Blocking the motion of a key protein frees oxygen to injury iron-dependent proteins in lung and breast cancer cells, slowing their enlargement and making them more straightforward to kill.
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Merck took a dominant position in frontline lung cancer with the approval of a combination of Keytruda and chemo. And it isn’t just waiting around to see if any combination of a PD-(L)1 with a CTLA4 can come along and knock it off its market-leading perch.
Chiatai Tianqing Pharmaceutical Group Co., Ltd. is conducting a randomized, controlled, double-blind, dual-simulation, multi-center, Phase III clinical study to evaluate D1553 versus docetaxel in the treatment of locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation-positive lung cancer that has failed prior standard therapy (D1553-III-01). “. Now recruiting nationwide. Trial Drug Profile D-1553 tablets are a novel targeted KRAS G12C mutation inhibitor, registered and classified as a chemical drug class 1. On December 29, 2023, China’s National Drug Administration (NMPA) has accepted the New Drug Marketing Application for D-1553 Tablets for the treatment of locally advanced or metastatic non-small cell lung cancer with disease progression or intolerable disease after prior first-line systemic therapy and with the presence of KRAS G12C mutation confirmed by testing. In August 2023, Chiatai Tianqing entered into a license and collaboration agreement with Yifang Bio to obtain the exclusive license rights for the ...
Small cell lung cancer (SCLC) is a highly aggressive type of cancer known for its ability to metastasize. The behavior of tumors is largely governed by which genes are turned on, or transcribed, irrespective of whether mutations are present. Researchers have identified various signature patterns of gene activation in SCLC, and these subtypes dictate how the cancer responds to treatments and its specific vulnerabilities. There is a significant need for blood-based tests that can determine SCLC subtypes, track disease progression, recognize transformations into other types of lung cancer, and identify potential treatment targets, especially when standard biopsies are not feasible. Scientists have now made progress towards a liquid biopsy capable of distinguishing between multiple SCLC subtypes from blood samples. New research at Fred Hutch Cancer Center (Seattle, WA, USA) has revealed that big-picture patterns of DNA packaging, gene activation, and mutations may provide the information required to develop a blood-based ...
Though a recent Phase III trial failed to achieve its primary endpoint with Imfinzi (durvalumab) in a specific subset of non-small cell lung cancer (NSCLC), AstraZeneca has announced that another Phase III study evaluating the checkpoint inhibitor has demonstrated a survival benefit in patients with limited-state small cell lung cancer (LS-SCLC). As per the 5 April press release, Imfinzi monotherapy demonstrated statistically and clinically meaningful improvements across the study’s primary endpoints of overall survival (OS) and progression-free survival (PFS). Additionally, the safety profile of the Imfinzi remained consistent with previous findings. The randomised, double-blind, placebo-controlled Phase III ADRIATIC study (NCT03703297) is actively evaluating Imfinzi as both a monotherapy and as a combination therapy with AstraZeneca’s Imjudo (tremelimumab) for the treatment of patients with LS-SCLC who have not progressed following concurrent chemoradiotherapy (cCRT). The study enrolled a total of 730 patients who were randomly assigned to receive placebo or 1500mg Imfinzi, ...
Don Tracy, Associate Editor Despite not having a positive outcome, safety profiles for Keytruda and Lynparza were consistent with previous findings. Merck revealed that its Phase III KEYLYNK-006 clinical trial, which tested a combination of Keytruda and Lynparza for the treatment of a subset of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), failed to meet the primary endpoint of improving overall survival (OS) and progression-free survival (PFS). According to the company, its trial compared Keytruda combined with chemotherapy with an additional round of Keytruda plus Lynparza vs. Keytruda with chemotherapy followed by maintenance chemotherapy. However, the safety profiles for both treatments were reported to be consistent with previous findings. Moving forward, Merck said that it plans on continuing to analyze data to share at a later date.1 “As lung cancer continues to be the leading cause of cancer death worldwide, we are committed to exploring Keytruda-based combinations and ...
Lung cancer is the leading cause of cancer-related deaths globally, with non-small cell lung cancers making up the majority of cases, which are often linked to smoking. When detected early, these cancers are usually confined to the lung, making surgery the preferred initial treatment. However, about 30% of these early-stage patients see their cancer advance to more critical areas, like the lymph nodes and organs, frequently affecting the brain first. This progression necessitates additional treatments such as chemotherapy, targeted drugs, radiation, or immunotherapy. Unfortunately, despite 70% of patients not developing brain metastasis, doctors have lacked the means to predict whose cancer will progress and often opt for aggressive treatments as a precautionary measure. Now, a new study offers hope in improving the approach to treating early-stage lung cancer by achieving the correct balance between proactive intervention and cautious monitoring. In the study, scientists at Washington University School of Medicine in ...
AstraZeneca’s (AZ) Tagrisso (osimertinib) has been approved by the US Food and Drug Administration (FDA) in combination with chemotherapy to treat a subset of advanced lung cancer patients. The epidermal growth factor receptor-mutated (EGFR)-tyrosine kinase inhibitor has specifically been authorised for use alongside chemotherapy in adults with locally advanced or metastatic EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). An estimated 200,000 people in the US are diagnosed with lung cancer each year and NSCLC accounts for up to 85% of all lung cancer cases. Approximately 15% of NSCLC patients in the US have an EGFRm, with this population “particularly sensitive” to treatment with an EGFR-tyrosine kinase inhibitor that blocks the cell-signalling pathways that drive the growth of tumour cells, AZ said. The FDA’s decision was supported by positive results from the late-stage FLAURA2 trial, which randomised more than 500 patients with locally advanced or metastatic EGFRm NSCLC to receive the ...
Pharmaceutical Executive Editorial Staff Phase III trial to investigate novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer. Image credit: Axel Kock | stock.adobe.com Merck and Moderna, Inc., have announced plans to launch the pivotal Phase III INTerpath-002 (NCT06077760) clinical trial of the novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC). V940 is comprised of synthetic mRNA coding for up to 34 neoantigens that are designed and produced based on the unique mutational signature of a patient’s tumor. After administration of the drug, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation. “As lung cancer is the leading cause ...
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