients who have previously received at least two lines of systemic chemotherapy in June 2023； First-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC in March 2024. Results from a Phase 2 OptiTROP-Lung01 study of sac-TMT in combination with tagitanlimab in first-line advanced or metastatic non-squamous NSCLC patients were presented in a poster session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting[1]. Dr. Michael Ge, CEO of Kelun-Biotech said, 'This designation by the NMPA highlights the importance of developing novel therapeutic options for diverse NSCLC subtypes. Sac-TMT in combination with tagitanlimab demonstrated clinically meaningful outcomes in key endpoints for patients with non-squamous NSCLC without actionable genomic alterations as a first-line treatment. We are excited about the therapeutic potential of TROP2 ADC- immunotherapy combinations, and we look forward to working with regulatory authorities in China to bring this combination therapy to patients in need as soon as possible.' [1] Abstract #8529: Lung Cancer – Non-Small Cell Metastatic, ASCO Annual Meeting, 2025 About sac-TMT (佳泰莱®)Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan). To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the CDE, and were included in the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab2 or other agents for several types of cancer. These studies are sponsored and led by MSD. About Tagitanlimab (科泰莱®)Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively. About Kelun-BiotechKelun-Biotech ( is a holding subsidiary of Kelun Pharmaceutical ( which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit Media: klbio_pr@
Yahoo
11-06-2025
- Business
- Yahoo
Kelun-Biotech Announces Breakthrough Therapy Designation Granted for Sacituzumab Tirumotecan (Sac-TMT) in Combination With Tagitanlimab in China for Certain Types of Non-Small Cell Lung Cancer
CHENGDU, China, June 10, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") today announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) (佳泰莱®) in combination with the PD-L1 monoclonal antibody tagitanlimab (科泰莱®) was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. Breakthrough Therapy Designation is granted for treatment options that demonstrate significant clinical advantages over currently available treatments and is aimed at expediting the research, development and marketing of innovative treatment options that address clinically urgent medical needs. This designation is based on the efficacy and safety data from the non-squamous cohort of the Phase II OptiTROP-Lung01 study. This marks the fifth Breakthrough Therapy Designation granted to sac-TMT by the NMPA. Sac-TMT has previously received this designation for: Locally advanced or metastatic triple-negative breast cancer (TNBC) in July 2022; EGFR-mutant, locally advanced or metastatic NSCLC after progression on EGFR-TKI therapy in January 2023; Locally advanced or metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) in patients who have previously received at least two lines of systemic chemotherapy in June 2023； First-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC in March 2024. Results from a Phase 2 OptiTROP-Lung01 study of sac-TMT in combination with tagitanlimab in first-line advanced or metastatic non-squamous NSCLC patients were presented in a poster session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting[1]. Dr. Michael Ge, CEO of Kelun-Biotech said, "This designation by the NMPA highlights the importance of developing novel therapeutic options for diverse NSCLC subtypes. Sac-TMT in combination with tagitanlimab demonstrated clinically meaningful outcomes in key endpoints for patients with non-squamous NSCLC without actionable genomic alterations as a first-line treatment. We are excited about the therapeutic potential of TROP2 ADC- immunotherapy combinations, and we look forward to working with regulatory authorities in China to bring this combination therapy to patients in need as soon as possible." [1] Abstract #8529: Lung Cancer – Non-Small Cell Metastatic, ASCO Annual Meeting, 2025 About sac-TMT (佳泰莱®)Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan). To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the CDE, and were included in the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab2 or other agents for several types of cancer. These studies are sponsored and led by MSD. About Tagitanlimab (科泰莱®)Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively. About Kelun-BiotechKelun-Biotech ( is a holding subsidiary of Kelun Pharmaceutical ( which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit Media: klbio_pr@ View original content to download multimedia: SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Iraqi News
03-06-2025
- Health
- Iraqi News
Combination therapy extends survival in advanced skin cancer, trial finds
In patients with an advanced type of skin cancer called cutaneous squamous cell carcinoma (cSCC), those who received the combination of the immunotherapy drug avelumab and targeted agent cetuximab had almost four times longer median progression-free survival compared to patients who received avelumab alone, according to the results of a phase 2 trial presented today at the American Society of Clinical Oncology (ASCO) meeting and concurrently published in the Journal of Clinical Oncology. "It is both an honor and humbling to develop clinical trials that can be potential options for our patients," said lead author and study chair for the trial, Dan Zandberg, M.D., associate professor of medicine at the University of Pittsburgh and medical oncology co-leader of the head and neck cancer program at UPMC Hillman Cancer Center. "My hope is that the insights we made with this trial will lead to additional studies that can ultimately bring a new immunotherapy-based combination into standard of care for patients with advanced cSCC." cSCC is a common type of skin cancer with about 1.8 million cases diagnosed in the U.S. each year. About 95% of cSCCs are detected early and can be treated with minor surgery. But in rare cases, patients will go on to develop advanced cSCC, which includes locally advanced tumors that cannot be surgically removed and metastatic disease. At this point, the prognosis is poor and treatment is focused on extending survival, not cure. Zandberg developed the Alliance A091802 (NCT03944941) phase 2 trial in collaboration with the Alliance for Clinical Trials in Oncology through the National Cancer Institute's (NCI) National Clinical Trials Network. This trial, which was open nationwide, included 57 patients with advanced cSCC. UPMC Hillman was the leading site for patient recruitment, with some of those patients recruited and treated at its network of more than 70 community cancer centers. Twenty-nine patients received avelumab and cetuximab and 28 received avelumab alone. Because the trial had a crossover design, nine patients in the avelumab group whose cancer progressed switched to the combination group. Avelumab is an immune checkpoint inhibitor drug that targets a protein found on cancer cells called PD-L1. When PD-L1 binds to a receptor on T cells called PD-1, it acts like a brake, slowing down the cancer-killing activity of T cells. Avelumab and other anti-PD-1/PD-L1 therapies release those brakes. Cetuximab is a monoclonal antibody that targets EGFR (epidermal growth factor receptor), a protein that plays a critical role in tumor cell growth, proliferation and survival and which is often found in high levels on cSCC cells. It activates natural killer cells, which help fight tumors, and can also activate dendritic cells, which can then stimulate T cells. Previous research done at UPMC Hillman by Robert Ferris, M.D., Ph.D. and his lab helped reveal cetuximab's effect on the immune system. "The rationale for the combination is that avelumab and other anti-PD-1/PD-L1 therapies have been shown to take the foot off the brake of the immune system, while cetuximab is pressing on the gas pedal—trying to work together to make the immune system go faster and attack the tumor," said Zandberg. "What's exciting is that in this trial the efficacy of the combination suggests that the two drugs were synergistic, rather than just additive." The study showed that the primary endpoint of progression-free survival was significantly higher in patients who received avelumab plus cetuximab with a median of 11 months compared to just 3 months in patients who received avelumab alone. Even though avelumab and cetuximab led to an almost quadrupling of median progression-free survival compared to avelumab alone, the trial does not support this combination as a standard treatment for patients. That's because since the trial was launched, two other anti-PD-1/PD-L1 therapies—cemiplimab and pembrolizumab—have been approved and had higher efficacy than avelumab in trials in patients with cSCC. However, the trial represents the first completed prospective randomized comparison of cetuximab plus blockade of the PD-1/PD-L1 pathway versus blockade of that pathway alone in cSCC or head and neck cancer, where this combination has also shown promise. The trial provides valuable information for future trials. "These findings highlight the potential benefits of combining cetuximab with an anti-PD-1/PD-L1 therapy and points to the importance of additional clinical trials combining either standard of care pembrolizumab or cemiplimab with cetuximab as a potential way to improve patient outcomes in advanced cSCC," said Zandberg. Notably, patients in the crossover arm had a similar progression-free survival to those who received the combination from the start. Currently, if a patient fails immunotherapy with pembrolizumab or cemiplimab, they switch to cetuximab or chemotherapy. But this trial suggests that continuing immunotherapy and adding cetuximab could be more beneficial.
Yahoo
02-06-2025
- Business
- Yahoo
BioNTech Gains 20% On $11.1 Billion Bristol Deal
BioNTech (NASDAQ:BNTX) surged 20% after Bristol Myers Squibb (NYSE:BMY) agreed to license its bispecific antibody BNT327targeting PD-L1 and VEGF-Afor solid tumors in a deal worth up to $11.1 billion. Under the agreement, BMY will pay a $1.5 billion upfront fee and $2 billion in guaranteed payments through 2028, with BioNTech eligible for up to $7.6 billion in milestones. Both companies will fund development and manufacturing costs equally and split global profits or losses. BNT327 is currently in a Phase 3 trial as a first-line treatment for extensive-stage small-cell and non-small-cell lung cancers, and a Phase 3 study in triple-negative breast cancer will launch by year-end. BMY and BNTX retain rights to pursue additional indications and combination regimens. Warning! GuruFocus has detected 2 Warning Signs with BNTX. Street analysts applauded the collaboration. BMO Capital Markets' Evan David Seigerman noted that Bristol gains a next-generation molecule to potentially replace Opdivo, while BioNTech taps Bristol's global distribution and oncology development expertise. Raymond James' Sean McCutcheon added that the move shores up Bristol's mid- to long-term growth pipeline ahead of an anticipated Opdivo revenue gap post-2028. Investors should care because this partnership accelerates BNT327's path to market with a Tier 1 oncology partner, de-risks late-stage development, and provides BioNTech with substantial non-dilutive capitalwhile Bristol secures a promising immunotherapy to bolster its portfolio. With the first $1.5 billion payment already recognized, markets will focus on upcoming BNT327 Phase 3 readouts and any future milestone announcements that unlock the remaining $7.6 billion. This article first appeared on GuruFocus.
